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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumat

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

Detailed Summary: This was an open-label long-term study that was completed following study drug approval in Japan for the treatment of JRA. Data are presented through Week 144 and for the final visit.
Sponsor: Abbott

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

Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.


Original Primary Outcome: ACR Pediatric 30 response [ Time Frame: Week 16 ]

Current Secondary Outcome:

  • Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16 [ Time Frame: Week 16 ]
    Response defined as at least 50/70% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 50/70% worsening in not more than 1 JRA criterion compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.
  • Number of Subjects Achieving PedACR 30/50/70 Responses [ Time Frame: Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit ]
  • Mean Serum Adalimumab Concentration [ Time Frame: Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60 ]
    Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method based on a double-antigen technique. Concentrations are reported as micrograms per milliliter (mcg/mL).
  • Number of Subjects Positive for Anti-adalimumab Antibodies (AAA) [ Time Frame: Week 24 and Week 60 ]
    Serum samples with adalimumab concentration below 2 mcg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.


Original Secondary Outcome:

  • ACR Pediatric 50/70 response [ Time Frame: Week 16 ]
  • ACR Pediatric 30/50/70 response [ Time Frame: Week 2, 4, 8, and 24, and every 12 weeks after Week 24 ]
  • AE, including vital signs and clinical laboratory test [ Time Frame: Week 24, and at appropriate interval after Week 24 ]
  • Serum adalimumab/AAA level [ Time Frame: Week 2, 4, 8, 16 and 24, and every 12 weeks after Week 24 ]


Information By: Abbott

Dates:
Date Received: June 2, 2008
Date Started: May 2008
Date Completion:
Last Updated: September 5, 2012
Last Verified: September 2012