Clinical trial NCT02092389: Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo
Official title: Fecal Calprotectin Levels, Quality of Life and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Moderate to Severe Ulcerative Colitis
Keywords: Ulcerative Colitis
Inflammatory Bowel Syndrome
Adalimumab
Tumor necrosis factor (TNF) alpha Antibody
Calprotectin
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe ulcerative colitis

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab
timeFrame: Month 12
Secondary outcomes:
measure: Change From Baseline to Month 12 in Patient's Workability Measured Using the Work Productivity and Activity Impairment:Ulcerative Colitis (WPAI:UC) Questionnaire
timeFrame: Baseline (Day 0) to Month 12
measure: Change From Baseline to Month 12 in Patient's Quality of Life (QoL) Measured Using the Short Inflammatory Bowl Disease Questionnaire (sIBDQ)
timeFrame: Baseline (Day 0) to Month 12
measure: Change From Baseline to Month 12 in Disease Activity Determined by Partial Mayo Score
timeFrame: Baseline (Day 0) to Month 12
measure: Correlation Between fC and Disease Activity Determined by Partial Mayo Score
timeFrame: Baseline (Day 0) to Month 12
measure: Correlation Between fC and Patient's QoL Determined by the sIBDQ
timeFrame: Baseline (Day 0) to Month 12
measure: Correlation Between fC and Workability Determined by WPAI:UC Questionnaire
timeFrame: Baseline (Day 0) to Month 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Austria
name: Alexander Dorr, MD
role: STUDY_DIRECTOR
References: