A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Hoffmann-La Roche
Study ID
NCT01904279
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks

Study Details

This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.

Key Dates

Start date
Jul 31, 2013
Status verified
May 2017
Primary completion
May 31, 2016
Completion
May 31, 2016

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TCZ SC 162 mg Q3W
    Participants with body weight less than (\<) 30 kilograms (kg) will be administered 162 milligrams (mg) of TCZ as a SC injection every 3 weeks (Q3W) for 52 weeks.
  • Experimental: TCZ SC 162 mg Q2W
    Participants with body weight greater than or equal to (\>/=) 30 kg will be administered 162 mg of TCZ as a SC injection every 2 weeks (Q2W) for 52 weeks.

Primary Outcome Measure

Minimum Serum Concentration (Cmin) of TCZ at Steady State [ Time Frame: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) ]

Locations (10)

FacilityCityStateZIPSite coordinators
-HartfordConnecticut06106-
-ChicagoIllinois60611-
-ChicagoIllinois60637-
-HackensackNew Jersey07601-
-CharlotteNorth Carolina28203-
-DurhamNorth Carolina27710-
-CincinnatiOhio45229-3039-
-TulsaOklahoma74135-
-Salt Lake CityUtah84109-
-SeattleWashington98105-

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