Phase 3
Completed N=559
A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT02019472 ↗
Enrolled (actual)
559
Serious AEs
12.0%
Results posted
Sep 2017
Primary outcomePrimary: Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24 — 6.89; 6.90; 6.91; -2.19 units on a scale — p=< 0.001
◆ Published Evidence
Established
28citations · ~4 / year
Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naïve patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study.
Summary
The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate.
Linked Publications
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Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naïve patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24 |
6.89; 6.90; 6.91; -2.19; -2.58; -2.96 | < 0.001 sig |
| PRIMARY Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24 |
31.7; 26.9; 35.3 | 0.306 |
| SECONDARY Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24 |
7.5; 12.9; 20.3 | 0.086 |
| SECONDARY Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24 |
56.5; 53.8; 58.8 | 0.603 |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening
- Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline
- Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or an inadequate responder to methotrexate
- Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent
- C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening
Exclusion Criteria
- Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept
- Has ever used tofacitinib therapy or any other JAK inhibitor
- Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration
- Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable
Data sourced from ClinicalTrials.gov (NCT02019472) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.