Status:
UNKNOWN
Real-world Effectiveness of Tofacitinib on Ulcerative Colitis Associated Spondyloarthropathy
Lead Sponsor:
Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
Conditions:
Ulcerative Colitis
Spondyloarthropathy
Eligibility:
All Genders
18+ years
Brief Summary
Tofacitinib (TOFA) is a JAK inhibitor already used in rheumatology for the treatment of moderate-to-severe active rheumatoid arthritis and psoriatic arthritis in adult patients who have responded inad...
Detailed Description
Participants will receive TOFA at study entry (week 0) as treatment for UC according to standard clinical practice and recommended dosage of the drug, and will be followed up to 52 weeks. At baseline,...
Eligibility Criteria
Inclusion
- An established diagnosis of UC and an established diagnosis of axial and/or peripheral SpA according to the Assessment of Spondyloarthritis international Society (ASAS) criteria
- Indication for treatment with TOFA as a therapy for UC according to the clinical practice and summary of product characteristics
- Active SpA at baseline assessed with an Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP ≥ 1.3 in case of axial SpA, and with a disease activity score (DAS)28-CRP ≥ 2.6 in case of peripheral SpA.
- Capability to express a written informed consent for the study
Exclusion
- Rheumatologic diseases other than UC-associated SpA (for example, previous diagnosis of rheumatoid arthritis or psoriatic arthritis)
- Inactive SpA at baseline
- Inability to understand or sign the informed consent
- Contraindications to treatment with TOFA (pregnancy, risk factors for venous thromboembolism, active infections, hepatic failure)
Key Trial Info
Start Date :
April 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05431283
Start Date
April 25 2022
End Date
December 31 2023
Last Update
June 24 2022
Active Locations (1)
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1
IBD Unit, Department of Internal Medicine, "Villa Sofia-Cervello" Hospital
Palermo, Italy