Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had 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 an existing medication called a tumour necrosis factor alpha inhibitor The primary objective of this study was to evaluate the efficacy of olokizumab (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 rheumatoid arthritis (RA) inadequately controlled by TNF-α inhibitor (TNFi) therapy.
Timeline
- Start
- 2017-01-25
- Primary completion
- 2019-09-12
- Completion
- 2019-10-01
Outcome
Met primary endpoint
registry Arm 1: Olokizumab 64 mg q4w vs Arm 3: Placebo q2w; p = 0.004; Risk Difference (RD) 0.190 (97.5% CI 0.030 to 0.337) NCT02760433 ↗
registry Arm 2: Olokizumab 64 mg q2w vs Arm 3: Placebo q2w; p = 0.0029; Risk Difference (RD) 0.203 (97.5% CI 0.038 to 0.353) NCT02760433 ↗
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, Fatenejad S, Grishin S, Korneva E, Luggen ME, Nasonov E, Samsonov M, Smolen JS, Fleischmann RM. Olokizumab, a monoclonal antibody against interleukin-6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by tumour necrosis factor inhibitor therapy: efficacy and safety results of a randomised controlled phase III study. Ann Rheum Dis. 2022 Dec;81(12):1661-1668. doi: 10.1136/ard-2022-222630. Epub 2022 Sep 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olokizumab | Monoclonal antibody | 64 mg | Subcutaneous |