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

June 6, 2014 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

301

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Murietta, California, United States
        • Research Site
    • Colorado
      • Longmont, Colorado, United States
        • Research Site
    • Delaware
      • Lewes, Delaware, United States
        • Research Site
    • Florida
      • Dunedin, Florida, United States
        • Research Site
      • Ocala, Florida, United States
        • Research Site
      • Orange Park, Florida, United States
        • Research Site
    • Illinois
      • Morton Grove, Illinois, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Massachusetts
      • Plymouth, Massachusetts, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
      • Reno, Nevada, United States
        • Research Site
    • New Jersey
      • Berkeley Heights, New Jersey, United States
        • Research Site
      • Summit, New Jersey, United States
        • Research Site
    • New York
      • Floral Park, New York, United States
        • Research Site
      • Orchard Park, New York, United States
        • Research Site
      • Smithtown, New York, United States
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • Research Site
      • Wilmington, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Mayfield Village, Ohio, United States
        • Research Site
      • Middleburg Heights, Ohio, United States
        • Research Site
    • Oklahoma
      • Edmund, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Mrytle Beach, South Carolina, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • San Anotnio, Texas, United States
        • Research Site
    • Virginia
      • Burke, Virginia, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Research Site
      • Spokane, Washington, United States
        • Research Site
    • Wisconsin
      • Franklin, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Key Inclusion Criteria

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.

Key Exclusion Criteria

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.

Note: Other protocol defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 14 weeks
14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 14 weeks
14 weeks
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
14 weeks
Discovery of novel genetic (DNA) predictors of response to anti-TNF therapy.
Time Frame: 14 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Crescendo Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 6, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999RA002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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