Status:
UNKNOWN
A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Medtronic - MITG
Conditions:
Crohns Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
phase 2 study. Target disease: Crohn's disease. Rational and relevance to IBD patients: Copaxone is known for its high safety profile and for acting as an effective immunomodulatory agent for the tr...
Detailed Description
Data evaluation: Evidence of therapeutic benefit and safety will be evaluated by the following assessments: Clinical assessments: * Crohn's disease activity will be assessed by components of the CDA...
Eligibility Criteria
Inclusion
- To be eligible for the trial, patients must meet all of the following criteria;
- Are 18-70 years old at the time of screening; may be male or female.
- Have Crohn's disease, diagnosed more than 3 months before enrollment and confirmed by endoscopy, radiology or surgery. Documentation should be performed within 36 months prior to screening.
- Moderately active Crohn's disease as indicated by a CDAI 220 - 450.
- Are able to adhere to the following concomitant medication requirements:
- Patients must never have received treatment with Copaxone.
- Patients taking 5-ASA compounds must have been taking the drug for at least 4 weeks with a stable dosage for at least 2 weeks prior to screening.
- Patients taking oral corticosteroids must have been taking the drug for at least 4 weeks prior to screening. These patients must be with a stable dose of up to20 mg prednisone/day or equivalent, or up to 6 mg budesonide/day for at least 2 weeks prior to screening.
- Inhaled or topical steroids are allowed.
- Patients taking AZA or 6MP must be on a stable dose for at least 12 weeks prior to screening.
- Patients taking antibiotic therapy for CD must be on a stable dose for at least 2 weeks prior to screening.
- Negative stool cultures for enteric pathogens (Salmonella, Shigella, Campylobacter) and negative Clostridium difficile toxin assay in stool.
- Women and men of childbearing potential must use medically acceptable methods of contraception \[surgical sterilization, IUD, hormonal preparations, or double barrier method (e.g. condom or diaphragm, and spermicide)\] throughout the study.
- Patients are able to self-inject or have a designee or healthcare professional who can inject the study medication daily.
- Patients are willing and able to provide written informed consent.
Exclusion
- Diagnosis of indeterminate, microscopic, lymphocytic, collagenous, or ulcerative colitis.
- Subjects with clinically significant active systemic infection.
- Subjects who in the opinion of the investigator have another clinically significant or unstable medical or surgical condition such as: cardiovascular, pulmonary, hepatic, renal, autoimmune, endocrine, metabolic or malignancy or any other condition that places the subject at undue risk by participating in the study.
- Short bowel syndrome or a bowel surgery within 3 month before randomization.
- Clinically significant obstructive symptoms with radiologic evidence of intestinal strictures. Ileostomy, colostomy, or parenteral nutrition Subjects who have fistula with abscess formation.
- The use of the following medications within the last 12 weeks prior to screening: TNF-a antibodies, Thalidomide, Methotrexate, Cyclosporine, Tacrolimus, or Mycophenolate Mofetil.
- The use of more than 100mg/d Aspirin.
- Use of another investigational drug within 3 months before screening.
- Pregnant or lactating woman.
- Concomitant substance or alcohol abuse.
- Subjects with known sensitivity to mannitol.
- Subjects unable to self-inject or do not have a designee or healthcare professional who can inject the study medication.
- Subject unable to comply with the planned schedule of study visits and study procedures
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00731172
Start Date
September 1 2008
End Date
July 1 2011
Last Update
March 3 2009
Active Locations (2)
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1
Weizmann Institute of Science
Rehovot, Israel, 76100
2
Tel Aviv Sourasky medical center
Tel Aviv, Israel, 64239