Control Crohn Safe Trial (CoCroS)
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|ClinicalTrials.gov Identifier: NCT03917303|
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : July 23, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease Inflammatory Bowel Diseases||Drug: Adalimumab Drug: standard step-up care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicenter randomised controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Control Crohn Safe With Episodic Adalimumab Monotherapy as First Line Treatment Study.|
|Actual Study Start Date :||December 23, 2019|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||September 2024|
Active Comparator: Adalimumab
Episodic adalimumab monotherapy as first line treatment for 6 months
episodic treatment with subcutaneous adalimumab for 6 months
Other Name: Humira
Active Comparator: Standard step-up care
Step-up care as first line treatment, starting with corticosteroids.
Drug: standard step-up care
conventional step-up care starting with corticosteroids
- Number of yearly-quarters of corticosteroid free remission as a measure of treatment efficacy [ Time Frame: at week 96 ]Remission is defined as combined clinical (MIAH scores (≤3)) and biochemical (C-reactive protein ≤5 mg/L (i.e. within normal range) and fecal calprotectin ≤ 200 μg/g) remission.
- Cumulative structural bowel damage as a measure of disease progression [ Time Frame: at week 96 ]
Disease progression on MRI-enterography based on the Lémann score (Crohn's Disease Digestive Damage Score); the Lémann score is an instrument to measure cumulative structural bowel damage in Crohn's disease. The score takes into account the damage location (upper digestive tract, small bowel, colon/rectum and anal/perianal), extent and severity.
Grades 0 (normal) to 3 (maximal) are given to each segment of the digestive tract, with grade 3 representing the most damage, or resection/bypass.
- Incidence of drug related serious adverse events [ Time Frame: at week 24, 48 and 96 ]Drug related serious adverse events
- Incidence of serious disease related adverse events [ Time Frame: at week 24, 48 and 96 ]Crohn disease related hospitalisation and surgery
- Integer amount of direct health care costs (in €) [ Time Frame: at week 96 ]
Direct costs include expenses for medication, diagnostic procedures, number of outpatient clinic visits, hospitalisations and surgeries.
Direct costs will be combined with indirect costs to report total health care costs.
- Integer amount of indirect health care costs (in €) [ Time Frame: at week 96 ]
Indirect costs consist of costs due to presenteeism and absenteeism and are assessed by questionnaires in the telemedicine tool myIBDcoach used for monitoring of IBD patients.
Indirect costs will be combined with direct costs to report total health care costs.
- Corticosteroid use [ Time Frame: at week 24, 48 and 96 ]Cumulative corticosteroid dose
- Endoscopic remission as assessed by SES-CD [ Time Frame: at week 24 ]Proportion of endoscopic remission based on SES-CD (simple endoscopic score for CD). Endoscopic remission is defined as a score below 3 and the absence of ulcers.
- Time to remission [ Time Frame: at week 96 ]Time to remission
- Quality of life as assessed by QoL EQ-5D-5L questionnaire [ Time Frame: at week 24, 48 and 96 ]
Quality of life as assessed by the QoL EQ-5D-5L questionnaire in which the level of severity is chosen for five domains (mobility, self-care, usual activities, pain, anxiety/depression).
A higher level (maximal 5) indicates more severe problems in that particular domain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917303
|Contact: M J Pierik, MD, PhD||+31 43 387 firstname.lastname@example.org|
|Contact: L M Janssen, MDemail@example.com|
|Maastricht University Medical Centre+||Recruiting|
|Contact: L Janssen +31433884190 firstname.lastname@example.org|
|Contact: M Pierik +31433875021 email@example.com|
|Principal Investigator: M. Pierik|
|Sub-Investigator: L. Janssen|
|Sub-Investigator: J. Haans|
|Zuyderland Medical Center||Recruiting|
|Contact: AA van Bodegraven|
|Principal Investigator: AA van Bodegraven|
|Sub-Investigator: M Romberg-Camps|
|Principal Investigator:||M J Pierik, MD, PhD||Maastricht University Medical Centre|