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

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

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

Study Overview

• Status: Completed
• Conditions: Relapsing Multiple Sclerosis
• Intervention / Treatment: Drug: Glatiramer Acetate

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.

• Study Type: Observational
• Enrollment (Actual): 368

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsing forms of MS

Description

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®.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

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

Collaborators and Investigators

• Sponsor: Cinnagen
• Investigators: Principal Investigator: Abdorreza Naser Moghadasi, Assistant Professor, Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2015
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: June 13, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 13, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Safety; Quality of Life; Relapsing; Glatiramer Acetate; Cinnomer; Annualized Relapse Rate
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Adjuvants, Immunologic; Glatiramer Acetate; (T,G)-A-L
• Other Study ID Numbers: CINNOMER.CIN.AN.94 (IV)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No