OBJECTIVE: To evaluate treatment with @entity1499 ( @entity1500 ) in @entity1 with newly diagnosed @entity226 ( @entity226 ) to determine if @entity1500 reduces @entity226 relapses and cumulative corticosteroid (CS) requirements and diminishes disease- and treatment-related morbidity. METHODS: This was a multicenter, randomized, double-blind study. Over 4 years, 16 centers from the International Network for the Study of Systemic Vasculitides enrolled @entity1 with unequivocal @entity226 . The initial treatment was 1 mg/kg/day (<or=60 mg every day) @entity229 , plus either 0.15 mg/kg/week @entity1500 (increased to 0.25 mg/kg/week, for a maximum weekly dosage of 15 mg) or placebo. Two physicians, both blinded to treatment allocation, evaluated each @entity1 at every trial visit. One physician was responsible for providing global medical care. The other assessed @entity226 status according to a standard protocol. Treatment failure was defined as 2 distinct relapses or persistence of disease activity after the first relapse, in spite of increased CS therapy. RESULTS: Ninety-eight @entity1 were enrolled. No significant differences between treatment groups were noted with regard to age, frequency of positive findings on temporal artery biopsy (placebo 87%, @entity1500 79%), or comorbidities at the time of enrollment. The median dosage of @entity1500 was 15 mg/week. The incidence of treatment failure was comparable between groups after 12 months: 57.5% in the @entity1500 group failed treatment (95% confidence interval [95% CI] 41.6-73.4%) compared with 77.3% in the placebo group (95% CI 61.9-92.8%) (P = 0.26). In a Cox regression analysis, @entity1500 was not associated with a reduced risk of treatment failure (relative risk 0.72; 95% CI 0.41-1.28). There were no significant differences between groups with regard to abnormal elevations of the erythrocyte sedimentation rate following initial remissions, serious morbidity due to @entity226 , cumulative CS dose, or treatment @entity137 . In the @entity1500 group, there were fewer cases of @entity226 relapse heralded by symptoms of @entity2760 rheumatica (1 case versus 5 in the placebo group; P = 0.05). CONCLUSION: The results of this randomized, multicenter trial do not support the adjunctive use of @entity1500 to control disease activity or to decrease the cumulative dose and @entity137 of CS in @entity1 with @entity226 .

A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant XXXX treatment for @entity226 .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity229 :: ('MESH:D011241', 'Chemical') :: ['prednisone'] @entity226 :: ('MESH:D013700', 'Disease') :: ['giant cell arteritis', 'GCA'] @entity1500 :: ('CHEBI:44185', 'Chemical') :: ['MTX'] @entity2760 :: ('MESH:D011111', 'Disease') :: ['isolated polymyalgia'] @entity1499 :: ('MESH:D008727', 'Chemical') :: ['methotrexate']
@entity1499 :: (MESH:D008727,Chemical) :: ['methotrexate']
