TOFACITINIB for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- Over 18 years old.\n- Diagnosis of UC according to the criteria of the European Crohn’s and Colitis Organisation (ECCO).\n- Have indication of treatment with anti-TNFα (infliximab, adalimumab or golimumab) o tofacitinib\n- Be the first received JAK-inhibitor or anti-TNFα with a given mechanism of action.\n- Have endoscopic activity of UC within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).\n- women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are: 1. Intrauterine device (IUD). 2. Bilateral tubal occlusion. 3. Couple with vasectomy. 4. Sexual abstinence."}

Exclusion criteria

• {"criterion_text":"- Under 18 years old.\n- Pregnancy or lactation.\n- Alcohol or drug abuse.\n- Ostomy.\n- Colectomy.\n- Active infection with hepatitis B, C or HIV virus.\n- Indication of anti-TNFα or JAK-inhibitors treatment for a cause other than UC.\n- abdominal surgery in the last 6 months\n- Have previously received a drug with the same mechanism of action (anti-TNFα or JAK-inhibitors)\n- Medical history of thromboembolic events.\n- Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.\n- Use of combined hormonal contraceptives or hormone replacement therapy.\n- Hereditary coagulation disorders.\n- Refusal to give consent for participation in the study.\n- Immune-mediated disease.\n- Neoplasm or active infection."}

Primary endpoints

• {"endpoint_text":"- Platelet activation status will be assessed ex vivo in platelet-rich plasma (PRP) samples from UC patients (active and quiescent) and healthy controls incubated in the absence or presence of drug (tofacitinib or anti-TNFα). Regarding the in vivo study, platelet activation will be analyzed in samples from patients with active UC before and after initiating treatment with tofacitinib or anti-TNFα. It will be mesured by rate of platelet agregation","definition_or_measurement_approach":"Platelet activation assessed ex vivo in platelet-rich plasma (PRP) samples from UC patients and healthy controls incubated with/without drug; in vivo platelet activation analyzed in patient samples before and after treatment initiation. Measurement: rate of platelet aggregation."}

Secondary endpoints

• {"endpoint_text":"- Endoscopic activity will be evaluated by the Mayo endoscopic sub-score; endoscopic activity will be considered as ≥ 2.","definition_or_measurement_approach":"Endoscopic activity measured using the Mayo endoscopic sub-score; activity defined as Mayo endoscopic sub-score ≥ 2."}
• {"endpoint_text":"- Endoscopic response will be defined as a decrease of ≥ 1 point in the Mayo endoscopic sub-score 3 months after starting treatment.","definition_or_measurement_approach":"Endoscopic response defined as a decrease ≥1 point in the Mayo endoscopic sub-score at 3 months after treatment start."}
• {"endpoint_text":"- Endoscopic remission will be defined as an endoscopic subscore ≤1, 3 months after starting treatment.","definition_or_measurement_approach":"Endoscopic remission defined as Mayo endoscopic sub-score ≤1 at 3 months after treatment start."}

Spain

Earliest CTIS Part Ii Submission Date

15-11-2024

Latest Decision Or Authorization Date

20-11-2024

Processing Time Days

5

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain