Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients (BATTER-UP)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: September 28, 2010
Last updated: February 7, 2013
Last verified: February 2013
The purpose of this study is to determine if researchers can find a way to predict if a specific patient with rheumatoid arthritis will be helped by anti-TNF medications.
||Observational Model: Cohort
Time Perspective: Prospective
||Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients
Primary Outcome Measures:
- Validation of the ability of an 8-gene biomarker set to differentiate between patients who meet or do not meet EULAR DAS-28 Good response criteria after treatment with anti-TNF therapy for 14 weeks in approximately 70 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
- •Comparison of the behavior of the 8-gene marker set in subjects who are anti-TNF naïve (approximately 200) versus those who begin their second anti-TNF treatment (sample size up to 100). [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- • Development, maintenance, and utilization of a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- •Discovery of novel genetic (DNA) predictors of response to anti-TNF therapy. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Whole blood, serum, plasma.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
Patients with rheumatoid arthritis (RA) are generally treated with Tumor Necrosis Factor-alpha (TNF) inhibitors as second-line therapy if an oral medication such as methotrexate (MTX) is not adequate to control the symptoms. If one anti-TNF therapy does not lead to adequate symptom control, the current standard of care dictates switching to another approved anti-TNF agent, even though response rates deteriorate with each cycle. Pilot research at Biogen Idec and academic collaborators has developed a panel of gene expression markers with approximately 90% positive and negative predictive values to identify individuals who did not achieve European League Against Rheumatism (EULAR) Disease Activity Score (DAS)-28 Good response after 14 weeks of treatment. Such a biomarker panel could be used as a diagnostic test to direct therapeutic options.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects who meet ACR criteria for 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.
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.
- Are 18 years of age or older.
- 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.
Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211678
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 28, 2010
||February 7, 2013
||United States: Food and Drug Administration
United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Connective Tissue Diseases
Immune System Diseases