(OSKIRA-X): ESTUDIO DE EXTENSION A LARGO PLAZO PARA EVALUAR LA SEGURIDAD Y EFICACIA DE FOSTAMATINIB DISODICO EN EL TRATAMIENTO DE LA ARTRITIS REUMATOIDEA.

Not Applicable

• Conditions: -M05; M05

• Registration Number: PER-092-10
• Lead Sponsor: AstraZeneca AB,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 116

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event<br><br>Measure:Percentage of Patients Who Had at Least 1 Adverse Event in Any Category<br>Timepoints:Entry in extension to end of study (variable duration; maximum 109 weeks)<br>