Study Stopped
Interim analysis of data failed to meet primary endpoint.
BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, PK, and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF
2 other identifiers
interventional
115
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 22, 2007
CompletedFirst Posted
Study publicly available on registry
April 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedJanuary 21, 2016
December 1, 2015
1.6 years
March 22, 2007
December 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy
26 weeks
Secondary Outcomes (2)
Assess the safety and tolerability of BG9924 in this participant population.
26 weeks
Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.
26 weeks
Study Arms (2)
BG9924
EXPERIMENTALSubcutaneous administration of BG9924 given every other week for 12 weeks
Placebo
PLACEBO COMPARATORSubcutaneous administration of placebo given every other week for 12 weeks
Interventions
Subcutaneous administration of placebo given every other week for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (1)
Stanford University
Palo Alto, California, 93404, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2007
First Posted
April 11, 2007
Study Start
March 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
January 21, 2016
Record last verified: 2015-12