Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glatiramer Acetate | Drug | Cinnomer® was injected subcutaneously 3 times per week at least 48 hours apart. |
|
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with relapsing forms of MS
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Abdorreza Naser Moghadasi, Assistant Professor | Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |