Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis

Sponsor
Abbott
Study ID
NCT00690573
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — BIOLOGICAL
    Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).

Study Details

To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis

Key Dates

Start date
May 31, 2008
Status verified
Sep 2012
Primary completion
Mar 31, 2010
Completion
Sep 30, 2011

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab

Primary Outcome Measure

Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 [ Time Frame: Week 16 ]