Ulcerative Colitis Clinical Trial
— RETUCASOfficial title:
Efficacia Nel Mondo Reale di Tofacitinib Sulla Spondiloartropatia Associata Alla Colite Ulcerosa
NCT number | NCT05431283 |
Other study ID # | 007 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 25, 2022 |
Est. completion date | December 31, 2023 |
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 inadequately to, or who are intolerant to one or more disease- modifying antirheumatic drugs. Furthermore, TOFA has been recently approved for the treatment of adult patients with moderate-to-severe active Ulcerative Colitis (UC) who had no response, lose response, or were intolerant to either conventional therapy or a biologic agent. The approval was based on the efficacy demonstrated by TOFA in three phase 3 randomized controlled trials named OCTAVE: two identically designed, 8-week, placebo- controlled, induction studies of oral TOFA 10 mg twice daily followed by the OCTAVE Sustain 52-week maintenance study. About sacroiliitis, 2 out of 8 patients treated with TOFA improved after 8 weeks, compared with 0 out of 3 patients in the placebo group. Obviously, these data should be interpreted with extreme caution since patient numbers were very low, and it should be again emphasized that these trials were not designed to explore the efficacy of TOFA onextraintestinal manifestations. On these premises, we designed a prospective, multicenter, observational, 52-week study with the aim of assess the effectiveness of TOFA on UC-associated spondyloarthropathy.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: 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) |
Country | Name | City | State |
---|---|---|---|
Italy | IBD Unit, Department of Internal Medicine, "Villa Sofia-Cervello" Hospital | Palermo |
Lead Sponsor | Collaborator |
---|---|
Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | joint response and steroid free joint response | evaluate the rate of patients achieving joint response and steroid free joint response on Ulcerative Colitis-associated spondyloarthropathy at week 8, 24, and 52 | week 8 | |
Primary | joint response and steroid free joint response | evaluate the rate of patients achieving joint response on Ulcerative Colitis-associated spondyloarthropathy | week 24 | |
Primary | joint response and steroid free joint response | evaluate the rate of patients achieving joint response and steroid free joint response on Ulcerative Colitis-associated spondyloarthropathy | week 52 | |
Secondary | clinical intestinal response CIR | To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis | week 8 | |
Secondary | clinical intestinal response CIR | To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis | week 24 | |
Secondary | clinical intestinal response CIR | To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis | week 52 | |
Secondary | steroid free clinical intestinal remission | To assess the rate of patients achieving a steroid free clinical intestinal remission for Ulcerative Colitis | week 52 | |
Secondary | impact of Ulcerative Colitis | To assess the impact of Ulcerative Colitis and therapy with TOFA on Work Productivity and Activity Impairment through the administration of WPAI Questionnaire at baseline | week 8 | |
Secondary | impact of Ulcerative Colitis | To assess the impact of Ulcerative Colitis and therapy with TOFA on Work Productivity and Activity Impairment through the administration of WPAI Questionnaire at baseline | week 24 | |
Secondary | impact of Ulcerative Colitis | To assess the impact of Ulcerative Colitis and therapy with TOFA on Work Productivity and Activity Impairment through the administration of WPAI Questionnaire at baseline | week 52 | |
Secondary | health-related quality of life | To assess the health-related quality of life of the patients with the administration of the Short IBDQ at baseline | week 24 and 52 | |
Secondary | health-related quality of life | To assess the health-related quality of life of the patients with the administration of the Short IBDQ at baseline | week 52 | |
Secondary | adverse events | To report the rate of adverse events with TOFA | 24 month | |
Secondary | redictors of joint response JR, steroid free joint response SFJR, clinical intestinal response CIR, and steroid free clinical intestinal remission SFCIR | To assess the predictors of joint response JR, steroid free joint response SFJR, clinical intestinal response CIR, and steroid free clinical intestinal remission SFCIR | 24 month |
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