title: Multicenter, randomized, double-blind, controlled trial of treatment of active rheumatoid arthritis with T-614 compared with methotrexate.
abstract: OBJECTIVE
  To assess the efficacy and safety of T-614 versus methotrexate (MTX) in patients with active rheumatoid arthritis (RA).
  
  
  METHODS
  In this multicenter, double-blind trial, 489 patients randomly received either T-614 25 mg/day for the first 4 weeks and 50 mg/day for the subsequent 20 weeks (group 1, n = 163), T-614 50 mg/day for 24 weeks (group 2, n = 163), or MTX 10 mg/week for the first 4 weeks and 15 mg/week for the subsequent 20 weeks (n = 163). Clinical and laboratory parameters were analyzed at baseline and at 4, 10, 17, and 24 weeks.
  
  
  RESULTS
  After 24 weeks of treatment, the American College of Rheumatology 20% improvement criteria response rate for patients in T-614 group 2 (63.8%) was not statistically significantly different from that for patients receiving MTX treatment (62.0%), and was superior to that for patients in T-614 group 1 (50.9%). The result of the noninferiority analysis indicated that the efficacy of T-614 (50 mg/day) was not lower than that of MTX by <10%. Rheumatoid factor and IgA, IgG, and IgM demonstrated a statistically significant decrease in all groups. Frequently reported adverse events included hematologic disorder, skin reactions, gastrointestinal symptoms, and transient liver enzyme elevations in the T-614 therapy groups. Side effects in the T-614 groups were generally fewer and milder than in the MTX group, except for skin reactions. There were no prominent cardiovascular adverse events and gastrointestinal ulcers found in the T-614 groups.
  
  
  CONCLUSIONS
  Results indicate that T-614 therapy 50 mg/day is effective and well tolerated, and represents a new option for the treatment of patients with active RA.
authors: Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors: Liang-Jing
authors: LJ
authors: Lu
authors: Chun-de
authors: CD
authors: Bao
authors: Min
authors: M
authors: Dai
authors: Jia-Lin
authors: JL
authors: Teng
authors: Wei
authors: W
authors: Fan
authors: Fang
authors: F
authors: Du
authors: Nan-Ping
authors: NP
authors: Yang
authors: Yin-Huan
authors: YH
authors: Zhao
authors: Zhi-Wei
authors: ZW
authors: Chen
authors: Jian-Hua
authors: JH
authors: Xu
authors: Pei-Gen
authors: PG
authors: He
authors: Hua-Xiang
authors: HX
authors: Wu
authors: Yi
authors: Y
authors: Tao
authors: Miao-Jia
authors: MJ
authors: Zhang
authors: Xing-Hai
authors: XH
authors: Han
authors: Xing-Fu
authors: XF
authors: Li
authors: Jie-Ruo
authors: JR
authors: Gu
authors: Jian-Hua
authors: JH
authors: Li
authors: Hao
authors: H
authors: Yu
mesh_terms: D000284:Administration, Oral; D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D001578:Benzopyrans / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D001578:Benzopyrans; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D013449:Sulfonamides; C077313:T 614; D008727:Methotrexate