Longitudinal Pharmacokinetic, Pharmacodynamic, Immunological, and Biochemical

NCT01330498 | Completed

• 1 other identifier: 001-002-TY
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed to assess the longitudinal pharmacokinetic, pharmacodynamic, immunological, and biochemical sample collection with MRI and relapse analysis of a Tysabri patient cohort. The study hopes to identify secondary and tertiary risk stratification markers that would aid in the clinical management of patients who are JC antibody positive.

Conditions

Multiple Sclerosis

Keywords

Longitudinal assessment of biomarkers; duration of natalizumab; stratification of risk for PML

Outcome Measures

Primary Outcomes (1)

• Duration Effect of natalizumab

  Primary: To further understand the duration effect of natalizumab at the biochemical, cellular, and pharmacokinetic levels in natalizumab patients; identify biomarkers which could aid in patient risk modification for (PML). Assess the stability of natalizumab concentration via pharmacokinetic measurement in ug/ml.

  18 months

Secondary Outcomes (1)

• Stability of cell trafficking inhibition

  18 months

Study Arms (1)

Tysabri (natalizumab) infusing

Patients with relapsing forms of MS who participated in 001-001-TY and are currently still infusing with Tysabri (natalizumab).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsing forms of MS. Conducted at one site in the US. Subjects currently enrolled in TOUCH Prescribing Program, and participated in Foley 001-001-TY eligible. Subset of approx. 40 patients to participate in Part B. 11 high risk bivalent patients 11 low risk monovalent patients 9 patients who participated in 2009 PK/PD study (Biogen Idec, 101MS406) 9 patients with infusion cycle of 38 days plus or minus 2 days Part C "Intracellular energetic in Tysabri therapy": Patients whose iATP fell into the bottom 20th percentile will be asked to participate in a sub-study that includes Part A with the addition of collecting iATP. This number is approximately 50 participants. Part D patients from 001-001-TY with low or normal IgG4 levels will be asked to participate in sub-study for an additional IgG4 assay collected at 3-5 days post-infusion. This number is approximately 30 participants.

You may qualify if:

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
• Aged 18 to 80 years old, inclusive, at the time of informed consent.
• Must be a patient with a relapsing form of Multiple Sclerosis enrolled in the TOUCH Prescribing Program who is not expected to discontinue Tysabri® therapy prior to completion of the requirements of this study.
• Must have participated in IIT I (Foley, IIT 1 001-001-TY) in March, April, or May of 2010.
• Must have a magnetic resonance imaging (MRI) brain scan, performed prior to the initiation of treatment with natalizumab, on file.
• Must weigh between 38 and 180 kg, inclusive.
• Up to 40 patients will be asked to also participate in Part B, the PK/PD subset,
• Approximately fifty patients will be asked to also participate in the sub-study Part C. These patients will have been in the bottom 20th percentile for iATP in Foley IIT 1 001-001-TY.

You may not qualify if:

• If subject answers 'Yes" to any question on the PML questionnaire that is not resolved prior to infusion as per standard operating procedure for natalizumab infusion.
• If subject consumes alcohol within 24 hours of blood specimen collection.

Sponsors & Collaborators

• John F. Foley, MD: lead
• Biogen: collaborator

Study Sites (1)

Rocky Mountain Multiple Sclerosis Clinic

Salt Lake City, Utah, 84103, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum for PK/PD, SVCAM back-up samples will be kept.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John F Foley, MD

  Rocky Mountain MS Research Group, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Ivestigator

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 7, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

US (1)