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

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Infliximab
AZA
Placebo Prednisolone
Prednisolone
AZA
Placebo Infliximab
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A

    Group B

    Arm Description

    Outcomes

    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.

    Secondary Outcome Measures

    Tolerability evaluation (labs parameters, vital signs, adverse events).
    Quality of life assessment, by IBDQ questionnaire.

    Full Information

    First Posted
    November 21, 2008
    Last Updated
    March 21, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00796250
    Brief Title
    Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)
    Official Title
    Efficacy of Infliximab as "Bridging Therapy" in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Due to poor patient recruitment, a decision was made to terminate this trial.
    Study Start Date
    November 1, 2003 (Actual)
    Primary Completion Date
    January 1, 2005 (Actual)
    Study Completion Date
    January 1, 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    Infliximab
    Other Intervention Name(s)
    Remicade, SCH 215596
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    AZA
    Other Intervention Name(s)
    Imuran
    Intervention Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Prednisolone
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Patients in this group were treated with AZA, infliximab, and placebo prednisolone. Placebo prednisolone was to be administered by oral use.
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone
    Other Intervention Name(s)
    Pediapred
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    AZA
    Other Intervention Name(s)
    Imuran
    Intervention Description
    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).
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo Infliximab
    Other Intervention Name(s)
    Placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Tolerability evaluation (labs parameters, vital signs, adverse events).
    Time Frame
    At each visit.
    Title
    Quality of life assessment, by IBDQ questionnaire.
    Time Frame
    Baseline, Week 10, and Week 30.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21688345
    Citation
    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.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

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

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