Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: Baminercept alfa 3; Biological: Baminercept alfa 1; Biological: Baminercept alfa 5; Biological: Placebo; Biological: Baminercept alfa 2; Biological: Baminercept alfa 4

• Registration Number: NCT00664716
• Lead Sponsor: Biogen

Brief Summary

Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• 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: COMPLETED
• Sex: All
• Target Recruitment: 391

Inclusion Criteria

• Diagnosis of RA (functional class I - III)
• Stable dose of MTX
• Inadequate response to at least one conventional DMARD therapy

Key

Exclusion Criteria

• Serious local infection or systemic infection
• History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment
• Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
• Clinical significant lab tests at screening
• Positive for Hep C or Hep B at screening

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Third Dose	Baminercept alfa 3	BG9924 - dosage level administered as per Biogen Idec protocol
One Dose	Baminercept alfa 1	BG9924 - dosage level administered as per Biogen Idec protocol
Fifth Dose	Baminercept alfa 5	BG9924 - dosage level administered as per Biogen Idec protocol
Placebo	Placebo	subcutaneous administration of placebo given for 12 weeks
Second Dose	Baminercept alfa 2	BG9924 - dosage level administered as per Biogen Idec protocol
Fourth Dose	Baminercept alfa 4	BG9924 - dosage level administered as per Biogen Idec protocol

Primary Outcome Measures

Name	Time	Method
Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy	3 months

Secondary Outcome Measures

Name	Time	Method
Assess the safety and tolerability of BG9924 in this participant population	3 months

Trial Locations

Locations (1)

Coordinating Research Site; 🇬🇧 Leeds, Yorkshire, United Kingdom