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

Relapsing Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928313
• Other study ID #: CINNOMER.CIN.AN.94 (IV)
• Status: Completed
• Start date: April 12, 2015
• Est. completion date: February 17, 2020

Study information

• Verified date: June 2021
• Source: Cinnagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: February 17, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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®.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Glatiramer Acetate
Cinnomer® was injected subcutaneously 3 times per week at least 48 hours apart.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cinnagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in Mean Number of T2 and Gd-enhancing lesions		Baseline, Month 14
Secondary	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
Secondary	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