Multiple Sclerosis
Conditions
Keywords
Relapse in multiple sclerosis, Psychometric properties of the patient self-report questionnaire, Evaluation of ARMS questionnaire
Brief summary
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.
Interventions
OTHERARMS 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.
Sponsors
Mallinckrodt
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent and HIPAA authorization must be obtained from the patient prior to any study-related procedures. * Patient is ≥ 18 years of age at the time of participation * Patient has confirmed MS relapse. * Patient must have been treated with oral or IV corticosteroids for their previous relapse. * Willingness to comply with all procedures and assessments.
Exclusion criteria
* Patient has pseudorelapse. * Patient was treated with any therapies other than corticosteroids for their previous relapse. * Any other condition which, in the opinion of the investigator, would not allow proper completion of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Composite Score (TCS) | After relapse treatment (1 month ± 1 week) | 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). |
Countries
United States
Outcome results
None listed