Sulfasalazine in the treatment of juvenile chronic arthritis: a randomized, double-blind, placebo-controlled, multicenter study. Dutch Juvenile Chronic Arthritis Study Group.
| Title: | Sulfasalazine in the treatment of juvenile chronic arthritis: a randomized, double-blind, placebo-controlled, multicenter study. Dutch Juvenile Chronic Arthritis Study Group. |
|---|---|
| Authors: | van Rossum MA; Leiden University Hospital, The Netherlands.; Fiselier TJ; Franssen MJ; Zwinderman AH; ten Cate R; van Suijlekom-Smit LW; van Luijk WH; van Soesbergen RM; Wulffraat NM; Oostveen JC; Kuis W; Dijkstra PF; van Ede CF; Dijkmans BA |
| Source: | Arthritis and rheumatism [Arthritis Rheum] 1998 May; Vol. 41 (5), pp. 808-16. |
| Publication Type: | Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial |
| Language: | English |
| Journal Info: | Publisher: Wiley-Blackwell Country of Publication: United States NLM ID: 0370605 Publication Model: Print Cited Medium: Print ISSN: 0004-3591 (Print) Linking ISSN: 00043591 NLM ISO Abbreviation: Arthritis Rheum Subsets: MEDLINE |
| Imprint Name(s): | Publication: : Hoboken, N.J. : Wiley-Blackwell; Original Publication: Atlanta [etc.] Arthritis Foundation [etc.] |
| MeSH Terms: | Antirheumatic Agents/*therapeutic use ; Arthritis, Juvenile/*drug therapy ; Sulfasalazine/*therapeutic use; Antirheumatic Agents/adverse effects ; Arthritis, Juvenile/pathology ; Arthritis, Juvenile/physiopathology ; Joints/pathology ; Joints/physiopathology ; Sulfasalazine/adverse effects ; Adolescent ; Arthrography ; Child ; Child, Preschool ; Disease Progression ; Double-Blind Method ; Female ; Humans ; Male ; Prospective Studies ; Safety ; Severity of Illness Index ; Treatment Outcome |
| Abstract: | Objective: To assess the efficacy, tolerability, and safety of sulfasalazine (SSZ) in the treatment of juvenile chronic arthritis (JCA).; Methods: We conducted a 24-week randomized, placebo-controlled, double-blind, multicenter study of patients with active JCA of both oligoarticular and polyarticular onset. Patients were treated with a dosage of 50 mg/kg/day of SSZ (maximum 2,000 mg/day) or placebo. The efficacy variables were joint scores, physician's, parents', and patient's overall assessments, and laboratory parameters of inflammation.; Results: Of the 69 patients enrolled, 52 (75%) completed the trial. Six patients (18%) withdrew from the placebo group, and 11 (31%) withdrew from the SSZ group (P = 0.18). In the intention-to-treat analysis of end point efficacy, between-group differences were significant for the overall articular severity score (P = 0.02), all global assessments (P = 0.01), and the laboratory parameters (P < 0.001). Adverse events occurred more frequently in the SSZ group and were the main reason for withdrawal (P < 0.001), but in all instances, these events were transient or reversible upon cessation of treatment.; Conclusion: The results of this first placebo-controlled study show that SSZ is effective and safe in the treatment of children with oligoarticular- and polyarticular-onset JCA, although it was not well tolerated in one-third of the patients. |
| Substance Nomenclature: | 0 (Antirheumatic Agents); 3XC8GUZ6CB (Sulfasalazine) |
| Entry Date(s): | Date Created: 19980520 Date Completed: 19980601 Latest Revision: 20131121 |
| Update Code: | 20260130 |
| DOI: | 10.1002/1529-0131(199805)41:53.0.CO;2-T |
| PMID: | 9588731 |
| Database: | MEDLINE |
Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial