Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran
- Conditions
- Relapsing Multiple Sclerosis
- Registration Number
- NCT04928313
- Lead Sponsor
- Cinnagen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 368
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment Throughout the study period (up to 14 months for each patient) 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).
- Secondary Outcome Measures
Name Time Method Change from Baseline in Annualized Relapse Rate Baseline, Month 14 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.
The proportion of relapse-free patients Baseline, Month 14 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.
Change from Baseline in Expanded Disability Status Scale (EDSS) Baseline, Month 14 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.
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 A score of 0 = the worst QoL and a score of 100 = the best QoL
Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score at month 14 Baseline, 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