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

Biogen

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: BG9924

Study type: Interventional

Funder types: Industry

Identifiers

NCT00523328

2007-000734-38 (EudraCT Number)

104RA205

Details and patient eligibility

About

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

Full description

Extension study for 104RA203 (NCT 00458861)

Enrollment: 72 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

BG9924

Experimental group

Description:

dosage administered as per Biogen-idec protocol

Treatment:

Drug: BG9924