Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS (RESPOND)
|ClinicalTrials.gov Identifier: NCT01903291|
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : July 25, 2016
|Condition or disease||Intervention/treatment|
|Relapsing Forms of Multiple Sclerosis||Drug: dimethyl fumarate|
|Study Type :||Observational|
|Actual Enrollment :||333 participants|
|Official Title:||A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
To be taken according to the United States Prescribing Information (USPI)
Drug: dimethyl fumarate
As described in the treatment arm
- Annualized Relapse Rate [ Time Frame: 12 months ]
- Change in 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. [ Time Frame: Baseline to 12 months ]TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction.
- Change in Short-Form 36 (SF-36) scores. [ Time Frame: Baseline to 12 months ]SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.
- Change in Modified Fatigue Impact Scale (MFIS-5) scores. [ Time Frame: Baseline to 12 months ]MFIS-5 is a modified form of the Fatigue Impact Scale that consists of five questions that assess the impact of fatigue on physical, cognitive, and psychosocial functioning, with five response levels ranging from 0 ("Never") to 4 ("Almost always"). Total scores range from 0 to 20, with higher scores representing a greater impact of fatigue.
- Change in Beck Depression Inventory (BDI-7) scores. [ Time Frame: Baseline to 12 months ]BDI-7 is a self-report inventory for measuring the severity of depression on a 7-item scale.
- Change in Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores. [ Time Frame: Baseline to 12 months ]The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
- Change in Morisky 8-item Medication Adherence Scale (MMAS-8) scores. [ Time Frame: Baseline to 12 months ]MMAS-8 is a self-reporting tool to facilitate the identification of barriers to and behaviors associated with adherence to chronic medications. Scores on the MMAS-8 range from 0-8, with scores of less than 6 reflecting low adherence.
- Change in Patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores. [ Time Frame: Baseline to 12 months ]The patient-reported EDSS measures disability status based on patient report of degree of difficulty in eight different functional areas (on a 4-point scale), and overall function, taking into account the eight areas and descriptions of gait.
- Proportion of patients experiencing a relapse. [ Time Frame: Baseline to 12 months ]
- Proportion of patients with relapses associated with hospitalizations. [ Time Frame: Baseline to 12 months ]
- Proportion of patients with relapses associated with steroid use. [ Time Frame: Baseline to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903291
|Study Director:||Medical Director||Biogen|