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

NCT00796250 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-03-23

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

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.

DRUG

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).

DRUG

Placebo Prednisolone

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

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.

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).

BIOLOGICAL

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-01
Primary Completion
2005-01-01
Completion
2005-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00796250 on ClinicalTrials.gov