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NCT01606761 · ClinicalTrials.gov registry record · Phase 3
A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 878
- Enrollment target
NCT01606761: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01606761 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 878 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01606761, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 878 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.
Primary Outcome
The ACR 20 Response is defined as greater than or equal to (\>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 =no pain to 10 =worst possible pain\]), physician's global assessmen
Interventions
- DRUG Placebo
- DRUG Sirukumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 878 participants |
| Start Date | 2012-08-06 |
| Est. Completion | 2016-01-12 |
| Phase | Phase 3 |
What the finished NCT01606761 record still lists
NCT01606761 is an interventional study that assigns participants to a tested intervention. The registered 878 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01606761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01606761 about?
NCT01606761 is a clinical study titled "A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)". The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.
What is the current status of trial NCT01606761?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 878 participants. The study started on 2012-08-06. Estimated completion is 2016-01-12.
What interventions are being tested in trial NCT01606761?
The interventions under investigation include: Placebo (DRUG), Sirukumab (DRUG).
Who is sponsoring clinical trial NCT01606761?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01606761's enrollment target sits among peer trials
878 370th of 2000 higher than 1,630 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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