A Study of Decreased Dose Frequency in Participants With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT01734382
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Participants will receive tocilizumab IV infusions of 12 mg/kg (for participants \< 30 kg) or 8 mg/kg (for participants \>/=30 kg) Q2W/Q3W/Q4W.

Study Details

PART1 Participants in Part 1 (Run-in-Phase) of study will receive tocilizumab (TCZ) (RoActemra/Actemra) 12 milligrams per kilogram (mg/kg) or 8 mg/kg intravenously (IV) every 2 weeks (Q2W) for up to 24 weeks. Participants who experience a laboratory abnormality during Part 1 may be eligible to move into Part 2 of the study. PART 2 This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of tocilizumab in reduced dose frequency in participants with adequately controlled systemic juvenile idiopathic arthritis who have experienced a laboratory abnormality on twice weekly tocilizumab dosing, that has since resolved. Participants will receive tocilizumab 12 mg/kg or 8 mg/kg intravenously every 3 weeks. After 5 consecutive infusions, participants who experience an event of neutropenia, thrombocytopenia or liver enzyme abnormality will move to every 4 weeks tocilizumab administration. Anticipated time on study treatment is 52 weeks.

Key Dates

Start date
Jun 10, 2013
Status verified
Apr 2020
Primary completion
Oct 9, 2019
Completion
Oct 9, 2019

Study Design

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

Arms

  • Experimental: Part 1: Tocilizumab (TCZ) Q2W
    Participants will receive tocilizumab intravenous (IV) infusions (12 mg/kg for participants \< 30 kg; 8 mg/kg for participants \>/= 30 kg) once every other week (Q2W) up to 24 weeks or until occurrence of a protocol defined laboratory abnormality in Part 1 of the study.
  • Experimental: Part 2: TCZ IV 12 mg/kg Q3W/Q4W
    Participants with weight \< 30 kg will receive tocilizumab IV infusions of 12 mg/kg once every three weeks (Q3W) up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who complete 5 consecutive infusions of Q3W and have a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality will switch to tocilizumab IV infusions of 12 mg/kg once every four weeks (Q4W) up to Week 52 in Part 2 of the study.
  • Experimental: Part 2: TCZ IV 8 mg/kg Q3W/Q4W
    Participants with weight \>/= 30 kg will receive tocilizumab IV infusions of 8 mg/kg Q3W up to 52 weeks or until occurrence of neutropenia, thrombocytopenia, or liver enzyme abnormality as per protocol criteria. Participants who complete 5 consecutive infusions of Q3W and have a laboratory abnormality of neutropenia, thrombocytopenia or elevated liver enzymes as per protocol criteria, after resolution of this laboratory abnormality will switch to tocilizumab IV infusions of 8 mg/kg Q4W up to Week 52 in Part 2 of the study.

Primary Outcome Measure

Juvenile Arthritis Disease Activity Score (JADAS-71) [ Time Frame: Part 2: Up to 52 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital Los Angeles; Division of RheumatoogyLos AngelesCalifornia90027-
Cincinnati Children'S Hospital Medical Center; Division of RheumatologyCincinnatiOhio45229-3039-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles; Division of Rheumatoogy· Los Angeles, CACincinnati Children'S Hospital Medical Center; Division of Rheumatology· Cincinnati, OH

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