Status:
COMPLETED
Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)
Lead Sponsor:
Amgen
Conditions:
Juvenile Rheumatoid Arthritis
Eligibility:
All Genders
4-18 years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objective of this study was to determine the efficacy of etanercept in children with polyarticular course JRA.
Detailed Description
This was a two-part study. In the first part of the study, all participants received open-label etanercept twice a week for 90 days. At the end of the 90 days, participants with disease response as de...
Eligibility Criteria
Inclusion
- Diagnosis of JRA by the American College of Rheumatology (ACR) criteria.
- Disease course must be polyarticular with disease duration long enough to have been given an adequate trial of non-steroidal anti-inflammatory drugs (NSAIDs) and low-dose methotrexate at a dose of at least 10 mg/m²/week
- Continuing active disease, defined as ≥ 5 swollen joints and ≥ 3 joints with limitation of motion accompanied by pain, tenderness or warmth.
- Disease refractory to methotrexate or intolerant of methotrexate.
- Have not received disease-modifying anti-rheumatic drugs (DMARDs) within 28 days prior to enrollment.
- Have not received methotrexate within 14 days prior to dosing of study drug.
Exclusion
- Pregnant or nursing female
- Functional class IV by ACR criteria
- Unable to meet concomitant medication restrictions
- Intraarticular corticosteroid injection within 4 weeks prior to enrollment
- Clinically significant deviations from normal, defined as:
- thrombocytopenia; platelet count \< 100,000/cmm
- leukopenia; total white cell count \< 4000 cells/cmm
- neutropenia; neutrophils \< 1000 cells/cmm
- hepatic transaminase levels \> two times the upper limit of normal (ULN)
- serum bilirubin \> 2 times ULN
- creatinine clearance \< 90 mL/min/1.73 m² body surface area (BSA) and/or a glomerular filtration rate (GFR) \< 90 mL/min/1.73 m² BSA.
- known human immunodeficiency virus (HIV), hepatitis B surface antigen positivity, or hepatitis C positivity.
- anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies or anti-cardiolipin antibodies present.
- Previously received antibody to TNF, antibody to cluster of differentiation (CD)4, or diphtheria interleukin (IL)-2-fusion protein (DAB-IL-2)
- Participated in a study of an investigational drug or biologic requiring informed consent within 3 months prior to study entry.
- Any concurrent medical condition which would, in the investigator's opinion, compromise the patient's ability to tolerate the study drug or make the patient unable to cooperate with the protocol.
- History of or current psychiatric illness that would interfere with ability to comply with protocol requirements or informed consent.
- History or drug or alcohol abuse that would interfere with ability to comply with protocol requirements
Key Trial Info
Start Date :
May 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 1998
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03780959
Start Date
May 1 1997
End Date
July 8 1998
Last Update
August 2 2019
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