Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire

Multiple Sclerosis Clinical Trial

— ARMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547351
• Other study ID #: QSC02-ARMS-01
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: October 18, 2016
• Start date: December 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Recurrence
• Sclerosis

Intervention

Other:
• ARMS Questionnaire
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.

Locations

Country	Name	City	State
United States	Tanner Center and Foundation for MS	Birmingham	Alabama
United States	Neurology Center of Fairfax	Fairfax	Virginia
United States	Infinity Clinical Research	Hollywood	Florida
United States	Neurology Center	Oceanside	California
United States	McCare Center Neurology Services	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Composite Score (TCS)	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).	After relapse treatment (1 month ± 1 week)	No