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NCT02019472 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 559
- Enrollment target
NCT02019472: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02019472 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 559 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02019472, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 559 participants
- Enrollment target
Study Summary
The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate.
Primary Outcome
The Disease Activity Index Score 28 using ESR \[DAS28 (ESR)\] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on
Interventions
- DRUG Placebo
- BIOLOGICAL adalimumab 40 mg
- BIOLOGICAL sirukumab 100 mg
- BIOLOGICAL sirukumab 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 559 participants |
| Start Date | 2014-04-04 |
| Est. Completion | 2016-08-17 |
| Phase | Phase 3 |
What the finished NCT02019472 record still lists
NCT02019472 is an interventional study that assigns participants to a tested intervention. The registered 559 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02019472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02019472 about?
NCT02019472 is a clinical study titled "A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis". The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate re...
What is the current status of trial NCT02019472?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 559 participants. The study started on 2014-04-04. Estimated completion is 2016-08-17.
What interventions are being tested in trial NCT02019472?
The interventions under investigation include: Placebo (DRUG), adalimumab 40 mg (BIOLOGICAL), sirukumab 100 mg (BIOLOGICAL), sirukumab 50 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT02019472?
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 NCT02019472's enrollment target sits among peer trials
559 673rd of 2000 higher than 1,328 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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