Multiple SclerosisNCT01905527
Adherence Trial With MS LifeLines ® Services
An observational study of Multiple Sclerosis and Relapsing-Remitting, run by EMD Serono at 1 site in United States.
Trial summary
This is a Phase IV study to compare the current level of MS LifeLines ® (MSLL) services (face-to-face nursing visits and phone contacts) with customized MSLL services, to determine the optimal services to enhance medication adherence and treatment persistence with Rebif ® subcutaneous three times a week. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Standard Services of Group A (Group A1), Customized Services of Group A (Group A2) and Group B
- Type of treatment
- Injection or infusion
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jan 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have been prescribed to Rebif® treatment by their treating physicians will be observed.
Who may be able to join
- Age 18 to 65 years at the time of informed consent signature
- Male or female
- Female subjects of child bearing potential who report they are not pregnant at screening and agree to avoid pregnancy during study participation by using adequate contraception, defined as two barrier methods, one barrier method with a spermicide, intrauterine device, or use of oral female contraceptive
- Outpatient status at time of online screening
- Subjects prescribed Rebif by their treating physicians as the first disease-modifying drug (DMD) they have received, or up to one prior treatment with either Rebif, Copaxone ®, Avonex ® , Extavia ®, Betaseron ®, Gilenya™, and Aubagio ® (with accelerated elimination), Tysabri ® and Tecfidera™
- Access to, and ability to use, a computer, a mouse, the internet, and an email address. In addition, subjects in the Group A will be required to have access to a telephone that accepts text messaging (in case randomized to the Custom subgroup)
- Subject-reported ability to complete online assignments and read English
- Electronically verified informed consent before any trial-related activities are carried out
Who cannot join
- Any combination therapy with another DMD for Multiple Sclerosis (MS) while participating in the trial
- Score of 4 on any of the items of the MSRS-R or a score between 5 and 8, inclusive, on the PDDS
- Surgical intervention planned during the 12-month study period
- Pregnant or breastfeeding. Note subjects who are 90 days postpartum, stable, and do not breastfeed may participate.
- History of malignancy, with the exception of skin cancer completely excised and considered cured;
- History of seizures or unexplained blackouts within 30 days prior to online screening
Show all 12Show fewer
- Current illegal drug use at the time of online screening;
- Any prior participation in an interventional clinical trial for MS (except for Aubagio ® or Tecfidera™), participation in any trial within 30 days prior to online screening, or current participation in another clinical trial;
- Current treatment of another autoimmune disorder other than stable thyroid disease at the time of online screening
- History of prior treatment for MS with any of the following: alemtuzumab, cyclophosphamide, methotrexate, azathioprine, cyclosporin, intravenous immunoglobulin (IVIg), and plasma exchange
- Other significant subject-reported disease that would exclude the subject from the trial
- Significant renal or hepatic impairment that would compromise completion of the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Call EMD Serono Medical Information for information on recruiting sites
Boston, Massachusetts
About this study
Official title: A Prospective, Parallel Group, Phase IV Study of Three Levels of MS LifeLines ® Support Services Provided to Patients Prescribed Rebif ® for Newly Diagnosed or First-switch Relapsing Remitting Multiple Sclerosis (RRMS)
This is a Phase IV study to compare the current level of MS LifeLines ® (MSLL) services (face-to-face nursing visits and phone contacts) with customized MSLL services, to determine the optimal services to enhance medication adherence and treatment persistence with Rebif ® subcutaneous three times a week.
Read the detailed description
The proposed study is a web-based, prospective, parallel group, Phase IV, 12-month study of patients receiving support services provided by MSLL and contracted nursing services. Following referral of patients to MSLL, consenting patients will be allocated to one of two groups (2:1), based on their geographic area. Group A will be further randomized 1:1 to the standard services subgroup (Group A1) or a customized services subgroup (Group A2). The standard subgroup will receive phones calls and nurse visits at set intervals. Patients in the custom services subgroup will have the option of selecting as many or as few of the "standard" services they will receive after the initial injection training. Subjects will have the option of receiving educational materials, planning tools, and reminders. Patients allocated to Group B will receive a visit for injection training and the follow-up call and then MSLL phone calls at set intervals. Over a period of 12 months (each month defined as a 28-day period), all subjects will receive support services (nurse visit and follow-up phone call, etc) and complete online assessments (MSRS-R, PDSS, etc).
The primary objective of the trial is to determine the impact of two different levels of support service, group A1 and A2, provided by MSLL within Group A, on adherence to prescribed treatment in newly diagnosed or first-switch relapsing remitting multiple sclerosis (RRMS) subjects.
Secondary Objective:
The secondary objectives are:
- To use a pair wise comparison to determine the impact on adherence of the two different levels of service intervention provided by MSLL not compared in the primary objective (Standard services subgroup of Group A (A1) to Group B and Customized service subgroup of Group A (A2) to Group B)
- To determine the correlation of adherence with subject-reported outcomes and other study data;
- To examine the changes from baseline in subject-reported outcomes in each service arm;
- To examine changes from baseline in risk for non-adherence in each service arm; and
- To determine rate of trial dropout between each service arm
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Standard Services of Group A (Group A1), Customized Services of Group A (Group A2), Group B
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Rebif, Quintiles Geographic Area Group, Standard Subgroup, Custom Subgroup, RxCrossroads Geographic Area Group
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Services of Group A (Group A1)Other
Support services provided in this group will include: Initial field nurse injection training visit; field nurse follow-up and subsequent visits; and follow-up phone calls at periodic intervals
Customized Services of Group A (Group A2)Other
In addition to the initial field nurse injection training visit and follow-up call, subjects will select from support services including field nurse follow-up visits; follow-up phone calls; email and/or text reminders; subject self-assessment and use of treatment planning tools; and mail/e-mail educational materials.
Group BOther
Support services provided in this group will include initial field nurse injection training visit and follow-up phone calls at periodic intervals.
| Study group | Role | What they receive |
|---|---|---|
| Standard Services of Group A (Group A1) | Not described Receives: Other: Standard Services of Group A (Group A1) | |
| Customized Services of Group A (Group A2) | Not described Receives: Other: Customized Services of Group A (Group A2) | |
| Group B | Not described Receives: Other: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-reported adherence to treatment, calculated as percent adherence ([number of actual injections / number of expected injections] * 100), for subjects in the Group A1 compared with subjects in the Group A2
Measured: Month 12
Secondary outcomes (15)
Subject-reported adherence to treatment in Group A1, Group A2 and Group B at Month 12
Measured: Month 12
Subject-reported adherence to treatment in Group A1, Group A2 and Group B at Months 3 and 6
Measured: Months 3 and 6
Subject-reported Multiple Sclerosis Rating Scale- Revised (MSRS-R) in Group A1, Group A2 and Group B
Measured: Months 6 and 12
Subject-reported Patient-determined Disease Steps Questionnaire (PDDS) in Group A1, Group A2 and Group B
Measured: Months 6 and 12
Subject-reported Multiple Sclerosis Self-management Scale - Revised (MSSM-R) in Group A1, Group A2 and Group B
Measured: Months 6 and 12
Subject-reported Multiple Sclerosis International Quality of Life (MusiQoL) in Group A1, Group A2 and Group B
Measured: Months 6 and 12
Subject-reported Morisky Medication Adherence Scale-4 (MMAS-4) in Group A1, Group A2 and Group B
Measured: Months 2, 6, 9 and 12
Change from Baseline in Subject-reported multiple Sclerosis Rating Scale- Revised (MSRS-R) in Group A1, Group A2 and Group B at Months 6 and 12
Measured: Months 6 and 12
Change from Baseline in Subject-reported Patient-determined Disease Steps Questionnaire (PDDS) in Group A1, Group A2 and Group B at Months 6 and 12
Measured: Months 6 and 12
Change from Baseline in Subject-reported Multiple Sclerosis Self-management Scale - Revised (MSSM-R) in Group A1, Group A2 and Group B at Months 6 and 12
Measured: Months 6 and 12
Change from Baseline in Subject-reported Multiple Sclerosis International Quality of Life (MusiQoL) in Group A1, Group A2 and Group B at Months 6 and 12
Measured: Months 6 and 12
Change from Baseline in Subject-reported score in Morisky Medication Adherence Scale-4 (MMAS-4) in Group A1, Group A2 and Group B at Months 2, 6, 9 and 12
Measured: Months 2, 6, 9 and 12
Percentage of subjects who dropped-out of the trial along with the reasons of dropping out in Group A1, Group A2 and Group B
Measured: Month 12
Percentage of subjects with more than 80 percent and 90 percent subject-reported adherence to treatment in Group A1, Group A2 and Group B
Measured: Month 12
Percentage of subject demographic characteristics in Group A1, Group A2 and Group B
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: The study was terminated as per the Sponsor's decision.
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.
- 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
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905527
- Sponsor's protocol ID
- EMR 200136-567
- Status last verified
- Jan 2015
- First submitted
- 18 Jul 2013
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Parallel Group, Phase IV Study of Three Levels of MS LifeLines ® Support Services Provided to Patients Prescribed Rebif ® for Newly Diagnosed or First-switch Relapsing Remitting Multiple Sclerosis (RRMS)
- ClinicalTrials.gov ID
- NCT01905527
- Acronym / sponsor ID
- EMR 200136-567
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Rebif, Quintiles Geographic Area Group, Standard Subgroup, Custom Subgroup, RxCrossroads Geographic Area Group
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated as per the Sponsor's decision.
- Enrolment
- 306 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Jul 2013 (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.
This is a Phase IV study to compare the current level of MS LifeLines ® (MSLL) services (face-to-face nursing visits and phone contacts) with customized MSLL services, to determine the optimal services to enhance medication adherence and treatment persistence with Rebif ® subcutaneous three times a week.
Detailed description
The proposed study is a web-based, prospective, parallel group, Phase IV, 12-month study of patients receiving support services provided by MSLL and contracted nursing services. Following referral of patients to MSLL, consenting patients will be allocated to one of two groups (2:1), based on their geographic area. Group A will be further randomized 1:1 to the standard services subgroup (Group A1) or a customized services subgroup (Group A2). The standard subgroup will receive phones calls and nurse visits at set intervals. Patients in the custom services subgroup will have the option of selecting as many or as few of the "standard" services they will receive after the initial injection training. Subjects will have the option of receiving educational materials, planning tools, and reminders. Patients allocated to Group B will receive a visit for injection training and the follow-up call and then MSLL phone calls at set intervals. Over a period of 12 months (each month defined as a 28-day period), all subjects will receive support services (nurse visit and follow-up phone call, etc) and complete online assessments (MSRS-R, PDSS, etc).
The primary objective of the trial is to determine the impact of two different levels of support service, group A1 and A2, provided by MSLL within Group A, on adherence to prescribed treatment in newly diagnosed or first-switch relapsing remitting multiple sclerosis (RRMS) subjects.
Secondary Objective:
The secondary objectives are:
- To use a pair wise comparison to determine the impact on adherence of the two different levels of service intervention provided by MSLL not compared in the primary objective (Standard services subgroup of Group A (A1) to Group B and Customized service subgroup of Group A (A2) to Group B)
- To determine the correlation of adherence with subject-reported outcomes and other study data;
- To examine the changes from baseline in subject-reported outcomes in each service arm;
- To examine changes from baseline in risk for non-adherence in each service arm; and
- To determine rate of trial dropout between each service arm
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Services of Group A (Group A1) | – | Other: Standard Services of Group A (Group A1) |
| Customized Services of Group A (Group A2) | – | Other: Customized Services of Group A (Group A2) |
| Group B | – | Other: Group B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have been prescribed to Rebif® treatment by their treating physicians will be observed.
Key inclusion criteria (8 listed)
- Age 18 to 65 years at the time of informed consent signature
- Male or female
- Female subjects of child bearing potential who report they are not pregnant at screening and agree to avoid pregnancy during study participation by using adequate contraception, defined as two barrier methods, one barrier method with a spermicide, intrauterine device, or use of oral female contraceptive
- Outpatient status at time of online screening
- Subjects prescribed Rebif by their treating physicians as the first disease-modifying drug (DMD) they have received, or up to one prior treatment with either Rebif, Copaxone ®, Avonex ® , Extavia ®, Betaseron ®, Gilenya™, and Aubagio ® (with accelerated elimination), Tysabri ® and Tecfidera™
Key exclusion criteria (12 listed)
- Any combination therapy with another DMD for Multiple Sclerosis (MS) while participating in the trial
- Score of 4 on any of the items of the MSRS-R or a score between 5 and 8, inclusive, on the PDDS
- Surgical intervention planned during the 12-month study period
- Pregnant or breastfeeding. Note subjects who are 90 days postpartum, stable, and do not breastfeed may participate.
