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TERMINATEDPHASE3

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

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

NCT00796250•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

Key Dates

Start Date

November 1, 2003

Primary Completion Date

January 1, 2005

Completion Date

January 1, 2005

Last Updated

March 23, 2017

Enrollment

ACTUAL participants

Conditions

Crohn's Disease

Interventions

Infliximab

BIOLOGICAL

AZA

DRUG

Placebo Prednisolone

DRUG

Prednisolone

DRUG

AZA

DRUG

Placebo Infliximab

BIOLOGICAL

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease