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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
Phase 2 trial testing Secukinmab in Rheumatoid Arthritis in 237 participants. Completed in 1 March 2011.
1 March 2011
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 237 |
| Start date | 1 July 2009 |
| Primary completion | 1 March 2011 |
| Estimated completion | 1 March 2011 |
| Sites | 58 locations across United States, Belgium, Czechia, Germany, Hungary, Japan, Poland, Russia |
Drugs / interventions tested
- Secukinmab — full drug profile →
- Placebo
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
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.
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Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks
Time frame: 16cweeks
A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease ac
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):
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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 -
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 -
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 -
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:
- PubMed search for NCT00928512
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
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- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00928512 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 7 October 2015
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing