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STARA Study

 

Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis Study

'If I stop the medication, will I stay in remission?'

'My RA medication put me in remission, but I'm worried about the side effects'

 

'Do I have to take my RA medication forever?'

This study looks to answer these questions,

commonly asked by people with RA in remission who take anti-TNF agents.

You may qualify to participate if you:

  • Have been in remission for at least 6 months while taking anti-TNFs and DMARDs*

  • Take Enbrel® (etanercept), Humira® (adalimumab) or Remicade® (infliximab)

  • Want to help us improve quality of life of people with RA

*DMARDs (Disease-Modifying Antirheumatic Drugs) are a class of otherwise unrelated drugs defined by their use in RA to slow down disease progression, e.g. Trexall™ (methotrexate), ARAVA® (leflunomide), Plaquenil® (hydroxychloroquine), Azulfidine® (sulfasalazine), Azoran® (azathioprine), cyclosporine, injectable or oral gold 

Interested? Enter your information to learn more or call us at 315-557-8171.

Click here to view the study flyer and a letter created by our COMPACT Member, Pam Sinicrope. COMPACT (Committee of Patients, Caregivers, and Other Stakeholders) is a special committee of RA patients of family members created to provide feedback on various aspects of the study.

 

Why are we doing this study?

'I have been feeling better taking this drug for my RA for a few years now, when can I wean off?'. This question is commonly asked by patients with Rheumatoid arthritis (RA). RA is a disease that causes joint swelling and stiffness, especially in the fingers, wrists, feet, and ankles (PCORI). This trial will see if patients with RA can remain in remission off Enbrel, Humira, or Remicade. Participants will be randomly assigned to receive either their current medication or placebo for 11 months. Study visits occur every 2-3 months and the study medication is provided at no charge.

What's involved in the study?

(**from the Patient-Centered Outcomes Research Institute site)

The research team is enrolling about 300 patients ages 18 and older who have RA and who have been in remission for at least six months. These patients are taking standard therapy as well as anti-TNF medicine. Participants are continuing to take their standard medicine and either their anti-TNF medicine or a placebo, a formula with no active ingredients. The participants and their doctors do not know whether each patient is receiving the medicine or a placebo.

The team is closely following study participants to check for a flare up of arthritis. Every three months for one year, participants are completing a health survey about joint pain, fatigue, and physical problems. Participants also have a full joint exam and blood tests. After one year passes, the research team is asking participants to complete the health survey every four months for another year. Participants return for a final visit about two years after the study starts.

The research team is looking to see if patients can stop taking anti-TNF medicine without having a flare up of arthritis. The team is also comparing joint damage and ability to do normal daily activities for patients who stop taking the anti-TNF medicine and for patients who continue taking it.

Doctors who treat arthritis are helping to plan the study. Patients and caregivers are helping to make sure the study is focusing on questions that matter to patients.

Click here to read more.

"" This project was funded in whole or in part with federal funding (UL1TR00010101 previously UL1RR031975) from the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through the Clinical and Translational Science Awards Program (CTSA). , a trademark of DHHS, as part of the "Re-Engineering the Clinical Research Enterprise" project.