Relapsing Multiple Sclerosis Clinical Trial
— STRATIFY-2Official title:
JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2
| Verified date | September 2016 |
| Source | Biogen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
The primary objective of this study is to demonstrate that the incidence of progressive
multifocal Leukoencephalopathy (PML) in natalizumab-treated participants who do not have
detectable antibodies to John Cunningham virus (JCV) (antibody negative) is lower than in
participants who have detectable antibodies to JCV (antibody positive).
The secondary objectives of this study are to: Estimate the incidence of PML in
natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody
positive, based on a meta-analysis of data obtained from this study and other data sources;
Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) participants
receiving natalizumab within the TYSABRI Outreach: United Commitment to Health (TOUCH)
Prescribing Program; Determine changes in anti-JCV antibody status over time.
| Status | Completed |
| Enrollment | 35895 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Key Inclusion Criteria: - Relapsing MS patients receiving commercial natalizumab - Patients receiving natalizumab and their prescribers must be enrolled in the TOUCH Prescribing Program. - Patients with suspected or confirmed PML who are at or referred to a participating STRATIFY-2 site may enroll into STRATIFY-2 for purposes of PML sample collection. Key Exclusion Criteria: - Patients may participate in any other clinical trial or study sponsored by Biogen Idec ; however, if the anti-JCV antibody test is included in the other clinical study and that study is performing a longitudinal analysis of those samples, the patient should withdraw from STRATIFY-2. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply |
N/A
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Research Site | Arecibo | |
| Puerto Rico | Research Site | Bayamon | |
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| Puerto Rico | Research Site | Mayaguez | |
| Puerto Rico | Research Site | Ponce | |
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| Lead Sponsor | Collaborator |
|---|---|
| Biogen |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Demonstrate that the incidence of PML in natalizumab-treated participants who do not have detectable antibodies to JC virus (JCV) (antibody negative) is lower than in patents who have detectable antibodies to JCV (antibody positive) | Up to 4 years | Yes | |
| Secondary | Estimate the incidence of PML in natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody positive, based on a meta-analysis of data obtained from this study and other data sources | Up to 4 years | Yes | |
| Secondary | Define the prevalence of anti-JCV antibody in relapsing MS participants receiving natalizumab within the TOUCH Prescribing Program | Up to 4 years | Yes | |
| Secondary | Determine changes in anti-JCV antibody status over time | Up to 4 years | Yes |
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Phase 3 | |
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Phase 3 | |
| Recruiting |
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Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
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Phase 3 | |
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A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
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Phase 3 | |
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Phase 3 | |
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Phase 2 | |
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Phase 3 |