Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire (ARMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: ARMS Questionnaire

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinical practice setting, including academic medical centers and private practices in the US

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARMS Questionnaire Group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Mallinckrodt

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 28, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Relapse in multiple sclerosis; Psychometric properties of the patient self-report questionnaire; Evaluation of ARMS questionnaire
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Multiple Sclerosis; Sclerosis; Recurrence
• Other Study ID Numbers: QSC02-ARMS-01