BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: BG9924

• Registration Number: NCT00523328
• Lead Sponsor: Biogen

Brief Summary

This study is to observe the long-term treatment of BG9924

Detailed Description

Extension study for 104RA203 (NCT 00458861)

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-17
• Study First Submitted QC: 2007-08-29
• Study First Posted: 2007-08-31
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2015-12
• Disposition First Submitted: 2015-12-17
• Disposition First Submitted QC: 2015-12-17
• Last Update Submitted: 2015-12-17
• Disposition First Posted: 2016-01-21
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Must be a participant from Study 104RA203 (NCT 00458861)

Exclusion Criteria

• Participants with a significant change in medical history from their previous BG9924 Study 104RA203 (NCT 00458861).
• Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.
• Male and female participants of child-bearing potential not willing to practice effective birth control for the duration of the study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BG9924	BG9924	dosage administered as per Biogen-idec protocol

Primary Outcome Measures

Name	Time	Method
To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.	The duration of this study is 18 months.

Trial Locations

Locations (1)

Coordinating Research Site; 🇬🇧 Newcastle, United Kingdom