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

NCT04928313 | Completed

• 1 other identifier: CINNOMER.CIN.AN.94 (IV)
• Study Type: observational
• Target: 368
• Locations: 0 countries
• Sites: N/A

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

Conditions

Relapsing Multiple Sclerosis

Keywords

Glatiramer Acetate; Multiple Sclerosis; Quality of Life; Cinnomer; Annualized Relapse Rate; Safety; Relapsing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from Baseline in Annualized Relapse Rate

  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 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

  Baseline, Month 14

Interventions

Glatiramer Acetate DRUG

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

Also known as: Cinnomer®

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsing forms of MS

You may qualify if:

• 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.
• ≤ EDSS ≤ 5
• ≤ Age ≤ 60

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Cinnagen: lead

MeSH Terms

Conditions

Multiple Sclerosis; Recurrence

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Abdorreza Naser Moghadasi, Assistant Professor

  Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: June 16, 2021
• Study Start: April 12, 2015
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: June 16, 2021

Record last verified: 2021-06