104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants (RESPOND-EXT)

Biogen

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: Baminercept alfa (BG9924)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664573

104RA204

2007-000733-19 (EudraCT Number)

Details and patient eligibility

About

To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.

Enrollment: 339 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be a participant from Study 104RA202 (NCT 00664716)
• Stable dose of Methotrexate for the duration of the study

Exclusion criteria

• Participants with a significant change in their medical history from their previous BG9924 study
• Any clinically significant infectious illness or serious local infection

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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339 participants in 4 patient groups

Group 2

Experimental group

Description:

Drug: BG9924 - dose administered as per Biogen-Idec protocol

Treatment:

Biological: Baminercept alfa (BG9924)

Group 1

Experimental group

Description:

Drug: BG9924 - dose administered as per Biogen-Idec protocol

Treatment:

Biological: Baminercept alfa (BG9924)

Group 3

Experimental group

Description:

Drug: BG9924 - dose administered as per Biogen-Idec protocol

Treatment:

Biological: Baminercept alfa (BG9924)

Group 4

Experimental group

Description:

Drug: BG9924 - dose administered as per Biogen-Idec protocol

Treatment:

Biological: Baminercept alfa (BG9924)