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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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Biological: Natalizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
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)
Study Start Date : July 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Natalizumab
300 mg intravenously (IV) every 4 weeks
 Biological: Natalizumab
As specified in the treatment arm
Other Names:
  • Tysabri
  • BG00002


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

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

Eligibility Criteria
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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
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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
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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
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Study Director: Medical Director Biogen
More Information
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Additional Information:

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01884935    
Other Study ID Numbers: 101MS328
2012-005082-13
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: January 2015
Keywords provided by Biogen:
Pediatric
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
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