Control Crohn Safe Trial

Study Purpose

Crohn's disease (CD) is a chronic disease with a heterogeneous clinical presentation, relapse rate and treatment response. Insufficient control of mucosal inflammation results in irreversible bowel damage and complications and at present no markers are available to predict such a complicated disease course at diagnosis. Therefore, to prevent overtreatment of low risk patients, step-up treatment with subsequent introduction of corticosteroids, thiopurines maintenance and TNF-blockers if a previous category fails is standard care. Combination treatment with thiopurines and a TNF-blocker is more effective than monotherapy but associated with a higher risk for infectious complications. Landmark studies convincingly showed an improved long-term outcome if the TNF-blocker infliximab is introduced early after diagnosis. The standard step-care approach thus prolongs steroid exposure and delays start of disease modifying biologicals in high risks patients. Given the higher efficacy of combination therapy with a thiopurine of infliximab and potential allergic reactions and lower response rates after re-initiation of this chimeric biological, temporary monotherapy with this TNF-blocker has not been studied as first line treatment before. Adalimumab is a humanised monoclonal antibody and subsequently, combination therapy of adalimumab + thiopurines has only a marginal effect on anti-drug anti-body formation. Furthermore, combination therapy with adalimumab does not enhance the clinical response. Therefore, periodic treatment with adalimumab in combination with close monitoring after drug-discontinuation, in newly diagnosed CD might improve outcome, reduce drug-related side effects while still preventing overtreatment. The aim of this study is to compare the long-term efficacy and safety of periodic adalimumab as initial treatment in newly diagnosed CD patients compared to standard step-care with corticosteroid/budesonide as the initial treatment

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Newly diagnosed CD patients or CD patients with a flare, visiting the outpatient clinic or endoscopy ward of the participating centres.

- CD diagnosis according to ECCO-guidelines + complete ileo-colonoscopy + complete small bowel imaging at diagnosis (MRI or CT-enterography ) - Naïve to biologicals.

- Sufficient knowledge of Dutch language.

- 18 years old ≤ 70 years old.

- Smartphone with internet access.

- Use of myIBDcoach or willingness to start using myIBDcoach.

Exclusion Criteria:

- 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 is adequately treated non-melanoma skin cancer.

- Contra-indication for TNF-blockers or immunosuppressive agents.

- Contra-indication for MRI- and CT-enterography.

- Patients with short bowel syndrome or an ostomy

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03917303
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Maastricht University Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	M J Pierik, MD, PhD
Principal Investigator Affiliation	Maastricht University Medical Centre
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn Disease, Inflammatory Bowel Diseases

Arms & Interventions

Arms

Active Comparator: Adalimumab

Episodic adalimumab monotherapy as first line treatment for 6 months

Active Comparator: Standard step-up care

Step-up care as first line treatment, starting with corticosteroids.

Interventions

Drug: - Adalimumab

episodic treatment with subcutaneous adalimumab for 6 months

Drug: - standard step-up care

conventional step-up care starting with corticosteroids

Contact a Trial Team

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