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Table 3 Clinical activity assessments in the multi dose phase at eight weeks

From: MTRX1011A, a humanized anti-CD4 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a Phase I randomized, double-blind, placebo-controlled study incorporating pharmacodynamic biomarker assessments

  Placebo MTRX1011A 1.5 mg/kg SC MTRX1011A 3.5 mg/kg SC MTRX1011A 5.0 mg/kg IV
  baseline eight weeks baseline eight weeks baseline eight weeks baseline eight weeks
ACR20, % patients   14   8   33   25
ACR50, % patients   0   0   25   0
ACR70, % patients   0   0   8   0
DAS-CRP 5.4 (4.3 to 6.6) 4.4 (3.2 to 5.9) 5.7 (4.1 to 6.7) 5.6 (4.0 to 7.7) 5.9 (3.7 to 6.8) 4.6 (2.6 to 6.8) 6.5 (4.2 to 8.0) 5.5 (3.2 to 6.8)
CRP, mg/dL 1.7 (0.03 to 4.0) 1.1 (0.1 to 3.0) 0.8 (0.02 to 2.3) 1.1 (0.02 to 4.2) 1.1 (0.02 to 7.7) 1.7 (0.1 to 9.8) 2.1 (0.1 to 8.2) 1.1 (0.1 to 3.9)
ESR, mm/hour 47 (15 to 120) 36 (8 to 104) 32 (8 to 60) 30 (6 to 108) 39 (0 to 78) 34 (8 to 58) 61 (26 to 110) 51 (29 to 104)
SJC 7 (0 to 16) 7 (0 to 19) 14 (2 to 30) 18 (2 to 51) 20 (7 to 52) 8 (0 to 36) 26 (3 to 59) 17 (0 to 30)
TJC 36 (10 to 53) 25 (3 to 62) 42 (12 to 65) 37 (4 to 67) 41 (8 to 68) 18 (0 to 66) 48 (22 to 65) 30 (24 to 33)
VAS,         
Patient, pain 60 (42 to 77) 39 (19 to 57) 57 (17 to 79) 59 (10 to 89) 62 (18 to 91) 54 (14 to 89) 78 (62 to 90) 47 (20 to 67)
Patient, overall 69 (54 to 94) 43 (18 to 75) 63 (17 to 98) 58 (17 to 88) 70 (40 to 93) 56 (10 to 87) 81 (60 to 100) 52 (25 to 75)
VAS, Physician, global 60 (26 to 78) 44 (25 to 63) 51 (21 to 80) 52 (12 to 88) 66 (35 to 100) 51 (13 to 88) 58 (45 to 76) 52 (33 to 73)
  1. Data are expressed as group mean, with ranges depicted between parentheses. ACR, American College of Rheumatology; CRP, C-reactive protein; DAS, disease activity score; ESR, erythrocyte sedimentation rate; IV, intravenous; SC, subcutaneous; SJC, swollen joint count; TJC, tender joint count; VAS, visual analog scale.