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NCT01197534 · 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 Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 913
- Enrollment target
NCT01197534: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01197534 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 913 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01197534, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 913 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 disease modifying anti-rheumatic drug (DMARD) 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. 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 | 913 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT01197534 record still lists
NCT01197534 is an interventional study that assigns participants to a tested intervention. The registered 913 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 (18% higher).
The record links to 0 conditions, and to 2 interventions - of which fostamatinib is the first listed.
NCT01197534 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01197534 about?
NCT01197534 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 Disease Modifying Anti-rheumatic Drug (DMARD) 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 disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1 year.
What is the current status of trial NCT01197534?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 913 participants. The study started on 2010-09. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01197534?
The interventions under investigation include: fostamatinib (DRUG), placebo, fostamatinib (DRUG).
Who is sponsoring clinical trial NCT01197534?
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 NCT01197534's enrollment target sits among peer trials
913 347th of 2000 higher than 1,654 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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