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NCT01645280 · ClinicalTrials.gov registry record · Phase 2
A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 274
- Enrollment target
NCT01645280: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT01645280 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 274 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (106% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01645280, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 274 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.
Primary Outcome
The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient's assessment of physical function as measured by health assessment questionn
Interventions
- DRUG Placebo + methotrexate (MTX) (Group 1)
- DRUG Ustekinumab + MTX (Group 2)
- DRUG Ustekinumab + MTX (Group 3)
- DRUG CNTO 1959 + MTX (Group 4)
- DRUG CNTO 1959 + MTX (Group 5)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01645280 record still lists
NCT01645280 is an interventional study that assigns participants to a tested intervention. The registered 274 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 (106% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo + methotrexate (MTX) (Group 1) is the first listed.
NCT01645280 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01645280 about?
NCT01645280 is a clinical study titled "A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy". The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population...
What is the current status of trial NCT01645280?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 274 participants. The study started on 2012-08. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01645280?
The interventions under investigation include: Placebo + methotrexate (MTX) (Group 1) (DRUG), Ustekinumab + MTX (Group 2) (DRUG), Ustekinumab + MTX (Group 3) (DRUG), CNTO 1959 + MTX (Group 4) (DRUG), CNTO 1959 + MTX (Group 5) (DRUG).
Who is sponsoring clinical trial NCT01645280?
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 NCT01645280's enrollment target sits among peer trials
274 203rd of 2000 higher than 1,797 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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