Control Crohn Safe with episodic adalimumab monotherapy as first line treatment study.

Phase 4

Recruiting

• Conditions: Chronic inflammatory bowel disease; Crohn's disease; 10017969

• Registration Number: NL-OMON52419
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• 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.
- CD diagnosis according to ECCO-guidelines including complete ileo-colonoscopy
(last endoscopy <12 months ago) + complete small bowel imaging at diagnosis
(MRI or CT-enterography)
- naïve to biologicals
- Sufficient knowledge Dutch language
- 18 years old <= 70 years old
- Smartphone with internet access
- Use of myIBDcoach

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Use of prednisone for longer than 4 weeks in the year before screening
- Use of budesonide (>=6 mg daily) for a duration longer than 3 months in the
year before screening
- Use of thiopurines in the 3 years before screening
- Indication for primary treatment with biologicals or surgery
- Malignancy in 5 years before treatment. Exception adequately treated
non-melanoma skin cancer
- Contra-indication for an TNF-blocker or immunosuppressant treatment.
(Contra-indications are: a symptomatic stricture, an abscess, a history of
tuberculosis or other granulomatous infection, a positive chest radiograph or
Quantiferon or tuberculin skin test with purified protein derivative, a recent
history of an opportunistic infection (within the previous 6 months), active
infection with hepatitis B or C, infection with the human immunodeficiency
virus, multiple sclerosis, cancer (except adequately treated non melanoma skin
cancer)).
- Contra-indication for MRI-and CT-enterography
- Patients with short bowel syndrome or an ostomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified