Multiple SclerosisARMSNCT01547351
Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire
An observational study of Multiple Sclerosis, run by Mallinckrodt at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ARMS Questionnaire
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 103 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical practice setting, including academic medical centers and private practices in the US
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Tanner Center and Foundation for MS
Birmingham, Alabama
Neurology Center of Fairfax
Fairfax, Virginia
Infinity Clinical Research
Hollywood, Florida
Neurology Center
Oceanside, California
McCare Center Neurology Services
Orlando, Florida
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- ARMS Questionnaire
- Keywords
- Relapse in multiple sclerosis, Psychometric properties of the patient self-report questionnaire, Evaluation of ARMS questionnaire
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARMS QuestionnaireOther
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ARMS Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Composite Score (TCS)
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).
Measured: After relapse treatment (1 month ± 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547351
- Sponsor's protocol ID
- QSC02-ARMS-01
- Acronym
- ARMS
- Status last verified
- Oct 2016
- First submitted
- 28 Feb 2012
- Last updated
- 19 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire - A Phase 4 Pilot Study
- ClinicalTrials.gov ID
- NCT01547351
- Acronym / sponsor ID
- ARMS / QSC02-ARMS-01
- Conditions
- Multiple Sclerosis
- Keywords
- Relapse in multiple sclerosis, Psychometric properties of the patient self-report questionnaire, Evaluation of ARMS questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARMS Questionnaire Group | – | Other: ARMS QuestionnairePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical practice setting, including academic medical centers and private practices in the US
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARMS QuestionnaireThe 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. | Other | ARMS Questionnaire Group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Mallinckrodt at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Composite Score (TCS) (time frame: After relapse treatment (1 month ± 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.