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

This study has been completed.
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00690573
First received: June 2, 2008
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Juvenile Rheumatoid Arthritis
Biological: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Mean Serum Adalimumab Concentration [ Time Frame: Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: May 2008
Study Completion Date: September 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab 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

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.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690573

Locations
Japan
Site Reference ID/Investigator# 47248
Aichi, Japan
Site Reference ID/Investigator# 47253
Fukuoka, Japan
Site Reference ID/Investigator# 47251
Hyogo, Japan
Site Reference ID/Investigator# 47254
Kagoshima, Japan
Site Reference ID/Investigator# 47250
Kobe, Japan
Site Reference ID/Investigator# 47255
Okinawa, Japan
Site Reference ID/Investigator# 7153
Sendai, Japan
Site Reference ID/Investigator# 47249
Takatsuki, Japan
Site Reference ID/Investigator# 47245
Tokyo, Japan
Site Reference ID/Investigator# 47244
Tokyo, Japan
Site Reference ID/Investigator# 47243
Tokyo, Japan
Site Reference ID/Investigator# 47246
Yokohama, Japan
Sponsors and Collaborators
Abbott
Eisai Co., Ltd.
Investigators
Study Director: Shigeki Hashimoto, PhD Abbott Japan Co.,Ltd
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00690573     History of Changes
Other Study ID Numbers: M10-240
Study First Received: June 2, 2008
Results First Received: March 4, 2011
Last Updated: September 5, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Juvenile Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Juvenile Rheumatoid
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 16, 2014