Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)

Phase 3

Terminated

• Conditions: Crohn's Disease
• Interventions: Biological: Infliximab; Drug: Prednisolone; Drug: AZA; Drug: Placebo Prednisolone; Biological: Placebo Infliximab

• Registration Number: NCT00796250
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11-01
• Primary Completion: 2005-01-01
• Study Completion: 2005-01-01
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	AZA	-
Group A	Infliximab	-
Group A	Placebo Prednisolone	-
Group B	Prednisolone	-
Group B	AZA	-
Group B	Placebo Infliximab	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Tolerability evaluation (labs parameters, vital signs, adverse events).	At each visit.
Quality of life assessment, by IBDQ questionnaire.	Baseline, Week 10, and Week 30.