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

Primary Purpose

Juvenile Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Rheumatoid Arthritis focused on measuring Juvenile Rheumatoid Arthritis

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 47248
  • Site Reference ID/Investigator# 47253
  • Site Reference ID/Investigator# 47251
  • Site Reference ID/Investigator# 47254
  • Site Reference ID/Investigator# 47250
  • Site Reference ID/Investigator# 47255
  • Site Reference ID/Investigator# 7153
  • Site Reference ID/Investigator# 47249
  • Site Reference ID/Investigator# 47243
  • Site Reference ID/Investigator# 47244
  • Site Reference ID/Investigator# 47245
  • Site Reference ID/Investigator# 47246

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adalimumab

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at 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.

Secondary Outcome Measures

Number of Subjects Achieving PedACR50 and PedACR70 Responses at 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
Mean Serum Adalimumab Concentration
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)
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.

Full Information

First Posted
June 2, 2008
Last Updated
September 5, 2012
Sponsor
Abbott
Collaborators
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00690573
Brief Title
Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
Collaborators
Eisai Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Rheumatoid Arthritis
Keywords
Juvenile Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
adalimumab, ABT-D2E7, Humira
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16
Description
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.
Time Frame
Week 16
Title
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
Title
Mean Serum Adalimumab Concentration
Description
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).
Time Frame
Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60
Title
Number of Subjects Positive for Anti-adalimumab Antibodies (AAA)
Description
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.
Time Frame
Week 24 and Week 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeki Hashimoto, PhD
Organizational Affiliation
Abbott Japan Co.,Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 47248
City
Aichi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47253
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 47251
City
Hyogo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47254
City
Kagoshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 47250
City
Kobe
Country
Japan
Facility Name
Site Reference ID/Investigator# 47255
City
Okinawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 7153
City
Sendai
Country
Japan
Facility Name
Site Reference ID/Investigator# 47249
City
Takatsuki
Country
Japan
Facility Name
Site Reference ID/Investigator# 47243
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47244
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47245
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47246
City
Yokohama
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30054164
Citation
Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.
Results Reference
derived
PubMed Identifier
23053683
Citation
Imagawa T, Takei S, Umebayashi H, Yamaguchi K, Itoh Y, Kawai T, Iwata N, Murata T, Okafuji I, Miyoshi M, Onoe Y, Kawano Y, Kinjo N, Mori M, Mozaffarian N, Kupper H, Santra S, Patel G, Kawai S, Yokota S. Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan. Clin Rheumatol. 2012 Dec;31(12):1713-21. doi: 10.1007/s10067-012-2082-5. Epub 2012 Oct 2.
Results Reference
derived

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

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