Phase 3 Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis


Phase 3
2 Years
18 Years
Not Enrolling
Both
Juvenile Rheumatoid Arthritis

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Trial Information

Phase 3 Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Determine the efficacy of etanercept in pediatric subjects with systemically active systemic onset juvenile rheumatoid arthritis

Outcome Time Frame:

13 months

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20021631

NCT ID:

NCT00078806

Start Date:

June 2001

Completion Date:

May 2004

Related Keywords:

  • Juvenile Rheumatoid Arthritis
  • Systemic Onset Juvenile Rheumatoid Arthiritis
  • SOJRA
  • Fever
  • Rash
  • Joint Pain
  • Arthritis
  • Arthritis, Rheumatoid
  • Arthritis, Juvenile Rheumatoid

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