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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.
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