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A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease (Cop1CD)

Primary Purpose

Crohns Disease

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

glatiramer acetate

placebo

About this trial

This is an interventional treatment trial for Crohns Disease focused on measuring crohns disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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.
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 Criteria:

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

Sites / Locations

Weizmann Institute of Science
Tel Aviv Sourasky medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

20 mg copaxone(glatiramer acetate)subcutaneous injection(daily through week 12)

placebo subcutaneous injection(daily through week 12)

Outcomes

Primary Outcome Measures

Primary endpoints: The proportion of patients at clinical remission (CDAI<150)

Secondary Outcome Measures

Proportion of patients at clinical remission

Full Information

NCT ID

NCT00731172

First Posted

August 6, 2008

Last Updated

March 1, 2009

Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

Teva Branded Pharmaceutical Products R&D, Inc., Medtronic - MITG

1. Study Identification

Unique Protocol Identification Number

NCT00731172

Brief Title

A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease

Acronym

Cop1CD

Official 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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

July 2010 (Anticipated)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

Teva Branded Pharmaceutical Products R&D, Inc., Medtronic - MITG

4. Oversight

Data Monitoring Committee

5. Study Description

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 treatment of MS. . In experimental models of IBD, a beneficial effect of Copaxone was demonstrated where significant amelioration of macroscopic colonic damage, preservation of the microscopic colonic structure, reduced weight loss, and improved long-term survival in treated compared with untreated mice was demonstrated. In addition, Copaxone suppressed the proliferation of local mesenteric lymphocytes to syngeneic colon extract, significantly reduced the overall secretion of TNF-α and induced the secretion of transforming growth factor (TGF)-β. The ability of Copaxone to effectively modulate the clinical manifestations and the detrimental immune response involved in experimental colitis, together with its high safety profile support its potential effect as a new treatment for CD. Patients: patients with moderately active Crohn's disease as indicated by a CDAI 220 - 450, whose diagnosis was done more than 3 months before enrollment. Study objectives: to test the efficacy and safety of Copaxone in CD patients. Study design: This will be a single center, randomized, double blind placebo controlled phase 2 study. Subjects will be assessed for study eligibility 1 to 2 weeks prior to baseline Eligible patients will be enrolled into the study after signing an informed consent form and allocated in a 1.5:1 ratio to receive either Copaxone or placebo. A total of 50 patients will be recruited. Subcutaneous injections (Copaxone or Placebo) will be administered daily through week 12. Patient assessment of safety and efficacy will be made at weeks 0,4,8,12 and 16. At week 12 non-responders would be offered an open label arm with daily Copaxone 20mg for the next 12 weeks

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 CDAI. Mucosal healing will be assessed by VCE (data will be quantitated using the Lewis score). Patients requiring colonoscopy according to Physicians decision would also be offered to participate in an endoscopic mucosal healing evaluation substudy. Patients participating will undergo colonoscopy and biopsies at the beginning (screening±1 week) and the end (week 12±1 week) of the treatment period. Endoscopic damage will be assessed using the CDEIS Mean (median) doses of corticosteroids and the average total aggregate dose of corticosteroids received per patient during the trial will be assessed. Quality of life will be assessed by components of the Inflammatory Bowel Disease Questionnaire(IBDQ). Safety: AE incidence Physical examination Clinical laboratory values Vital signs Tolerability and Safety: Adverse events, dropout rate will be registered. Proportion of subjects who prematurely discontinue the study. Proportion of subjects who prematurely discontinue the study due to Aes Time to premature discontinuation Time to premature discontinuation due to Aes. Immunologic assessment (including lymphocyte proliferation and cytokine secretion assays) will be performed at the baseline visit as well as weeks 4 and 12 and 16. Serum samples for cytokine studies 24 hours after first injection would also be collected.

6. Conditions and Keywords

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

Crohns Disease

Keywords

crohns disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

20 mg copaxone(glatiramer acetate)subcutaneous injection(daily through week 12)

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo subcutaneous injection(daily through week 12)

Intervention Type

Drug

Intervention Name(s)

glatiramer acetate

Intervention Description

20 mg daily subcutaneous injection through week 12

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

subcutaneous daiky injection through week 12

Primary Outcome Measure Information:

Title

Primary endpoints: The proportion of patients at clinical remission (CDAI<150)

Time Frame

week 12.

Secondary Outcome Measure Information:

Title

Proportion of patients at clinical remission

Time Frame

at weeks 4 and 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Iris Dotan, MD

Phone

972-3-6947305

irisd@tasmc.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iris Dotan, MD

Organizational Affiliation

Tel-Aviv Sourasky Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weizmann Institute of Science

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ruth Arnon, PhD

Phone

972 -8- 9344017

ruth.arnon@weizmann.ac.il

Facility Name

Tel Aviv Sourasky medical center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Iris Dotan, MD

Phone

972-3-6947305

irisd@tasmc.health.gov.il

First Name & Middle Initial & Last Name & Degree

Iris Dotan, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

15677903

Citation

Aharoni R, Kayhan B, Arnon R. Therapeutic effect of the immunomodulator glatiramer acetate on trinitrobenzene sulfonic acid-induced experimental colitis. Inflamm Bowel Dis. 2005 Feb;11(2):106-15. doi: 10.1097/00054725-200502000-00003.

Results Reference

background

PubMed Identifier

16624971

Citation

Aharoni R, Kayhan B, Brenner O, Domev H, Labunskay G, Arnon R. Immunomodulatory therapeutic effect of glatiramer acetate on several murine models of inflammatory bowel disease. J Pharmacol Exp Ther. 2006 Jul;318(1):68-78. doi: 10.1124/jpet.106.103192. Epub 2006 Apr 19.

Results Reference

background

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A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease

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