Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease
Summary
The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving but not fully responding to treatment with methotrexate (MTX). The primary objective of this study was to evaluate the efficacy of OKZ 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active RA inadequately controlled by MTX therapy. The secondary objective was to evaluate the efficacy of OKZ relative to adalimumab in subjects with moderately to severely active RA inadequately controlled by MTX therapy.
Timeline
- Start
- 2016-06-06
- Primary completion
- 2019-08-02
- Completion
- 2019-11-05
Outcome
Met primary endpoint
registry analysis (superiority test); Arm 1: Olokizumab q4w + Methotrexate vs Arm 4: Placebo q2w + Methotrexate; p <0.0001; Risk Difference (RD) 0.270 (97.5% CI 0.183 to 0.352); Chi-squared NCT02760407 ↗
registry analysis (superiority test); Arm 2: Olokizumab q2w + Methotrexate vs Arm 4: Placebo q2w + Methotrexate; p <0.0001; Risk Difference (RD) 0.258 (97.5% CI 0.171 to 0.341); Chi-squared NCT02760407 ↗
paper In patients with rheumatoid arthritis who were receiving maintenance methotrexate, olokizumab was superior to placebo and noninferior to adalimumab in producing an ACR20 response at 12 weeks. PMID 36001712 ↗
Publications
- Fleischmann RM, Strand V, Feist E, Lisitsyna T, Sparks JA, Nasonov E, Samsonov M, Grishin S, Egorova A, Kuzkina S, Smolen JS. Olokizumab Improves Patient-Reported Outcomes in Patients with Active Rheumatoid Arthritis up to 106 Weeks (Results from the Open-Label Extension of Phase III Randomized Clinical Trials). Rheumatol Ther. 2026 May 16. doi: 10.1007/s40744-026-00852-3. Online ahead of print.
- Feist E, Luggen ME, Nasonov EL, Yakushin SS, Bukhanova DV, Egorova AN, Grishin SA, Samsonov MY, Smolen JS. The impact of comorbidities on the efficacy of IL-6 inhibitor olokizumab compared to adalimumab in a randomized controlled trial. Arthritis Res Ther. 2025 Nov 14;27(1):213. doi: 10.1186/s13075-025-03682-w.
- Smolen JS, Feist E, Fatenejad S, Grishin SA, Korneva EV, Nasonov EL, Samsonov MY, Fleischmann RM; CREDO2 Group. Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2022 Aug 25;387(8):715-726. doi: 10.1056/NEJMoa2201302.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Olokizumab | Monoclonal antibody | 64 mg | Subcutaneous |