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

NCT01433432 | Withdrawn Phase 2

• 1 other identifier: C2/13/DR-6MP-02 EXT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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:

1. 1.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?
2. 2.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?

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (1)

• Maintenance of or improvement in safety assessments

  12 weeks

Study Arms (2)

Purinethol

ACTIVE COMPARATOR

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

Drug: 80 mg DR-6MP

Test Drug

EXPERIMENTAL

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

Drug: 80 mg DR-6MP

Interventions

80 mg DR-6MP DRUG

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.

Purinethol; Test Drug

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva GTC: lead

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Yaron Ilan, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Eran Goldin, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 14, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 7, 2013

Record last verified: 2013-03