Control Crohn Safe With Episodic Adalimumab Monotherapy as First Line Treatment Study.

Who is this study for? Adult patients with Crohn's Disease
What treatments are being studied? Adalimumab
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Maastricht University Medical Centre+
RECRUITING
Maastricht
St. Antonius Ziekenhuis
RECRUITING
Nieuwegein
Laurentius Ziekenhuis
RECRUITING
Roermond
Zuyderland Medical Center
RECRUITING
Sittard
Máxima Medisch Centrum
RECRUITING
Veldhoven
VieCuri
RECRUITING
Venlo
Contact Information
Primary
M J Pierik, MD, PhD
m.pierik@mumc.nl
+31 43 387 4362
Backup
L M Janssen, MD
laura.janssen@maastrichtuniversity.nl
Time Frame
Start Date: 2019-12-23
Estimated Completion Date: 2026-09
Participants
Target number of participants: 158
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center
Collaborators: Maastricht University, ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov