Crohn's Disease
Conditions
Brief summary
This is a double-blind, double-dummy, prednisolone-controlled, multi-center, randomized, parallel-group clinical study to evaluate the therapeutic efficacy of repeated infliximab infusions in order to maintain Crohn's disease remission at the end of the study.
Interventions
BIOLOGICALInfliximab
Patients in this group were treated with azathioprine (AZA), infliximab, and placebo prednisolone. Infliximab was to be administered at a dose of 5 mg/kg at Visit 2 (Week 0), and at Weeks 2, 6, and 14 (total of four infusions). Infliximab infusions were administered by the investigators in the hospital during the patient's visit, usually in the morning.
DRUGAZA
Patients in this group were treated with AZA, infliximab, and placebo prednisolone. All patients were treated with AZA, by oral use, with a 2 mgkg dose a day until the end of the study (30 weeks).
Patients in this group were treated with AZA, infliximab, and placebo prednisolone. Placebo prednisolone was to be administered by oral use.
DRUGPrednisolone
Patients in this group were treated with AZA, prednisolone, and placebo infliximab. Prednisolone was to be administered by oral use, with the decreasing dose of 40 mg a day, 35 mg a day, 30 mg a day and 25 mg a day every week for each dosage, respectively; 20 mg a day for five weeks; 15 mg a day, 10 mg a day and 5 mg a day for one week for each dosage respectively, until discontinuation.
BIOLOGICALPlacebo Infliximab
Patients in this group were treated with AZA, prednisolone, and placebo infliximab. Placebo infliximab was to be administered at Visit 2 (Week 0), and at Weeks 2, 6, and 14 (total of four infusions). Infliximab infusions were administered by the investigators in the hospital during the patient's visit, usually in the morning.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and Female patients with age between 18 and 65 years. * Patients suffering from corticodependent Crohn's disease, in reheightening phase, with CDAI value \>=220. * Patients able to participate and to comply with the study. * Patients with adequate bone marrow stock: GB \>=3.5x109/L, PLTs \>=100 x 103, Hb \>=9 gr/dL. * Patients able and willing to give written informed consent.
Exclusion criteria
* Patients with abscesses or active perianal diseases. * Clinically symptomatic and/or with retrodilatation intestinal stenosis. * Patients previously treated with infliximab. * Patients with history of allergy to murine proteins. * Treatment with immunosuppressant such as AZA, 6-mercaptopurine, methotrexate and cyclosporine A during the previous 3 months. * Positive feces exams for intestinal pathogens, parasitic or toxin of clostridium difficilis. * Tuberculosis (TBC) both active and inactive, evaluated by means of a detailed description (personal history of tuberculosis or possible previous contact with a source of TBC infection), and appropriate screening tests, Thorax Rx, tuberculin test. * Presence of severe infections such as hepatitis, pneumonia, pyelonephritis within the past 3 months before the enrolment. Less severe infections, such as those in charge of the upper respiratory tract (cold syndrome), are not considered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the therapeutic efficacy of repeated infliximab infusions in order to maintain Crohn's disease remission (Crohn's disease Activity Index [CDAI] <=150) at the end of the study. | Week 30 |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability evaluation (labs parameters, vital signs, adverse events). | At each visit. |
| Quality of life assessment, by IBDQ questionnaire. | Baseline, Week 10, and Week 30. |
Outcome results
None listed