Phase 3 Rheumatoid Arthritis Trial, Completed NCT00960440 Sponsor: Pfizer 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 (NCT00960440) looked at a medicine called CP-690,550 (tested at two dose levels — 5 mg and 10 mg) compared to a dummy treatment (placebo) in people with rheumatoid arthritis. A total of 399 people took part across four groups: 133 received the 5 mg dose, 134 received the 10 mg dose, and 132 received placebo (some of whom later switched to one of the active doses). The trial measured three main things at the 3-month mark: the proportion of participants whose joint tenderness, swelling, pain and other arthritis-related measures improved by at least 20% (called an ACR20 response); how much difficulty participants had with everyday tasks like dressing, eating and walking (scored on a scale of 0 to 3, where 0 means no difficulty); and the proportion of participants whose overall disease activity score fell into a range considered to indicate remission. The reported data shows that at 3 months, approximately 42% of participants in the 5 mg group and 48% in the 10 mg group met the ACR20 improvement threshold, compared with around 24% in the placebo group. For everyday physical tasks, the average difficulty score at the start of the trial was about 1.60 (5 mg group), 1.50 (10 mg group), and 1.63 (placebo group). By 3 months, the reported average change from that starting score was a reduction of 0.41 points in both active-dose groups, compared with a reduction of 0.17 points in the placebo group. Regarding remission-level disease activity scores, approximately 7% of the 5 mg group and 11% of the 10 mg group reached that threshold, versus about 2% of the placebo group. The reported data also shows results at earlier and later time points. At 2 weeks, around 28% (5 mg) and 33% (10 mg) met the ACR20 threshold, compared with 17% on placebo. A stricter measure — at least 50% improvement (ACR50) — was reported in roughly 27% of both active-dose groups at 3 months, compared with about 8% on placebo. At 6 months, after placebo participants had switched to an active dose, ACR20 response rates across all groups ranged from approximately 40% to 55%, though the reported data does not allow a direct comparison with placebo at those later time points. 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

NCT00960440
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 are an adult who has been diagnosed with moderate to severe rheumatoid arthritis
  • You are taking methotrexate at a steady, unchanged dose
  • You have tried TNF inhibitor medications (a type of treatment that targets inflammation) but they have not worked well enough for you

Who may not be able to join:

  • You are pregnant
  • You have a serious short-term or long-term medical condition (confirm with trial site)
  • You have a serious active infection
  • Your blood tests or other lab results show significant abnormalities (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: Pfizer CT.gov Call Center, Pfizer

Australian sites

Pfizer Investigational Site, Kogarah, New South Wales
Pfizer Investigational Site, Daw Park, South Australia
Pfizer Investigational Site, Heidelberg, 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
Sponsor
Registry
ClinicalTrials.gov
Start date
1 October 2009
Est. completion
1 March 2011

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇮🇪 Ireland 🇮🇹 Italy Puerto Rico 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3; Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3; Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3

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