Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients

Arthritis, Rheumatoid Clinical Trial

— BATTER-UP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211678
• Other study ID #: 999RA002
• Status: Completed
• Phase: N/A
• First received: September 28, 2010
• Last updated: June 6, 2014
• Start date: June 2010
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Crescendo Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Development, maintenance, and utilization of a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses.		14 weeks	No
Secondary	Discovery of novel genetic (DNA) predictors of response to anti-TNF therapy.		14 weeks	No