Clinical trial NCT04928313: Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Multiple Sclerosis
Keywords: Glatiramer Acetate
Multiple Sclerosis
Quality of Life
Cinnomer
Annualized Relapse Rate
Safety
Relapsing
Lead sponsor: Cinnagen
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsing forms of MS

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.

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®.

Primary outcomes:
measure: Safety assessment
timeFrame: Throughout the study period (up to 14 months for each patient)
Secondary outcomes:
measure: Change from Baseline in Annualized Relapse Rate
timeFrame: Baseline, Month 14
measure: The proportion of relapse-free patients
timeFrame: Baseline, Month 14
measure: Change from Baseline in Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, Month 14
measure: Change in Mean Number of T2 and Gd-enhancing lesions
timeFrame: Baseline, Month 14
measure: Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Questionnaire Scale Score at Month 14
timeFrame: Baseline, Month 14
measure: Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score at month 14
timeFrame: Baseline, Month 14
Other outcomes:
Locations:
Study officials:
affiliation: Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
name: Abdorreza Naser Moghadasi, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References: