Multiple SclerosisCogniPlusNCT01491100
Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Bayer at 17 sites in 17 countries.
Trial summary
Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1b (Betaseron, BAY86-5046)
- Type of treatment
- Injection or infusion
- How many people
- 1,085 participants
- Where
- 17 sitesin 17 countries
- Study dates
- 30 Apr 2012to 5 Apr 2017
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community Sample
Who may be able to join
- Patients with Relapsing Remitting Multiple Sclerosis (RRMS), and treated with Betaferon, with the decision for treatment made at the discretion of the attending physician, documented with a prescription of Betaferon by the physician
- EDSS 0 - 6
- Written informed consent
Who cannot join
- Patients who do not meet the local indication criteria for Betaferon treatment.
- Contraindications listed in the local SmPCs have to be considered.
- Patients with a history of severe head trauma.
- Patients with alcohol and/or drug abuse.
- Patients with mental retardation.
- Patients with learning disability.
Trial locations and contacts
17 sites in 17 countries.
17 sites in 17 countries
About this study
Official title: Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®
Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaseron, BAY86-5046)
- Keywords
- Cognition, Physical Activity, Relapsing Remitting Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (Betaseron, BAY86-5046)Drug
Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)
Measured: 24 months
Physical activity as measured by the Baecke questionnaire
Measured: 24 months
Secondary outcomes (4)
Disability as measured by EDSS (Expanded Disability Status Scale)
Measured: 24 months
Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions)
Measured: 24 months
Depression as measured by the CES-D (Center for Epidemiologic Studies Depression)
Measured: 24 months
Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study start30 Apr 2012
- Primary completion22 Dec 2016
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Prospective
- Enrolment
- 1,085 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491100
- Sponsor's protocol ID
- 16036
- Other IDs
- BF1101
- Acronym
- CogniPlus
- Status last verified
- Apr 2018
- First submitted
- 12 Dec 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®
- ClinicalTrials.gov ID
- NCT01491100
- Acronym / sponsor ID
- CogniPlus / 16036
- Conditions
- Multiple Sclerosis
- Keywords
- Cognition, Physical Activity, Relapsing Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,085 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2012 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 13 Dec 2011 (estimated)
- 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.
Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (3 listed)
- Patients with Relapsing Remitting Multiple Sclerosis (RRMS), and treated with Betaferon, with the decision for treatment made at the discretion of the attending physician, documented with a prescription of Betaferon by the physician
- EDSS 0 - 6
- Written informed consent
Key exclusion criteria (6 listed)
- Patients who do not meet the local indication criteria for Betaferon treatment.
- Contraindications listed in the local SmPCs have to be considered.
- Patients with a history of severe head trauma.
- Patients with alcohol and/or drug abuse.
- Patients with mental retardation.
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 |
|---|---|---|
| Interferon beta-1b (Betaseron, BAY86-5046)Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice. | Drug | Group 1 |
Primary outcome
Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)
Time frame: 24 months
Physical activity as measured by the Baecke questionnaire
Time frame: 24 months
4 secondary outcomes
Disability as measured by EDSS (Expanded Disability Status Scale)
Time frame: 24 months
Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions)
Time frame: 24 months
Depression as measured by the CES-D (Center for Epidemiologic Studies Depression)
Time frame: 24 months
Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life)
Time frame: 24 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 5 Apr 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.
Bayer Study Director study director
Bayer
17 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bayer at 17 sites in 17 countries.
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 3 inclusion and 6 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Albania, Algeria, Argentina, Belgium, Czechia and 12 more countries. 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?
Cognitive performance as measured by SDMT (Symbol Digit Modalities Test) (time frame: 24 months). The study lists 2 primary outcomes in all. 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 5 Apr 2018.