A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis
Summary
The purpose of this study is to assess the efficacy of ustekinumab, in adult participants with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha agents, as measured by the reduction in signs and symptoms of radiographic AxSpA.
Timeline
- Start
- 2015-09-03
- Primary completion
- 2017-03-22
- Completion
- 2017-09-06
Outcome
Missed primary endpoint
Stopped: “Neither dose achieved the study's primary or major secondary endpoints. The safety profile was consistent with previous ustekinumab studies.”
paper For study 1, the primary and major secondary end points were not met, and the study was discontinued. PMID 30225992 ↗
registry analysis (superiority test); Placebo vs Ustekinumab 45 Milligram (mg); p = 0.669; Percentage difference 2.586 (95% CI -9.138 to 14.310); Cochran-Mantel-Haenszel NCT02437162 ↗
registry analysis (superiority test); Placebo vs Ustekinumab 90 mg; p = 0.913; Percentage difference -0.646 (95% CI -12.180 to 10.887); Cochran-Mantel-Haenszel NCT02437162 ↗
Publications
- Kavanaugh A, Baraliakos X, Gao S, Chen W, Sweet K, Chakravarty SD, Song Q, Shawi M, Rahman P. Genetic and Molecular Distinctions Between Axial Psoriatic Arthritis and Radiographic Axial Spondyloarthritis: Post Hoc Analyses from Four Phase 3 Clinical Trials. Adv Ther. 2023 May;40(5):2439-2456. doi: 10.1007/s12325-023-02475-4. Epub 2023 Mar 30.
- Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ustekinumab | Monoclonal antibody | 45 mg | Subcutaneous |
| Subject | Ustekinumab | Monoclonal antibody | 90 mg | Subcutaneous |
| Background | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |