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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

February 17, 2010
June 20, 2014
March 2010
November 2015   (final data collection date for primary outcome measure)
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 ]
Correlation of JCV Antibody positivity and development of PML. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01070836 on ClinicalTrials.gov Archive Site
  • 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 ]
Define the sero prevalence of JCV Antibody in this US representative sample of MS patients. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
John Cunningham Virus (JCV) Antibody Study of Multiple Sclerosis (MS) Patients With Relapsing Forms of MS Receiving Treatment With Tysabri
JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2

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.

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.

Observational
Not Provided
Not Provided
Retention:   Samples With DNA
Description:

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

Probability Sample

US Patients with relapsing MS receiving commercial Tysabri.

Multiple Sclerosis
Drug: Tysabri
commercial Tysabri
Tysabri-treated Participants with Relapsing MS
United States (US) patients with relapsing MS receiving commercial Tysabri.
Intervention: Drug: Tysabri
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
8000
November 2015
November 2015   (final data collection date for primary outcome measure)

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.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01070836
101JC402
No
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP