A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease (Cop1CD)
Recruitment status was Recruiting
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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.|
- Primary endpoints: The proportion of patients at clinical remission (CDAI<150) [ Time Frame: week 12. ] [ Designated as safety issue: No ]
- Proportion of patients at clinical remission [ Time Frame: at weeks 4 and 16 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||July 2011|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
20 mg copaxone(glatiramer acetate)subcutaneous injection(daily through week 12)
Drug: glatiramer acetate
20 mg daily subcutaneous injection through week 12
Placebo Comparator: 2
placebo subcutaneous injection(daily through week 12)
subcutaneous daiky injection through week 12
Data evaluation: Evidence of therapeutic benefit and safety will be evaluated by the following 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).
- 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.
|Contact: Iris Dotan, MDfirstname.lastname@example.org|
|Weizmann Institute of Science||Not yet recruiting|
|Rehovot, Israel, 76100|
|Contact: Ruth Arnon, PhD 972 -8- 9344017 email@example.com|
|Tel Aviv Sourasky medical center||Recruiting|
|Tel Aviv, Israel, 64239|
|Contact: Iris Dotan, MD 972-3-6947305 firstname.lastname@example.org|
|Principal Investigator: Iris Dotan, MD|
|Principal Investigator:||Iris Dotan, MD||Tel-Aviv Sourasky Medical Center|