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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00690573
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : April 1, 2011
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Abbott

Tracking Information
First Submitted Date  ICMJE June 2, 2008
First Posted Date  ICMJE June 4, 2008
Results First Submitted Date  ICMJE March 4, 2011
Results First Posted Date  ICMJE April 1, 2011
Last Update Posted Date September 10, 2012
Study Start Date  ICMJE May 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2011)
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 Measures  ICMJE
 (submitted: June 3, 2008)
ACR Pediatric 30 response [ Time Frame: Week 16 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • 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 Measures  ICMJE
 (submitted: June 3, 2008)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis
Official Title  ICMJE A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis
Brief Summary To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Juvenile Rheumatoid Arthritis
Intervention  ICMJE Biological: Adalimumab
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).
Other Name: adalimumab, ABT-D2E7, Humira
Study Arms  ICMJE Experimental: Adalimumab
Intervention: Biological: Adalimumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2008)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Diagnosis of polyarticular juvenile rheumatoid arthritis (JRA) according to the criteria of the American College on Rheumatology (ACR)
  • Disease activity inadequately controlled by nonsteroidal anti-inflammatory drugs (NSAIDs) or methotrexate (MTX)
  • Presence at screening of at least 5 swollen joints (not due to deformity) and at least 3 joints with limitation of passive motion with pain by passive motion or/and pain by pressure (tenderness)
  • Stable dosage of MTX for at least 12 weeks prior to the screening visit or discontinuation of MTX at least 14 days prior to baseline visit (Day 1)
  • Discontinuation of disease-modifying antirheumatic drugs (DMARDs) other than MTX at least 28 days before screening visit

Exclusion Criteria

  • History of inflammatory joint disease other than JRA
  • Functional class IV JRA by ACR criteria
  • Clinically significant cardiac disease or laboratory abnormalities
  • Any subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690573
Other Study ID Numbers  ICMJE M10-240
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Eisai Co., Ltd.
Investigators  ICMJE
Study Director: Shigeki Hashimoto, PhD Abbott Japan Co.,Ltd
PRS Account Abbott
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP