Phase 3 Rheumatoid Arthritis Trial, Completed NCT01142726 Sponsor: Bristol-Myers Squibb Condition: Rheumatoid Arthritis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 351 people with rheumatoid arthritis across three groups: one group received abatacept combined with methotrexate (119 people), one received abatacept alone with a dummy (placebo) version of methotrexate (116 people), and one received methotrexate alone with a placebo version of abatacept (116 people). The trial was measuring how many participants reached "remission" — meaning their joint disease activity score dropped below a certain threshold — using a scoring system called the DAS28-CRP, which takes into account tender and swollen joints, a blood marker of inflammation, and the patient's own rating of their health. The reported data shows that for the main (primary) outcome — reaching remission at month 12 — about 60.9% of people in the abatacept-plus-methotrexate group met that threshold, compared with 45.2% in the methotrexate-alone group. When a stricter measure was applied — remission at both month 12 and month 18 — the reported figures were 14.8% and 7.8% respectively. For the abatacept-alone group, the reported remission rate at month 12 was 42.5%, dropping to 12.4% when both time points were required. A separate scoring tool called the SDAI also showed remission rates at month 12 of 42.0% (combination group), 29.3% (abatacept alone), and 25.0% (methotrexate alone). Disease activity scores across all three groups decreased from their starting points over the course of the trial, with the reported reductions being largest in the combination group at most time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Rheumatoid Arthritis Trial, Completed

NCT01142726
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have active joint swelling and inflammation in at least 2 joints (one of which must be a small joint, such as in the hand or foot), and this has been present for at least 8 weeks before your initial assessment
  • Your joint symptoms started no more than 2 years before your initial assessment
  • You have tested positive for a specific antibody called anti-CCP2, which is associated with rheumatoid arthritis
  • You have either never taken methotrexate, or have had very limited exposure to it (no more than 10 mg per week for 4 weeks or less, and none in the month before your assessment)
  • You have never been treated with any biologic medications, including experimental ones
  • Your disease activity score, measured using a specific scoring system (DAS28-CRP), is 3.2 or higher at your initial assessment
  • If you were taking certain arthritis medications (chloroquine, hydroxychloroquine, or sulfasalazine), you have stopped taking them for at least 28 days before the study begins
  • If you are taking steroid tablets, you have been on a stable low dose (10 mg per day or less of prednisone or equivalent) for at least 4 weeks
  • You are able to have an MRI scan

Who may not be able to join:

  • You have been diagnosed with another rheumatic disease, such as lupus
  • You have received steroid treatment by injection or drip (into a vein, muscle, or joint) within 4 weeks before the study starts
  • You are planning to have or expecting to need joint replacement surgery
  • Your doctor believes you are likely to need high-dose steroid treatment during the study for another condition
  • You have had a cancer diagnosis within the last 5 years
  • You have had a serious bacterial infection in the last 3 months that was not fully treated or cleared up with antibiotics, or you have ongoing or repeated bacterial infections
  • You are considered to be at risk for tuberculosis
  • You currently have signs of an active bacterial or viral infection, including HIV, shingles (herpes zoster), or cytomegalovirus (CMV) that cleared up less than 2 months ago (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb

Australian sites

Local Institution, Cairns, Queensland
Local Institution, Maroochydore, Queensland
Local Institution, Woodville, South Australia
Local Institution, Heidelberg, Victoria
Local Institution, Malvern, Victoria
Local Institution, Victoria Park, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 December 2010
Est. completion
1 September 2013

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇲🇽 Mexico 🇵🇱 Poland 🇷🇺 Russia 🇿🇦 South Africa 🇰🇷 South Korea 🇸🇪 Sweden 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov