CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 159 enrolled
Drug / intervention
Methotrexate +4 moredrug
Likely dose
Methotrexate 15mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02374021
NCT02374021Phase 4Completed
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Treatments Against RA and Effect on FDG-PET/CT (The TARGET Trial)

Brigham and Women's Hospital·interventional·Posted Feb 27, 2015·Updated Oct 26, 2022

In Brief

A Phase 4 clinical trial evaluating Methotrexate, Sulfasalazine, and 3 other interventions for Arthritis, Rheumatoid. Completed, enrolled 159 participants across 31 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesUnited States
CollaboratorsColumbia University

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 27, 2015
Enrollment StartJul 1, 2016
Primary CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.3 years ago

Interventions

Methotrexatedrug

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.

Sulfasalazinedrug

1 gm bid

Hydroxychloroquinedrug

200 mg twice daily, not to exceed 6.5mg/kg

Etanerceptdrug

50 mg SC weekly

Adalimumabdrug

40 mg SQ every other week