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Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)

NCT00764725 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 487

Last updated 2008-12-23

No results posted yet for this study

Summary

The Swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (DMARDs), versus a combination including a newer "biological" anti-TNF medication. In order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (MTX). After 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by Eular.

Conditions

Interventions

DRUG

conventional DMARD combination

MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol

BIOLOGICAL

MTX plus anti-TNF

MTX + infliximab; can be changed to MTX + etanercept within protocol

Sponsors & Collaborators

Principal Investigators

  • Johan Bratt, MD PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2007-04-30
Completion
2008-12-31

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Entities

Diseases
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 NCT00764725 on ClinicalTrials.gov