drugset / Trial / NCT02683239
Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
Phase 3
Completed
5331 enrolled
Regeneron Pharmaceuticals
Teva Pharmaceutical Industries, Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.
Timeline
- Start
- 2016-02-17
- Primary completion
- 2020-12-01
- Completion
- 2021-06-15
Outcome
Met primary endpoint
registry analysis (superiority test); Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 1 mg SC Q8W; p = 0.0010; Least Squares Mean -0.73 (95% CI -1.159 to -0.293); Mixed Models Analysis NCT02683239 ↗
registry analysis (superiority test); Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 1 mg SC Q8W; p = 0.0007; Least Squares Mean -0.74 (95% CI -1.163 to -0.309); Mixed Models Analysis NCT02683239 ↗
Publications
- DiMartino SJ, Cicirello H, Magyar A, Eng S, Ho T, Manvelian G, Patel Y, Pervin K, Trinh N, Fetell M, Braunstein N, Geba GP, Dakin P. A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip. RMD Open. 2026 Jan 16;12(1):e006436. doi: 10.1136/rmdopen-2025-006436.
- DiMartino SJ, Gao H, Neogi T, Fuerst T, Zaim S, Eng S, Ho T, Manvelian G, Braunstein N, Geba GP, Dakin P. Prevalence of preexisting articular bone pathology in patients with osteoarthritis screened for fasinumab clinical trials identified by X-ray or magnetic resonance imaging. Osteoarthritis Cartilage. 2024 Dec;32(12):1601-1609. doi: 10.1016/j.joca.2024.07.001. Epub 2024 Jul 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fasinumab | Monoclonal antibody | 1 mg | Subcutaneous |