Country: Japan Site: multicenter Number: 376 Iguratimod group () SASP group () Placebo group () Sex: female/male = 306 : 70
T-614 group: iguratimod 25 mg daily for the first 4 weeks and 50 mg daily for the subsequent 24 weeks SASP group: salazosulfapyridine (SASP) 1000 mg daily Placebo group: placebo tablets
28 weeks of clinical assessment at 0, 4, 6, 12, 18, 24, and 28 weeks.
ACR20, ACR50, tender joint count, swollen joint count, rest pain, physician's and patient's global assessment of disease activity (VAS, mm), physician's global assessment of disease activity, HAQ score, ESR, CRP, and adverse events.
Described in article but not validated because the author could not be reached via email.
Country: China Site: multicenter Number: 489 T-614 group 1 () T-614 group 2 () MTX group () Sex: female/male = 418 : 81
T-614 group 1: T-614 25 mg daily for the first 4 weeks and 50 mg daily for the subsequent 20 weeks T-614 group 2: T-614 50 mg per day MTX group: MTX 10 mg weekly for the first 4 weeks and 15 mg weekly for the subsequent 20 weeks
24 weeks of clinical assessment at 0, 4, 10, 17, and 24 weeks.
ACR20, ACR50, ACR70, tender joint count, swollen joint count, tender joint score (TJS), swollen joint score (SJS), rest pain, duration of morning stiffness, grip strength, physician and patient global assessment of disease activity, ESR, CRP, and adverse events.
Detailed in article and validity ascertained through telephone.
Country: Japan Site: multicenter Number: 252 T-614 + MTX group () MTX + placebo group () Sex: female/male = 204 : 48
T-614 + MTX group: T-614 25 mg daily for the first 4 weeks and 50 mg daily for the subsequent 20 weeks Placebo + MTX group: MTX at low dosages of 6 or 8 mg weekly and folic acid at dosage of 5 mg weekly
28 weeks of clinical assessment at 0, 4, 6, 8, 20, 12, 16, 20, and 24 weeks.
ACR20, ACR50, ACR70, tender joint count, swollen joint count, patient's and physician's global assessment of disease activity, HAQ score, DAS28-CRP, ESR, CRP, and adverse events.
Described in article but not validated because the author could not be reached via email.