Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo

AbbVie

Status: Terminated

Conditions: Moderate to Severe Ulcerative Colitis

Study type: Observational

Funder types: Industry

Identifiers

NCT02092389

P14-323

Details and patient eligibility

About

The objectives of this study are to explore the fecal calprotectin (fC) levels of UC patients under adalimumab therapy and the correlation with their general wellbeing (Quality of Life [QoL]), workability, and disease activity.

Full description

This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of the patient to a adalimumab containing regimen has to be decided in advance and has to be current practice. The prescription of adalimumab is clearly separated from the decision to include the participant in this study.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (AZA/6-MP); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC
• Patients who are able to complete patients questionnaires (e.g., WPAI:UC and sIBDQ questionnaire)
• Patients must fulfill national and international guidelines for the use of biologic therapies in UC (Chest X-ray and Interferon-Gamma-Release Assay (IGRA) or tuberculin purified protein derivative (PPD)-skin test negative for tuberculosis).
• Patients who have been prescribed adalimumab in line with the European SmPC (Summary of Product Characteristics)

Exclusion criteria

• Previous therapy with TNF-alpha (Tumor necrosis factor alpha) blocker
• No signed written authorization to use data
• Contraindication to adalimumab therapy according to the SmPC
• Patients with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or planned bowel surgery.
• Patients received intravenous (IV) corticosteroids within 14 days of Screening or during the Screening period.
• Pregnant patients

Trial design

10 participants in 1 patient group

Moderate to Severe Ulcerative Colitis

Description:

Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine \[AZA\]/ 6-mercaptopurine \[6-MP\]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.