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

This study has been terminated.
(Due to poor patient recruitment, a decision was made to terminate this trial.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00796250
First received: November 21, 2008
Last updated: May 8, 2014
Last verified: May 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00796250     History of Changes
Other Study ID Numbers: P02732
Study First Received: November 21, 2008
Last Updated: May 8, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Methylprednisolone acetate
Prednisolone acetate
Infliximab
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Antibodies, Monoclonal
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on September 30, 2014