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PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

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.
 
ClinicalTrials.gov Identifier: NCT01884935
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE June 20, 2013
First Posted Date  ICMJE June 24, 2013
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsing-Remitting Multiple Sclerosis
Intervention  ICMJE Biological: Natalizumab
As specified in the treatment arm
Other Names:
  • Tysabri
  • BG00002
Study Arms  ICMJE Experimental: Natalizumab
300 mg intravenously (IV) every 4 weeks
Intervention: Biological: Natalizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2015)		 13
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2013)		 12
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01884935
Other Study ID Numbers  ICMJE 101MS328
2012-005082-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Biogen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Biogen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date January 2015

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