CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 221 enrolled
Drug / intervention
secukinumab (AIN457) +1 morebiological
Likely dose
Not stated in 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/NCT01359943
NCT01359943Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an Intravenous (i.v.) or Subcutaneous (s.c.) Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate

Novartis Pharmaceuticals·interventional·Posted May 25, 2011·Updated Mar 2, 2015

In Brief

A Phase 2 clinical trial evaluating secukinumab (AIN457) and placebo for Rheumatoid Arthritis. Completed, enrolled 221 participants across 39 sites in 8 countries.

Detailed Summary

The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite treatment with Methotrexate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Canada, Hungary, Italy, Poland, Puerto Rico, Slovakia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.1 years ago

Interventions

secukinumab (AIN457)biological

Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).

placebodrug

Matching placebo to AIN457 i.v. and to AIN457 s.c..