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NCT Number: NCT04928313

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

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

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Key information

Conditions

Relapsing Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®.

Treatment and study plan

Glatiramer Acetate

Drug

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

Other names: Cinnomer®

Primary outcomes

  1. Safety assessment

    Time frame: 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 outcomes

  1. Change from Baseline in Annualized Relapse Rate

    Time frame: 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.

  2. The proportion of relapse-free patients

    Time frame: 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.

  3. Change from Baseline in Expanded Disability Status Scale (EDSS)

    Time frame: 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.

  4. Change in Mean Number of T2 and Gd-enhancing lesions

    Time frame: Baseline, Month 14

  5. Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Questionnaire Scale Score at Month 14

    Time frame: Baseline, Month 14

    A score of 0 = the worst QoL and a score of 100 = the best QoL

  6. Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score at month 14

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cinnagen

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2021
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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