A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Hoffmann-La Roche
Study ID
NCT01455701
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 24 Months
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab will be administered as indicated in the arm description.

Study Details

This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active sJIA. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on study treatment is 12 weeks (Main evaluation period). Participants will have the option to continue tocilizumab treatment until participant reaches 2 years of age or up to one year from baseline, whichever is longer. An optional extension period will follow the main evaluation period.

Key Dates

Start date
Oct 26, 2012
Status verified
Oct 2019
Primary completion
Jul 28, 2016
Completion
Jul 13, 2017

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Participants will receive tocilizumab intravenous (IV) infusion at a dose of 12 milligrams per kilogram (mg/kg) every two weeks (Q2W) during main evaluation period of 12 weeks (a total of 6 infusions including one at baseline visit). Participants will have the option to be treated in an optional extension period after completion of main evaluation period. In optional extension period, participants will receive tocilizumab 12 mg/kg IV infusion Q2W from Week 12 until the participant reaches 2 years of age or has been treated for one year from baseline, whichever is longer.

Primary Outcome Measure

Maximum Serum Concentration (Cmax) of Tocilizumab [ Time Frame: Pre-infusion (Hour 0) on Days 1, 15, 29, 43, 57, 71, and 85; at the end of infusion on Days 1, 29 and 71; and anytime on Days 8, 36, and 78 (infusion length = 1 hour) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Children's National Medical Center; Pediatric RheumatologyWashington D.C.District of Columbia20010-2970-
The University of Chicago;Department of PediatricsChicagoIllinois60649-
University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research UnitLouisvilleKentucky40202-
Children's Hospital Boston Pediatric MedicineBostonMassachusetts02115-
The Floating Hospital for Children at Tufts Medical CenterBostonMassachusetts02111-
Children's Speciality Center of NevadaLas VegasNevada89109-
Hackensack University Medical Center; Pediatric RheumatologyHackensackNew Jersey07601-
Cincinnati Children'S Hospital Medical Center; Division of RheumatologyCincinnatiOhio45229-3039-
Children's Hospital Of PittsburghPittsburghPennsylvania15224-

Find similar trials in Washington D.C., DC

By research site
Children's National Medical Center; Pediatric Rheumatology· Washington D.C., DCThe University of Chicago;Department of Pediatrics· Chicago, ILUniversity of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit· Louisville, KYChildren's Hospital Boston Pediatric Medicine· Boston, MAThe Floating Hospital for Children at Tufts Medical Center· Boston, MAChildren's Speciality Center of Nevada· Las Vegas, NV

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