Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire
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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 |
- 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 |
Clinical practice setting, including academic medical centers and private practices in the US
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| 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 | |
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 Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013