Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: ARMS Questionnaire

• Registration Number: NCT01547351
• Lead Sponsor: Mallinckrodt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-07
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARMS Questionnaire Group	ARMS Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (5)

Tanner Center and Foundation for MS; 🇺🇸 Birmingham, Alabama, United States

Neurology Center; 🇺🇸 Oceanside, California, United States

Neurology Center of Fairfax; 🇺🇸 Fairfax, Virginia, United States

Infinity Clinical Research; 🇺🇸 Hollywood, Florida, United States

McCare Center Neurology Services; 🇺🇸 Orlando, Florida, United States