Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritis

Phase 1

• Conditions: lcerative colitis and concomitant peripheral arthritis; MedDRA version: 20.0Level: LLTClassification code 10045282Term: UCSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-003006-31-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-02
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Male and female patients, 18-70 years old
•A moderately-to-severely active UC and a concomitant active peripheral arthritis.
•Indication in clinical practice to start therapy with tofacitinib
•Fertile female who accepts to not get pregnant during the study (see Appendix 1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

-Patients not able to provide a written informed consent
-Any contraindication to tofacitinib, according to RCP:
- hypersensitivity to the active substance or to any of the excipients;
- active tuberculosis, serious infections, opportunistic infections, sepsis;
-pregnancy and breastfeeding;
-severe hepatic impairment (Child Pugh C);
-Haemoglobin < 9 g/dl;
-absolute lymphocyte count <750 cells/mm3 and absolute neutrophil count < 1000/mm3;
-Concomitant therapy with biological therapies, such as anti TNF-alpha, IL-1R or IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL12-23 antagonists, anti-integrins, or other immunosuppressants such as thiopurines (azatioprina or 6-mercaptopurine), cyclosporine and tacrolimus, according to RCP.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified