Individualization Treatment Through a Self-managed Web-based Solution in Ulcerative Colitis

NCT03604536 | Terminated

• 1 other identifier: H-17038710
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of individualized monotherapy with Mesalazine (Pentasa Sachet ®) on time to remission in patients with mild to moderate UC in an eHealth setting.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis

Keywords

Adherence; eHealth; Aminosalicylate

Outcome Measures

Primary Outcomes (1)

• Change in Total Inflammation Burden Scoring (TIBS)

  Self reported disease activity in combination with a fecal biomarker of inflammation (fecal calprotectin) results in TIBS. Disease activity is scored by 6 questions yielding: remission (\<3) , mild to moderate disease activity (3-4) and severe disease activity ( \>5). Fecal calprotectin: remission (\<200mg/kg ), mild to moderate (200-599 mg/kg ), severe (\>599 mg/kg). The two items are added together in a weighted manner giving the Total inflammation burden scoring (TIBS): remission (0-8), mild to moderate (9-32), severe (33-99).

  At baseline and at 12 weeks or until remission, which ever comes first

Secondary Outcomes (5)

• Disease course type

  At baseline and after 12 weeks

• Compliance with medication

  at baseline and after 12 weeks

• Short Inflammatory Bowel Disease Questionnaire

  at baseline and after 12 weeks

• Disability

  at baseline and after 12 weeks

• Fatigue

  at baseline and after 12 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 patients with mild to moderate ulcerative colitis will be included from the Out patient clinic at the gastroenterology department, North Zealand University Hospital, Capitol region of Denmark

You may qualify if:

• Fulfil the Copenhagen Diagnostic criteria for UC
• Age between 18 and 75 years
• New and relapse patients diagnosed with Mild-to-moderate UC
• Current relapse (minimum 1 out of 2) SCCAI\>2 (with a positive score in the variable of blood in stool) FC ≥200
• Diagnosed with left sided or extensive UC(24)
• Understand written and spoken Danish
• Easy access to internet and smartphone

You may not qualify if:

• Evidence of enteric infection
• Treatment with immunomodulators such as steroids, azathioprine, methotrexate, or infliximab within the last 8 weeks
• Two or more courses of oral steroids in the past 12 months
• Diagnosed with proctitis
• Severe disease activity (SCCAI \>6 or FC ≥600)

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

North zealand university hospital

Frederikssund, 3600, Denmark

Location

Related Publications (4)

• Vinding KK, Elsberg H, Thorkilgaard T, Belard E, Pedersen N, Elkjaer M, Marker D, Carlsen K, Burisch J, Munkholm P. Fecal Calprotectin Measured By Patients at Home Using Smartphones--A New Clinical Tool in Monitoring Patients with Inflammatory Bowel Disease. Inflamm Bowel Dis. 2016 Feb;22(2):336-44. doi: 10.1097/MIB.0000000000000619.

  PMID: 26535869 BACKGROUND

• Pedersen N, Thielsen P, Martinsen L, Bennedsen M, Haaber A, Langholz E, Vegh Z, Duricova D, Jess T, Bell S, Burisch J, Munkholm P. eHealth: individualization of mesalazine treatment through a self-managed web-based solution in mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2014 Dec;20(12):2276-85. doi: 10.1097/MIB.0000000000000199.

  PMID: 25248002 BACKGROUND

• Elkjaer M, Shuhaibar M, Burisch J, Bailey Y, Scherfig H, Laugesen B, Avnstrom S, Langholz E, O'Morain C, Lynge E, Munkholm P. E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided 'Constant-care' approach. Gut. 2010 Dec;59(12):1652-61. doi: 10.1136/gut.2010.220160.

  PMID: 21071584 BACKGROUND

• Pedersen N, Elkjaer M, Duricova D, Burisch J, Dobrzanski C, Andersen NN, Jess T, Bendtsen F, Langholz E, Leotta S, Knudsen T, Thorsgaard N, Munkholm P. eHealth: individualisation of infliximab treatment and disease course via a self-managed web-based solution in Crohn's disease. Aliment Pharmacol Ther. 2012 Nov;36(9):840-9. doi: 10.1111/apt.12043.

  PMID: 22971016 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Pia Munkholm, Prof

  North Zealand University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 27, 2018
• Study Start: December 2, 2019
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)