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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

February 28, 2012
September 26, 2012
December 2011
September 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01547351 on ClinicalTrials.gov Archive Site
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Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Multiple Sclerosis
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.
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.
Intervention: Other: ARMS Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01547351
QSC02-ARMS-01
Not Provided
Questcor Pharmaceuticals, Inc.
Questcor Pharmaceuticals, Inc.
Not Provided
Not Provided
Questcor Pharmaceuticals, Inc.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP