Health Condition 1: null- Rheumatoid Arthritis
Conditions
Interventions
Intervention1: Fostamatinib: Fostamatinib 100mg twice daily, oral administration, duration 1 year
Intervention2: Fostamatinib: Fostamatinib 150 mg once daily
oral administration, duration 1 year
Inter
Sponsors
AstraZeneca Research and Development
Quintiles Research India Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: No upper age limit 1. Provision of informed consent, prior to any study-specific procedures. 2. Patients who have successfully completed a qualifying study (ie, Studies D4300C00001(CTRI/2011/06/001799), D4300C00002(CTRI/2011/06/001801), D4300C00003 (India not participating) or D4300C00004 (India not participating)) with FosD. 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).
Exclusion criteria
Exclusion criteria: 1. Premature withdrawal from the qualifying study. 2. Development of any of the withdrawal criteria from the qualifying study, including: − Any physical symptoms of hepatotoxicity. − Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or bilirubin rise to a value 5 x upper limit of normal (ULN) at any time. − AST or ALT rises to a value 3 x ULN accompanied by an elevation of total bilirubin 2 x ULN. − ALT or AST rises to 3 x ULN with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash or eosinophilia. Persistent uncontrolled hypertension despite treatment/dose adjustment (as defined in Appendix F). − Persistent or recurrent gastrointestinal (GI) intolerance or dizziness despite dose reduction. − Significant infection. − Cancer: any malignant lesion. 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 patients ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to evaluate the long-term safety and tolerability of fostamatinib disodium Timepoint: Every 12 weeks over the range of one year | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess physical function status of patients after administration of FosD using the Health Assessment Questionnaire - Disability Index (HAQ-DI). Timepoint: Every 12 weeks over the range of one year;To assess physical function status of patients after administration of FosD using the Health Assessment Questionnaire - Disability Index (HAQ-DI). Timepoint: Every 12 weeks over the range of one year;To assess the long-term efficacy of FosD 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. Timepoint: Every 12 weeks over the range of one year;To investigate the effects of FosD on patient reported health outcomes as measured by the 36-item Short Form Health Survey (SF-36). Timepoint: Every 12 weeks over the range of one year | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States of America
Contacts
Public ContactSuneela Thatte
Quintiles
Outcome results
None listed