Clinical trial NCT01547351: Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire
Official title: Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire - A Phase 4 Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Relapse in multiple sclerosis
Psychometric properties of the patient self-report questionnaire
Evaluation of ARMS questionnaire
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical practice setting, including academic medical centers and private practices in the US

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total Composite Score (TCS)
timeFrame: After relapse treatment (1 month ± 1 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Tanner Center and Foundation for MS
state: Alabama
city: Oceanside
country: United States
facility: Neurology Center
state: California
city: Hollywood
country: United States
facility: Infinity Clinical Research
state: Florida
city: Orlando
country: United States
facility: McCare Center Neurology Services
state: Florida
city: Fairfax
country: United States
facility: Neurology Center of Fairfax
state: Virginia
Study officials:
References: