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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 28, 2012
Last Updated Date	September 26, 2012
Start Date ^ICMJE	December 2011
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 2, 2012)	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).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01547351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire
Official Title ^ICMJE	Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire - A Phase 4 Pilot Study
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Clinical practice setting, including academic medical centers and private practices in the US
Condition ^ICMJE	Multiple Sclerosis
Intervention ^ICMJE	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.
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	103
Completion Date	September 2012
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01547351
Other Study ID Numbers ^ICMJE	QSC02-ARMS-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Questcor Pharmaceuticals, Inc.
Study Sponsor ^ICMJE	Questcor Pharmaceuticals, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Questcor Pharmaceuticals, Inc.
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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