Study for the research of predictive factors of response to Tofacitinib therapy in patients with ulcerative rectal colitis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universita' Degli Studi Di Roma Tor Vergata

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

16 Dec 2021 → 6 May 2025

Decision date (initial)

2024-11-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518577-34-00

EudraCT number

2018-004890-28

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Research of predictive factors for response to Tofacitinib therapy in patients with ulcerative rectal colitis

Conditions and MedDRA coding

Ulcerative colitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Provided written informed consent. 2. >18 years of age 3. Confirmed diagnosis of ulcerative colitis according to international guidelines (ECCO). 4. Patients with moderately-to-severely active disease, as defined as a Mayo score of 6-12, with a rectal bleeding subscore of 1 to 3. 5. Endoscopic Mayo subscore of 2-3. 6. Patients who had failure or intolerant to at least one of the following agents: oral or intravenous glucocorticoids, azathioprine, 6-mercaptopurine, infliximab, golimumab or adalimumab. 7. Because the effects of Tofacitinib on pregnancy are not fully understood, women in childbearing age have to avoid pregnancy. Therefore the above cited patients have to use a suitable contraceptive method such as diaphragm, spiral or contraceptive pill before entering the study, for its entire duration and for 15 weeks after the suspension of the aforementioned drug

Exclusion criteria 1

1. 1. Clinical findings suggestive of Crohn’s disease. 2. Ulcerative colitis limited to the distal 15 cm of colon. 3. Clinical signs of fulminant colitis, toxic megacolon, or indeterminate, microscopic, ischemic, or infectious colitis. 4. Patients at high risk of thromboembolism: 1) Patients with heart failure 2) Patients with inherited coagulation disorders 3) Patients who have history of venous thromboembolism, either deep venous thrombosis or pulmonary embolism. 4) Patients who use combined hormonal contraceptives or hormone replacement therapy. 5) Patients with malignancy 6) Patients undergoing major surgery 5. Known hypersensitivity/intolerance to tofacitinib (Xeljanz). 6. Presence of Child-Pugh class C hepatic impairment or eGFR<30 ml/min. 7. Chronic HIV, HBV, HCV infections (excluding patients with HCV infection treated with anti-viral agents in which serum HCV-RNA is not detectable). 8. Active TB or history of latent TB that has not been adequately treated, history of symptomatic herpes zoster (HZV) or any history of disseminated herpes simples (HSV) infections. Active opportunistic, clinically significant infections. 9. History of malignancy in the last 5 years. 10. Pregnant or lactating females. 11. Females of reproductive potential who are unwilling to abide by protocol specified contraceptive methods 8as defined by Appendix 1 in the Study protocol)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Immunological characterization

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universita' Degli Studi Di Roma Tor Vergata

Sponsor organisation

Universita' Degli Studi Di Roma Tor Vergata

Address

Via Montpellier 1

City

Rome

Postcode

00133

Country

Italy

Scientific contact point

Organisation

Universita' Degli Studi Di Roma Tor Vergata

Contact name

Massimo Claudio Fantini

Public contact point

Organisation

Universita' Degli Studi Di Roma Tor Vergata

Contact name

Massimo Claudio Fantini

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications