Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire
Completed
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT01547351
- Run by
- Mallinckrodt
- People needed
- 103
- Starts
- 2011-12-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2016-10-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Tanner Center and Foundation for MS — Birmingham, Alabama, United States
- Neurology Center — Oceanside, California, United States
- Infinity Clinical Research — Hollywood, Florida, United States
- McCare Center Neurology Services — Orlando, Florida, United States
- Neurology Center of Fairfax — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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