Stopping Anti-Tumor Necrosis Factor Agents in Rheumatoid Arthritis (STARA) Clinical Trial

Background: Anti-tumor necrosis factor (anti-TNF) medications, such as etanercept, adalimumab, and infliximab, when added to standard treatment for patients with rheumatoid arthritis (RA) can result in significant benefit for 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 lymphoma.  

Objectives: This clinical trial will examine whether RA patients who have been in long-term remission while taking anti-TNF medications and stop those medications have a higher relapse rate than those who continue to take them. We will also determine whether stopping anti-TNF medications leads to more physical incapacity and more joint damage observed on X-rays. We will try to predicts, by immunological blood testing and careful analysis of the joint inflammation by examination, MRI, and ultrasound, which patients will experience a flare of active arthritis.

Methods: The study will enroll 291 patients at many research sites. Their RA will have been in remission for at least six months on standard therapy while taking an anti-TNF medication. Study participants will continue to receive their standard medications, such as methotrexate, and receive injections or infusions of either their anti-TNF drug or a placebo. The participants, investigators, and treating rheumatologists will not know whether each patient is receiving the drug or placebo. Study participants will be closely followed for a flare of active arthritis at any time, and during research visits every three months they will answer detailed questions about joint pain, fatigue, and physical impairments and undergo a full joint examination and blood tests. After the trial ends, participants will be called at four-month intervals to see whether they are well, and they will complete a health questionnaire. Participants will return for a final visit at week 100.

Patient Outcomes: The main outcome is whether patients who have been in remission and are taking anti-TNF medications can stop them but remain in long-term remission. This question is very important to both patients with RA and their treating physicians.