A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3

Phase 1

• Conditions: MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis; Rheumatoid Arthritis

• Registration Number: EUCTR2010-020745-27-FR
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-05
• Study Completion: 2013-02-11
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Male or female aged 18 and over
2. A diagnosis of RA after the age of 16
3. Currently taking methotrexate
4. Currently receiving, or have previously received, a single TNF-alpha antagonist for the treatment of RA
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Females who are pregnant or lactating
2.Any systemic inflammatory conditions (other than RA),connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data
3.Poorly controlled blood pressure
4.History of liver function abnormality requiring investigation

Study & Design

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