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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-01

Study Completion Date

2005-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

Group Type EXPERIMENTAL

Infliximab

Intervention Type BIOLOGICAL

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.

AZA

Intervention Type DRUG

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).

Placebo Prednisolone

Intervention Type DRUG

Patients in this group were treated with AZA, infliximab, and placebo prednisolone. Placebo prednisolone was to be administered by oral use.

Group B

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

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.

AZA

Intervention Type DRUG

Patients in this group were treated with AZA, prednisolone, and placebo infliximab. All patients were treated with AZA, by oral use, with a 2 mgkg dose a day until the end of the study (30 weeks).

Placebo Infliximab

Intervention Type BIOLOGICAL

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.

Interventions

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Infliximab

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.

Intervention Type BIOLOGICAL

AZA

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).

Intervention Type DRUG

Placebo Prednisolone

Patients in this group were treated with AZA, infliximab, and placebo prednisolone. Placebo prednisolone was to be administered by oral use.

Intervention Type DRUG

Prednisolone

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.

Intervention Type DRUG

AZA

Patients in this group were treated with AZA, prednisolone, and placebo infliximab. All patients were treated with AZA, by oral use, with a 2 mgkg dose a day until the end of the study (30 weeks).

Intervention Type DRUG

Placebo 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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Remicade SCH 215596 Imuran Placebo Pediapred Imuran Placebo

Eligibility Criteria

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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.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No