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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug5 0.25% albumin placebo solution with rHuPH20 Wiki 1.00
drug1033 HYQVIA Wiki 1.00

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D020277 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating NIH 1.00
D011129 Polyradiculoneuropathy NIH 1.00

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

This is a Phase III, prospective, multicenter study with two study parts (epochs) to evaluate the efficacy, safety, and tolerability of HYQVIA/HyQvia (IGI, 10% with recombinant human hyaluronidase (rHuPH20) administered subcutaneously) for maintenance therapy to prevent relapse (Epoch 1) and GAMMAGARD LIQUID/KIOVIG (immunoglobulin G intravenous (IGIV) 10% administered intravenously) for the treatment of CIDP (Epoch 2). This study will enroll adult subjects with a confirmed diagnosis of CIDP and who have remained on a stable dosing regimen (monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval of 2 to 6 weeks) of IGIV therapy for at least 3 months prior to screening. In this double-blind, placebo-controlled phase of the study (Epoch 1), eligible subjects will be randomized in a 1:1 ratio to receive either HYQVIA/HyQvia or 0.25% albumin placebo solution with rHuPH20 every two, three, or four weeks in a double-blind fashion for a period of 6 months or until relapse. Subjects who relapse during Epoch 1 will enter Epoch 2 to receive IGIV treatment for a period of 6 months.

NCT02549170 Chronic Inflammatory Demyelinating Polyradiculoneuropathy Biological: HYQVIA Biological: 0.25% albumin placebo solution with rHuPH20 Biological: IGIV
MeSH:Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Primary Outcomes

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of greater than or equal to (>=)1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Pre-SC Baseline Week 1

Time: Pre-SC Baseline (Week 1)

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 5

Time: Week 5

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 9

Time: Week 9

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 13

Time: Week 13

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 15

Time: Week 15

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 19

Time: Week 19

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 23

Time: Week 23

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 27 (End of Epoch 1 Treatment [EOE1T])/Unscheduled relapse visit assessment (UV)/Early Termination (ET)

Time: Week 27 (EOET1)/UV/ET

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Pre-SC Baseline

Time: Pre-SC Baseline

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 5

Time: Week 5

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 8

Time: Week 8

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 11

Time: Week 11

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 14

Time: Week 14

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 17

Time: Week 17

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 20

Time: Week 20

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 23

Time: Week 23

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 26 (EOE1T)/Unscheduled relapse visit assessment (UV)/Early Termination (ET)

Time: Week 26 (EOE1T)/UV/ET

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Pre-SC Baseline

Time: Pre-SC Baseline

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 5

Time: Week 5

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 8

Time: Week 8

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 12

Time: Week 12

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 16

Time: Week 16

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 20

Time: Week 20

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 24

Time: Week 24

Description: Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).

Measure: Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 28 (EOET1)/Unscheduled relapse visit assessment (UV)/Early Termination (ET)

Time: Week 28 (EOET1)/UV/ET

Description: Responder rate is defined as clinically meaningful improvement in functional ability defined as a decrease of >=1 point in the adjusted INCAT disability score at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.

Measure: Epoch 2: Responder Rate on Every 3 Weeks Dosing Regimen at Pre-Baseline (Week 1)

Time: Pre-IV Baseline (Week 1)

Description: Responder rate is defined as clinically meaningful improvement in functional ability defined as a decrease of >=1 point in the adjusted INCAT disability score at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.

Measure: Epoch 2: Responder Rate on Every 3 Weeks Dosing Regimen up to 6 Months (End of Epoch 2 Treatment [EOE2T])/Unscheduled visit assessment (UV)/Early Termination

Time: Up to 6 Months/UV/ET

Secondary Outcomes

Description: Time to relapse is defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse.

Measure: Epoch 1: Time to Relapse

Time: Throughout Epoch 1, up to 6 months

Description: The Rasch-Built Overall Disability Scale (R-ODS) is a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participant with immune-mediated peripheral neuropathies including chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.

Measure: Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS) Score

Time: Pre-subcutaneous (SC) treatment baseline, then weekly through Epoch 1 (up to 6 months); Unscheduled relapse visit assessment; & if early termination occurs.

Description: An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.

Measure: Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality

Time: Throughout Epoch 1, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.

Measure: Epoch 1: Number of Participants Experiencing Causally Related Serious And/or Non-Serious Adverse Events (SAEs And/or AEs)

Time: Throughout Epoch 1, up to 6 months

Description: An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.

Measure: Epoch 1: Number of Participants With Serious And/Or Non-serious Adverse Reactions (ARs) Plus Suspected ARs

Time: Throughout Epoch 1, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.

Measure: Epoch 1: Number of Infusions Associated with Treatment-emergent Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs), Regardless of Causality

Time: Throughout Epoch 1, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.

Measure: Epoch 1: Number of Infusions Associated with Causally Related Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs)

Time: Throughout Epoch 1, up to 6 months

Description: AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 1: Number of Infusions Temporally Associated with Adverse Events (AEs)

Time: During an infusion or within 72 hours after completion of an infusion

Description: An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.

Measure: Epoch 1: Number of Infusions Associated with Serious And/Or Non-serious Adverse Reactions (ARs) plus Suspected ARs

Time: Throughout Epoch 1, up to 6 months

Description: A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.

Measure: Epoch 1: Number of Infusions Associated with Treatment-emergent Systemic Adverse Events (AEs)

Time: Throughout Epoch 1, up to 6 months

Measure: Epoch 1: Number of Infusions Associated with Treatment-emergent Local Infusion Site Reactions

Time: Throughout Epoch 1, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 1: Number of Infusions for Which the Infusion Rate Was Reduced And/Or the Infusion Was Interrupted or Stopped Due to Intolerability And/Or Adverse Events (AEs)

Time: Throughout Epoch 1, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion

Time: Throughout Epoch 1, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events per Participant

Time: Throughout Epoch 1, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events per Participant-year

Time: Throughout Epoch 1, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion

Time: Throughout Epoch 1, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Participant

Time: Throughout Epoch 1, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events per Participant-year

Time: Throughout Epoch 1, up to 6 months

Description: An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.

Measure: Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Ars, Expressed as Number of Events per Infusion

Time: Throughout Epoch 1, up to 6 months

Description: An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.

Measure: Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events per Participant

Time: Throughout Epoch 1, up to 6 months

Description: An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.

Measure: Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events per Participant-Year

Time: Throughout Epoch 1, up to 6 months

Measure: Epoch 1: Number of Participants Who Develop Binding And/Or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)

Time: Throughout Epoch 1, up to 6 months

Measure: Epoch 2: Number of Participants Experiencing Any Treatment-emergent Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs), Regardless of Causality

Time: Throughout Epoch 2, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.

Measure: Epoch 2: Number of Participants Experiencing Causally Related Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs)

Time: Throughout Epoch 2, up to 6 months

Description: A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.

Measure: Epoch 2: Number of Participants with Serious And/Or Non-serious Adverse Reactions (ARs) plus Suspected ARs

Time: Throughout Epoch 2, up to 6 months

Description: A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.

Measure: Epoch 2: Number of Infusions Associated with Treatment-emergent Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs), Regardless of Causality

Time: Throughout Epoch 2, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.

Measure: Epoch 2: Number of Infusions Associated With Causally Related Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs)

Time: Throughout Epoch 2, up to 6 months

Description: AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 2: Number of Infusions Temporally Associated with Adverse Events (AEs)

Time: During an infusion or within 72 hours after completion of an infusion

Description: A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.

Measure: Epoch 2: Number of Infusions Associated with Serious And/Or Non-serious Adverse Reactions (ARs) plus Suspected ARs

Time: Throughout Epoch 2, up to 6 months

Description: A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.

Measure: Epoch 2: Number of Infusions Associated with Treatment-emergent Systemic Adverse Events (AEs)

Time: Throughout Epoch 2, up to 6 months

Measure: Epoch 2: Number of Infusions Associated with Treatment-emergent Local Infusion Site Reactions

Time: Throughout Epoch 2, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 2: Number of Infusions for Which the Infusion Rate Was Reduced And/Or the Infusion Was Interrupted or Stopped Due to Intolerability And/Or Adverse Events (AEs)

Time: Throughout Epoch 2, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion

Time: Throughout Epoch 2, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant

Time: Throughout Epoch 2, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant-year

Time: Throughout Epoch 2, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion

Time: Throughout Epoch 2, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant

Time: Throughout Epoch 2, up to 6 months

Description: An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.

Measure: Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-Year

Time: Throughout Epoch 2, up to 6 months

Description: An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.

Measure: Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Ars, Expressed as Number of Events Per Infusion

Time: Throughout Epoch 2, up to 6 months

Description: An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.

Measure: Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events Per Participant

Time: Throughout Epoch 2, up to 6 months

Description: An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.

Measure: Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events Per Participant-Year

Time: Throughout Epoch 2, up to 6 months

Description: Defined as one or more of the following: an increase of >=1 point relative to the pre-subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) scores; who experience chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) worsening (defined as a >=8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand); >=4 points decrease in Rasch-built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score (at the time of withdrawal from the SC treatment period).

Measure: Epoch 1: Proportion of Participants Who Experience a Worsening of Functional Disability

Time: Throughout Epoch 1, up to 6 months

Description: Defined as one or more of the following: a decrease of >=1 point in the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score at 2 consecutive time points; who experience chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) improvement (defined as ≥8 kilo Pascal (kPa) increase in hand grip strength in the more affected hand; >=4 points increase in Rasch-built Overall Disability Scale (R-ODS)) at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.

Measure: Epoch 2: Proportion of Participants With Clinically Meaningful Improvement in Functional Ability

Time: Throughout Epoch 2, up to 6 months


No related HPO nodes (Using clinical trials)