A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy

• Status: Active, not recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase IV

Design : Prospective, open-label, randomized three-arms study

Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months

Primary objective To demonstrate that Infliximab scheduled maintenance with or without antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free remission over 2 years, while the latter is non inferior with regards to the mean time spent in remission over the same duration

Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2 years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate.

Number of subjects 225 randomized patients (75 per arm)

Study duration: 3 + 2 years Enrollment: 3 years Follow-up: 2 years

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Collaborator: Saint-Louis Hospital, Paris, France
• Treatments: 6-Mercaptopurine; Antimetabolites; Azathioprine; Infliximab; Mercaptopurine; Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of Crohn's disease.

• Male or female, age > 18 years.

• Currently treated with a combination therapy with infliximab and anti-metabolites for luminal Crohn's disease.

• Combined therapy with scheduled infliximab and anti-metabolites for at least 8 months.

• Scheduled administration of infliximab 5 mg/Kg every 8 weeks over the last 4 months.

• Antimetabolites administered at a stable dosage for the last 3 months: at least 1 mg/Kg or 2 mg/Kg for mercaptopurine and azathioprine, respectively, or the highest tolerated dosage if intolerance to standard dose; at least 15 mg/week subcutaneously for methotrexate.

• Patients in steroid free clinical remission for at least 6 months according to retrospective assessment of the patients' files.

• CDAI < 150 at baseline.

• A contraceptive during the whole study for childbearing potential female patients.

• Patients able to understand the information provided to them and to give written informed consent for the study

Exclusion Criteria:

• Patients who have presented a severe acute or delayed reaction to infliximab.

• Perianal fistulae as the main indication for infliximab treatment

• Active perianal/abdominal fistulae at time of inclusion, defined by active drainage

• Patients with ostomy or ileoanal pouch

• Pregnancy or planned pregnancy during the study

• Inability to follow study procedures as judged by the investigator

• Non-compliant subjects.

• Participation in another therapeutic study

• Steroid use ≤6 months prior to screening

• Currently receiving steroids, immunosuppressive agents (other than purine, methotrexate), biologic treatment (other than infliximab) or thalidomide