Home basEd faecaL calProtectin Measurements Predicting Adalimumab Induction Destiny

NCT02634060 | Completed

• 1 other identifier: S58392
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Recently a smartphone application IBDoc® was developed to enable patients to measure faecal calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in patients with moderate-to-severe IBD. Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study. They will be asked to collect a stool sample at 3 different time points (week 0, 4 and 8). This faecal sample needs to be loaded on a test cassette with an extraction device. In a second step, the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp® which is based on an immunochromatographic test. Finally, the CalApp® will transmit the test results securely to the health care professional. In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc® on clinical, biological and endoscopic outcome at week 12. Furthermore, we want to evaluate the correlation between IBDoc® and classical ELISA measurements of faecal calprotectin, and the convenience of this system to the patient and the health care professional.

Conditions

Crohn Disease; Colitis, Ulcerative

Keywords

adalimumab; fecal calprotectin; home based

Outcome Measures

Primary Outcomes (2)

• In UC: Steroid-free mucosal healing (Mayo 0 or 1) at week 8 without prior need for ADA dose optimization, taking into account all kind of topical and systemic steroids.

  The predictive value of an early faecal calprotectin amelioration (EFCA) measured by IBDoc between baseline and week 4, in predicting steroid-free mucosal healing (Mayo 0 or 1) at week 8 without prior need for ADA dose optimization, taking into account all kind of topical and systemic steroids. EFCA is defined as a decrease in faecal calprotectin measured by IBDoc between baseline and week 4 with at least 80% or a faecal calprotectin less than 50 μg/g at week 4.

  Week 8

• In CD: Steroid-free clinical remission at week 12, defined as an Harvey-Bradshaw-Index <5 and a C-reactive protein <5 mg/L, without prior need for ADA dose optimization and taking into account all kind of topical and systemic steroids

  The predictive value of EFCA measured by IBDoc® between baseline and week 4, in predicting steroid-free clinical remission at week 12 , defined as an Harvey-Bradshaw-Index \<5 and a C-reactive protein \<5 mg/L, without prior need for ADA dose optimization and taking into account all kind of topical and systemic steroids. EFCA is defined as a decrease in faecal calprotectin measured by IBDoc® between baseline and week 4 with at least 80% or a faecal calprotectin less than 50 μg/g at week 4.

  Week 12

Secondary Outcomes (6)

• In UC: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 4

  4 weeks

• In UC: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 8

  8 weeks

• In CD: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 4

  4 weeks

• In CD: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 8

  8 weeks

• In UC and CD: correlations with IBDoc® measurements of faecal calprotectin and ELISA measurements of faecal calprotectin, different components of the Mayo score, C reactive protein and serum albumin

  26 weeks

Study Arms (1)

Home Based Fecal Calprotectin

EXPERIMENTAL

IBDoc® at week 0, 4 and 8 using smartphone. All material will be provided by the third party The same stool sample of the home base faecal calprotectin will be brought to the hospital and used for ELISA faecal calprotectin measurement at week 0, 4 and 8 for UC patients and week 0 and 4 for CD patients. IBDoc® results will be forwarded to the patient and the health care professional.

Device: Home Based Fecal Calprotectin

Interventions

Home Based Fecal Calprotectin DEVICE

Home Based Fecal Calprotectin measurement at weeks 0, 4 and 8

Also known as: IBDoc

Home Based Fecal Calprotectin

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age;
• Established diagnosis of UC or CD for at least 3 months, with histopathological confirmation available in the record of the patient;
• Patients having failed steroids or immunomodulatory therapy for at least 3 months, or being intolerant to this therapy;
• Patients should have moderate-to-severe disease at baseline, defined as For CD: an Harvey-Bradshaw-Index above 7 and a C-reactive protein of at least 5 mg/L; For UC: a total Mayo score of at least 6 and an endoscopic sub-score of at least 2;
• Latent tuberculosis excluded within 3 months prior to ADA therapy using Chest X-ray and IFNγ release assay or tuberculin skin test; or adequate treatment for latent tuberculosis initiated for at least four weeks in case of positive screening;
• The patients should have a smartphone and be able to use a new smartphone application;
• Written informed consent must be obtained and documented;

You may not qualify if:

• Diagnosis of IBD type unclassified (IBDU);
• Previous (procto)colectomy for UC;
• Patients with an ostomy;
• Previous therapy with ADA;
• Patients with CD with a baseline CRP \< 5mg/L at baseline;
• Patients with CD and absence of luminal disease;
• Patient with UC lacking faecal blood loss (Mayo bleeding score 0);
• Patients with UC with an ileal pouch-anal or ileo-rectal anastomosis
• Patients with acute severe IV steroid refractory colitis;
• Patients with any condition that would prevent completion of the study including history of drug or alcohol abuse, history of mental illness, or history of noncompliance with treatments or visits;
• Patients with absolute or relative contraindications for anti-TNF therapy, including intra-abdominal collections, symptomatic strictures, demyelinating disease, heart failure, …;

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW: collaborator

Study Sites (1)

UZ Leuven

Leuven, B3000, Belgium

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc Ferrante, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 17, 2015
• Study Start: March 31, 2016
• Primary Completion: June 1, 2018
• Study Completion: September 5, 2022
• Last Updated: June 27, 2024

Record last verified: 2017-10

Locations

BE (1)