Real-World Emulation of the SWEFOT Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT05051137
• Date of registration: 10/09/2021
• Prospective Registration: No
• Primary sponsor: Karolinska Institutet
• Public title: Real-World Emulation of the SWEFOT Trial SWEFOT-RWEM
• Scientific title: Comparison of Infliximab With Sulfasalazine/Hydroxychloroquine Initiated After Methotrexate by Rheumatoid Arthritis Patients Treated in Clinical Practice (Real-World Emulation of SWEFOT Trial)
• Date of first enrolment: January 12, 2006
• Target sample size: 509
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT05051137
• Study type: Observational

Countries of recruitment

Sweden

Contacts

• Name: Thomas Frisell, PhD
• Affiliation: Karolinska Institutet

Key inclusion & exclusion criteria

Inclusion criteria:

- Have started methotrexate less than 540 days after RA debut.

- Have used methotrexate for more then 30 days but less than 540 days before study
treatment start.

- Have a baseline DAS28-ESR of more than 3.2 at study treatment start.

- Were residents of Sweden within 5 years before study treatment start

Exclusion criteria:

- Have used other DMARDs (antirheumatic drugs) than methotrexate before treatment start

- Have initiated study treatments later than May 2020



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Infliximab

Drug: Sulfasalazine + Hydroxychloroquine

Primary Outcome(s)

Good EULAR Response [Time Frame: 9 months after study treatment initiation]

Secondary Outcome(s)

Good or Moderate EULAR Response [Time Frame: 9 months after study treatment initiation]

Secondary ID(s)

SWEFOT-RWEM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Harvard Medical School