Relapsing Multiple SclerosisNCT04928313
Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran
An observational study of Relapsing Multiple Sclerosis, run by Cinnagen.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Glatiramer Acetate
- Type of treatment
- Injection or infusion
- How many people
- 368 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2015to 17 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with relapsing forms of MS
Who may be able to join
- 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
Who cannot join
- 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®.
About this study
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
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
Read the 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.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Glatiramer Acetate
- Keywords
- Glatiramer Acetate, Multiple Sclerosis, Quality of Life, Cinnomer, Annualized Relapse Rate, Safety, Relapsing
- Medical subject headings
- Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glatiramer AcetateDrug
Also called Cinnomer®
Cinnomer® was injected subcutaneously 3 times per week at least 48 hours apart.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Throughout the study period (up to 14 months for each patient)
Secondary outcomes (6)
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.
Measured: Baseline, Month 14
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.
Measured: 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.
Measured: Baseline, Month 14
Change in Mean Number of T2 and Gd-enhancing lesions
Measured: 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
Measured: 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
Measured: Baseline, Month 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start12 Apr 2015
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinnagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abdorreza Naser Moghadasi, Assistant Professor, Principal investigator, Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928313
- Sponsor's protocol ID
- CINNOMER.CIN.AN.94 (IV)
- Status last verified
- Jun 2021
- First submitted
- 14 Apr 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04928313
- Acronym / sponsor ID
- CINNOMER.CIN.AN.94 (IV)
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Glatiramer Acetate, Multiple Sclerosis, Quality of Life, Cinnomer, Annualized Relapse Rate, Safety, Relapsing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- CinnagenIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2015 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with relapsing forms of MS
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glatiramer AcetateAlso: Cinnomer®Cinnomer® was injected subcutaneously 3 times per week at least 48 hours apart. | Drug | – |
Primary outcome
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).
6 secondary outcomes
Change from Baseline in Annualized Relapse Rate
Time frame: Baseline, Month 14
The proportion of relapse-free patients
Time frame: Baseline, Month 14
Change from Baseline in Expanded Disability Status Scale (EDSS)
Time frame: Baseline, Month 14
Change in Mean Number of T2 and Gd-enhancing lesions
Time frame: Baseline, Month 14
Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Questionnaire Scale Score at Month 14
Time frame: Baseline, Month 14
Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score at month 14
Time frame: Baseline, Month 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdorreza Naser Moghadasi, Assistant Professor principal investigator
Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Multiple Sclerosis, run by Cinnagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment (time frame: Throughout the study period (up to 14 months for each patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.