Control Crohn Safe Trial: Long term outcome and tolerability of six months adalimumab as initial treatment for newly diagnosed Crohn's disease versus standard step-up treatment.

Phase 1

• Conditions: The chronic inflammatory bowel disease Crohn's disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-004588-11-NL
• Lead Sponsor: niversity Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-10
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

- Newly diagnosed CD patients or patients with a flare of an established diagnosis visiting the outpatient clinic or endoscopy ward of the participating centres.
- naïve to biologicals or thiopurines
- CD diagnosis according to ECCO-guidelines including complete ileo-colonoscopy + complete small bowel imaging at diagnosis (MRI or CT-enterography)
- Sufficient knowledge Dutch language
- 18 years old = 70 years old
- Smartphone with internet access
- Use of myIBDcoach or willingness to start using myIBDcoach
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 158
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Malignancy in 5 years before treatment. Exception adequate treated non-melanoma skin cancer
•active perianal fistula at diagnosis
•Sever disease requiring hospitalisation at diagnosis/inclusion
•Contra-indication for anti-TNF or immunosuppressive
- Patients with the short bowel syndrome or an ostomy
- use of corticosteroids for a duration longer than 4 months in the year before screening
- contra-indication for MRI- and CT-enterography

Study & Design

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