Clinical Trials Logo
  1. Home
  2. Relapsing Multiple Sclerosis
  3. NCT01070836

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

Relapsing Multiple Sclerosis Clinical Trial

Official title:
JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01070836
Study type Observational
Source Biogen
Contact
Status Completed
Phase N/A
Start date March 2010
Completion date November 2015
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04121065 - Role of ADA SNPs in Subjects With Relapsing Multiple Sclerosis (RMS)
Active, not recruiting NCT03996291 - Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis Phase 2
Recruiting NCT04510220 - 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis Phase 3
Terminated NCT02241785 - Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis (MS) After Failure on Other Therapies Phase 4
Completed NCT02792218 - Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis Phase 3
Completed NCT01412333 - A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis Phase 3
Completed NCT03257358 - A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod Phase 4
Completed NCT01628393 - Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients Phase 2/Phase 3
Completed NCT04626921 - A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis Phase 2/Phase 3
Withdrawn NCT02234869 - Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy Phase 4
Withdrawn NCT05077956 - Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
Active, not recruiting NCT04486716 - A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis Phase 3
Recruiting NCT04121403 - Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) Phase 3
Recruiting NCT05809986 - Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Terminated NCT00988052 - A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course Phase 3
Active, not recruiting NCT05232825 - 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 Phase 3
Terminated NCT01047319 - A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis Phase 3
Completed NCT04847596 - A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Completed NCT01006941 - Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study Phase 2
Completed NCT01127750 - Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients Phase 3