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

Metagenomic analysis of the gut microbiota in patients with psoriatic arthritis upon treatment with the jak-stat inhibitor tofacitinib: correlations with immunological, clinical and imaging markers - MiCROBPsA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001773-90-IT

Enrollment

Registered

2021-06-17

Start date

2020-03-10

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Interventions

Trade Name: XELJANZ - Product Name: Tofacitinib Product Code: [N.A] Pharmaceutical Form: Film-coated tablet CAS Number: 477600-75-2 Current Sponsor code: Tofacitinib Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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: 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)	—

Measure

Time frame

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: 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)

—

Countries

Italy

Contacts

Public ContactUOC Medicina Interna

Azienda Ospedaliera Sant'Andrea

bruno.lagana@uniroma1.it0633775531

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026