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Trial record 1 of 1 for:    NCT01884935
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PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01884935
First Posted: June 24, 2013
Last Update Posted: June 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.

Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis Biological: Natalizumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • predose (trough) concentrations from multiple dosing (Cpredose) [ Time Frame: Up to week 16 ]
  • maximum plasma concentration (Cmax) [ Time Frame: Up to Week 16 ]
  • time to maximum plasma concentration (Tmax) [ Time Frame: Up to Week 16 ]
  • area under the plasma concentration curve from time of first dose to infinity (AUCinf) [ Time Frame: Up to Week 16 ]
  • apparent clearance (Cl/F) [ Time Frame: Up to Week 16 ]
  • volume of distribution [ Time Frame: Up to Week 16 ]
  • elimination half-life (t1/2) [ Time Frame: Up to Week 16 ]

Secondary Outcome Measures:
  • the average and minimum saturation values of α4 integrin over the dosing interval [ Time Frame: Up to Week 16 ]
  • incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs [ Time Frame: Up to Week 16 ]
  • the presence of anti-natalizumab antibodies [ Time Frame: Up to Week 16 ]

Enrollment: 13
Study Start Date: July 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Natalizumab
300 mg intravenously (IV) every 4 weeks
Biological: Natalizumab
As specified in the treatment arm
Other Names:
  • Tysabri
  • BG00002

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

- Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load, as compared to a previous recent magnetic resonance imaging (MRI)

Key Exclusion Criteria:

  • History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than MS), or psychiatric disorders that might preclude participation in the study in the opinion of the Investigator.
  • Prior natalizumab therapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884935


Locations
Italy
Research Site
Cefalu, Italy
Research Site
Gallarate, Italy
Research Site
Milan, Italy
Research Site
Padua, Italy
Research Site
Rome, Italy
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Additional Information:
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01884935     History of Changes
Other Study ID Numbers: 101MS328
2012-005082-13
First Submitted: June 20, 2013
First Posted: June 24, 2013
Last Update Posted: June 23, 2016
Last Verified: January 2015

Keywords provided by Biogen:
Pediatric

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs