BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Placebo Comparator; Biological: BG9924

• Registration Number: NCT00458861
• Lead Sponsor: Biogen

Brief Summary

This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-22
• Study First Submitted QC: 2007-04-09
• Study First Posted: 2007-04-11
• 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: 115

Inclusion Criteria

• Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline
• Methotrexate (10 mg/week to 25 mg/week) > 3 months prior to Day 0 (stable dose > 4 weeks prior to Day 0)
• Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy

Key

Exclusion Criteria

Medical History

• Serious local infection or systemic infection within 3 months of Day 0
• History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
• Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period

Laboratory Tests

• Clinically significant lab tests at screening; or
• Positive for hepatitis C antibody or hepatitis B at screening

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Comparator	Subcutaneous administration of placebo given every other week for 12 weeks
BG9924	BG9924	Subcutaneous administration of BG9924 given every other week for 12 weeks

Primary Outcome Measures

Name	Time	Method
Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy	26 weeks

Secondary Outcome Measures

Name	Time	Method
Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.	26 weeks
Assess the safety and tolerability of BG9924 in this participant population.	26 weeks

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States