Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients

This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.

Study Overview

• Status: Completed
• Conditions: Celiac Disease

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2X8
      • University of Alberta
• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego
    • San Diego, California, United States, 92111
      • Kaiser Permanente Southern California, Allergy Department
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado, Denver
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Celiac Disease Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York City, New York, United States, 10032
      • Columbia University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Biopsy proven celiac disease patients

Description

Inclusion Criteria:

• History of biopsy proven celiac disease
• Adherence to a gluten-free diet (established patients only)
• TG2 negative (established patients only)
• TG2 positive (newly diagnosed patients only)
• Signed informed consent

Exclusion Criteria:

• History of IgE-mediated reactions to gluten
• Significant laboratory abnormalities
• History of untreated or GI disease
• Positive pregnancy test
• Any medical condition which could adversely affect study participation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Gluten challenge; Gluten containing or gluten-free study food in established celiac disease patients
Observation; Observation in newly diagnosed celiac disease patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in symptoms using patient reported outcome instruments	Sensitivity of the patient reported outcome instruments to detect change over time in celiac disease symptoms with and without a gluten challenge	8 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - incidence of adverse events	Safety will be evaluated by incidents of adverse events including clinical significant laboratory evaluations and serious adverse events	8 and 12 weeks

Collaborators and Investigators

• Sponsor: Alvine Pharmaceuticals Inc.
• Investigators: Study Chair: Daniel Adelman, MD, Alvine Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: March 20, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): October 10, 2013
• Last Update Submitted That Met QC Criteria: October 9, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Celiac Disease; Coeliac Disease; Celiac Sprue; Keilakia Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: ALV003-1121