Status:
TERMINATED
Adherence Trial With MS LifeLines ® Services
Lead Sponsor:
EMD Serono
Conditions:
Multiple Sclerosis
Relapsing-Remitting
Eligibility:
All Genders
18-65 years
Brief 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 service...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT01905527
Start Date
July 1 2013
End Date
January 1 2015
Last Update
February 2 2015
Active Locations (1)
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1
Call EMD Serono Medical Information for information on recruiting sites
Boston, Massachusetts, United States