Covid 19 Research using Clinical Trials (Home Page)
Placebo to match filgotinibWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug940 | Filgotinib Wiki | 1.00 |
| drug1856 | Placebo to match adalimumab Wiki | 1.00 |
| drug123 | Adalimumab Wiki | 1.00 |
| drug472 | COVID-19 convalescent plasma Wiki | 0.50 |
There is one clinical trial.
Clinical Trials
1 A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE).
NCT04115748 Psoriatic Arthritis Drug: Filgotinib Drug: Adalimumab Drug: Placebo to match filgotinib Drug: Placebo to match adalimumab MeSH:Arthritis Arthritis, Psoriatic
HPO:Arthritis Polyarticular arthritis
Primary Outcomes
Description: ACR20 is calculated as an at least 20% improvement from baseline in both tender and swollen joint counts and an at least 20% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire - disability index (HAQ-DI) and an acute-phase reactant high sensitivity C-reactive protein (hsCRP).
Measure: Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 Time: Week 12
Secondary Outcomes
Description: PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS covers the physician's global assessment of disease activity and participant's global assessment of disease activity, the Short-Form Health Survey (SF-36) Physical Component Score (PCS), swollen and tender joint counts, enthesitis and dactylitis, as well as hsCRP. A lower score indicates better function.
Measure: Change from Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Time: Baseline; Weeks 4, 16
Description: Minimal disease activity will be determined by tender and swollen joint counts, PASI or body surface area (BSA), participant's assessment of pain, participant's global assessment of disease activity, HAQ-DI, and SPARCC Enthesitis Index.
Measure: Percentage of Participants who Achieved Minimal Disease Activity (MDA) Response Time: Weeks 4, 8, 12, 16
Description: VLDA will be determined by tender and swollen joint counts, PASI or BSA, participant's assessment of pain, participant's global assessment of disease activity, HAQ-DI, and SPARCC Enthesitis Index.
Measure: Percentage of Participants who Achieved Very Low Disease Activity (VLDA) Response Time: Weeks 4, 8, 12, 16
Description: DAPSA is a psoriatic arthritis disease activity measure, calculated by summing swollen and tender joint counts, participant's assessment of pain, participant's global assessment of disease activity, and hsCRP.
Measure: Change from Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: The physician's global assessment of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician, using a 6-point scale, which ranges from 0 (cleared) to 5 (severe).
Measure: Change from Baseline in Physician's Global Assessment of Psoriasis (PhGAP) in Participants with Psoriasis Covering ≥ 3% of the BSA at Baseline Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Measure: Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) in Participants with Psoriatic Nail Involvement at Baseline Time: Baseline; Weeks 4, 8, 12, 16
Description: Enthesitis will be assessed using LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Measure: Change from Baseline in Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16
Description: The PsAID questionnaire assesses the impact of PsA on people's lives. It is a 12-item questionnaire, where each item will be scored between 0 and 10. All items are prioritized according to importance of the health domain it represents. A higher score on the PsAID indicates more impact of the disease.
Measure: Change from Baseline in 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) Time: Baseline; Weeks 4, 16
Description: PASDAS LDA is defined as PASDAS ≤ 3.2.
Measure: Percentage of Participants with Psoriatic Arthritis Disease Activity Score (PASDAS) Low Disease Activity (LDA) Time: Baseline; Weeks 4, 16
Description: PASDAS remission is defined as PASDAS ≤ 1.9.
Measure: Percentage of Participants who Achieve PASDAS Remission Time: Baseline; Weeks 4, 16
Description: ACR20 is calculated as an at least 20% improvement from baseline in both tender and swollen joint counts and an at least 20% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI and an acute-phase reactant hsCRP.
Measure: Percentage of Participants who Achieve an American College of Rheumatology 20% Improvement Response Time: Baseline; Weeks 2, 4, 8, 16
Description: ACR50 is calculated as an at least 50% improvement from baseline in both tender and swollen joint counts and an at least 50% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI, and an acute-phase reactant hsCRP.
