Multiple SclerosisSTRATIFY-1NCT01070823
JC-Virus (JCV) Antibody Program
An observational study of Multiple Sclerosis, run by Biogen at 11 sites in United States.
Trial summary
The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Tysabri® (natalizumab)
- How many people
- 1,096 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2010to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with relapsing Multiple Sclerosis (MS) receiving commercial Tysabri® (natalizumab) and patients being considered for such treatment.
Who may be able to join
- Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab).
Who cannot join
- Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Research Site
Atlanta, Georgia, 30327
Research Site
Aurora, Colorado, 80045
Research Site
Barrington, Illinois, 60010
Research Site
Brighton, Massachusetts, 2135
Research Site
Cullman, Georgia, 35058
Research Site
Farmington Hills, Michigan, 48334
Research Site
Milwaukee, Wisconsin, 53215
Research Site
Portland, Oregon, 97225
Research Site
Raleigh, North Carolina, 27607
Research Site
Round Rock, Texas, 78681
Research Site
Salt Lake City, Utah
About this study
Official title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1
The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.
Read the detailed description
This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.
- Conditions
- Multiple Sclerosis
- Being tested
- Tysabri® (natalizumab)
- Keywords
- Sample Collection, JCV, PML
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tysabri® (natalizumab)Drug
Also called natalizumab, BG0002
Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program
| Study group | Role | What they receive |
|---|---|---|
| Relapsing Multiple Sclerosis | Participants receiving or considering treatment with Tysabri® (natalizumab). Receives: Drug: Tysabri® (natalizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of serum anti-JC virus (JCV) antibody
Prevalence of anti-JCV antibodies will be estimated as the number of participants with anti-JCV antibodies detected in serum divided by the total number of participants with a serum sample that was evaluated.
Measured: Day 1
Number of participants with a false negative test
Confirm the false negative rate for serum anti-JCV antibody [assay].
Measured: Day 1
Secondary outcomes (1)
Changes in JCV antibody status over time
Measured: Every 6 months for 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionJun 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.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 1,096 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United BioSource, LLC, Elan Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070823
- Sponsor's protocol ID
- 101JC401
- Acronym
- STRATIFY-1
- Status last verified
- Oct 2016
- First submitted
- 17 Feb 2010
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1
- ClinicalTrials.gov ID
- NCT01070823
- Acronym / sponsor ID
- STRATIFY-1 / 101JC401
- Conditions
- Multiple Sclerosis
- Keywords
- Sample Collection, JCV, PML
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,096 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- United BioSource, LLC, Elan Pharmaceuticals
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Feb 2010 (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.
The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.
Detailed description
This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsing Multiple Sclerosis | – | Drug: Tysabri® (natalizumab)Participants receiving or considering treatment with Tysabri® (natalizumab). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with relapsing Multiple Sclerosis (MS) receiving commercial Tysabri® (natalizumab) and patients being considered for such treatment.
Key inclusion criteria (1 listed)
- Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab).
Key exclusion criteria (2 listed)
- Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Tysabri® (natalizumab)Also: natalizumab, BG0002Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program | Drug | Relapsing Multiple Sclerosis |
Primary outcome
Prevalence of serum anti-JC virus (JCV) antibody
Time frame: Day 1
Prevalence of anti-JCV antibodies will be estimated as the number of participants with anti-JCV antibodies detected in serum divided by the total number of participants with a serum sample that was evaluated.
Number of participants with a false negative test
Time frame: Day 1
Confirm the false negative rate for serum anti-JCV antibody [assay].
1 secondary outcome
Changes in JCV antibody status over time
Time frame: Every 6 months for 2 Years
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 5 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.
Medical Director study director
Biogen
11 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 Biogen at 11 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 1 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: finished, as of the sponsor's last update on 5 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 11 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?
Prevalence of serum anti-JC virus (JCV) antibody (time frame: Day 1). The study lists 2 primary outcomes in all. 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 5 Oct 2016.