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NCT01359943 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 221
- Enrollment target
NCT01359943: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01359943 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 221 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01359943, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 221 participants
- Enrollment target
Study 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.
Primary Outcome
A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
Interventions
- DRUG placebo
- BIOLOGICAL secukinumab (AIN457)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01359943 record still lists
NCT01359943 is an interventional study that assigns participants to a tested intervention. The registered 221 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 (66% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01359943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01359943 about?
NCT01359943 is a clinical study titled "Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate". 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 Methotrex...
What is the current status of trial NCT01359943?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 221 participants. The study started on 2011-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01359943?
The interventions under investigation include: placebo (DRUG), secukinumab (AIN457) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01359943?
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 NCT01359943's enrollment target sits among peer trials
221 275th of 2000 higher than 1,726 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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