Measure: Percentage of Participants who Achieve an American College of Rheumatology 50% Improvement Response Time: Weeks 2, 4, 8, 12, 16
Description: ACR70 is calculated as an at least 70% improvement from baseline in both tender and swollen joint counts and an at least 70% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant'ss assessment of pain, HAQ-DI and an acute-phase reactant (high sensitivity C-reactive protein [hsCRP]).
Measure: Percentage of Participants who Achieve an American College of Rheumatology 70% Improvement Response Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: Components of ACR include tender and swollen joint counts, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI and hsCRP.
Measure: Change from Baseline in Individual Components of the American College of Rheumatology Response Criteria Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity and hsCRP. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Measure: Change from Baseline in Participants who Achieve Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: DAS28(CRP) LDA is defined as DAS28(CRP) ≤ 3.2.
Measure: Percentage of Participants who Achieve DAS28(CRP) LDA Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: DAS28(CRP) remission is defined as DAS28(CRP) < 2.6.
Measure: Percentage of Participants who Achieve DAS28(CRP) Remission Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: Time to achieve DAS28(CRP) LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAS28(CRP) LDA, or censored if a participant does not achieve DAS28(CRP) LDA or missing.
Measure: Time to Achieve DAS28(CRP) LDA Time: First dose date up to 16 weeks
Description: DAPSA LDA is defined as DAPSA ≤ 14.
Measure: Percentage of Participants who Achieve DAPSA LDA Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: DAPSA remission is defined as DAPSA ≤ 4.
Measure: Percentage of Participants who Achieve DAPSA Remission Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: Time to achieve DAPSA LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAPSA LDA, or censored if a participant does not achieve DAPSA LDA or missing.
Measure: Time to Achieve DAPSA LDA Time: First dose date up to 16 weeks
Description: PsARC consists of four components: assessment of joint tenderness and swelling utilizing 68/66 joint counts respectively, participant's global assessment of disease activity, and physician's global assessment of disease activity.
Measure: Percentage of Participants who Achieve Psoriatic Arthritis Response Criteria (PsARC) Response Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: PASI will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Measure: Change from Baseline in Psoriasis Area and Severity Index (PASI) in Participants with Psoriasis Covering ≥ 3% of the BSA at Baseline Time: Baseline; Weeks 4, 8, 12, 16
Description: The PASI50 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI50 response represents at least a 50% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 50% Improvement (PASI50) Response Time: Weeks 4, 8, 12, 16
Description: The PASI75 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI75 response represents at least a 75% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 75% Improvement (PASI75) Response with Psoriasis Covering ≥ 3% of the Body Surface Area Time: Weeks 4, 8, 12, 16
Description: The PASI90 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI90 response represents at least a 90% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 90% Improvement (PASI90) Response Time: Weeks 4, 8, 12, 16
Description: The PASI100 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI100 response represents a 100% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 100% Improvement (PASI100) Response Time: Weeks 4, 8, 12, 16
Description: The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. Tenderness is quantified as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.
Measure: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16
Description: LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [no tenderness] to 3 [tender and withdrawn]. A higher LDI indicates worse dactylitis.
Measure: Change from Baseline in Leeds Dactylitis Index (LDI) in Participants with Dactylitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16
Description: TDC will be assessed in participants with dactylitis at Baseline. TDC is a simple count based on the presence or absence of tender joints.
Measure: Change from Baseline in Tender Dactylitis Count (TDC) Time: Baseline; Weeks 4, 8, 12, 16
Description: HAQ-DI is used to monitor the participant's self-assessed physical function or disability. This 20 -question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 function areas (getting dressed, arising, eating, walking, hygiene, reaching, gripping, and activities). HAQ-DI total score ranges from 0 to 3, with higher scores indicating greater dysfunction.
Measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Time: Baseline; Weeks 2, 4, 8, 12, 16
Description: FACIT-Fatigue is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). FACIT-Fatigue total score ranges 0 to 52. Higher scores represent better fatigue status.
Measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Time: Baseline; Weeks 4, 16
Description: Composite endpoint of change from baseline in MCS and PCS scores in SF-36 Version 2. The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain will be scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Measure: Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes SF-36 Version 2 Time: Baseline; Weeks 4, 16
Related HPO nodes (Using clinical trials)
HP:0001369: Arthritis
Genes 263
CCN6 IL2RA NFKBIL1 LBR SPTB BLNK TRAPPC2 EPB42 MVK CD79A IL36RN COMP STAT3 IL2RB TGFB3 MEFV IL12A-AS1 CASP10 MLX MMP13 SLCO2A1 COL2A1 COL2A1 ASAH1 IGHM COL2A1 APOE HNF4A COL2A1 ADA2 PTPN22 MMP14 NOD2 CD247 BTK SCARB2 COL2A1 GLA UMOD CCR1 COL11A2 LRBA CCR6 COMP EXT1 IL6 RREB1 KLRC4 COL11A1 PTPN22 PSTPIP1 HNF1B SAMHD1 HLA-C COL11A2 LRP6 GPR101 COL2A1 RAG1 KIF7 DCLRE1C NOD2 CTLA4 NLRP3 HPRT1 ABCG8 HGD MMP13 HLA-DRB1 NLRP3 SH3KBP1 SLC37A4 TF CCN6 ZNF687 GJB2 IL2RA PFKM AIP FASLG TREX1 HLA-B MATN3 ASPN TNFRSF1A C4A COL2A1 MYH14 UBAC2 FAS ARVCF ACP5 EXT2 PRG4 AEBP1 MTHFD1 ANKRD55 PTPN22 TFR2 GCH1 GJB6 COL9A1 COL11A2 PTPN22 SPP1 RNASEH2B TRAPPC2 OCRL TREX1 LRRC8A GBA COL1A1 LMX1B ACAN GP1BB TLR4 ANK1 COMP UFD1 SLC12A3 NLRP3 FAS HGD IL12A SEC61A1 PHEX COPA HPGD IRF5 FCGR2B TRPV4 PSMB9 WIPF1 CTLA4 CAV1 MVK HLA-DRB1 ATP7B MUC1 COL9A1 ACAN ATP7B EPCAM DNASE1L3 CLCNKB LMNA MMP2 IL10 IL12B RASGRP1 PTPN2 COMT COL2A1 STAT4 SLC37A4 GNAS MIF HLA-DRB1 WAS STAT4 RNF168 CLCN7 JMJD1C IL23R MEFV G6PC CFI ERAP1 F8 PSTPIP1 GHR HLA-B HIRA PRPS1 ADAR DNAJB11 MEFV PTPN2 IL10 ANKH IFIH1 STAT4 COL5A1 FRZB HPGD KIF22 TBX1 CIITA CD79B IGLL1 IRAK1 IL2RB MATN3 COL9A2 COL9A3 TNFRSF11B COMP HLA-B STAT4 PADI4 MATN3 HJV COL2A1 SMAD3 F9 TRPS1 UFSP2 RAG2 COL1A1 MEFV COL5A1 ANKRD55 SLC40A1 SLC4A1 SPTA1 FBN1 BTK RNASEH2C DNASE1 CANT1 TBX1 PHEX CD247 TCF3 PSMB4 PIK3R1 AGA CD244 COL5A2 LEMD3 FGFR3 RNASEH2A ACAN HPRT1 ANKH SEC24C GDF5 SLC22A4 UMOD HPRT1 TRPV4 HPGD BTK FAS COL9A3 UFSP2 ZMPSTE24 PTPN22 LACC1 HPRT1 NLRP3 HNF1B HOXD10 PRKCD SLC26A2 COL9A2 SMAD3 FCGR2A CCN2 CLCN7 COL3A1 ASAH1 NLRP12
Primary Outcomes
Description: ACR20 is calculated as an at least 20% improvement from baseline in both tender and swollen joint counts and an at least 20% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire - disability index (HAQ-DI) and an acute-phase reactant high sensitivity C-reactive protein (hsCRP).
