CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 237 enrolled
Drug / intervention
Secukinmab +1 moredrug
Likely dose
Secukinmab 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00928512
NCT00928512Phase 2Completed
CompareCT.gov

A 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab (AIN457) Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate

Novartis Pharmaceuticals·interventional·Posted Jun 26, 2009·Updated Oct 30, 2015

In Brief

A Phase 2 clinical trial evaluating Secukinmab and Placebo for Rheumatoid Arthritis. Completed, enrolled 237 participants across 58 sites in 11 countries.

Detailed Summary

This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Czechia, Germany, Hungary, Japan, Poland, Russia, Slovakia, South Korea, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2009
Enrollment StartJul 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.0 years ago

Interventions

Secukinmabdrug

Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.

Placebodrug

Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.