RETUCAS: Real-world Effectiveness of Tofacitinib on Ulcerative Colitis Associated Spondyloarthropathy

Sponsor

Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) (Other)

Overall Status

Recruiting

CT.gov ID

NCT05431283

Collaborator

(none)

100

Enrollment

Location

20.2

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Spondyloarthropathy	Drug: Tofacitinib

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, all enrolled patients will undergo a detailed assessment including gender, age, duration of disease, smoking status, extension of disease (according to Montreal classification), clinical activity (assessed with the partial Mayo Score), C-Reactive Protein (CRP) values, faecal calprotectin, previous and concomitant therapies, data on SpA (axial vs. peripheral SpA, and assessment of ASDAS-CRP and/or DAS28-CRP scores). The joint response (JR), steroid free joint response (SFJR), clinical intestinal response (CIR), steroid free clinical intestinal remission (SFCIR), CRP and calprotectin values will be assessed at 8, 24 and 52 weeks (see further for the definitions of the outcomes). The burden of UC and therapy with TOFA on work productivity and health- related quality of life will be evaluated through the administration of the Work Productivity and Activity Impairment (WPAI) Questionnaire and the Short Inflammatory Bowel Disease Questionnaire Score (Short IBDQ), respectively, at baseline and at 24 and 52 weeks. The patients will be assessed with direct visits and biochemical evaluations, including monitoring of serum lipid levels, according to the routine clinical practice established for subjects treated with TOFA. The support by a rheumatologist is suggested in the clinical evaluation of patients All data will be collected anonymously in a specifically arranged eCRF form inside the IG-IBD registry.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Efficacia Nel Mondo Reale di Tofacitinib Sulla Spondiloartropatia Associata Alla Colite Ulcerosa

Actual Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

joint response and steroid free joint response [week 8]
evaluate the rate of patients achieving joint response and steroid free joint response on Ulcerative Colitis-associated spondyloarthropathy at week 8, 24, and 52
joint response and steroid free joint response [week 24]
evaluate the rate of patients achieving joint response on Ulcerative Colitis-associated spondyloarthropathy
joint response and steroid free joint response [week 52]
evaluate the rate of patients achieving joint response and steroid free joint response on Ulcerative Colitis-associated spondyloarthropathy

Secondary Outcome Measures

clinical intestinal response CIR [week 8]
To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis
clinical intestinal response CIR [week 24]
To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis
clinical intestinal response CIR [week 52]
To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis
steroid free clinical intestinal remission [week 52]
To assess the rate of patients achieving a steroid free clinical intestinal remission for Ulcerative Colitis
impact of Ulcerative Colitis [week 8]
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
impact of Ulcerative Colitis [week 24]
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
impact of Ulcerative Colitis [week 52]
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
health-related quality of life [week 24 and 52]
To assess the health-related quality of life of the patients with the administration of the Short IBDQ at baseline
health-related quality of life [week 52]
To assess the health-related quality of life of the patients with the administration of the Short IBDQ at baseline
adverse events [24 month]
To report the rate of adverse events with TOFA
redictors of joint response JR, steroid free joint response SFJR, clinical intestinal response CIR, and steroid free clinical intestinal remission SFCIR [24 month]
To assess the predictors of joint response JR, steroid free joint response SFJR, clinical intestinal response CIR, and steroid free clinical intestinal remission SFCIR

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)