Control Crohn Safe Trial

NCT ID: NCT03917303

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-23
• Study Completion Date: 2026-09-30

Brief Summary

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

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adalimumab

Episodic adalimumab monotherapy as first line treatment for 6 months

Group Type: ACTIVE_COMPARATOR

Adalimumab

Intervention Type: DRUG

episodic treatment with subcutaneous adalimumab for 6 months

Standard step-up care

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

Group Type: ACTIVE_COMPARATOR

standard step-up care

Intervention Type: DRUG

conventional step-up care starting with corticosteroids

Interventions

Adalimumab

episodic treatment with subcutaneous adalimumab for 6 months

Intervention Type: DRUG

standard step-up care

conventional step-up care starting with corticosteroids

Intervention Type: DRUG

Other Intervention Names

Humira

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University

OTHER

Sponsor Role: collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M J Pierik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Locations

Maastricht University Medical Centre+

Maastricht, , Netherlands

Site Status: RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status: RECRUITING

Laurentius Ziekenhuis

Roermond, , Netherlands

Site Status: RECRUITING

Zuyderland Medical Center

Sittard, , Netherlands

Site Status: RECRUITING

Máxima Medisch Centrum

Veldhoven, , Netherlands

Site Status: RECRUITING

VieCuri

Venlo, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

M J Pierik, MD, PhD

Role: CONTACT

m.pierik@mumc.nl

+31 43 387 4362

L M Janssen, MD

Role: CONTACT

laura.janssen@maastrichtuniversity.nl

Facility Contacts

L Janssen

Role: primary

laura.janssen@maastrichtuniversity.nl

+31433884190

M Pierik

Role: backup

m.pierik@mumc.nl

+31433875021

P van Boeckel

Role: primary

THC Munnecom

Role: primary

AA van Bodegraven

Role: primary

P Boekema

Role: primary

M Aquarius

Role: primary

References

Janssen L, Romberg-Camps M, van Bodegraven A, Haans J, Aquarius M, Boekema P, Munnecom T, Brandts L, Joore M, Masclee A, Jonkers D, Pierik M. Control Crohn Safe with episodic adalimumab monotherapy as first-line treatment study (CoCroS): study protocol for a randomised controlled trial. BMJ Open. 2021 May 4;11(5):e042885. doi: 10.1136/bmjopen-2020-042885.

Reference Type: DERIVED

PMID: 33947729 (View on PubMed)

Other Identifiers

NL64005.068.18

Identifier Type: -

Identifier Source: org_study_id