NCT02374021

Treatments Against RA and Effect on FDG-PET/CT

Treatments Against RA and Effect on FDG-PET/CT (The TARGET Trial)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

In a randomized controlled clinical trial, investigators will compare the effects on \[18F\]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening).

Detailed description

Consenting subjects will be screened for eligibility and randomized to a treatment arm. Subjects will be randomized to a treatment arm with either synthetic disease-modifying antirheumatic drugs (DMARDs) \[triple therapy: sulfasalazine, methotrexate, and hydroxychloroquine\] or biologic DMARDs \[etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening\]. Once randomized, a baseline visit will be conducted with each subject. Baseline data collection includes questionnaires, disease activity score, and the first FDG-PET/CT imaging. After the baseline at week 0, subjects will visit with their rheumatologist at weeks 6, 12, 18, and 24 for safety labs and further collection of disease activity scores and questionnaires. The second FDG-PET/CT will be performed at week 24. Blood specimens will be collected at weeks 0, 6, 18, and 24 for bioassays. Subject participation will end after the week 24 visit. Patients and care providers will be unblinded. The FDG-PET/CT image readers will be blinded to treatment arm as well as timepoint of image acquisition.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Methotrexate	Subjects entering trial will continue on MTX dose of at least 15mg MTX/week. At the discretion of the treating rheumatologist, may be switched to SQ route.
DRUG	Sulfasalazine	1 gm bid
DRUG	Hydroxychloroquine	200 mg twice daily, not to exceed 6.5mg/kg
DRUG	Etanercept	50 mg SC weekly
DRUG	Adalimumab	40 mg SQ every other week

Timeline

• Start date: 2016-07-01
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2015-02-27
• Last updated: 2022-10-26
• Results posted: 2022-10-26

Locations

31 sites across 1 country: United States