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NCT01197521 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 923
- Enrollment target
NCT01197521: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01197521 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 923 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01197521, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 923 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.
Primary Outcome
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
Interventions
- DRUG fostamatinib
- DRUG placebo, fostamatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 923 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01197521 record still lists
NCT01197521 is an interventional study that assigns participants to a tested intervention. The registered 923 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which fostamatinib is the first listed.
NCT01197521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01197521 about?
NCT01197521 is a clinical study titled "Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.". The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.
What is the current status of trial NCT01197521?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 923 participants. The study started on 2010-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01197521?
The interventions under investigation include: fostamatinib (DRUG), placebo, fostamatinib (DRUG).
Who is sponsoring clinical trial NCT01197521?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01197521's enrollment target sits among peer trials
923 343rd of 2000 higher than 1,657 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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