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

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-020892-22-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-05
• Study Completion: 2013-09-18
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1912

Inclusion Criteria

For inclusion in the study patients must fulfil the following criteria.
1.Provision of informed consent, prior to any study-specific procedures.
2.Patients who have successfully completed a qualifying study (ie, Studies D4300C00001, D4300C00002, D4300C00003 or D4300C00004 or D4300C00033) with fostamatinib.
Or
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).
Or
Patients who have participated in D4300C00033 and who require a dose reduction.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Patients must not enter the study if any of the following exclusion criteria are fulfilled:
1.Premature discontinuation of investigational product or withdrawal from the qualifying study.
2.Development of any of the withdrawal criteria from the qualifying study
3.Females who are pregnant or lactating.
4.Any other clinically significant disease or disorder, which in the opinion of the investigator (by its nature or by being inadequately controlled) might put the patient at risk due to participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified