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Treatments Against RA and Effect on FDG-PET/CT

NCT02374021 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2022-10-26

Study results available
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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).

Conditions

  • Arthritis, Rheumatoid

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Daniel Solomon · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02374021 on ClinicalTrials.gov