IBD under control with less medicatio

Phase 1

• Conditions: Crohn's disease, ulcerative colitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-001811-26-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-08
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- Aged 12-25 years
- Diagnosed with luminal Crohn’s disease or ulcerative colitis
- Treated with either 8-weekly infliximab or 2-weekly adalimumab
- Three consecutive faecal calprotectin results in the target range in the previous 6 months or confirmed endoscopic remission within 2 months before study entry
- Absence of symptoms associated with active IBD
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Perianal fistula
- Presence of ileostomy or ileoanal pouch
- Any inflammatory comorbidity, such as rheumatoid arthritis
- Current treatment with corticosteroids (prednisone or budesonide)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified