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

NCT00731172 | Unknown Phase 2

• 1 other identifier: TASMC-08-ID-037-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Conditions

Crohns Disease

Keywords

crohns disease

Outcome Measures

Primary Outcomes (1)

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

  week 12.

Secondary Outcomes (1)

• Proportion of patients at clinical remission

  at weeks 4 and 16

Study Arms (2)

1

EXPERIMENTAL

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

Drug: glatiramer acetate

2

PLACEBO COMPARATOR

placebo subcutaneous injection(daily through week 12)

Drug: placebo

Interventions

glatiramer acetate DRUG

20 mg daily subcutaneous injection through week 12

1

placebo DRUG

subcutaneous daiky injection through week 12

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator
• Medtronic - MITG: collaborator

Study Sites (2)

Weizmann Institute of Science

Rehovot, 76100, Israel

NOT YET RECRUITING

Tel Aviv Sourasky medical center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (2)

• 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.

  PMID: 15677903 BACKGROUND

• 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.

  PMID: 16624971 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Iris Dotan, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Dotan, MD

CONTACT

972-3-6947305; irisd@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: March 3, 2009

Record last verified: 2009-03

Locations

IL (2)