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Open Label Extension Study to Protocol C2/13/DR-6MP-02 (OLE)

Primary Purpose

Crohn's Disease

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
80 mg DR-6MP
Sponsored by
Teva GTC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and (non-pregnant) female subjects, who completed Protocol C2/13/DR-6MP-02, aged 18-75 years (inclusive)with no serious adverse events or complications and with the consent of the PI

  2. Study entry screening laboratory tests must meet the following criteria:

    WBC greater than or equal to 3000mm3 ALT, AST less than 2 x upper limit of normal Total and direct bilirubin less than 2 x upper limit of normal Note: induction study Protocol C2/13/DR6MP-02 Week 12 termination labs can serve as screening labs for the extension study provided that the subject enters the extension study within 2 weeks of completing the induction study. If the interval is longer, however, repeat screening labs must be conducted.

  3. Subjects must agree not to be taking any treatment for Crohn's disease other than stable dose of 5-ASA, chronic antibiotics or low-dose oral steroids (prednisolone up to 15 mg daily; budesonide up to 6 mg daily) at extension study entry and throughout the study.
  4. Subjects willing and able to provide written informed consent.

Exclusion Criteria:

  1. Subjects with a body weight at extension study entry below 42.5 kg
  2. Women who are pregnant or nursing at the time of extension study entry or who intend to be during the study period
  3. Women of childbearing potential who do not practice an acceptable method of birth control [acceptable methods of birth control are: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy, a double-protection method (condom or diaphragm with spermicide) or abstinence]
  4. Subjects with planned elective surgery or hospitalization during the course of the study (that may interfere with study compliance or outcome)
  5. Subjects who will be unavailable for the duration of the trial, are unable to comply with the planned schedule of study visits, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Purinethol

    Test Drug

    Arm Description

    Subjects who previously received 12 weeks of Purinethol (at 1-1.5 mg/kg)in the original study will now receive 80 mg DR-6MP (2 x 40 mg tablets) once dailyh, in the evening, for an additional 12 weeks

    Subjects who previously received test drug (80 mg DR-6MP) for 12 weeks in the original study, will continue to receive 80 mg DR-6MP (2 x 40 mg tablets) once daily, in the evening, for an additional 12 weeks

    Outcomes

    Primary Outcome Measures

    Maintenance of or reduction in CDAI score
    Maintenance of or reduction in CDAI score at week 12X (end of extension study) relative to extension study start

    Secondary Outcome Measures

    Maintenance of or improvement in safety assessments
    Evaluate and compare the incidence, frequency and severity of Adverse Events between the 2 groups (those who previously received 80 mg DR6MP and continue to receive it vs. those who previously received Purinethol (1-1.5 mg/kg) and are now introduced to 80 mg DR6MP) over 12 weeks. This includes all Adverse Events reported, as well as changes in body weight and changes in clinically significant laboratory values, specifically, WBC, ALT, AST, direct and total bilirubin.

    Full Information

    First Posted
    September 12, 2011
    Last Updated
    March 5, 2013
    Sponsor
    Teva GTC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01433432
    Brief Title
    Open Label Extension Study to Protocol C2/13/DR-6MP-02
    Acronym
    OLE
    Official Title
    Clinical Efficacy and Safety of Delayed Release 6-Mercaptopurine (DR-6MP) for Targeted Ileal Delivery in Patients With Moderately Active Crohn's Disease - Open Label Extension Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor withdrew support for study due to reorganization and project prioritization
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    June 2012 (Anticipated)
    Study Completion Date
    August 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Teva GTC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The open label extension study (Protocol C2/13/DR-6MP-02 EXT) is designed to evaluate the clinical efficacy and safety of 80 mg DR-6MP test formulation for an additional 12 weeks in subjects who already completed 12 weeks of Protocol C2/13/DR-6MP-02. Crohn's disease (CD) therapy is aimed at reducing inflammation via induction of remission after a flare-up and maintenance of the remission for as long as possible. The questions being asked in this extension study are: For subjects who received 80 mg DR-6MP for 12 weeks: Can the clinical efficacy and safety status achieved following 12 weeks of treatment be maintained or improved following an additional 12 weeks of DR-6MP treatment? For subjects who received oral Purinethol (1-1.5 mg/kg daily) for 12 weeks: Can the clinical efficacy and safety at 12 weeks be maintained or improved following the introduction of 12 weeks of 80 mg DR-6MP treatment?
    Detailed Description
    By following the 2 groups of subjects, i.e, those who originally received the test formulation (80 mg DR-6MP) and are now continuing for another 12 weeks on test drug vs. those who received the reference drug (Purinethol, 1-1.5 mg/kg daily) and are now being introduced to 12 weeks of 80 mg DR6MP test drug, and monitoring the CDAI scores, immunology parameters (ex. ESR and CRP) and safety assessments (i.e., adverse events occurrences, weight changes, laboratory test results) and comparing to the parameters at extension study start, the study will effectively answer the following questions: Does an additional 12 weeks of 80 mg DR6MP test drug treatment maintain or improve CDAI scores? Is an additional 12 weeks of 80 mg DR6MP test drug treatment safer due to negligible drug availability systemically? Can an additional 12 weeks of 80 mg DR6MP test drug treatment evoke a more effective immunological systemic response? In the subset of subjects willing to undergo colonoscopy/ileoscopy, does an additional 12 weeks of 80 mg DR6MP test drug induce effective mucosal healing?

