Table 1.

Baseline characteristics of subjects assigned to the two treatment groups

	Rituximab group (n=41)	Placebo group (n=40)
Sex
Female	28 (68%)	24 (60%)
Male	13 (32%)	16 (40%)
Age (years)	53.0 (45.0–58.0)	52.5 (43.0–57.0)
C-reactive protein concentration (mg/L), normal <5 mg/L	3.0 (1.5–5.2)	2.9 (1.0–5.0)
Erythrocyte sedimentation rate (mm/hour), range 1–140	10.0 (5.0–15.5)	10.0 (5.0–15.8)
Patient Global Assessment of Disease Activity (mm), range 0–100	31.0 (13.0–52.0)	23.5 (8.0–40.5)
TJC68 (range 0–68, 68=maximum)	2.0 (0–29.0)	0.0 (0–48.0)
SJC66 (range 0–66, 66=maximum)	0.0	0.0
IgM-RF positive*
Low positive level	15.0 (37%)	16.0 (40%)
High positive level	25.0 (61%)	23.0 (58%)
ACPA positive†
Low positive level	6.0 (15%)	4.0 (10%)
High positive level	34.0 (83%)	36.0 (90%)
Shared epitope positive‡	21/30 (70.0%)	24/33 (72.7%)
Body mass index (kg/m2)	28.2 (24.4–31.3)	26.2 (24.4–29.2)
Smoking history ever	32 (84%)	27 (71%)
Current NSAID use	23 (56%)	26 (65%)

Data are n (%), median (IQR). High positive level is defined by >3 times the upper limit of normal; low positive level is defined by ≤3 times the upper limit of normal.

ACPA, anti-citrullinated peptide antibody; IgM-RF, IgM rheumatoid factor; NSAID, non-steroidal anti-inflammatory drug; SJC66, swollen joint count assessing 66 joints; TJC68, tender joint count assessing 68 joints.

*Of two subjects, IgM titres were not determined at baseline; they were elevated in a prebaseline assessment.

†Of one subject, ACPA titres were not determined at baseline; they were elevated in a prebaseline assessment.

‡Of 11 subjects of the rituximab and seven subjects of the placebo group no data on shared epitope are available.