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

NCT02092389 | Terminated Results

• 1 other identifier: P14-323
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Moderate to Severe Ulcerative Colitis

Keywords

Ulcerative Colitis; Inflammatory Bowel Syndrome; Adalimumab; Tumor necrosis factor (TNF) alpha Antibody; Calprotectin

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab

  Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The study was terminated due to low enrollment. Although no meaningful analysis can be presented, data for subjects with available data for fC levels at Month 12 at the end of study (termination) are provided.

  Month 12

Secondary Outcomes (6)

• Change From Baseline to Month 12 in Patient's Workability Measured Using the Work Productivity and Activity Impairment:Ulcerative Colitis (WPAI:UC) Questionnaire

  Baseline (Day 0) to Month 12

• Change From Baseline to Month 12 in Patient's Quality of Life (QoL) Measured Using the Short Inflammatory Bowl Disease Questionnaire (sIBDQ)

  Baseline (Day 0) to Month 12

• Change From Baseline to Month 12 in Disease Activity Determined by Partial Mayo Score

  Baseline (Day 0) to Month 12

• Correlation Between fC and Disease Activity Determined by Partial Mayo Score

  Baseline (Day 0) to Month 12

• Correlation Between fC and Patient's QoL Determined by the sIBDQ

  Baseline (Day 0) to Month 12

Study Arms (1)

Moderate to Severe Ulcerative Colitis

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe ulcerative colitis

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

The study was terminated due to low enrollment; therefore, safety and efficacy data should be interpreted with caution because of the small number of participants and incomplete data.

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

1-800-633-9110

Study Officials

• Alexander Dorr, MD

  AbbVie Austria

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-01