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Stopping Anti-tumor necrosis factor Agents in Rheumatoid Arthritis (STARA) clinical trial
Investigator (PI): Constantinescu, Florina
Past Investigator: Weinstein, Arthur
Performing Organization (PO): (Current): Georgetown University, School of Medicine, Department of Medicine / (202) 687-0100
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2015
Final Year: 2022
Record Source/Award ID: PCORI/CER-1402-10522
Funding: Total Award Amount: $1,793,777
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background. Anti-tumor necrosis factor (TNF) medications such as etanercept, adalimumab, and infliximab, when added to standard treatment for patients with rheumatoid arthritis (RA), such as methotrexate, can result in significant benefit in joint inflammation. Some patients achieve clinical remission with few symptoms and normal blood tests. However, these anti-TNF medications are expensive, and may lead to serious infections and the development of lymphoma. Objectives: This clinical trial will attempt to determine whether RA patients who have been in long-term remission taking these anti-TNF medications can stop them without suffering a relapse of their RA compared to patients who continue to take the medications. We will also determine whether stopping the anti-TNF medications leads to more physical incapacity and more joint damage on X-rays. We also are studying whether we can predict who will flare and who will not, by careful analysis of the joint inflammation by examination, MRI, and ultrasound and by immunological blood testing. Methods: The study will enroll 291 patients at many research sites. Their RA has been in remission for at least 6 months on standard therapy and one of the anti-TNF agents. Study participants will continue to receive their standard medications and the injections or infusions but these will be either the anti-TNF drug that they were on or placebo. The participants, the investigators, and the treating rheumatologists will not know which is being administered. Study participants will be closely followed for a flare of active arthritis at any time, and during research visits every 3 months there will be detailed questions about joint pain, fatigue, physical impairments, and a full joint examination and blood tests. After the trial ends, participants will be called at 4-month intervals to see if they are well; they will fill out questionnaires on the computer about their health and return for a final visit at week 100. Patient outcomes: The main outcome is whether patients who have been in remission taking the anti-TNF medications can safely stop them and remain in long-term remission. This is a very important question for both patients with RA and their treating physicians. Patient and stakeholder engagement: Stakeholder investigators (rheumatologists) helped to develop the research trial protocol and a committee of patients, caregivers, and stakeholders has been struck to analyze the outcomes for clinical relevance and to participate in the ongoing conduct and monitoring of the study. Anticipated impact: This study will provide practicing rheumatologists and patients with RA knowledge about the likelihood of successfully withdrawing from anti-TNF agents and which RA patients may be effectively withdrawn. This should result in significant cost saving to the patient and society and may prevent long-term drug toxicity.
MeSH Terms:
  • Antirheumatic Agents /*administration & dosage
  • Arthritis, Rheumatoid /*drug therapy
  • Clinical Trials as Topic
  • Fatigue
  • Humans
  • Inflammation /drug therapy
  • Magnetic Resonance Imaging
  • Outcome Assessment, Health Care
  • Remission Induction
  • Time Factors
  • Tumor Necrosis Factor-alpha /*antagonists & inhibitors
  • X-Rays
Country: United States
State: District of Columbia
Zip Code: 20057
UI: 20153228
CTgovId: NCT01793519
Project Status: Ongoing
Record History: ('2019: Project extended to 2022. 2017: Project extended to 2020 and changed PI.',)