A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Hoffmann-La Roche
Study ID
NCT01904292
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Subcutaneous 162 mg dose QW or Q2W for 52 weeks

Study Details

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (\<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (\>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight \<30 kg.

Key Dates

Start date
Aug 15, 2013
Status verified
Nov 2017
Primary completion
Jun 13, 2017
Completion
Jun 13, 2017

Study Design

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

Arms

  • Experimental: Tocilizumab
    Participants will receive SC dose of tocilizumab based on body weight; participants with \<30 kg will receive 162 milligrams (mg) of tocilizumab Q2W and those participants =\>30 kg will receive 162 mg of tocilizumab QW, for 52 weeks.

Primary Outcome Measure

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Tocilizumab [ Time Frame: Age <2 years: 0 hours(h) on Days(D) 0,84; on D5,14,42,70,85,88,98,182,266, 364. Weight <30kg, Age>=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266, 364 ]

Locations (11)

FacilityCityStateZIPSite coordinators
Arkansas Children's Hospital Research InstituteLittle RockArkansas72202-
Connecticut Children's Medical Center; 5E Clinical Trials UnitHartfordConnecticut06106-
Ann & Robert H. Lurie Children's Hospital of Chicago; Division of RheumatologyChicagoIllinois60611-
The University of Chicago;Department of PediatricsChicagoIllinois60649-
Hackensack University Medical Center; Pediatric RheumatologyHackensackNew Jersey07601-
Levine Children's Hospital; Divison of Pediatric Rheumatology; Department of PediatricsCharlotteNorth Carolina28203-
Duke UniversityDurhamNorth Carolina27710-
Cincinnati Children'S Hospital Medical Center; Division of RheumatologyCincinnatiOhio45229-3039-
Cleveland Clinic FndnClevelandOhio44195-
University of Utah; Immunology/Rheumatology/AllergySalt Lake CityUtah84109-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Hospital Research Institute· Little Rock, ARConnecticut Children's Medical Center; 5E Clinical Trials Unit· Hartford, CTAnn & Robert H. Lurie Children's Hospital of Chicago; Division of Rheumatology· Chicago, ILThe University of Chicago;Department of Pediatrics· Chicago, ILHackensack University Medical Center; Pediatric Rheumatology· Hackensack, NJLevine Children's Hospital; Divison of Pediatric Rheumatology; Department of Pediatrics· Charlotte, NC

Related Studies