Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

Phase 3

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Fostamatinib

• Registration Number: NCT01242514
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Study Start: 2011-01
• Results First Submitted: 2013-12-18
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-25
• Last Update Submitted: 2014-02-25
• Results First Posted: 2014-04-04
• Last Update Posted: 2014-04-04
• Primary Completion: 2015-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1917

Inclusion Criteria

• Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
• Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).

Exclusion Criteria

• Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
• Females who are pregnant or breast feeding
• Poorly controlled hypertension
• Significant liver function test abnormalities or physical symptoms of hepatotoxicity
• Significant infection
• Gastrointestinal intolerance
• Cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Fostamatinib	Oral treatment
B	Fostamatinib	Oral treatment
C	Fostamatinib	Oral treatment

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category	Entry in extension to end of study (variable duration; maximum 109 weeks)	AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event

Secondary Outcome Measures

Name	Time	Method
Mean DAS28-CRP Score	Weeks 0, 12, 24, 36 and 52	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. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily
Mean mTSS Score	Weeks 0 and 52	mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily
Mean HAQ-DI Score	Weeks 0, 12, 24, 36 and 52	HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily

Trial Locations

Locations (1)

Research Site; 🇬🇧 Wirral, United Kingdom