drugset / Trial / NCT03259074
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).
Timeline
- Start
- 2017-11-30
- Primary completion
- 2021-11-12
- Completion
- 2021-11-29
Outcome
Missed primary endpoint
registry analysis (superiority test); AIN457 150 mg/Placebo vs GP2017 40mg; p = 0.7164; Marginal difference 1.51 (95% CI -6.63 to 9.64) NCT03259074 ↗
registry analysis (superiority test); AIN457 300 mg vs GP2017 40mg; p = 0.6925; Marginal difference 1.67 (95% CI -6.61 to 9.95) NCT03259074 ↗
Publications
- Sieper J, Poddubnyy D. Twenty years of clinical trials in axial spondyloarthritis: what can we learn for the future? Curr Opin Rheumatol. 2021 Jul 1;33(4):363-369. doi: 10.1097/BOR.0000000000000804.
- Baraliakos X, Ostergaard M, Gensler LS, Poddubnyy D, Lee EY, Kiltz U, Martin R, Sawata H, Readie A, Porter B; SURPASS Study Group. Comparison of the Effects of Secukinumab and Adalimumab Biosimilar on Radiographic Progression in Patients with Ankylosing Spondylitis: Design of a Randomized, Phase IIIb Study (SURPASS). Clin Drug Investig. 2020 Mar;40(3):269-278. doi: 10.1007/s40261-020-00886-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |