Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Questcor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01547351
First received: February 28, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Other: ARMS Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire - A Phase 4 Pilot Study

Resource links provided by NLM:


Further study details as provided by Questcor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Total Composite Score (TCS) [ Time Frame: After relapse treatment (1 month ± 1 week) ] [ Designated as safety issue: No ]
    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).


Enrollment: 103
Study Start Date: December 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547351

Locations
United States, Alabama
Tanner Center and Foundation for MS
Birmingham, Alabama, United States
United States, California
Neurology Center
Oceanside, California, United States
United States, Florida
Infinity Clinical Research
Hollywood, Florida, United States
McCare Center Neurology Services
Orlando, Florida, United States
United States, Virginia
Neurology Center of Fairfax
Fairfax, Virginia, United States
Sponsors and Collaborators
Questcor Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Questcor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01547351     History of Changes
Other Study ID Numbers: QSC02-ARMS-01
Study First Received: February 28, 2012
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Questcor Pharmaceuticals, Inc.:
Relapse in multiple sclerosis
Psychometric properties of the patient self-report questionnaire
Evaluation of ARMS questionnaire

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014