Real-world Effectiveness of Tofacitinib on Ulcerative Colitis Associated Spondyloarthropathy

NCT05431283 | Unknown

• 1 other identifier: 007
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Spondyloarthropathy

Outcome Measures

Primary Outcomes (3)

• 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

• joint response and steroid free joint response

  evaluate the rate of patients achieving joint response on Ulcerative Colitis-associated spondyloarthropathy

  week 24

• 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 Outcomes (11)

• clinical intestinal response CIR

  week 8

• clinical intestinal response CIR

  week 24

• clinical intestinal response CIR

  week 52

• steroid free clinical intestinal remission

  week 52

• impact of Ulcerative Colitis

  week 8

Interventions

Tofacitinib DRUG

This study aims to assess the effectiveness of TOFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients aged 18 years or older admitted at each IG-IBD center that agrees to participate could be be screened for inclusion

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Italian Group for the study of Inflammatory Bowel Disease (IG-IBD): lead

Study Sites (1)

IBD Unit, Department of Internal Medicine, "Villa Sofia-Cervello" Hospital

Palermo, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Spondylarthropathies

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Central Study Contacts

Carola Lauritano

CONTACT

+393397793868; ctm@igibd.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: June 24, 2022
• Study Start: April 25, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

IT (1)