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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 February 2021
Main ID:  NCT02177071
Date of registration: 26/06/2014
Prospective Registration: Yes
Primary sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Public title: 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
Scientific title: 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
Date of first enrolment: October 9, 2015
Target sample size: 211
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02177071
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Australia Belgium France
Contacts
Name:     Benjamin PARIENTE, doctor
Address: 
Telephone:
Email:
Affiliation:  Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: AZATHIOPRINE
Drug: INFLIXIMAB
Drug: MERCAPTOPURINE
Drug: Methotrexate
Primary Outcome(s)
co-primary efficacy end points [Time Frame: 2 ans]
Secondary Outcome(s)
Endoscopic remission [Time Frame: 2 years]
relapse in each arm. [Time Frame: 2 years]
Sustained clinical remission [Time Frame: 2years]
Tissue damage progression [Time Frame: 2 years]
Treatment failure [Time Frame: 2 years]
Secondary ID(s)
GETAID 2014-03
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Saint-Louis Hospital, Paris, France
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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