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.

• Register: EUCTR
• Last refreshed on: 5 April 2021
• Main ID: EUCTR2017-004588-11-NL
• Date of registration: 10/09/2019
• Prospective Registration: Yes
• Primary sponsor: University Maastricht
• Public title: 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.
• Scientific title: Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease. - CoCroS trial
• Date of first enrolment: 10/09/2019
• Target sample size: 158
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004588-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: yes; Other specify the comparator: Standard Step-up treatment; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Netherlands

Contacts

• Name: Nutrim
• Affiliation: University Maastricht

• Name: Nutrim
• Affiliation: University Maastricht

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

The chronic inflammatory bowel disease Crohn's disease

Intervention(s)

Trade Name: Humira
Pharmaceutical Form: Suspension for injection in pre-filled pen

Primary Outcome(s)

Main Objective: The aim of this study is to compare the long-term efficacy and safety of standard step-care with corticosteroid/budesonide as the initial treatment, with step-care with adalimumab as initial treatment for newly diagnosed CD patients.
Primary outcome
Quartiles of clinical and biochemical disease remission at week 96

Timepoint(s) of evaluation of this end point: week 96

Primary end point(s): Quartiles of clinical and biochemical disease remission at week 96

Secondary Objective: Safety outcome
Disease progression at week 96 on MRI-enterography
Drug related serious adverse events
Serious disease related adverse events (hospitalisation, surgery)

Secondary outcomes
Total health care costs at week 96
Cumulative corticosteroid dose at week 24, 48 and 96
Proportion of endoscopic remission at week w24
time to remission
PROM: quality of life week 24, 48 and 96
PROM: (work) disability week 24, 48 and 96
PROM: tolerability of treatment week 24, 48 and 96

Secondary Outcome(s)

Secondary end point(s): Safety outcome
Disease progression at week 96 on MRI-enterography
Drug related serious adverse events
Serious disease related adverse events (hospitalisation, surgery)

Secondary outcomes
Total health care costs at week 96
Cumulative corticosteroid dose at week 24, 48 and 96
Proportion of endoscopic remission at week w24
time to remission
PROM: quality of life week 24, 48 and 96
PROM: (work) disability week 24, 48 and 96
PROM: tolerability of treatment week 24, 48 and 96

Timepoint(s) of evaluation of this end point: see E.5.2.

Secondary ID(s)

ABR64005

Source(s) of Monetary Support

ZonMW

Ethics review

Status: Approved
Approval date: 21/08/2019
Contact: