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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Infliximab (Biological); AZA (Drug); Placebo Prednisolone (Drug); Prednisolone (Drug); AZA (Drug); Placebo Infliximab (Biological)

Phase: Phase 3

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

Official title: Efficacy of Infliximab as "Bridging Therapy" in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

Tolerability evaluation (labs parameters, vital signs, adverse events).

Quality of life assessment, by IBDQ questionnaire.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: November 2003
Last updated: April 21, 2015

Page last updated: August 23, 2015

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