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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003006-31-IT

Enrollment

Registered

2021-08-02

Start date

2021-02-08

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Ulcerative colitis and concomitant peripheral arthritis MedDRA version: 20.0 Level: LLT Classification code 10045282 Term: UC System Organ Class: 100000004856

Interventions

Product Name: TOFACINITIB Product Code: [TOFACINITIB] Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: TOFACINITIB CAS Number: 477600-75-2 Current Sponsor code: TOFACINITIB Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Description of baseline and post treatment CM and ST specific profile in terms of CD68+, CD21+, CD20+, CD3+ and CD117+ and JAK/STAT activation pathway of UC patients with concomitant peripheral arthritis possibly associated with JAK inhibitor response. Secondary objectives;Secondary Objective: Obtain the gene signature of synovial tissue and colonic mucosa of UC patients with peripheral joint involvement and a list of deregulated gene of synovial tissue and colonic mucosa paired samples.;Primary end point(s): -Primary endpoint: to indentify mucosal and synovial biomarkers predicting response to tofacinitib in patients affected by UC and concomitant peripheral arthrits at 12 months; Response to tofacitinib therapy will be measured in terms of: -clinical remission of UC, defined as =2 points and no individual subscore >1 point of PMS; 7 -clinical remission defined as DAS44 < 1.6 and/or Boolean defined remission (ACR EULAR Classification criteria)10-11;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Main Objective: Description of baseline and post treatment CM and ST specific profile in terms of CD68+, CD21+, CD20+, CD3+ and CD117+ and JAK/STAT activation pathway of UC patients with concomitant peripheral arthritis possibly associated with JAK inhibitor response. Secondary objectives;Secondary Objective: Obtain the gene signature of synovial tissue and colonic mucosa of UC patients with peripheral joint involvement and a list of deregulated gene of synovial tissue and colonic mucosa paired samples.;Primary end point(s): -Primary endpoint: to indentify mucosal and synovial biomarkers predicting response to tofacinitib in patients affected by UC and concomitant peripheral arthrits at 12 months; Response to tofacitinib therapy will be measured in terms of: -clinical remission of UC, defined as =2 points and no individual subscore >1 point of PMS; 7 -clinical remission defined as DAS44 < 1.6 and/or Boolean defined remission (ACR EULAR Classification criteria)10-11;Timepoint(s) of evaluation of this end point: 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): -Secondary endpoint: to characterize the gene signature of synovial tissue and colonic mucosa of UC patients with concomitant peripheral arthrits.;Timepoint(s) of evaluation of this end point: 24 months	—

Countries

Italy

Contacts

Public ContactDOREZIONE SCIENTIFICA

FONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI IRCCS

DIREZIONE.SCIENTIFICA@POLICLINICOGEMELLI.IT0630155701

Outcome results

None listed

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