Back to resultsBG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BG9924
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Active Rheumatoid Arthritis (RA)
Eligibility Criteria
Key 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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BG9924
Placebo
Arm Description
Subcutaneous administration of BG9924 given every other week for 12 weeks
Subcutaneous administration of placebo given every other week for 12 weeks
Outcomes
Primary Outcome Measures
Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy
Secondary Outcome Measures
Assess the safety and tolerability of BG9924 in this participant population.
Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00458861
Brief Title
BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis of data failed to meet primary endpoint.
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Active Rheumatoid Arthritis (RA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BG9924
Arm Type
Experimental
Arm Description
Subcutaneous administration of BG9924 given every other week for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous administration of placebo given every other week for 12 weeks
Intervention Type
Biological
Intervention Name(s)
BG9924
Intervention Description
Subcutaneous administration of BG9924 given every other week for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Intervention Description
Subcutaneous administration of placebo given every other week for 12 weeks
Primary Outcome Measure Information:
Title
Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Assess the safety and tolerability of BG9924 in this participant population.
Time Frame
26 weeks
Title
Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
93404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
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