Relapsing-Remitting Multiple SclerosisNCT03284970
Retrospective Study to Determine Effect of Rebif and Tecfidera on Infections and Lymphocytes
An observational study of Relapsing-Remitting Multiple Sclerosis, run by EMD Serono Research & Development Institute, Inc. at 1 site in United States.
Trial summary
This study will be a single center, retrospective, pilot study to determine the effect of Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total lymphocyte counts, grade of lymphopenia, Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) counts and ratios in subjects… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- Type of treatment
- Injection or infusion
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to 11 May 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include subjects aged 50 years or older with relapsing RRMS, identified from a feasibility assessment conducted at a single center in United States, who were treated with either interferon beta-1a SC 44 micro-gram or dimethyl fumarate between January 1, 2015 to December 31, 2015.
Who may be able to join
- RRMS subjects who have been treated with interferon beta 1a SC 44 micro-gram thrice a week and dimethyl fumarate in inpatient or outpatient settings during the period from January 1, 2015 to December 31, 2015.
- Subjects with at least one year of laboratory values post-index date to analyze lymphocyte counts, and CD4 and CD8 counts. The date of first blood draw for laboratory tests after January 1, 2015 will be defined as the subject's index date.
Who cannot join
- Subjects who have been on treatment for less than 1 year after their index date.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurology Center of New England
Foxborough, Massachusetts, 02035
About this study
Official title: Effect of Interferon Beta-1a SC 44 µg Three Times Weekly (Tiw) (Rebif) and Dimethyl Fumarate (DMF, Tecfidera) on Infections and Lymphocytes in Patients 50 Years or Older From a Single Center Chart Review
This study will be a single center, retrospective, pilot study to determine the effect of Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total lymphocyte counts, grade of lymphopenia, Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) counts and ratios in subjects aged 50 years and above with Relapsing-Remitting Multiple Sclerosis (RRMS).
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Interferon beta-1a, Dimethyl fumarate, Rebif, Tecfidera, Relapsing-Remitting Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rebif (interferon beta 1a) | This study will retrospectively collect the data from the subjects who had been treated with Rebif subcutaneously (SC) at a dose of 44 micro-grams three times a week. | |
| Tecfidera (dimethyl fumarate) | This study will retrospectively collect the data from the subjects who had been treated with Tecfidera. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With One or More Infections
Measured: Up to 12 months
Secondary outcomes (10)
Percentage of Subjects With One or More Serious Infections
Measured: Baseline, 6 Months, 12 Months
Percentage of Subjects With One or More Opportunistic Infections
Measured: Baseline, 6 Months, 12 Months
Number of Infections per Subject
Measured: Baseline, 6 Months, 12 Months
Number of Serious Infections per Subject
Measured: Baseline, 6 Months, 12 Months
Number of Opportunistic Infections per Subject
Measured: Baseline, 6 Months, 12 Months
Total Lymphocyte Levels
Measured: Baseline, 6 Months, 12 Months
Percentage of Subjects With Lymphopenia Grades I, II, III and IV
Measured: Baseline, 6 Months, 12 Months
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts
Measured: Baseline, 6 Months, 12 Months
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio
Measured: Baseline, 6 Months, 12 Months
Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Baseline, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start23 Aug 2017
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284970
- Sponsor's protocol ID
- MS200136_0077
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2017
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interferon Beta-1a SC 44 µg Three Times Weekly (Tiw) (Rebif) and Dimethyl Fumarate (DMF, Tecfidera) on Infections and Lymphocytes in Patients 50 Years or Older From a Single Center Chart Review
- ClinicalTrials.gov ID
- NCT03284970
- Acronym / sponsor ID
- MS200136_0077
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Interferon beta-1a, Dimethyl fumarate, Rebif, Tecfidera, Relapsing-Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 15 Sep 2017 (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 study will be a single center, retrospective, pilot study to determine the effect of Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total lymphocyte counts, grade of lymphopenia, Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) counts and ratios in subjects aged 50 years and above with Relapsing-Remitting Multiple Sclerosis (RRMS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebif (interferon beta 1a) | – | –This study will retrospectively collect the data from the subjects who had been treated with Rebif subcutaneously (SC) at a dose of 44 micro-grams three times a week. |
| Tecfidera (dimethyl fumarate) | – | –This study will retrospectively collect the data from the subjects who had been treated with Tecfidera. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include subjects aged 50 years or older with relapsing RRMS, identified from a feasibility assessment conducted at a single center in United States, who were treated with either interferon beta-1a SC 44 micro-gram or dimethyl fumarate between January 1, 2015 to December 31, 2015.
Key inclusion criteria (2 listed)
- RRMS subjects who have been treated with interferon beta 1a SC 44 micro-gram thrice a week and dimethyl fumarate in inpatient or outpatient settings during the period from January 1, 2015 to December 31, 2015.
- Subjects with at least one year of laboratory values post-index date to analyze lymphocyte counts, and CD4 and CD8 counts. The date of first blood draw for laboratory tests after January 1, 2015 will be defined as the subject's index date.
Key exclusion criteria (1 listed)
- Subjects who have been on treatment for less than 1 year after their index date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Subjects With One or More Infections
Time frame: Up to 12 months
10 secondary outcomes
Percentage of Subjects With One or More Serious Infections
Time frame: Baseline, 6 Months, 12 Months
Percentage of Subjects With One or More Opportunistic Infections
Time frame: Baseline, 6 Months, 12 Months
Number of Infections per Subject
Time frame: Baseline, 6 Months, 12 Months
Number of Serious Infections per Subject
Time frame: Baseline, 6 Months, 12 Months
Number of Opportunistic Infections per Subject
Time frame: Baseline, 6 Months, 12 Months
Total Lymphocyte Levels
Time frame: Baseline, 6 Months, 12 Months
Percentage of Subjects With Lymphopenia Grades I, II, III and IV
Time frame: Baseline, 6 Months, 12 Months
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts
Time frame: Baseline, 6 Months, 12 Months
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio
Time frame: Baseline, 6 Months, 12 Months
Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline, 6 Months, 12 Months
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 6 Aug 2018.
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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.
Medical Responsible study director
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis, run by EMD Serono Research & Development Institute, Inc. at 1 site in United States.
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 2 inclusion and 1 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 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Percentage of Subjects With One or More Infections (time frame: Up to 12 months). 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 6 Aug 2018.