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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.