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

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Relapsing Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Glatiramer Acetate


Participation Criteria
=================
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®.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glatiramer Acetate|Cinnomer® was injected subcutaneously 3 times per week at least 48 hours apart.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Throughout the study period (up to 14 months for each patient) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Month 14 | 
| The proportion of relapse-free patients | 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. | Baseline, Month 14 | 
| Change from Baseline in Expanded Disability Status Scale (EDSS) | The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in seven functional systems on examination by a neurologist. | Baseline, Month 14 | 
| Change in Mean Number of T2 and Gd-enhancing lesions |  | Baseline, Month 14 | 
| Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Questionnaire Scale Score at Month 14 | A score of 0 = the worst QoL and a score of 100 = the best QoL | Baseline, Month 14 | 
| Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score at month 14 | Depressive symptoms were measured by the BDI-II, a 21-item, self-reported rating inventory that measures characteristic attitudes and symptoms of depression | Baseline, Month 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glatiramer Acetate, Multiple Sclerosis, Quality of Life, Cinnomer, Annualized Relapse Rate, Safety, Relapsing