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

AstraZeneca

Status and phase: Terminated; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Fostamatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01242514

D4300C00005

2010-020892-22 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 1,917 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,917 participants in 3 patient groups

A

Experimental group

Description:

Oral treatment

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

B

Experimental group

Description:

Oral treatment

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

C

Experimental group

Description:

Oral treatment

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib