Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Hoffmann-La Roche
Study ID
NCT02165345
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    162 mg tocilizumab will be administered by SC injection at the following intervals: pJIA participants less than (\<) 30 kilograms (kg): every 3 weeks; pJIA participants greater than or equal to (\>=) 30 kg: every 2 weeks; sJIA participants \<30 kg: every 2 weeks; sJIA participants \>/= 30 kg: once weekly

Study Details

This open-label extension of the JIGSAW studies (WA28117 \[NCT01904279\] and WA28118 \[NCT01904292\]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis subtype and body weight. Participants will receive the treatment until commercial availability of the drug or for a maximum of 5 years, whichever is earlier.

Key Dates

Start date
Jul 16, 2014
Status verified
Feb 2022
Primary completion
Nov 24, 2021
Completion
Nov 24, 2021

Study Design

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

Arms

  • Experimental: Tocilizumab
    Participants will receive tocilizumab until the commercial availability of the drug or up to 5 years, whichever is earlier.

Primary Outcome Measure

Juvenile Arthritis Disease Activity Score (JADAS-71) [ Time Frame: Baseline up to 3 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
Arkansas Children's Hospital Research InstituteLittle RockArkansas72202-
University of Chicago HospitalChicagoIllinois60637-
Hackensack University Medical Center; Pediatric RheumatologyHackensackNew Jersey07601-
Duke UniversityDurhamNorth Carolina27705-
Cincinnati Children'S Hospital Medical Center; Division of RheumatologyCincinnatiOhio45229-3039-
Cleveland Clinic FndnClevelandOhio44195-
Healthcare Research ConsultantsTulsaOklahoma74135-
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, ARUniversity of Chicago Hospital· Chicago, ILHackensack University Medical Center; Pediatric Rheumatology· Hackensack, NJDuke University· Durham, NCCincinnati Children'S Hospital Medical Center; Division of Rheumatology· Cincinnati, OHCleveland Clinic Fndn· Cleveland, OH

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