Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732) (TERMINATED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00796250

Purpose

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	Intervention	Phase
Crohn's Disease	Biological: Infliximab Drug: AZA Drug: Placebo Prednisolone Drug: Prednisolone Biological: Placebo Infliximab	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Infliximab Azathioprine Azathioprine sodium salt

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Infliximab as "Bridging Therapy" in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine

Further study details as provided by Schering-Plough:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerability evaluation (labs parameters, vital signs, adverse events). [ Time Frame: At each visit. ] [ Designated as safety issue: Yes ]
Quality of life assessment, by IBDQ questionnaire. [ Time Frame: Baseline, Week 10, and Week 30. ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	November 2003
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	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.
Group B: Active Comparator	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 placbeo 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.

Arms

Assigned Interventions

Group A: Experimental

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.

Group B: Active Comparator

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 placbeo 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P02732
Study First Received:	November 21, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00796250
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Gastrointestinal Diseases
Infliximab
Methylprednisolone
Inflammatory Bowel Diseases
Methylprednisolone acetate
Prednisolone acetate
Intestinal Diseases

Digestive System Diseases
Azathioprine
Crohn Disease
Prednisolone
Gastroenteritis
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Protective Agents
Neuroprotective Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009