Clinical trial NCT00690573: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Juvenile Rheumatoid Arthritis
Keywords: Juvenile Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Eisai Co., Ltd.
First posted: 2008-06-04
Enrollment: 25
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16
timeFrame: Week 16
measure: Number of Subjects Achieving PedACR 30/50/70 Responses
timeFrame: 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
measure: Mean Serum Adalimumab Concentration
timeFrame: Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60
measure: Number of Subjects Positive for Anti-adalimumab Antibodies (AAA)
timeFrame: Week 24 and Week 60
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 47248
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 47253
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 47251
city: Kagoshima
country: Japan
facility: Site Reference ID/Investigator# 47254
city: Kobe
country: Japan
facility: Site Reference ID/Investigator# 47250
city: Okinawa
country: Japan
facility: Site Reference ID/Investigator# 47255
city: Sendai
country: Japan
facility: Site Reference ID/Investigator# 7153
city: Takatsuki
country: Japan
facility: Site Reference ID/Investigator# 47249
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 47243
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 47244
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 47245
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 47246
Study officials:
affiliation: Abbott Japan Co.,Ltd
name: Shigeki Hashimoto, PhD
role: STUDY_DIRECTOR
References:
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.
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.