Rheumatoid Arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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) 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). 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the long-term safety and tolerability of fostamatinib in patients with active rheumatoid arthritis (RA) by assessment of adverse event (AE) reports, laboratory safety data, vital signs, electrocardiograms (ECGs) and physical examination.;Secondary Objective: The secondary objectives of the study are: •To assess the long-term efficacy of fostamatinib as measured by: -Signs and symptoms of RA, as measured by components of American College of Rheumatology (ACR) response criteria and Disease Activity Score based on a 28 joint count (DAS28) score. -Structural joint damage, as measured by radiographic modified total Sharp score (mTSS) and components of mTSS. •To assess physical function status of patients after administration of fostamatinib using the Health Assessment Questionnaire - Disability Index (HAQ-DI). •To investigate the effects of fostamatinib on patient reported health outcomes as measured by the 36-item Short Form Health Survey (SF-36).;Primary end point(s): As this is an extension study, no endpoints have been defined. | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactInformation Centre
AstraZeneca AB
Outcome results
None listed