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

CinnaGen

Status: Completed

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: Glatiramer Acetate

Study type: Observational

Funder types: Industry

Identifiers

NCT04928313

CINNOMER.CIN.AN.94 (IV)

Details and patient eligibility

About

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

Full 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.

Enrollment: 368 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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®.