A prospective randomized controlled study comparing continuing treatment with an anti-TNF antibody (infliximab) and an antimetabolite to contiuing with a single agent, either with the anti-TNF antibody or the anti-metabolite in Crohn’s disease in patients without clinical sympthoms and without steroids on combination therapy
- Conditions
- Crohn´s diseaseTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2014-002311-41-SE
- Lead Sponsor
- GETAID
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 225
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
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 202
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method