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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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
574 Previous Clinical Trials
27,078,769 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
1,450 Patients Enrolled for Rheumatoid Arthritis
~23 spots leftby Nov 2025
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