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

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ClinicalTrials.gov Identifier: NCT00796250

Recruitment Status : Terminated (Due to poor patient recruitment, a decision was made to terminate this trial.)

First Posted : November 24, 2008

Last Update Posted : March 23, 2017

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Crohn's Disease	Biological: Infliximab Drug: AZA Drug: Placebo Prednisolone Drug: Prednisolone Biological: Placebo Infliximab	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	9 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Efficacy of Infliximab as "Bridging Therapy" in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine
Actual Study Start Date :	November 1, 2003
Actual Primary Completion Date :	January 1, 2005
Actual Study Completion Date :	January 1, 2005

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Infliximab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A	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. Other Names: Remicade SCH 215596 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). Other Name: Imuran Drug: Placebo Prednisolone Patients in this group were treated with AZA, infliximab, and placebo prednisolone. Placebo prednisolone was to be administered by oral use. Other Name: Placebo
Active Comparator: Group B	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. Other Name: Pediapred 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). Other Name: Imuran 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. Other Name: Placebo

Arm

Intervention/treatment

Experimental: Group A

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.

Other Names:

Remicade
SCH 215596

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).

Other Name: Imuran

Drug: Placebo Prednisolone

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

Other Name: Placebo

Active Comparator: Group B

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.

Other Name: Pediapred

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).

Other Name: Imuran

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.

Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: Week 30 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Study Data/Documents: CSR Synopsis This link exits the ClinicalTrials.gov site

Publications of Results:

Leombruno JP, Nguyen GC, Grootendorst P, Juurlink D, Einarson T. Hospitalization and surgical rates in patients with Crohn's disease treated with infliximab: a matched analysis. Pharmacoepidemiol Drug Saf. 2011 Aug;20(8):838-48. doi: 10.1002/pds.2132. Epub 2011 Jun 17.

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Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00796250
Other Study ID Numbers:	P02732
First Posted:	November 24, 2008 Key Record Dates
Last Update Posted:	March 23, 2017
Last Verified:	March 2017

Additional relevant MeSH terms:

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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Azathioprine Infliximab Prednisolone hemisuccinate Prednisolone phosphate	Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Dermatologic Agents Antirheumatic Agents

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