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NCT00928512 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 237
- Enrollment target
NCT00928512: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT00928512 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 237 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00928512, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 237 participants
- Enrollment target
Study 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.
Primary Outcome
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 activity, patient's self-assesseddisability (Health Assessment Questionnaire \[HAQ©\] score)and acute
Interventions
- DRUG Placebo
- DRUG Secukinmab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
What the finished NCT00928512 record still lists
NCT00928512 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00928512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00928512 about?
NCT00928512 is a clinical study titled "Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)". 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 M...
What is the current status of trial NCT00928512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 237 participants. The study started on 2009-07. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00928512?
The interventions under investigation include: Placebo (DRUG), Secukinmab (DRUG).
Who is sponsoring clinical trial NCT00928512?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00928512's enrollment target sits among peer trials
237 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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