Analysis of Gut bacteria in patients with psoriatic arthritis upon treatment with tofacitinib correlations with serologic, clinical and ultrasound markers of disease activity

Phase 1

• Conditions: Psoriatic Arthritis; MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-001773-90-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SANT'ANDREA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

-Male or female, 18 to 65 years of age, inclusive
-PsA diagnosis according to the CASPAR criteria, moderate to severe activity (more than 4 swollen joints and/or DAPSA = 15 and/or ASDASpcr = 1.3 and/or BASDAI =4),
-able to understand the study procedures and sign the informed consent.
-Current therapy with methotrexate at standard dosage.
-Inadequate responder, as for EULAR response criteria, to at least six months methotrexate therapy at standard dosage
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Any sort of contraindications to tofacitinib at the time of enrolment as for local label (SmPc), hypersensitivity to the active substance or to any of the excipients, active tuberculosis, serious infections such as sepsis or opportunistic infections, severe hepatic impairment, pregnancy and lactation, malignancies, known risk factors for VTE, any uncontrolled clinically significant laboratory abnormality, experiencing intolerance to MTX

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Aim of this prospective study is to analyse the variety and composition of the gut microbiota in PsA patients before and upon treatment with the jak-stat inhibitor tofacitinib throughout a 1-year follow-up.;Secondary Objective: Correlations between the gut microbiota composition and validated immunological/clinical and US parameters of disease activity will also be evaluated aiming at identifying possible predictors markers of tofacitinib effectiveness.;Primary end point(s): The mean change from baseline in microbial diversity and the mean microbial variations at each taxonomic level at T2 and T4;Timepoint(s) of evaluation of this end point: At six and twelve months from baseline visit (T2 and T4)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Correlations between gut micro-organisms variations at each taxonomic level, and disease activity changes from baseline at T2 and T4 in particular:<br>DAPSA, BASDAI, ASDAS at the clinical examination, power-doppler signal, synovial hypertrophy and tendon thickness at the ultrasonography;Timepoint(s) of evaluation of this end point: At six and twelve months from baseline visit (T2 and T4)