Name (Synonyms) | Correlation | |
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drug5 | 0.25% albumin placebo solution with rHuPH20 Wiki | 1.00 |
drug1033 | HYQVIA Wiki | 1.00 |
Name (Synonyms) | Correlation | |
---|---|---|
D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating NIH | 1.00 |
D011129 | Polyradiculoneuropathy NIH | 1.00 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
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.
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 5Description: 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 9Description: 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 13Description: 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 15Description: 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 19Description: 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 23Description: 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/ETDescription: 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 BaselineDescription: 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 5Description: 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 8Description: 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 11Description: 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 14Description: 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 17Description: 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 20Description: 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 23Description: 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/ETDescription: 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 BaselineDescription: 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 5Description: 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 8Description: 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 12Description: 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 16Description: 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 20Description: 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 24Description: 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/ETDescription: 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/ETDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 infusionDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 infusionDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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