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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: 16 December 2017
Main ID:  NCT00796250
Date of registration: 21/11/2008
Prospective Registration: No
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)
Scientific title: Efficacy of Infliximab as "Bridging Therapy" in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine
Date of first enrolment: November 1, 2003
Target sample size: 9
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00796250
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 3
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

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 exclusion criteria as
well as the uncomplicated urinary tract infections, contracted during the previous 3
months before study inclusion.

- Ongoing infections due to CMV, pneumocystis carinii, atypical mycobacterium. Proved
HIV infection, presence of ARC or AIDS.

- Necessity during the study of elective or emergency surgical operation.

- Altered hepatic function: total bilirubin >=1.5 times the upper limit of the normal
ranges (UNL), AST (SGOT) >=2 UNL, phosphatase alkaline >=2.5 UNL, or PTT - INR >=1.5
UNL.

- Altered renal function: creatinine >=1.5 mg.

- Presence of serious concomitant illnesses (cardiac, pulmonary, neurological diseases).

- History of pathology in charge of the haemopoietic system and of lymphoproliferative
diseases such as lymphoma, lymphadenopathies of unusual localisation (i.e. at the
nape, epitochlear or periaortic) or splenomegaly.

- Presence of neoplastic or pre-neoplastic lesions, or history of neoplasm in the past 5
years.

- Presence or history of drug or alcohol abuse.

- Pregnant or lactating women.

- Women of childbearing potential without adequate contraception except in case of
surgical menopause. These methods of birth control should also be used during the 6
months after the last infusion.

- Contraindications for AZA (i.e. lymphoproliferative diseases, leukopenia) and
prednisolone (i.e. peptic ulcer, systemic fungal infections) as laid out in the
summary of product characteristics.

- Hyperamylasemia >=1.5 times the upper limit of the normal ranges.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Biological: Infliximab
Biological: Placebo Infliximab
Drug: AZA
Drug: Placebo Prednisolone
Drug: Prednisolone
Primary Outcome(s)
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. [Time Frame: Week 30]
Secondary Outcome(s)
Quality of life assessment, by IBDQ questionnaire. [Time Frame: Baseline, Week 10, and Week 30.]
Tolerability evaluation (labs parameters, vital signs, adverse events). [Time Frame: At each visit.]
Secondary ID(s)
P02732
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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