A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Hoffmann-La Roche
Study ID
NCT00988221
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab was supplied as a sterile solution in vials.
  • Placebo — DRUG
    Placebo to tocilizumab was supplied as a sterile solution in vials.

Study Details

This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients \< 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.

Key Dates

Start date
Nov 30, 2009
Status verified
Jun 2017
Primary completion
Nov 30, 2011
Completion
Jan 28, 2013

Study Design

Enrollment
188 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab 10 mg/kg in patients weighing < 30 kg
    Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
  • Experimental: Tocilizumab 8 mg/kg in patients weighing < 30 kg
    Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
  • Experimental: Tocilizumab 8 mg/kg in patients weighing ≥ 30 kg
    Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
  • Placebo Comparator: Placebo
    Patients received placebo to tocilizumab intravenously every 4 weeks.

Primary Outcome Measure

Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40) [ Time Frame: Week 16 through Week 40 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Connecticut Children's Medical Center; 5E Clinical Trials UnitHartfordConnecticut06106-
Children's National Medical Center; Pediatric RheumatologyWashington D.C.District of Columbia20010-2970-
Delray Research AssociatesDelray BeachFlorida33484-
Miami Children's HospitalMiamiFlorida33155-3009-
The University of Chicago;Department of PediatricsChicagoIllinois60649-
University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research UnitLouisvilleKentucky40202-
Children's HospitalNew OrleansLouisiana70118-
Hackensack University Medical Center; Pediatric RheumatologyHackensackNew Jersey07601-
Cincinnati Children'S Hospital Medical Center; Division of RheumatologyCincinnatiOhio45229-3039-
Healthcare Research ConsultantsTulsaOklahoma74135-

Find similar trials in Hartford, CT

By research site
Connecticut Children's Medical Center; 5E Clinical Trials Unit· Hartford, CTChildren's National Medical Center; Pediatric Rheumatology· Washington D.C., DCDelray Research Associates· Delray Beach, FLMiami Children's Hospital· Miami, FLThe University of Chicago;Department of Pediatrics· Chicago, ILUniversity of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit· Louisville, KY

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