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TNF Inhibitor
Stopping TNF Inhibitors for Rheumatoid Arthritis (STARA Trial)
Phase 4
Waitlist Available
Led By Florina Constantinescu, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Age greater than or equal to 18 years
Must not have
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
Absence of documentation of age-appropriate cancer screening at the time of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is testing whether people in remission from RA can stay in remission after discontinuing use of a TNF inhibitor drug, and whether clinical, imaging and immunological measurements can help predict which patients will flare after discontinuing the drug.
Who is the study for?
This trial is for adults over 18 with Rheumatoid Arthritis (RA) that's under control using TNF inhibitors. The study aims to enroll 291 patients who are in remission and will test if they can stay in remission without these drugs.
What is being tested?
The trial is testing whether RA patients can remain in remission after stopping TNF inhibitors like Etanercept, Adalimumab, or Infliximab. Participants will either continue their medication or switch to a placebo, with follow-ups over two years.
What are the potential side effects?
Potential side effects of continuing TNF inhibitors include an increased risk of serious infections and certain types of cancer. Stopping the drug may lead to a return of RA symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've been in remission for 6 months, on specific treatments, with low disease activity.
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I am 18 years old or older.
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I have been diagnosed with rheumatoid arthritis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had tests or treatment for TB before starting anti-TNF therapy.
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I haven't had the recommended cancer screenings for my age.
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I am currently being treated with golimumab or certolizumab.
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I have taken more than 10 mg of prednisone daily in the past 6 months.
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I have taken more than 5 mg of prednisone daily in the past 3 months.
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I am not willing to stop taking my anti-TNF medication.
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I have been treated with anakinra, abatacept, or tocilizumab in the past 6 months.
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I haven't been tested or treated for hepatitis B.
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I have not had treatment for solid tumors or non-melanoma skin cancer in the last 5 years, and I have no history of melanoma or blood cancers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Anti-tumor necrosis factor agentActive Control3 Interventions
Anti-TNF agent - etanercept, infliximab, adalimumab - administered parentally at standard dosage and frequencies
Group II: PlaceboPlacebo Group1 Intervention
Administered appropriately to active comparator
Find a Location
Who is running the clinical trial?
The Arthritis Clinic of Northern Virginia, P.C.UNKNOWN
Arthritis & Rheumatism Associates, P.C.OTHER
2 Previous Clinical Trials
30 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
576 Previous Clinical Trials
27,079,397 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
1,450 Patients Enrolled for Rheumatoid Arthritis
Rheumatology Associates of Baltimore, L.L.C.UNKNOWN
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
498 Previous Clinical Trials
1,089,296 Total Patients Enrolled
45 Trials studying Rheumatoid Arthritis
560,718 Patients Enrolled for Rheumatoid Arthritis
Arthritis and Pain Associates of PG CountyUNKNOWN
Arthritis and Rheumatic Disease Associates, P.C.UNKNOWN
Georgetown UniversityLead Sponsor
350 Previous Clinical Trials
138,874 Total Patients Enrolled
University of Maryland, College ParkOTHER
158 Previous Clinical Trials
46,073 Total Patients Enrolled
University of Maryland, BaltimoreOTHER
713 Previous Clinical Trials
379,080 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
44 Patients Enrolled for Rheumatoid Arthritis