Adherence Trial With MS LifeLines ® Services

NCT01905527 | Terminated

• 1 other identifier: EMR 200136-567
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

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 services to enhance medication adherence and treatment persistence with Rebif ® subcutaneous three times a week.

Conditions

Multiple Sclerosis; Relapsing-Remitting

Keywords

Multiple Sclerosis; Relapsing-Remitting; Rebif; Quintiles Geographic Area Group; Standard Subgroup; Custom Subgroup; RxCrossroads Geographic Area Group

Outcome Measures

Primary Outcomes (1)

• 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

  Month 12

Secondary Outcomes (15)

• Subject-reported adherence to treatment in Group A1, Group A2 and Group B at Month 12

  Month 12

• Subject-reported adherence to treatment in Group A1, Group A2 and Group B at Months 3 and 6

  Months 3 and 6

• Subject-reported Multiple Sclerosis Rating Scale- Revised (MSRS-R) in Group A1, Group A2 and Group B

  Months 6 and 12

• Subject-reported Patient-determined Disease Steps Questionnaire (PDDS) in Group A1, Group A2 and Group B

  Months 6 and 12

• Subject-reported Multiple Sclerosis Self-management Scale - Revised (MSSM-R) in Group A1, Group A2 and Group B

  Months 6 and 12

Study Arms (3)

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

Interventions

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

Standard Services of Group A (Group A1)

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.

Customized Services of Group A (Group A2)

Group B OTHER

Support services provided in this group will include initial field nurse injection training visit and follow-up phone calls at periodic intervals.

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have been prescribed to Rebif® treatment by their treating physicians will be observed.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (1)

Call EMD Serono Medical Information for information on recruiting sites

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Responsible

  EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 2, 2015

Record last verified: 2015-01

Locations

US (1)