Status:
ACTIVE_NOT_RECRUITING
Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Maryland, Baltimore
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Background: * Rheumatoid arthritis (RA) is often treated with drugs known as tumor necrosis factor (TNF) inhibitors, that can help decrease joint pain and swelling and can even result in RA remission...
Detailed Description
Remission of rheumatoid arthritis (RA) is an achievable goal with currently available medications, including the anti-tumor necrosis factor (anti-TNF) agents. However, it is uncertain if patients with...
Eligibility Criteria
Inclusion
- Study personnel will evaluate participant eligibility using a checklist of inclusion and exclusion criteria as outlined below. Clinical information will be obtained from subjects by interview and from the medical record.
- At the screening visit, potential participants will be included if:
- Age greater than or equal to 18 years
- Have RA, as defined by the 1987 revised American College of Rheumatology criteria
- In sustained clinical remission for the last 6 months while receiving treatment with either etanercept, infliximab, or adalimumab, and greater than or equal to 1 DMARD (methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, minocycline, cyclosporine, azathioprine, gold, penicillamine). DAS28 should be less than 2.6 on each visit over the preceding 6 months, with at least one visit 2-4 months before enrollment. If there is no visit 6 months before enrollment, the nearest visit in the 6-12 month period before enrollment should be considered and have a DAS28 less than 2.6.
- Potential participants will be excluded if:
- Had dose increase of anti-TNF agent or DMARD in the last 6 months
- Had change of anti-TNF agent or DMARD in the last 6 months
- Treated currently with golimumab or certolizumab
- Treated with greater than 10 mg of prednisone (or equivalent) daily in the last 6 months
- Treated with greater than 5 mg of prednisone (or equivalent) daily in the last 3 months
- Treated with intramuscular or intravenous corticosteroids in the last 6 months for RA activity
- Treated with anakinra, abatacept, or tocilizumab in the last 6 months
- Treated with rituximab in the last 12 months
- Treated with an investigational RA drug in the last 6 months
- Pregnant (or anticipate pregnancy during the study period) or lactating women
- Absence of documentation in the medical record of clinical remission for the last 6 months
- Unwilling to discontinue anti-TNF agent
- Absence of documentation of negative tuberculin skin test, negative QuantiFERON-TB Gold test, or treatment for latent tuberculosis prior to starting treatment with the anti-TNF agent
- Treatment of solid malignancy or non-melanoma skin cancer within the past 5 years, or any history of melanoma or hematologic or lymphoproliferative malignancy
- Absence of documentation of age-appropriate cancer screening at the time of randomization
- Absence of documentation of negative hepatitis B serologies, absence of completion of treatment for chronic hepatitis B, or absence of suppressive antiviral treatment
- Unable to provide informed consent
- Anticipate not being available or able to comply with the schedule of study visits
- Study entry is not limited by gender or ethnicity. Children are excluded because inflammatory polyarthritis developing before age 16 is considered juvenile idiopathic arthritis and not RA. Patients who developed RA while age 17 would be eligible, but given the time needed to achieve remission, these patients would in most cases be 18 or older by the time they would meet other criteria for study entry.
- Participants will largely be recruited from the practices of study investigators. To identify potential subjects, investigators may search rosters of patients in their practice for patients who meet the inclusion criteria. The number of patients screened and reasons for exclusion will be tabulated at each site. Subjects may also be recruited by physician referral. Information about the study will be mailed to local rheumatologists and posted on the NIAMS website. We do not anticipate self-referral of subjects but eligible self-referred subjects will not be excluded.
- During the course of the study, enrollment of subjects treated with a particular anti-TNF agent may be suspended or terminated to permit adequate representation of patients treated with each of the 3 anti-TNF medications, due to problems procuring medication, or due to other unforeseen issues.
Exclusion
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT01793519
Start Date
January 1 2013
End Date
August 30 2024
Last Update
February 28 2024
Active Locations (2)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
2
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892