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Table 1 Demographics and baseline characteristics of the patients

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

 

Single dose phase

Multi dose phase

Characteristics

Placebo

MTRX1011A

Placebo

MTRX1011A

Gender

(Female:Male)

4:2

15:9

6:1

24:5

Age, years

Mean (range)

51 (41 to 64)

56 (27 to 77)

57 (43 to 57)

53 (25 to 76)

Race

(White:Black)

5:1

23:1

7:0

24:5

Disease Duration (median years)

3.8

5.7

5.0

8.1

RF positive, %

66.7

58.3

42.9

34.5

CCP positive, %

100

100

100

100

RF and anti-CCP positive, %

66.7

58.3

42.9

34.5

Concomitant

    

Meds:

    

   % on MTX

67

75

57

66

   % on

0

4

14

0

leflunomide

% on steroids

33

50

43

48

CRP, mg/dL

Mean (range)

0.53 (0.50 to 0.93)

0.65 (0.04 to 2.89)

1.68 (003 to 3.99)

1.11 (0.02 to 8.21)

ESR, mm/hour

Mean (range)

26 (0 to 42)

25 (4 to 49)

47 (15 to 120)

40 (0 to 110)

SJC

Mean (range)

17 (10 to 33)

17 (0 to 63)

7 (0 to 16)

18 (2 to 59)

TJC

Mean (range)

25 (6 to 44)

31 (1 to 68)

36 (10 to 53)

43 (58 to 68)

Baseline DAS-CRP

4.8 (3.85 to 5.68)

5.15 (2.66 to 7.17)

5.43 (4.28 to 6.62)

5.93 (3.74 to 8)

  1. anti-CCP, anti-cyclic citrullinated peptide antibodies; CRP, C-reactive protein; DAS, disease activity score; ESR, erythrocyte sedimentation rate; MTX, methotrexate; RF, rheumatoid factor; SJC, swollen joint count; TJC, tender joint count; TNF, tumor necrosis factor.
  2. RF positive was defined as RF ≥20 IU/ml; anti-CCP positive was defined as anti-CCP ≥5 U/ml.