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NCT01142726 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
NCT01142726: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01142726 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 511 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01142726, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
Study Summary
The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.
Primary Outcome
DAS28-CRP remission defined as \<2.6; TP=treatment phase; WP=withdrawal phase. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall
Interventions
- DRUG Abatacept
- DRUG Methotrexate
- DRUG Methotrexate placebo
- DRUG Abatacept placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT01142726 record still lists
NCT01142726 is an interventional study that assigns participants to a tested intervention. The registered 511 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 (34% lower).
The record links to 0 conditions, and to 4 interventions - of which Abatacept is the first listed.
NCT01142726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01142726 about?
NCT01142726 is a clinical study titled "Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis". The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.
What is the current status of trial NCT01142726?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2010-12. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01142726?
The interventions under investigation include: Abatacept (DRUG), Methotrexate (DRUG), Methotrexate placebo (DRUG), Abatacept placebo (DRUG).
Who is sponsoring clinical trial NCT01142726?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01142726's enrollment target sits among peer trials
511 728th of 2000 higher than 1,272 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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