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Purinethol
    Arm Type
    Active Comparator
    Arm Description
    Subjects who previously received 12 weeks of Purinethol (at 1-1.5 mg/kg)in the original study will now receive 80 mg DR-6MP (2 x 40 mg tablets) once dailyh, in the evening, for an additional 12 weeks
    Arm Title
    Test Drug
    Arm Type
    Experimental
    Arm Description
    Subjects who previously received test drug (80 mg DR-6MP) for 12 weeks in the original study, will continue to receive 80 mg DR-6MP (2 x 40 mg tablets) once daily, in the evening, for an additional 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    80 mg DR-6MP
    Intervention Description
    All subjects from the original study, Protocol C2/13/DR-6MP-02, whether they received test drug for 12 weeks or Purinethol for 12 weeks, will now receive an additional 12 weeks of 80 mg DR-6MP drug to be administered as 2 x 40 mg DR-6MP test tablets, once nightly, before bedtime.
    Primary Outcome Measure Information:
    Title
    Maintenance of or reduction in CDAI score
    Description
    Maintenance of or reduction in CDAI score at week 12X (end of extension study) relative to extension study start
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Maintenance of or improvement in safety assessments
    Description
    Evaluate and compare the incidence, frequency and severity of Adverse Events between the 2 groups (those who previously received 80 mg DR6MP and continue to receive it vs. those who previously received Purinethol (1-1.5 mg/kg) and are now introduced to 80 mg DR6MP) over 12 weeks. This includes all Adverse Events reported, as well as changes in body weight and changes in clinically significant laboratory values, specifically, WBC, ALT, AST, direct and total bilirubin.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and (non-pregnant) female subjects, who completed Protocol C2/13/DR-6MP-02, aged 18-75 years (inclusive)with no serious adverse events or complications and with the consent of the PI Study entry screening laboratory tests must meet the following criteria: WBC greater than or equal to 3000mm3 ALT, AST less than 2 x upper limit of normal Total and direct bilirubin less than 2 x upper limit of normal Note: induction study Protocol C2/13/DR6MP-02 Week 12 termination labs can serve as screening labs for the extension study provided that the subject enters the extension study within 2 weeks of completing the induction study. If the interval is longer, however, repeat screening labs must be conducted. Subjects must agree not to be taking any treatment for Crohn's disease other than stable dose of 5-ASA, chronic antibiotics or low-dose oral steroids (prednisolone up to 15 mg daily; budesonide up to 6 mg daily) at extension study entry and throughout the study. Subjects willing and able to provide written informed consent. Exclusion Criteria: Subjects with a body weight at extension study entry below 42.5 kg Women who are pregnant or nursing at the time of extension study entry or who intend to be during the study period Women of childbearing potential who do not practice an acceptable method of birth control [acceptable methods of birth control are: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy, a double-protection method (condom or diaphragm with spermicide) or abstinence] Subjects with planned elective surgery or hospitalization during the course of the study (that may interfere with study compliance or outcome) Subjects who will be unavailable for the duration of the trial, are unable to comply with the planned schedule of study visits, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yaron Ilan, MD
    Organizational Affiliation
    Hadassah Medical Organization
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Eran Goldin, MD
    Organizational Affiliation
    Shaare Zedek Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Open Label Extension Study to Protocol C2/13/DR-6MP-02

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