Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire

NCT01547351 | Completed

• 1 other identifier: QSC02-ARMS-01
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Sclerosis

Keywords

Relapse in multiple sclerosis; Psychometric properties of the patient self-report questionnaire; Evaluation of ARMS questionnaire

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

ARMS Questionnaire OTHER

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.

ARMS Questionnaire Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (5)

Tanner Center and Foundation for MS

Birmingham, Alabama, United States

Location

Neurology Center

Oceanside, California, United States

Location

Infinity Clinical Research

Hollywood, Florida, United States

Location

McCare Center Neurology Services

Orlando, Florida, United States

Location

Neurology Center of Fairfax

Fairfax, Virginia, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 7, 2012
• Study Start: December 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (5)