Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2011 |
| End Date: | September 2012 |
Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire - A Phase 4 Pilot Study
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.
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.
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.
We found this trial at
5
sites
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