Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients
BATTER-UP
1 other identifier
observational
301
1 country
30
Brief Summary
The primary objective of this study was to validate the ability of an 8-gene biomarker set to differentiate between participants who met or did not meet European League Against Rheumatism (EULAR) Disease Activity Score (DAS)-28 Good Response criteria after treatment with anti-Tumor Necrosis Factor (TNF) therapy for 14 weeks in approximately 200 anti-TNF-naïve participants. The secondary objectives of this study was (i) to compare the behavior of the 8-gene marker set in participants who were anti-TNF naïve versus those who began their second anti-TNF treatment , (ii) to develop, maintain, and utilize a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses and (iii) to discover novel genetic (DNA) predictors of response to anti-TNF therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Typical duration for all trials
30 active sites
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
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJune 9, 2014
June 1, 2014
3.1 years
September 28, 2010
June 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Validation of the ability of an 8-gene biomarker set to differentiate between participants who meet or do not meet EULAR DAS-28 Good response criteria after treatment with anti-TNF therapy
14 weeks
Secondary Outcomes (3)
Comparison of the behavior of the 8-gene marker set in participants who are anti-TNF naïve versus those who begin their second anti-TNF treatment
14 weeks
Development, maintenance, and utilization of a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses.
14 weeks
Discovery of novel genetic (DNA) predictors of response to anti-TNF therapy.
14 weeks
Eligibility Criteria
Participants who meet American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA) and who, in the opinion of their treating rheumatologist, are not adequately treated with existing therapy and should begin treatment with either an anti TNF agent for the first time or with a different anti-TNF agent.
You may qualify if:
- To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of enrollment:
- Are willing and able to provide informed consent..
- Meet the ACR criteria for RA as determined by a rheumatologist who is board certified in Rheumatology or a member of the ACR.
- Have 4 or more tender and 4 or more swollen joints out of 28 joints as assessed by their treating rheumatologist or a trained joint assessor.
- Subjects are not taking any of the following treatments and/or have washed out for the minimum duration as defined below. If subjects are currently taking these treatments, must have been on a stable dosing regimen for the minimum duration as defined below:
- Oral DMARDs (MTX, hydroxychloroquine, sulfasalazine, leflunomide, cyclosporine, azathioprine): on drug for at least 3 months and washed out or stable for at least 6 weeks prior to baseline sample collection.
- Oral corticosteroids: washed out or stable AND ≤10 mg/day of prednisone equivalent for at least 4 weeks prior to baseline sample collection.
- Intraarticular or parenteral corticosteroids: Washed out or stable for at least 4 weeks prior to baseline sample collection.
- NSAIDs: Washed out or stable for at least 2 weeks prior to baseline sample collection.
- Are about to start treatment with an anti-TNF agent approved for the treatment of RA for the first time OR Have not, in the opinion of the treating rheumatologist, achieved or maintained an adequate response to treatment with their first anti-TNF agent (any anti-TNF agent approved for the treatment of RA), and have been prescribed a different anti TNF agent. Subjects who switch for any reason other than lack of efficacy will be excluded.
You may not qualify if:
- Any medical condition that would preclude safe use of an anti-TNF agent for at least 14 weeks.
- Previous participation in the present study as a subject in the anti-TNF-naïve group.
- Prior exposure to 2 or more anti-TNF agents.
- Prior exposure to Orencia (abatacept, or CTLA4-Ig) and/or Rituxan (anti CD20), or other biologic therapy for RA or other diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
- Crescendo Biosciencescollaborator
Study Sites (30)
Research Site
Murrieta, California, United States
Research Site
Longmont, Colorado, United States
Research Site
Lewes, Delaware, United States
Research Site
Dunedin, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Orange Park, Florida, United States
Research Site
Morton Grove, Illinois, United States
Research Site
Baltimore, Maryland, United States
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Plymouth, Massachusetts, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Reno, Nevada, United States
Research Site
Berkeley Heights, New Jersey, United States
Research Site
Summit, New Jersey, United States
Research Site
Floral Park, New York, United States
Research Site
Orchard Park, New York, United States
Research Site
Smithtown, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Mayfield Village, Ohio, United States
Research Site
Middleburg Heights, Ohio, United States
Research Site
Edmund, Oklahoma, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Mrytle Beach, South Carolina, United States
Research Site
Dallas, Texas, United States
Research Site
San Anotnio, Texas, United States
Research Site
Burke, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Spokane, Washington, United States
Research Site
Franklin, Wisconsin, United States
Biospecimen
Whole blood, serum, plasma.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2010
First Posted
September 29, 2010
Study Start
June 1, 2010
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
June 9, 2014
Record last verified: 2014-06