Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients (BATTER-UP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Crescendo
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01211678
First received: September 28, 2010
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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.


Condition
Arthritis, Rheumatoid

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

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 ]

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 ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma.


Estimated Enrollment: 300
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria

To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of enrollment:

  1. Are willing and able to provide informed consent.
  2. Are 18 years of age or older.
  3. Meet the ACR criteria for RA as determined by a rheumatologist who is board certified in Rheumatology or a member of the ACR.
  4. 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.
  5. 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.
  6. 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.

Exclusion Criteria

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:

  1. Any medical condition that would preclude safe use of an anti-TNF agent for at least 14 weeks.
  2. Previous participation in the present study as a subject in the anti-TNF-naïve group.
  3. Prior exposure to 2 or more anti-TNF agents.
  4. Prior exposure to Orencia (abatacept, or CTLA4-Ig) and/or Rituxan (anti CD20), or other biologic therapy for RA or other diseases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211678

  Show 30 Study Locations
Sponsors and Collaborators
Biogen Idec
Crescendo
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01211678     History of Changes
Other Study ID Numbers: 999RA002
Study First Received: September 28, 2010
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014