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NCT00928512

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

Completed Phase 2 Results posted Last updated 7 October 2015
What this trial tests

Phase 2 trial testing Secukinmab in Rheumatoid Arthritis in 237 participants. Completed in 1 March 2011.

Timeline
1 July 2009
Primary endpoint
1 March 2011
1 March 2011

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment237
Start date1 July 2009
Primary completion1 March 2011
Estimated completion1 March 2011
Sites58 locations across United States, Belgium, Czechia, Germany, Hungary, Japan, Poland, Russia

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Multifunctional nanoparticle-mediated combining therapy for human diseases.
    Li X, Peng X, Zoulikha M, Boafo GF, et al · · 2024 · cited 207× · PMID 38161204 · DOI 10.1038/s41392-023-01668-1
  2. One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study.
    Genovese MC, Durez P, Richards HB, Supronik J, et al · · 2014 · cited 77× · PMID 24429175 · DOI 10.3899/jrheum.130637
  3. Secukinumab for rheumatology: development and its potential place in therapy.
    Koenders MI, van den Berg WB. · · 2016 · cited 29× · PMID 27445458 · DOI 10.2147/dddt.s105263
  4. Abstracts of the 3rd World Psoriasis & Psoriatic Arthritis Conference 2012: "Psoriasis-a global health challenge" : Stockholm, Sweden, June 27-July 1, 2012.
    · 2012 · PMID 24318398 · DOI 10.1007/s13555-012-0010-x

Verify or expand the search:

Other trials of Secukinmab

Trials testing the same drug.

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00928512.

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