Measure: Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement Response at Week 12 Time: Week 12Secondary Outcomes
Description: PASDAS is a composite disease activity measure for psoriatic arthritis. The PASDAS covers the physician's global assessment of disease activity and participant's global assessment of disease activity, the Short-Form Health Survey (SF-36) Physical Component Score (PCS), swollen and tender joint counts, enthesitis and dactylitis, as well as hsCRP. A lower score indicates better function.
Measure: Change from Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Time: Baseline; Weeks 4, 16Description: Minimal disease activity will be determined by tender and swollen joint counts, PASI or body surface area (BSA), participant's assessment of pain, participant's global assessment of disease activity, HAQ-DI, and SPARCC Enthesitis Index.
Measure: Percentage of Participants who Achieved Minimal Disease Activity (MDA) Response Time: Weeks 4, 8, 12, 16Description: VLDA will be determined by tender and swollen joint counts, PASI or BSA, participant's assessment of pain, participant's global assessment of disease activity, HAQ-DI, and SPARCC Enthesitis Index.
Measure: Percentage of Participants who Achieved Very Low Disease Activity (VLDA) Response Time: Weeks 4, 8, 12, 16Description: DAPSA is a psoriatic arthritis disease activity measure, calculated by summing swollen and tender joint counts, participant's assessment of pain, participant's global assessment of disease activity, and hsCRP.
Measure: Change from Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Time: Baseline; Weeks 2, 4, 8, 12, 16Description: The physician's global assessment of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician, using a 6-point scale, which ranges from 0 (cleared) to 5 (severe).
Measure: Change from Baseline in Physician's Global Assessment of Psoriasis (PhGAP) in Participants with Psoriasis Covering ≥ 3% of the BSA at Baseline Time: Baseline; Weeks 2, 4, 8, 12, 16Description: Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Measure: Change from Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) in Participants with Psoriatic Nail Involvement at Baseline Time: Baseline; Weeks 4, 8, 12, 16Description: Enthesitis will be assessed using LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Measure: Change from Baseline in Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16Description: The PsAID questionnaire assesses the impact of PsA on people's lives. It is a 12-item questionnaire, where each item will be scored between 0 and 10. All items are prioritized according to importance of the health domain it represents. A higher score on the PsAID indicates more impact of the disease.
Measure: Change from Baseline in 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) Time: Baseline; Weeks 4, 16Description: PASDAS LDA is defined as PASDAS ≤ 3.2.
Measure: Percentage of Participants with Psoriatic Arthritis Disease Activity Score (PASDAS) Low Disease Activity (LDA) Time: Baseline; Weeks 4, 16Description: PASDAS remission is defined as PASDAS ≤ 1.9.
Measure: Percentage of Participants who Achieve PASDAS Remission Time: Baseline; Weeks 4, 16Description: ACR20 is calculated as an at least 20% improvement from baseline in both tender and swollen joint counts and an at least 20% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI and an acute-phase reactant hsCRP.
Measure: Percentage of Participants who Achieve an American College of Rheumatology 20% Improvement Response Time: Baseline; Weeks 2, 4, 8, 16Description: ACR50 is calculated as an at least 50% improvement from baseline in both tender and swollen joint counts and an at least 50% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI, and an acute-phase reactant hsCRP.
Measure: Percentage of Participants who Achieve an American College of Rheumatology 50% Improvement Response Time: Weeks 2, 4, 8, 12, 16Description: ACR70 is calculated as an at least 70% improvement from baseline in both tender and swollen joint counts and an at least 70% improvement in at least 3 of the following 5 measures: participant's global assessment of disease activity, physician's global assessment of disease activity, participant'ss assessment of pain, HAQ-DI and an acute-phase reactant (high sensitivity C-reactive protein [hsCRP]).
Measure: Percentage of Participants who Achieve an American College of Rheumatology 70% Improvement Response Time: Baseline; Weeks 2, 4, 8, 12, 16Description: Components of ACR include tender and swollen joint counts, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's assessment of pain, HAQ-DI and hsCRP.
Measure: Change from Baseline in Individual Components of the American College of Rheumatology Response Criteria Time: Baseline; Weeks 2, 4, 8, 12, 16Description: DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity and hsCRP. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Measure: Change from Baseline in Participants who Achieve Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) Time: Baseline; Weeks 2, 4, 8, 12, 16Description: DAS28(CRP) LDA is defined as DAS28(CRP) ≤ 3.2.
Measure: Percentage of Participants who Achieve DAS28(CRP) LDA Time: Baseline; Weeks 2, 4, 8, 12, 16Description: DAS28(CRP) remission is defined as DAS28(CRP) < 2.6.
Measure: Percentage of Participants who Achieve DAS28(CRP) Remission Time: Baseline; Weeks 2, 4, 8, 12, 16Description: Time to achieve DAS28(CRP) LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAS28(CRP) LDA, or censored if a participant does not achieve DAS28(CRP) LDA or missing.
Measure: Time to Achieve DAS28(CRP) LDA Time: First dose date up to 16 weeksDescription: DAPSA LDA is defined as DAPSA ≤ 14.
Measure: Percentage of Participants who Achieve DAPSA LDA Time: Baseline; Weeks 2, 4, 8, 12, 16Description: DAPSA remission is defined as DAPSA ≤ 4.
Measure: Percentage of Participants who Achieve DAPSA Remission Time: Baseline; Weeks 2, 4, 8, 12, 16Description: Time to achieve DAPSA LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAPSA LDA, or censored if a participant does not achieve DAPSA LDA or missing.
Measure: Time to Achieve DAPSA LDA Time: First dose date up to 16 weeksDescription: PsARC consists of four components: assessment of joint tenderness and swelling utilizing 68/66 joint counts respectively, participant's global assessment of disease activity, and physician's global assessment of disease activity.
Measure: Percentage of Participants who Achieve Psoriatic Arthritis Response Criteria (PsARC) Response Time: Baseline; Weeks 2, 4, 8, 12, 16Description: PASI will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Measure: Change from Baseline in Psoriasis Area and Severity Index (PASI) in Participants with Psoriasis Covering ≥ 3% of the BSA at Baseline Time: Baseline; Weeks 4, 8, 12, 16Description: The PASI50 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI50 response represents at least a 50% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 50% Improvement (PASI50) Response Time: Weeks 4, 8, 12, 16Description: The PASI75 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI75 response represents at least a 75% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 75% Improvement (PASI75) Response with Psoriasis Covering ≥ 3% of the Body Surface Area Time: Weeks 4, 8, 12, 16Description: The PASI90 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI90 response represents at least a 90% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 90% Improvement (PASI90) Response Time: Weeks 4, 8, 12, 16Description: The PASI100 will be assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. A PASI100 response represents a 100% improvement from baseline in the PASI score.
Measure: Percentage of Participants who Achieve Psoriasis Area and Severity Index 100% Improvement (PASI100) Response Time: Weeks 4, 8, 12, 16Description: The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. Tenderness is quantified as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.
Measure: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16Description: LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [no tenderness] to 3 [tender and withdrawn]. A higher LDI indicates worse dactylitis.
Measure: Change from Baseline in Leeds Dactylitis Index (LDI) in Participants with Dactylitis at Baseline Time: Baseline; Weeks 4, 8, 12, 16Description: TDC will be assessed in participants with dactylitis at Baseline. TDC is a simple count based on the presence or absence of tender joints.
Measure: Change from Baseline in Tender Dactylitis Count (TDC) Time: Baseline; Weeks 4, 8, 12, 16Description: HAQ-DI is used to monitor the participant's self-assessed physical function or disability. This 20 -question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 function areas (getting dressed, arising, eating, walking, hygiene, reaching, gripping, and activities). HAQ-DI total score ranges from 0 to 3, with higher scores indicating greater dysfunction.
Measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Time: Baseline; Weeks 2, 4, 8, 12, 16Description: FACIT-Fatigue is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). FACIT-Fatigue total score ranges 0 to 52. Higher scores represent better fatigue status.
Measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Time: Baseline; Weeks 4, 16Description: Composite endpoint of change from baseline in MCS and PCS scores in SF-36 Version 2. The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain will be scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Measure: Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes SF-36 Version 2 Time: Baseline; Weeks 4, 16