Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis
Condition: Juvenile Chronic Polyarthritis; Juvenile Idiopathic Arthritis; Juvenile Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: methotrexate; methotrexate - etanercept - prednisolone arm
Intervention description: Methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus placebo etanercept and and placebo prednisolone; methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus etanercept 0.8 mg/kg given by sub cutaneous injection once per week, plus prednisolone, by mouth daily with decreasing dose tapered over 16 weeks.
Intervention MeSH terms: Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Etanercept; Methotrexate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 85.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Childhood Arthritis; Juvenile Arthritis; Juvenile Arthritis Treatment; Childhood Arthritis Drug Treatment; Juvenile Arthritis Remission; Inactive Disease in Juvenile Arthritis; Childhood Polyarthritis; Extended Oligoarthritis

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  Received or currently receiving disease-modifying antirheumatic drugs (DMARDs),
             biologic, or prednisone for any duration for treatment of poly-JIA, with the following
             exceptions:

               1. 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),

               2. 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