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Completed

NCT Number: NCT01547351

Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanner Center and Foundation for MS, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Total Composite Score (TCS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study title

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

Acronym: ARMS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2012
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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