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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00731172
Date of registration: 06/08/2008
Prospective Registration: Yes
Primary sponsor: Tel-Aviv Sourasky Medical Center
Public title: A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease Cop1CD
Scientific title: A Pilot Single Center,Randomized,Double Blind Placebo Controlled Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Inducing Remission in Patients With Moderately Active Crohn's Disease.
Date of first enrolment: September 2008
Target sample size: 50
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00731172
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Israel
Contacts
Name:     Iris Dotan, MD
Address: 
Telephone: 972-3-6947305
Email: irisd@tasmc.health.gov.il
Affiliation: 
Name:     Iris Dotan, MD
Address: 
Telephone:
Email:
Affiliation:  Tel-Aviv Sourasky Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

To be eligible for the trial, patients must meet all of the following criteria;

1. Are 18-70 years old at the time of screening; may be male or female.

2. 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.

3. Moderately active Crohn's disease as indicated by a CDAI 220 - 450.

4. Are able to adhere to the following concomitant medication requirements:

1. Patients must never have received treatment with Copaxone.

2. 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.

3. 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.

4. Patients taking AZA or 6MP must be on a stable dose for at least 12 weeks prior
to screening.

5. Patients taking antibiotic therapy for CD must be on a stable dose for at least
2 weeks prior to screening.

5. Negative stool cultures for enteric pathogens (Salmonella, Shigella, Campylobacter)
and negative Clostridium difficile toxin assay in stool.

6. 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.

7. Patients are able to self-inject or have a designee or healthcare professional who
can inject the study medication daily.

8. Patients are willing and able to provide written informed consent.

Exclusion Criteria:

1. Diagnosis of indeterminate, microscopic, lymphocytic, collagenous, or ulcerative
colitis.

2. Subjects with clinically significant active systemic infection.

3. 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.

4. Short bowel syndrome or a bowel surgery within 3 month before randomization.

5. Clinically significant obstructive symptoms with radiologic evidence of intestinal
strictures. Ileostomy, colostomy, or parenteral nutrition Subjects who have fistula
with abscess formation.

6. The use of the following medications within the last 12 weeks prior to screening:
TNF-a antibodies, Thalidomide, Methotrexate, Cyclosporine, Tacrolimus, or
Mycophenolate Mofetil.

7. The use of more than 100mg/d Aspirin.

8. Use of another investigational drug within 3 months before screening.

9. Pregnant or lactating woman.

10. Concomitant substance or alcohol abuse.

11. Subjects with known sensitivity to mannitol.

12. Subjects unable to self-inject or do not have a designee or healthcare professional
who can inject the study medication.

13. Subject unable to comply with the planned schedule of study visits and study
procedures



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohns Disease
Intervention(s)
Drug: glatiramer acetate
Drug: placebo
Primary Outcome(s)
Primary endpoints: The proportion of patients at clinical remission (CDAI<150) [Time Frame: week 12.]
Secondary Outcome(s)
Proportion of patients at clinical remission [Time Frame: at weeks 4 and 16]
Secondary ID(s)
TASMC-08-ID-037-CTIL
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Given Imaging Ltd.
Teva Pharmaceutical Industries
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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