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TNF Inhibitor

Anti-tumor necrosis factor agent 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

STARA Trial 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.Check my eligibility

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.See study design

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.

STARA Trial 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.

STARA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Remission by Disease Activity Score - 28 over 48 weeks

Secondary outcome measures

Change in Health Assessment Questionnaire Disability Index over 48 weeks

Change in Sharp-van der Heijde radiographic score over 48 weeks

STARA 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

0 / 3Eligibility criteria met

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

552 Previous Clinical Trials

29,997,568 Total Patients Enrolled

3 Trials studying Rheumatoid Arthritis

1,450 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"Per the details on clinicaltrials.gov, recruitment for this trial is closed. The initial posting was made on January 1st, 2013, with the last update occurring on November 6th, 2019. While this specific study is no longer accepting participants, it's noteworthy that there are currently 410 alternative trials actively seeking enrollees."

Answered by AI

What are the risks associated with using anti-tumor necrosis factor agents in individuals?

"Given that this is a Phase 4 trial, the safety rating for the anti-tumor necrosis factor agent has been rated as 3 by our team at Power, indicating its established approval status."

Answered by AI

What is the collective count of individuals actively involved in this research trial?

"At present, this trial is not open for enrollment. Originally uploaded on January 1st, 2013, the last revision occurred on November 6th, 2019. For those interested in alternative research opportunities, there are currently 376 ongoing trials accepting participants with rheumatoid arthritis and an additional 34 studies actively enrolling individuals seeking Anti-tumor necrosis factor agents."

Answered by AI

Are there any previous research studies that have explored the use of Anti-tumor necrosis factor agents?

"At present, there are 34 ongoing studies exploring the Anti-TNF agent, with 4 trials in Phase III. While several clinical trials testing this agent are being conducted in Padova and Antwerpen, a total of 166 sites worldwide are actively engaged in research involving the Anti-tumor necrosis factor agent."

Answered by AI

For which medical condition is the anti-tumor necrosis factor drug frequently prescribed?

"The management of psoriasis often involves the use of anti-tumor necrosis factor agents. These medications are not only beneficial for addressing psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and phototherapy but also show promise in managing other related conditions."

Answered by AI

Is this a groundbreaking clinical study?

"Presently, there are 34 ongoing investigations on anti-tumor necrosis factor agents being carried out in 35 urban areas spanning across 18 nations. The inaugural exploration into these agents commenced back in the year of 2007 and was overseen by Wyeth, which is currently a fully integrated subsidiary under Pfizer's umbrella. This specific study enlisted the participation of 20 individuals and successfully navigated through its Phase 4 regulatory validation process. Subsequent to that initial inquiry dating back to over a decade ago, an impressive total of 20,563 research endeavors have been brought to fruition within this realm."

Answered by AI

Recent research and studies

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

Arthritis & RheumatismJournal

Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States: Part II

Lawrence, Reva C., David T. Felson, Charles G. Helmick, Lesley M. Arnold, Hyon Choi, Richard A. Deyo, Sherine Gabriel, et al.. 2007. “Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States: Part II”. Arthritis & Rheumatism. Wiley. doi:10.1002/art.23176.

clinicaltrials.govStudy

Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis

2013. "Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01793519.

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