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 the long-term safety and tolerability of a medicine called tofacitinib in people with rheumatoid arthritis (a condition causing joint pain and inflammation). The trial had two phases: an initial period and a shorter extension period. In the initial period, 1,123 people received a lower dose (5 mg twice daily) and 3,358 received a higher dose (10 mg twice daily), making a total of 4,481 participants. A separate group of 48 participants took part in the extension period, receiving the 5 mg dose. The trial's main focus was on tracking unwanted medical events (called adverse events) and changes in laboratory test results over time. The reported data shows that during the initial period, across all participants combined, 4,154 out of 4,481 people experienced at least one treatment-emergent adverse event (an unwanted medical occurrence that appeared or worsened during treatment). The average age of participants was reported as around 61 years. During the extension period, 16 out of 48 participants experienced adverse events, and 5 experienced serious adverse events (those involving hospitalisation, life-threatening situations, or similar serious outcomes). Thirty participants in the extension period showed at least one abnormal laboratory test result. Approximately 31.3% of extension period participants had an adverse event, and around 4.2% stopped taking the medicine due to an adverse event, according to the reported figures. The reported data also shows results for a secondary measure — how much participants' rheumatoid arthritis symptoms improved. Using a standard scoring system (ACR20/50/70, which measures percentage improvement in joint tenderness, swelling, and related symptoms), around 70–78% of participants across the different dose groups and time points reached at least a 20% improvement in symptoms at various stages of the trial, with similar figures reported for 50% and 70% improvement thresholds. These figures varied depending on the dose group and the time point 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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 41448717) ↗
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
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 must have already taken part in a separate, randomised clinical trial of CP-690,550 (also called tofacitinib) for rheumatoid arthritis that qualifies you for this study
- If you are currently taking part in a specific related study (A3921024), you must have been taking CP-690,550 at a dose of 10 mg twice daily for at least 3 months, and must have taken more than 80% of your prescribed doses during that time
Who may not be able to join:
- You have serious health conditions that could make taking CP-690,550 potentially unsafe for you (confirm with trial site)
- You have had a confirmed flu or pneumococcal (a type of bacterial) infection within the last 3 months before joining this study
- You have received any vaccine within the last month before joining this study
- You have received a flu vaccine within the last 6 months before joining this study
- You have received a pneumococcal vaccine within the last 5 years before joining this study
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.
Contact this trial
Principal Investigator: Pfizer CT.gov Call Center, Pfizer
Australian sites
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
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports; Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs); Extension Period: Number of Participants With Laboratory Test Abnormalities; Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis; Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.