Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis

Completed · Phase 4 · Has a placebo group

Conditions studied: Juvenile Chronic Polyarthritis, Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis

In brief

The purpose of this study is to compare two aggressive drug regimens for children with poly-juvenile idiopathic arthritis (JIA) and extended oligo JIA.

Key facts

Study ID

NCT00443430

Run by

Seattle Children's Hospital

People needed

85

Starts

2007-05-01

Expected to finish

2010-10-01

Last updated by the study team

2013-05-31

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of active poly-JIA as determined by International League of Associations for Rheumatology (ILAR) criteria
• Onset of signs and symptoms of poly-JIA for 12 months or less prior to study screening
• Willing to use acceptable forms of contraception for the duration of the study and for 3 months after the study
• Parent or guardian willing to provide informed consent
• Able to attend all study visits

You may not qualify if…

• Received or currently receiving disease-modifying antirheumatic drugs (DMARDs), biologic, or prednisone for any duration for treatment of poly-JIA, with the following exceptions:
• Methotrexate duration must be less than or equal to 6 weeks at a dose of less than or equal to 0.5 mg/kg/week (40 mg max),
• Steroid use has been less than or equal to 4 weeks and the subject is off of steroids for at least 1 week prior to enrollment
• Received intramuscular or soft-tissue injections of corticosteroids for treatment of poly-JIA before receiving the first dose of study medication. Up to 2 joint injections with intra-articular steroids (IAS) will be allowed up to 7 days after the baseline visit.
• History of or active cancer of any type
• Active gastrointestinal disease (e.g., inflammatory bowel disease)
• Chronic or acute kidney or liver disorder
• Significant blood clotting defect
• AST (SGOT), ALT (SGPT), or BUN levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline
• Chronic condition (e.g., diabetes, epilepsy) that is either not stable or poorly controlled and may interfere with study participation
• Received any investigational medication within 30 days prior to the first dose of study medication or scheduled to receive an investigational drug (other than the study medications) during the course of the study
• Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to study screening
• HIV infected
• Known past or current hepatitis infection
• Received a live virus vaccine within 1 month prior to baseline
• Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
• Pregnancy
• Any medical condition that would make study participation difficult or inadvisable in the opinion of the investigator
• History of or current psychiatric illness that would interfere with study participation
• History of alcohol or drug abuse within the 6 months prior to study entry that would interfere with study participation
• Inability to comply with study requirements for any reason

Where it is running

• Stanford University Medical Center — Palo Alto, California, United States
• Rady Children's Hospital — San Diego, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• Children's Hospital of Boston — Boston, Massachusetts, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Schneider Children's Hospital — New Hyde Park, New York, United States
• Children's Hospital at Montefiore — The Bronx, New York, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Children's Hospital of Columbus — Columbus, Ohio, United States
• Oklahoma University Health Science Center — Oklahoma City, Oklahoma, United States
• Texas Scottish Rite Hospital — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Seattle Children's Hospital and Regional Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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