Multiple SclerosisIIT12NCT02965170
Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in MS
An observational study of Multiple Sclerosis, run by Rocky Mountain MS Research Group, LLC at 1 site in United States.
Trial summary
Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this newly developed test will be compared to Tysabri® serum levels measured in parallel using an independent test. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to May 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Only patients with multiple sclerosis who have had one or more doses of Tysabri® (natalizumab) and are currently being treated with Tysabri® will be included in this study.
Who may be able to join
- Infusing with Tysabri at a single site, Rocky Mountain MS Clinic
Who cannot join
- If subject donated or received blood, plasma, or any other blood products between the last Tysabri® infusion and the time of sample collection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain MS Clinic
Salt Lake City, Utah, 84103
About this study
Official title: Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in a Multiple Sclerosis Patient Cohort
Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this newly developed test will be compared to Tysabri® serum levels measured in parallel using an independent test. We will also simultaneously measure a pharmacodynamic marker of Tysabri®, receptor saturation levels on blood immune cells, which is thought to correlate with Tysabri® serum levels.
Read the detailed description
From a single site, consenting patients with relapsing forms of multiple sclerosis who are currently begin treated with Tysabri® (natalizumab) and meeting the eligibility criteria will be asked to provide blood samples on the same day, and prior to, a scheduled infusion of Tysabri® 300 mg IV. Up to 500 patients will be enrolled in this study. Each patient may be asked to donate blood up to 2 times (one blood draw per cycle) to obtain longitudinal data points. Each patient will also be asked to fill out a wellness patient reported outcome (PRO) questionnaire along with the blood draws
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MS Tysabri | Patients with relapsing forms of multiple sclerosis and who are currently undergoing Tysabri® therapy at Rocky Mountain Multiple Sclerosis Research Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natalizumab Concentrations in Serum
Validate a novel peptide-based laboratory test enabling the measurement of nadir natalizumab (Tysabri®) serum levels in multiple sclerosis patients undergoing therapy compared to the traditional ELISA assay
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017
- Study completionMay 2018
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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain MS Research Group, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Abreos Biosciences
- Responsible party
- Principal investigator, John F. Foley, MD, Rocky Mountain MS Research Group, LLC
- Investigators
- John F Foley, MD, Principal investigator, Rocky Mountain MS Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965170
- Sponsor's protocol ID
- 001-012-TY
- Acronym
- IIT12
- Status last verified
- Apr 2019
- First submitted
- 8 Nov 2016
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in a Multiple Sclerosis Patient Cohort
- ClinicalTrials.gov ID
- NCT02965170
- Acronym / sponsor ID
- IIT12 / 001-012-TY
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Rocky Mountain MS Research Group, LLCUniversity, hospital or other
- Collaborators
- Abreos Biosciences
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 16 Nov 2016 (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.
Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this newly developed test will be compared to Tysabri® serum levels measured in parallel using an independent test. We will also simultaneously measure a pharmacodynamic marker of Tysabri®, receptor saturation levels on blood immune cells, which is thought to correlate with Tysabri® serum levels.
Detailed description
From a single site, consenting patients with relapsing forms of multiple sclerosis who are currently begin treated with Tysabri® (natalizumab) and meeting the eligibility criteria will be asked to provide blood samples on the same day, and prior to, a scheduled infusion of Tysabri® 300 mg IV. Up to 500 patients will be enrolled in this study. Each patient may be asked to donate blood up to 2 times (one blood draw per cycle) to obtain longitudinal data points. Each patient will also be asked to fill out a wellness patient reported outcome (PRO) questionnaire along with the blood draws
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS Tysabri | – | –Patients with relapsing forms of multiple sclerosis and who are currently undergoing Tysabri® therapy at Rocky Mountain Multiple Sclerosis Research Group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients with multiple sclerosis who have had one or more doses of Tysabri® (natalizumab) and are currently being treated with Tysabri® will be included in this study.
Key inclusion criteria (1 listed)
- Infusing with Tysabri at a single site, Rocky Mountain MS Clinic
Key exclusion criteria (1 listed)
- If subject donated or received blood, plasma, or any other blood products between the last Tysabri® infusion and the time of sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Natalizumab Concentrations in Serum
Time frame: 12 Months
Validate a novel peptide-based laboratory test enabling the measurement of nadir natalizumab (Tysabri®) serum levels in multiple sclerosis patients undergoing therapy compared to the traditional ELISA assay
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 24 Apr 2019.
- Individual participant dataSharing planned: No
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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.
John F Foley, MD principal investigator
Rocky Mountain MS Research Group
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 Rocky Mountain MS Research Group, LLC 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 1 inclusion and 1 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 24 Apr 2019. 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 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?
Natalizumab Concentrations in Serum (time frame: 12 Months). 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 24 Apr 2019.