Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire
This Phase 4 pilot cross-sectional descriptive/exploratory study is to be conducted in clinical practice settings (including MS (Multiple sclerosis) specialty clinics, general neurology practices, or other academic or private practice settings) in the United States to assess the psychometric properties of the ARMS questionnaire in approximately 100 adult patients with MS who are experiencing a confirmed relapse, as identified by the investigator or designee at each site. Neither efficacy nor safety of treatment will be evaluated in this study.
The ARMS questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on 1 page. Part 1 is designed to evaluate the patient's relapse symptoms and how the symptoms affect daily activities and overall function, as well as patient's response to past treatments for previous relapses, as a means of guiding treatment selection. Part 2 is designed to evaluate treatment response in terms of symptom relief and functioning, as well as treatment tolerability. Part 1 of the survey is to be completed when the patient presents with new relapse of MS. Part 2 of the survey is to be completed 1 month (± 1 week) after initiation of treatment for relapse of MS. Treatment for relapse will be at the sole discretion of the investigator.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire - A Phase 4 Pilot Study|
- Total Composite Score (TCS) [ Time Frame: After relapse treatment (1 month ± 1 week) ] [ Designated as safety issue: No ]Total composite score is calculated from three interrelated questions on part 2 of the ARMS questionnaire (to be completed 1 month ± 1 week after relapse treatment).
|Study Start Date:||December 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
ARMS Questionnaire Group
Patients with confirmed multiple sclerosis relapse who are willing to participate in the ARMS questionnaire. These patients could not have been treated with any therapies other than oral or intravenous corticosteroids for their previous relapse.
Other: ARMS Questionnaire
The ARMS Questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on 1 page. Eligible patients will be administered part 1 of the survey when the patient presents with new relapse. Part 2 of the survey is to be completed 1 month (± 1 week) after initiation of treatment for relapse.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547351
|United States, Alabama|
|Tanner Center and Foundation for MS|
|Birmingham, Alabama, United States|
|United States, California|
|Oceanside, California, United States|
|United States, Florida|
|Infinity Clinical Research|
|Hollywood, Florida, United States|
|McCare Center Neurology Services|
|Orlando, Florida, United States|
|United States, Virginia|
|Neurology Center of Fairfax|
|Fairfax, Virginia, United States|