Immunological characteristics in UC patients that predict response on Vedolizumab

Immunological characteristics in UC patients that predict response on Vedolizumab - Characteristics in UC patients that predict the respons on Vedolizumab

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44411

Enrollment

Registered

2017-12-27

Start date

2018-01-25

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

inflammatory bowel disease Ulcerative colitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - UC patients with an exacerbation under 5-ASA and/or thiopurines. An exacerbation is defined as clinical symptoms of diarrhoea, rectal blood loss, abdominal pain or weight loss who need sigmoidscopy to confirm endoscopic exacerbation. - UC patients with moderate to severe disease activity (

Exclusion criteria

Exclusion criteria: - UC patients under IFX treatment or after colectomy. - UC patients under treatment with steroids. - If the gastro-enterologist prefers to start Infliximab instead of Vedolizumab. - Patients diagnosed with another immune suppressive disease (e.g. HIV). - Patients who underwent splenectomy in the past. - Patients diagnosed with any other autoimmune diseases (e.g. Diabetes Mellitus type I, rheumatoid arthritis, celiac disease, psoriasis, systemic lupus erythematosus). - Patients diagnosed with cancer including hematologic malignancies (e.g. (non-)Hodgkin lymphoma , leukemia), solid tumors and carcinoma in situ, within 5 years before screening with the following caveats: o Local basal or squamous cell carcinoma of the skin that has been excised and is considered cured is not exclusionary. o Chronic myelogenous leukemia, hairy cell leukemia, melanoma, renal cell carcinoma, or Kaposi sarcoma are exclusionary irrespective of the duration of time before screening. o Cervical smear indicating the presence of adenocarcinoma I situ (AIS), high-grade squamous intraepithelial lesions (HSIL), or cervical intraepithelial neoplasia (CIN) of grade>1, is exclusionary, irrespective of the duration of time before screening.

Design outcomes

Primary

Measure	Time frame
The description of the different mucosal T-cells, serological markers and histological features at first presentation and at week 16 in UC patients.	—

Secondary

Measure	Time frame
Investigate if there are clinical and immunological differences between patients with a better endoscopic response on Vedolizumab at week 16.	—

Countries

Netherlands

Outcome results