- History of malignancy, with the exception of skin cancer completely excised and considered cured;
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 |
|---|---|---|
| Standard Services of Group A (Group A1)Support services provided in this group will include: Initial field nurse injection training visit; field nurse follow-up and subsequent visits; and follow-up phone calls at periodic intervals | Other | Standard Services of Group A (Group A1) |
| Customized Services of Group A (Group A2)In addition to the initial field nurse injection training visit and follow-up call, subjects will select from support services including field nurse follow-up visits; follow-up phone calls; email and/or text reminders; subject self-assessment and use of treatment planning tools; and mail/e-mail educational materials. | Other | Customized Services of Group A (Group A2) |
| Group BSupport services provided in this group will include initial field nurse injection training visit and follow-up phone calls at periodic intervals. | Other | Group B |
Primary outcome
Subject-reported adherence to treatment, calculated as percent adherence ([number of actual injections / number of expected injections] * 100), for subjects in the Group A1 compared with subjects in the Group A2
Time frame: Month 12
15 secondary outcomes
Subject-reported adherence to treatment in Group A1, Group A2 and Group B at Month 12
Time frame: Month 12
Subject-reported adherence to treatment in Group A1, Group A2 and Group B at Months 3 and 6
Time frame: Months 3 and 6
Subject-reported Multiple Sclerosis Rating Scale- Revised (MSRS-R) in Group A1, Group A2 and Group B
Time frame: Months 6 and 12
Subject-reported Patient-determined Disease Steps Questionnaire (PDDS) in Group A1, Group A2 and Group B
Time frame: Months 6 and 12
Subject-reported Multiple Sclerosis Self-management Scale - Revised (MSSM-R) in Group A1, Group A2 and Group B
Time frame: Months 6 and 12
Subject-reported Multiple Sclerosis International Quality of Life (MusiQoL) in Group A1, Group A2 and Group B
Time frame: Months 6 and 12
Subject-reported Morisky Medication Adherence Scale-4 (MMAS-4) in Group A1, Group A2 and Group B
Time frame: Months 2, 6, 9 and 12
Change from Baseline in Subject-reported multiple Sclerosis Rating Scale- Revised (MSRS-R) in Group A1, Group A2 and Group B at Months 6 and 12
Time frame: Months 6 and 12
Change from Baseline in Subject-reported Patient-determined Disease Steps Questionnaire (PDDS) in Group A1, Group A2 and Group B at Months 6 and 12
Time frame: Months 6 and 12
Change from Baseline in Subject-reported Multiple Sclerosis Self-management Scale - Revised (MSSM-R) in Group A1, Group A2 and Group B at Months 6 and 12
Time frame: Months 6 and 12
Change from Baseline in Subject-reported Multiple Sclerosis International Quality of Life (MusiQoL) in Group A1, Group A2 and Group B at Months 6 and 12
Time frame: Months 6 and 12
Change from Baseline in Subject-reported score in Morisky Medication Adherence Scale-4 (MMAS-4) in Group A1, Group A2 and Group B at Months 2, 6, 9 and 12
Time frame: Months 2, 6, 9 and 12
Percentage of subjects who dropped-out of the trial along with the reasons of dropping out in Group A1, Group A2 and Group B
Time frame: Month 12
Percentage of subjects with more than 80 percent and 90 percent subject-reported adherence to treatment in Group A1, Group A2 and Group B
Time frame: Month 12
Percentage of subject demographic characteristics in Group A1, Group A2 and Group B
Time frame: Month 12
Results and safety
The study was stopped early (reason given: The study was terminated as per the Sponsor's decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
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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, an affiliate 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 Multiple Sclerosis and Relapsing-Remitting, run by EMD Serono 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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 Feb 2015. 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 was stopped early (reason given: The study was terminated as per the Sponsor's decision.). Results are not available in the source record.
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?
Subject-reported adherence to treatment, calculated as percent adherence ([number of actual injections / number of expected injections] * 100), for subjects in the Group A1 compared with subjects in the Group A2 (time frame: Month 12). 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 2 Feb 2015.