PMID- 18466681
OWN - NLM
STAT- MEDLINE
DCOM- 20080708
LR  - 20080509
IS  - 0366-6999 (Print)
IS  - 0366-6999 (Linking)
VI  - 121
IP  - 7
DP  - 2008 Apr 5
TI  - Safety and efficacy of T-614 in the treatment of patients with active rheumatoid 
      arthritis: a double blind, randomized, placebo-controlled and multicenter trial.
PG  - 615-9
AB  - BACKGROUND: A novel anti-rheumatic drug, T-614, has been shown to have an 
      anti-inflammatory effect and to improve abnormal immunological findings in 
      rheumatoid arthritis (RA). To assess the safety and efficacy of T-614 versus 
      placebo in patients with active RA we conducted a 24-week clinical study in 280 
      Chinese patients. METHODS: In a multicenter, randomized, double blind, placebo 
      controlled study, 280 patients were randomly assigned to receive placebo (n = 95) 
      or T-614 at 50 mg (n = 93) or 25 mg (n = 92) daily. Active disease was defined by 
      4 of the following 5 criteria: >or= 5 tender joints, >or= 3 swollen joints, 
      morning stiffness lasting for >or= 60 minutes, and Westergren erythrocyte 
      sedimentation rate (ESR) >or= 28 mm/h, the assessment of pain at the rest by 
      patient as moderate or severe. Clinical and laboratory parameters were analyzed 
      at baseline, 2, 4, 6, 12, 18 and 24 weeks. The primary efficacy variable at week 
      24 was the American College of Rheumatology (ACR) response rate using the 
      intent-to-treat population. RESULTS: The ACR response rate was significantly 
      higher in the T-614 treatment group compared with the placebo group within 8 
      weeks after the initiation of treatment. After 24 weeks, the 25 mg/d and 50 mg/d 
      dosage groups and the placebo group showed 39.13%, 61.29% and 24.21% in ACR20 and 
      23.91%, 31.18% and 7.37% in ACR50, respectively. A time-response in ACR response 
      was observed, with clear superiority for the 25 mg/d and 50 mg/d dosage groups 
      compared to placebo (P < 0.0001), and the 50 mg/d dose compared to the 25 mg/d 
      dose (P < 0.05) when using the ACR response analyses after 24 weeks. ESR and 
      c-reactive protein (CRP) were significantly different in the treatment groups 
      after 24 weeks. The incidence of adverse events (AEs) was not significantly 
      higher with T-614 than with placebo, but upper abdominal discomfort, leucopenia, 
      elevated serum alanine aminotransferase (sALT), skin rash and/or pruritus were 
      more common in the 50 mg and 25 mg dosage groups. CONCLUSION: T-614, a new 
      slow-acting drug, is effective in treatment of rheumatoid arthritis and is well 
      tolerated.
FAU - Lu, Liang-jing
AU  - Lu LJ
AD  - Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University, 
      Shanghai 200001, China.
FAU - Teng, Jia-lin
AU  - Teng JL
FAU - Bao, Chun-de
AU  - Bao CD
FAU - Han, Xing-hai
AU  - Han XH
FAU - Sun, Ling-yun
AU  - Sun LY
FAU - Xu, Jiang-hua
AU  - Xu JH
FAU - Li, Xing-fu
AU  - Li XF
FAU - Wu, Hua-xiang
AU  - Wu HX
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - China
TA  - Chin Med J (Engl)
JT  - Chinese medical journal
JID - 7513795
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Benzopyrans)
RN  - 0 (Sulfonamides)
RN  - 123663-49-0 (T 614)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Benzopyrans/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Sulfonamides/adverse effects/*therapeutic use
EDAT- 2008/05/10 09:00
MHDA- 2008/07/09 09:00
CRDT- 2008/05/10 09:00
PHST- 2008/05/10 09:00 [pubmed]
PHST- 2008/07/09 09:00 [medline]
PHST- 2008/05/10 09:00 [entrez]
PST - ppublish
SO  - Chin Med J (Engl). 2008 Apr 5;121(7):615-9.