At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of rheumatoid arthritis
- ✓DMARD-naive or prior failure of at least one DMARD agent (MTX, leflunomide, or sulfasalazine)
- ✓Permitted to use up to 3 DMARDs (MTX, sulfasalazine, hydroxychloroquine) with stable dose for ≥4 weeks before study treatment
- ✓Active disease: ≥6 of 28 tender joints AND ≥6 of 28 swollen joints AND hsCRP >10 mg/L at screening
- ✕Severe rheumatoid arthritis (ACR 1991 functional status class IV)
- ✕Prior exposure to secukinumab or any biologic agent, including TNF inhibitors
- ✕Current use of high-potency opioid analgesics
- ✕Pregnant or nursing women
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension
In Brief
A Phase 2 clinical trial evaluating Placebo and Secukinumab for Rheumatoid Arthritis. Completed, enrolled 100 participants across 36 sites in 5 countries.
Detailed Summary
This study aims to confirm if patients with a specific biomarker might have a better response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done. The goals of these exploratory studies are to (1) find biomarkers that will identify persons with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to identify persons who will have fewer side effects in order to maximize their benefit from secukinumab.
Study Details
Timeline
Interventions
Matching placebo to secukinumab I.V.
In part 1 (blinded period), participants randomized to secukinumab received 10 mg/kg I.V.. Participants, enrolled in part 2 (open label), received secukinumab 300 mg subcutaneous.