Multiple SclerosisNCT01539395
A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by MSDx, Inc. at 1 site in United States.
Trial summary
This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MSDx Complex-1 Biomarker Test
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who currently diagnosed with relapsing remitting multiple sclerosis
Who may be able to join
- Age 45 years or older of either gender and of any racial/ethnic group.
- Subjects must be in generally good health.
- Subjects must be able and willing to comply with the requirements of the protocol.
- Must be diagnosed with RRMS
- Meets the criteria to enter Group 1 or Group 2
Who cannot join
- Subject is currently in middle of an active episode of an autoimmune condition (e.g. rheumatoid arthritis, system lupus erythematosis)
- Subject currently has a condition such as active influenza that would stimulate the immune system
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, 85741
About this study
This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- MSDx Complex-1 Biomarker Test
- Keywords
- Relapsing Remitting, MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSDx Complex-1 Biomarker TestOther
A biomarker test for the level of MSDx Complex-1
| Study group | Role | What they receive |
|---|---|---|
| Inactive Disease | Inactive disease; RRMS patients who have been treated with monthly infusions of Tysabri for 12 months and have had stable disease for the last 6 months or more and show stable or improving neurological deficits over 3 months on Tysabri. Receives: Other: MSDx Complex-1 Biomarker Test | |
| Active Disease | Active disease; RRMS patients in acute clinical relapse or with active MRI. Blood sample obtained within 30 days of event AND before steroid treatment (or) patients in early disease on or off first line agents with relapse in prior 3 months AND not treated with steroids for at least 2 months. Receives: Other: MSDx Complex-1 Biomarker Test | |
| Active Disease - Steroid Therapy | Patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin steroid therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI). Receives: Other: MSDx Complex-1 Biomarker Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker Differential
A difference in the levels of Complex-1 between subjects with controlled, stable MS vs. subjects in acute MS relapse
Measured: Baseline
Secondary outcomes (1)
Biomarker reduction with steroid therapy
A decrease in the level of MSDx Complex-1 in response to steroid therapy for a relapse of MS.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2012 (estimated)
- Study completionJul 2012 (estimated)
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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MSDx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeanette K Wendt, MD, Principal investigator, Northwest NeuroSpecialists, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539395
- Sponsor's protocol ID
- MSDX0211
- Status last verified
- Aug 2020
- First submitted
- 21 Feb 2012
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01539395
- Acronym / sponsor ID
- MSDX0211
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing Remitting, MS
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MSDx, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 27 Feb 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 is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inactive Disease | – | Other: MSDx Complex-1 Biomarker TestInactive disease; RRMS patients who have been treated with monthly infusions of Tysabri for 12 months and have had stable disease for the last 6 months or more and show stable or improving neurological deficits over 3 months on Tysabri. |
| Active Disease | – | Other: MSDx Complex-1 Biomarker TestActive disease; RRMS patients in acute clinical relapse or with active MRI. Blood sample obtained within 30 days of event AND before steroid treatment (or) patients in early disease on or off first line agents with relapse in prior 3 months AND not treated with steroids for at least 2 months. |
| Active Disease - Steroid Therapy | – | Other: MSDx Complex-1 Biomarker TestPatient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin steroid therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who currently diagnosed with relapsing remitting multiple sclerosis
Key inclusion criteria (5 listed)
- Age 45 years or older of either gender and of any racial/ethnic group.
- Subjects must be in generally good health.
- Subjects must be able and willing to comply with the requirements of the protocol.
- Must be diagnosed with RRMS
- Meets the criteria to enter Group 1 or Group 2
Key exclusion criteria (2 listed)
- Subject is currently in middle of an active episode of an autoimmune condition (e.g. rheumatoid arthritis, system lupus erythematosis)
- Subject currently has a condition such as active influenza that would stimulate the immune system
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 |
|---|---|---|
| MSDx Complex-1 Biomarker TestA biomarker test for the level of MSDx Complex-1 | Other | Active Disease, Active Disease - Steroid Therapy, Inactive Disease |
Primary outcome
Biomarker Differential
Time frame: Baseline
A difference in the levels of Complex-1 between subjects with controlled, stable MS vs. subjects in acute MS relapse
1 secondary outcome
Biomarker reduction with steroid therapy
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
Jeanette K Wendt, MD principal investigator
Northwest NeuroSpecialists, PLLC
1 site 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 MSDx, Inc. at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Biomarker Differential (time frame: Baseline). 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 2 Sep 2020.