Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran

Cinnagen368 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

368

Conditions

Relapsing Multiple Sclerosis

Interventions

Glatiramer AcetateDRUG

Cinnomer® was injected subcutaneously 3 times per week at least 48 hours apart.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

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).

Time frame: Throughout the study period (up to 14 months for each patient)

Secondary Outcomes

Change from Baseline in Annualized Relapse Rate

A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.