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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Juvenile Rheumatoid Arthritis

Intervention: Adalimumab (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Shigeki Hashimoto, PhD, Study Director, Affiliation: Abbott Japan Co.,Ltd

Summary

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

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16

Secondary outcome:

Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16

Number of Subjects Achieving PedACR 30/50/70 Responses

Mean Serum Adalimumab Concentration

Number of Subjects Positive for Anti-adalimumab Antibodies (AAA)

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

Minimum age: 4 Years. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

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# 47243, Tokyo, Japan

Site Reference ID/Investigator# 47244, Tokyo, Japan

Site Reference ID/Investigator# 47245, Tokyo, Japan

Site Reference ID/Investigator# 47246, Yokohama, Japan

Additional Information

Starting date: May 2008
Last updated: September 5, 2012

Page last updated: August 23, 2015

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