A Phase IV, Post-marketing, Prospective, Multicenter Study to Investigate the Safety and Effectiveness of Cinnomer® (Glatiramer-Acetate) in Multiple Sclerosis (MS) Treatment in Iran
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Relapsing Multiple Sclerosis
- Sponsor
- Cinnagen
- Enrollment
- 368
- Primary Endpoint
- Safety assessment
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This trial was an obsevational phase IV prospective multicenter study designed to evaluate the safety and effectiveness of Cinnomer® in patients with MS in Iran.
The primary objective of this study was safety assessment of Cinnomer®
Secondary objectives were:
- Effectiveness assessment of Cinnomer®
- Assessment of the patients' QoL
- Evaluation of the patients' depression status
Detailed Description
This trial was an observational phase IV prospective multicenter study designed to evaluate the safety and effectiveness of Cinnomer® in patients with MS in Iran. The primary objective of this study was safety evaluation. To evaluate the safety of Cinnomer®, at each visit, the AEs, seriousness of observed AEs, and abnormal laboratory findings were recorded. To evaluate the effectiveness of Cinnomer® as the secondary objective, the indicative parameters of MS activity, including relapse information, MRI findings, and EDSS scores were considered. Also, questionnaires assessing the patients' QoL and depression were evaluated. The sample size of 368 patients and the 14 months of the study was considered applicable for safety and effectiveness evaluation of Cinnomer®, 40 mg/ml, three times per week, in patients with relapsing forms of MS.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with RRMS
- •Patients diagnosed as SPMS with relapse
- •All the patients taking other DMTs and their medication had been changed to Cinnomer® due to any reason.
- •0 ≤ EDSS ≤ 5
- •18 ≤ Age ≤ 60
Exclusion Criteria
- •History of hypersensitivity to Glatiramer Acetate, mannitol, or any component of the formulation.
- •In the investigator's opinion, any reason that makes the subject unsuitable for treatment with Cinnomer®.
Outcomes
Primary Outcomes
Safety assessment
Time Frame: Throughout the study period (up to 14 months for each patient)
To evaluate the safety of Cinnomer®, in each visit, the AEs with any severities were recorded using system organ classes and preferred terms of the medical dictionary for regulatory activities (MedDRA Desktop Browser 4.0 Beta).
Secondary Outcomes
- Change from Baseline in Annualized Relapse Rate(Baseline, Month 14)
- Change in Mean Number of T2 and Gd-enhancing lesions(Baseline, Month 14)
- The proportion of relapse-free patients(Baseline, Month 14)
- Change from Baseline in Expanded Disability Status Scale (EDSS)(Baseline, Month 14)
- Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Questionnaire Scale Score at Month 14(Baseline, Month 14)
- Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score at month 14(Baseline, Month 14)