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Real-World Emulation of the SWEFOT Trial

NCT05051137 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 509

Last updated 2021-09-28

No results posted yet for this study

Summary

This study will compare rheumatoid arthritis (RA) patients who have been treated in clinical practice with either infliximab or a combination of sulfasalazine and hydroxychloroquine, after having an active disease despite treatment with methotrexate for at least one month. To establish which patients respond to treatment, DAS28-ESR measurements (disease activity score using 28 joints and erythrocyte sedimentation rate) taken at treatment start and nine months thereafter, and the EULAR (European League Against Rheumatism) definition of a "good response" will be employed.

The purpose of the study is to verify if the same conclusion could be reached using data from patients treated in real world clinical practice as in a previous randomized controlled trial comparing the two treatment strategies (SWEFOT -- ClinicalTrials.gov Identifier: NCT00764725).

Inclusion criteria similar to the ones used in the emulated trial will be applied.

In real clinical practice, patients who receive infliximab may have more severe RA and may also differ in other ways from patients receiving sulfasalazine and hydroxychloroquine. To be able to compare the proportions of responders under each treatment in this "real-world" setting, the data will be re-weighted, so that patient characteristics become balanced between treatment groups.

Conditions

Interventions

BIOLOGICAL

Infliximab

Initiation of infliximab in any dose and frequency of administration. Could be discontinued for safety reasons and replaced by etanercept.

DRUG

Sulfasalazine + Hydroxychloroquine

Initiation of sulfasalazine and hydroxychloroquine not more than 180 days apart, in any dose and frequency of administration. Any one of the two drugs could be discontinued. while continuing the other, or both could be replaced by cyclosporine, for safety reasons.

Sponsors & Collaborators

Principal Investigators

  • Thomas Frisell, PhD · Karolinska Institutet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-12
Primary Completion
2020-11-16
Completion
2020-11-16

Countries

  • Sweden

Study Locations

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Entities

Drugs
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 NCT05051137 on ClinicalTrials.gov