Adherence Trial With MS LifeLines ® Services

Merck KGaA (EMD Serono)

Status

Terminated

Conditions

Relapsing-Remitting

Multiple Sclerosis

Treatments

Other: Group B

Other: Standard Services of Group A (Group A1)

Other: Customized Services of Group A (Group A2)

Study type

Observational

Funder types

Industry

Identifiers

NCT01905527

EMR 200136-567

Details and patient eligibility

About

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.

Full 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

Enrollment

306 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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