Relationship Between Baseline Burden of Disease and TDM in Ulcerative Colitis

NCT03808506 | Withdrawn

• 1 other identifier: 113446
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often follows a relapsing/remitting course. Anti-TNF therapies are proven to be effective in UC and studies indicate that having adequate drug levels correlate with improved patient outcomes. It is unknown, however, if a high burden of disease at baseline impacts drug utilization or loss. In this study, we investigate whether measures of high burden of disease (fecal calprotectin, bowel ultrasound, and colonoscopy) at baseline predicts low drug levels after standard anti-TNF induction therapy.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Therapeutic drug monitoring; fecal calprotectin; adalimumab; bowel ultrasound

Outcome Measures

Primary Outcomes (1)

• Baseline fecal calprotectin concentration

  Fecal calprotectin concentration at baseline prior to starting adalimumab therapy. Fecal Calprotectin will be used as the primary outcome measure to determine burden of inflammation

  Performed within 4 weeks of starting adalimumab therapy

Secondary Outcomes (3)

• Post Induction fecal calprotectin concentration

  Performed 6 weeks post induction therapy

• Baseline Mayo Endoscopic Score

  Performed within 12 weeks of study entry

• Baseline bowel ultrasound inflammatory score

  Performed within 12 weeks of starting adalimumab therapy

Study Arms (1)

Ulcerative colitis patients

Patients with documented ulcerative colitis who are initiating adalimumab therapy will have baseline bowel ultrasound and fecal calprotectin completed.

Diagnostic Test: Fecal calprotectin

Interventions

Fecal calprotectin DIAGNOSTIC_TEST

Stool test to look at baseline burden of inflammation

Ulcerative colitis patients

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

Adult patients with documented ulcerative colitis with active inflammation who are starting adalimumab therapy. All other concomittant therapies are allowed.

You may qualify if:

• Adult outpatients \>=18 y of age with a confirmed diagnosis of ulcerative colitis
• Patients beginning adalimumab for active disease as clinically indicated according to the treating physician's discretion, either biologic naïve or switching biologic due to failure of prior biologic therapy
• Have had a colonoscopy or flexible sigmoidoscopy within 12 weeks of study entry
• Any other concomitant therapies are allowed (including 5'ASA, corticosteroids, azathioprine, and methotrexate).

You may not qualify if:

• Inability to provide informed consent
• Inability to provide a fecal calprotectin
• Contraindication to starting anti-TNF therapy

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A5W9, Canada

Location

Related Publications (24)

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MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Brian Yan, H.B Sc, MD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 17, 2019
• Study Start: September 1, 2019
• Primary Completion: June 19, 2022
• Study Completion: July 19, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)