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John Cunningham Virus (JCV) Antibody Study of Multiple Sclerosis (MS) Patients With Relapsing Forms of MS Receiving Treatment With Tysabri (STRATIFY-2)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01070836
First received: February 17, 2010
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

The primary objective of this study is to demonstrate that the incidence of progressive multifocal Leukoencephalopathy (PML) in Tysabri-treated patients 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).

The secondary objectives of this study are as follows:

  • Estimate the incidence of PML in Tysabri-treated patients 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) patients receiving Tysabri within the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program.
  • Determine changes in anti-JCV antibody status over time.

Condition Intervention
Multiple Sclerosis
Drug: Tysabri

Study Type: Observational
Official Title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Demonstrate that the incidence of PML in Tysabri-treated patients 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). [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimate the incidence of PML in Tysabri-treated patients 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. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
  • Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) patients receiving Tysabri within the TYSABRI Outreach: Unite Commitment to Health (TOUCH) Prescribing Program. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
  • Determine changes in anti-JCV antibody status over time. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Plasma, Serum, Urine, Whole Blood, Peripheral blood mononuclear cell (PBMC)


Estimated Enrollment: 8000
Study Start Date: March 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tysabri-treated Participants with Relapsing MS
United States (US) patients with relapsing MS receiving commercial Tysabri.
Drug: Tysabri
commercial Tysabri

Detailed Description:

No treatment is provided in this observational, longitudinal cohort study. Study population will consist of United States (US) patients with relapsing MS receiving commercial Tysabri. There are no study-mandated visits. Serum samples will be collected during routine patient care or follow-up visits at enrollment into the study and then every 6 months thereafter for up to 4 years after the initial sample collection. Samples will be sent to a central laboratory for analysis (presence of anti-JCV antibody), and remaining serum aliquots will be stored for future Tysabri and PML research. Additional samples will be collected at participating sites from patients who qualify and consent to participate in focused sampling group (patients who are anti-JCV antibody positive at any timepoint AND have received ≥12 infusions of Tysabri, whether or not they have a history of immunosuppressant use). These samples will be stored for future Tysabri and PML research, including biomarker analysis.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

US Patients with relapsing MS receiving commercial Tysabri.

Criteria

Inclusion Criteria:

  • Relapsing MS patients receiving commercial Tysabri
  • Patients receiving Tysabri 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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070836

  Show 495 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01070836     History of Changes
Other Study ID Numbers: 101JC402
Study First Received: February 17, 2010
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
JCV
Sample Collection
PML
Antibody

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014