Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire

Mallinckrodt

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: ARMS Questionnaire

Study type: Observational

Funder types: Industry

Identifiers

NCT01547351

QSC02-ARMS-01

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

103 participants in 1 patient group

ARMS Questionnaire Group

Description:

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.

Treatment:

Other: ARMS Questionnaire