Performance of the preliminary definition of improvement in juvenile chronic arthritis patients treated with methotrexate

A randomized trial of parenteral methotrexate comparing an intermediate dose with a higher dose in children with juvenile idiopathic arthritis who failed to respond to standard doses of methotrexate

“…Moreover, for the first time, MTX efficacy has been evaluated using the ACR pediatric 50 and ACR pediatric 70 criteria. By using the ACR pediatric 30, the percentage of responders was similar (72%) to that reported by us in an open-label trial (66%) (12) and to that reported by Giannini et al in their controlled study (63%) (4) that used a different definition of improvement. Interestingly, a high percentage of response was also observed when the clinically more meaningful ACR pediatric 50 and ACR pediatric 70 criteria were applied (61% and 38%, respectively).…”

“…In order to be randomized to receive a higher dose of MTX, eligible patients had to have at least 5 joints with active arthritis plus abnormal results for at least 2 of any of the 5 remaining JIA core set criteria (11,12). Other eligibility criteria for the randomization phase were treatment with standarddose MTX for 6 months (screening phase period), a stable dose of no more than 1 nonsteroidal antiinflammatory drug for at least 1 month prior to randomization, and a stable, low dosage of prednisone (Յ0.2 mg/kg/day or 10 mg/day, whichever was less) for at least 1 month prior to randomization, as well as administration of adequate birth control methods in patients who were sexually active (the decision about which birth control methods should be used was left to the attending physician, family, and patient), and the ability of the patient to communicate meaningfully with the medical staff.…”

“…As primary outcome measures, we used the validated ACR pediatric 30 definition of improvement (11,12,15). According to the ACR pediatric 30, patients were considered to be responders to treatment with MTX if they demonstrated at least 30% improvement from baseline in at least 3 of any 6 JIA core set variables with no more than 1 of the remaining variables worsening by more than 30% (11,12). The ACR pediatric 30 allows researchers or clinicians to dichotomize patients into responders or nonresponders.…”

“…As secondary outcomes measures, we used the individual validated JIA core set variables (11,12), which include the number of joints with active arthritis (defined as a joint with swelling or a joint with pain and limitation on movement) (range 0-71) (17), the number of joints with limited range of motion (range 0-67) (18), the physician's global evaluation of disease activity on a double-anchored 10-cm visual analog scale (VAS) (anchoring words 0 ϭ inactive, 10 ϭ very severe), the parent's global assessment of the child's overall well-being on a double-anchored 10-cm VAS (anchoring words 0 ϭ very well, 10 ϭ very poor) as reported on the Childhood Health Assessment Questionnaire (CHAQ) (19,20), the disability index of the CHAQ, and the Westergren ESR. All measures related to assessment of the joints are reported as a joint count only, to avoid redundancy with the scoring method for joint evaluation (18,21).…”

A randomized, placebo‐controlled trial of infliximab plus methotrexate for the treatment of polyarticular‐course juvenile rheumatoid arthritis

“…Serum infliximab concentrations were determined with an enzyme-linked immunoassay (18) Definitions of response to therapy. Response to therapy was defined based on the combination of the following 6 JRA core set parameters (19,20): 1) physician global assessment of disease activity, on a 10-cm visual analog scale (VAS); 2) parent/patient global assessment of overall well-being, on a 10-cm VAS; 3) a measure of physical function, which for this trial was the cross-culturally adapted and validated version of a measure of functional ability in children with JRA, i.e., the Childhood Health Assessment Questionnaire (21,22); 4) the number of joints with active arthritis, defined by the presence of swelling or, if no swelling was present, limitation of motion accompanied by pain, tenderness, or both (16); 5) the number of joints with limited range of motion; and 6) a laboratory measure of inflammation, which for this trial was the erythrocyte sedimentation rate. Whenever possible, each patient's joints were evaluated by the same assessor at each visit.…”