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.SPARE

Phase 1

• Conditions: uminal 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; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-002311-41-NL
• Lead Sponsor: GETAID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-18
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

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 (lower dose than standard dose is also allowed if 6 TGN > 235 pmol) ; 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified