drugset / Trial / NCT02374021

Treatments Against RA and Effect on FDG-PET/CT

NCT02374021

RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start
2016-07
Primary completion
2021-05
Completion
2021-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Comparator Etanercept Protein / enzyme biologic 50 mg Subcutaneous
Comparator Hydroxychloroquine Small molecule 200 mg
Comparator Sulfasalazine Small molecule 1 g
Comparator Methotrexate Small molecule 15 mg Subcutaneous

Indications