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NCT01856309 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,820
- Enrollment target
NCT01856309 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 1,820 participants.
The verdict
NCT01856309, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,820 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
Interventions
- DRUG Placebo
- DRUG Sirukumab 50 mg
- DRUG Sirukumab 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,820 participants |
| Start Date | 2013-08-07 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01856309
The ClinicalTrials.gov registry entry for NCT01856309 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,820 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01856309 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01856309 about?
NCT01856309 is a clinical study titled "Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003". The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
What is the current status of trial NCT01856309?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,820 participants. The study started on 2013-08-07. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT01856309?
The interventions under investigation include: Placebo (DRUG), Sirukumab 50 mg (DRUG), Sirukumab 100 mg (DRUG).
Who is sponsoring clinical trial NCT01856309?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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