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ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis Clinical research trials and ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis. ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis clinical trial. Test subjects typically receive the most expert healthcare available for their ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis  ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis
ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis
For Condition: Juvenile Rheumatoid Arthritis
Status: Recruiting
Sponsor(s): Immunex Corporation ,
Synopsis: Rationale: etanercept inhibits the effects of tumor necrosis factor, which plays an important role in the progression of rheumatoid arthritis. A study of children with polyarticular course juvenile rheumatoid arthritis showed that Enbrel had efficacy and was generally well tolerated in children ages 4-17 who had moderately to severely active disease and who failed treatment with one or more disease modifying antiarthritic drugs. The children in the study may have had arthritis onset of pauciarticular, polyarticular, or systemic nature. Systemic onset juvenile rheumatoid arthritis (SOJRA) may result in approximately one-third of patients having significant long-term disability. Purpose: the Phase 4 study is designed to further define the safety and efficacy of etanercept in those children with SOJRA.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 2 Years/18 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - 2 - 18 years of age - SOJRA for at least 3 months, with stable systemic features - If taking methotrexate, hydroxychloroquine, or NSAIDs, dose must be stable - Must take prednisone at a stable dose EXCLUSION CRITERIA: - Need for other DMARDs or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids - Pregnant or nursing female - Clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology - Previous receipt of any TNF inhibitor - Live virus vaccine within 12 weeks of study entry - Participation in another study requiring informed consent within 12 weeks of entry - Diabetes that requires insulin treatment - Infection, chronic, recurrent, or currently active - Any serious medical or psychiatric condition or history of alcohol or drug abuse
Total Enrollment: 75
Location and Contact Information:
Overall Study Official:
WayneTsuji, Study Director, Immunex Corporation
Immunex Corporation *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Professional Services 800-466-8639
Additional Information:
Study ID Numbers: 016.0031;
Study Start Date: June 2001
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039949
Other Juvenile Rheumatoid Arthritis Studies:
1. Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis
2. Meloxicam suspension in Juvenile Rheumatoid Arthritis (JRA)
3. ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis
4. Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases
5. Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis
Related Studies:
Other Juvenile Rheumatoid Arthritis Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
ENBREL(R) (etanercept) as Treatment for Children with Systemic Onset Juvenile Rheumatoid Arthritis
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