Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire - A Phase 4 Pilot Study

Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire

Sponsors

Lead sponsor: Mallinckrodt

Source 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.

Overall Status Completed
Start Date December 2011
Completion Date September 2012
Primary Completion Date September 2012
Study Type Observational
Primary Outcome
Measure Time Frame
Total Composite Score (TCS) After relapse treatment (1 month ± 1 week)
Enrollment 103
Condition
Intervention

Intervention type: Other

Intervention name: ARMS Questionnaire

Description: The ARMS Questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on 1 page. Eligible patients will be administered part 1 of the survey when the patient presents with new relapse. Part 2 of the survey is to be completed 1 month (± 1 week) after initiation of treatment for relapse.

Arm group label: ARMS Questionnaire Group

Eligibility

Sampling method: Non-Probability Sample

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
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
Location Countries

United States

Verification Date

October 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: 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.

Acronym ARMS
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov