Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01604343 · ClinicalTrials.gov registry record · Phase 3
A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,670
- Enrollment target
NCT01604343: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01604343 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 1,670 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (116% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01604343, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,670 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) and inhibition of radiographic progression in patients with active RA who are unresponsive to treatment with disease-modifying antirheumatic drugs (DMARD).
Primary Outcome
ACR 20 response is greater than or equal to (\>=) 20 percent (%) improvement in both tender joint count (68) and swollen joint count (66) and \>= 20% improvement in 3 of following 5 assessments:Participant's assessment of pain using visual analog scale (VAS) (0-10 scale, 0=no pain and 10=worst possible pain),Participant's global assessment of disease activity by using VAS (scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), Physician's global assessment of disease activity using VAS
Interventions
- DRUG Placebo
- DRUG Sirukumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,670 participants |
| Start Date | 2012-08-15 |
| Est. Completion | 2016-12-06 |
| Phase | Phase 3 |
What the finished NCT01604343 record still lists
NCT01604343 is an interventional study that assigns participants to a tested intervention. Its 1,670 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (116% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01604343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01604343 about?
NCT01604343 is a clinical study titled "A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)". 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) and inhibition of radiographic progression in patients with active RA who are unresponsive to treatment with disease-modifying antirheumatic drugs (DMA...
What is the current status of trial NCT01604343?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,670 participants. The study started on 2012-08-15. Estimated completion is 2016-12-06.
What interventions are being tested in trial NCT01604343?
The interventions under investigation include: Placebo (DRUG), Sirukumab (DRUG).
Who is sponsoring clinical trial NCT01604343?
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 NCT01604343's enrollment target sits among peer trials
1,670 136th of 2000 higher than 1,864 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04852887 · 1,670 participants · Phase 3
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
- NCT06644625 · 1,665 participants
CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study
- NCT06034405 · 1,663 participants
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
- NCT06376565 · 1,680 participants · NA
Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI