Phase 3 Rheumatoid Arthritis Trial, Completed NCT00547521 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 looked at a medication called abatacept, given by injection under the skin (subcutaneous), in people with rheumatoid arthritis. A total of 100 people took part in the main four-month study — 51 in a group receiving abatacept together with another medicine called methotrexate, and 49 in a group receiving abatacept on its own. A separate longer-term follow-up phase then enrolled 90 participants. The main thing the trial was measuring was whether participants developed antibodies against the abatacept medication itself — in other words, whether the body's immune system started to recognise and react to the drug. The trial also tracked a disease activity score called DAS28-CRP, which is a combined measure of joint tenderness, joint swelling, a blood inflammation marker, and the participant's own rating of their condition, all rolled into a single number. The reported data shows that, when tested using the standard laboratory method (ELISA) at the end of the four-month study, zero participants in either group were found to have developed detectable antibodies against abatacept. When a more sensitive laboratory method (ECL/MSD) was used across the same period, only one participant in the combination group showed a positive antibody result at any point, while zero in the monotherapy group did across most time points. For the disease activity score, the reported data shows an average decrease (improvement) of 1.67 points in the combination group and 1.94 points in the monotherapy group from their starting scores to the end of the four months. For two of the primary outcome measures relating to antibody responses in subgroups, no numerical data was reported on ClinicalTrials.gov. 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

NCT00547521
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 been diagnosed with Rheumatoid Arthritis by a doctor
  • You rate your overall disease condition as at least 20 out of 100 on a simple sliding scale measurement
  • You are willing and able to stop taking all biological treatments and most other arthritis medications, except for methotrexate, which you may continue

Who may not be able to join:

  • You have previously been treated with a medication called rituximab
  • You have previously been treated with any of the following: immunoadsorption columns (such as Prosorba columns), mycophenolate mofetil (also known as Cellcept®), cyclosporine A, other similar immune-suppressing drugs known as calcineurin inhibitors, or D-Penicillamine

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 28 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, Maroochydore, Queensland
Local Institution, Hobart, Tasmania
Local Institution, Malvern, Victoria

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 2007
Est. completion
1 December 2008

Where this trial is recruiting

🇦🇺 Australia 🇲🇽 Mexico 🇿🇦 South Africa 🇺🇸 United States

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

Primary endpoints

Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study; Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study; Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study; Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for ELISA Results); Immunogenicity in MTX Naive and MTX-previous Us...

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: 28 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