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NCT01264770 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)
A Phase 2 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 2
- Development phase
- 644
- Enrollment target
NCT01264770: Clinical Trial Phase 2 study, sponsored by AstraZeneca.
NCT01264770 is a Phase 2 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 644 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (384% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01264770, a Phase 2 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 644 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The study will last for approximately six months
Primary Outcome
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = a
Interventions
- DRUG Fostamatinib and placebo injections
- DRUG Adalimumab and placebo of fostamatinib
- DRUG Placebo of fostamatinib, fostamatinib, and placebo injections
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 644 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
Why NCT01264770 stopped before completion
NCT01264770 is an interventional study that assigns participants to a tested intervention. The registered 644 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (384% higher).
The record links to 0 conditions, and to 3 interventions - of which Fostamatinib and placebo injections is the first listed.
NCT01264770 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01264770 about?
NCT01264770 is a clinical study titled "Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)". The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The s...
What is the current status of trial NCT01264770?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 644 participants. The study started on 2011-01. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01264770?
The interventions under investigation include: Fostamatinib and placebo injections (DRUG), Adalimumab and placebo of fostamatinib (DRUG), Placebo of fostamatinib, fostamatinib, and placebo injections (DRUG).
Who is sponsoring clinical trial NCT01264770?
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 NCT01264770's enrollment target sits among peer trials
644 50th of 2000 higher than 1,951 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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