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JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab (STRATIFY-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01070836
First received: February 17, 2010
Last updated: July 16, 2015
Last verified: July 2015

February 17, 2010
July 16, 2015
March 2010
November 2015   (final data collection date for primary outcome measure)
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) [ Time Frame: Up to 4 years ] [ 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 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 [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]
  • Define the prevalence of anti-JCV antibody in relapsing MS participants receiving natalizumab within the TOUCH Prescribing Program [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]
  • Determine changes in anti-JCV antibody status over time [ Time Frame: Up to 4 years ] [ 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
 
JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab
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 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.

No treatment is provided in this observational, longitudinal cohort study. Study population will consist of United States (US) participants with relapsing MS receiving commercial natalizumab. There are no study-mandated visits. Serum samples will be collected during routine patient care or follow-up visits and will be sent to a central laboratory for analysis (presence of anti-JCV antibody), and remaining serum aliquots will be stored for future natalizumab and PML research. Additional samples will be collected at participating sites from participants who qualify and consent to participate in focused sampling group (participants who are anti-JCV antibody positive at any time point AND have received ≥12 infusions of natalizumab, whether or not they have a history of immunosuppressant use). These samples will be stored for future natalizumab and PML research.

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

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

Probability Sample

US participants with relapsing MS receiving commercial natalizumab.

Relapsing Multiple Sclerosis
Drug: natalizumab
Administered as specified in the treatment arm
Other Names:
  • Tysabri
  • BG00002
natalizumab
US participants with relapsing MS receiving commercial natalizumab
Intervention: Drug: natalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36065
November 2015
November 2015   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01070836
101JC402
No
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
July 2015

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