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

Juvenile Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690573
• Other study ID #: M10-240
• Status: Completed
• Phase: Phase 3
• First received: June 2, 2008
• Last updated: September 5, 2012
• Start date: May 2008
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Juvenile Rheumatoid Arthritis

Intervention

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).

Locations

Country	Name	City	State
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# 47243	Tokyo
Japan	Site Reference ID/Investigator# 47244	Tokyo
Japan	Site Reference ID/Investigator# 47245	Tokyo
Japan	Site Reference ID/Investigator# 47246	Yokohama

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 16	No
Secondary	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.	Week 16	No
Secondary	Number of Subjects Achieving PedACR 30/50/70 Responses		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	No
Secondary	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).	Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60	No
Secondary	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.	Week 24 and Week 60	No