Table 1.
Baseline characteristics at the initiation of the respective treatment periods
| Disease characteristics (1),(2) | Treatment period MTX (N = 25) | Treatment period PBO (N = 21) | P |
|---|---|---|---|
| Age [years], mean ± sd | 62.8 ± 13.7 | 69.3 ± 11.9 | 0.374 |
| Male sex [%] | 44.4 | 36.4 | 0.754 |
| Number of tender joints(3), median | 4.5 [2.75 – 12.0] | 5.5 [2.0 – 9.25] | 0.465 |
| Number of swollen joints(4) , median | 2.5 [1.0 – 4.75] | 2.0 [1.0 – 9.5] | 0.782 |
| CRP(5) [mg/l], median | 3.0 [2.0 – 7.0] | 3.15 [2.0 – 6.93] | 0.632 |
| DAS44(6), median | 2.5 [1.7 – 3.0] | 2.1 [1.7 – 3.1] | 0.957 |
| Pain - VAS(7), median | 6 [4.75 – 8.25] | 6 [5 – 7] | 0.270 |
| Physician global assessment(8), median | 4.5 [3 – 6.25] | 5 [4 – 6] | 0.311 |
| Number of analgesics/week(9), median | 13.5 [2.0 – 28.0] | 10.0 [2.5 – 26.0] | 0.684 |
| Number of self-reported flares(10), median | 1 [0 – 2] | 1 [0 – 1] | 0.763 |
| Clinical presentation(11) [N (%)] | |||
| Monoarticular | 3 (12%) | 2 (10%) | 0.957 |
| Oligoarticular | 10 (40%) | 9 (43%) | |
| Polyarticular | 12 (48%) | 10 (48%) | |
| Persistence of symptoms(12) [N (%)] | |||
| Recurrent arthritides (‘pseudogout’) | 4 (22%) | 7 (39%) | 0.471 |
| Chronic arthritides | 14 (78%) | 11 (61%) |
(1)Since this is a crossover trial, patients can contribute both to the MTX and the PBO arm. Patient and disease characteristics are compared at the initiation of the respective treatment periods, which could either be at T0 or T +5 on Figure 1. (2)Values are given in mean (standard deviations (sd)), in medians (interquartile ranges), or in absolute numbers (proportions), as indicated. (3)The number of tender joints could range from 0 to 44; (4)the number of swollen joints could range from 0 to 44; (5)C-reactive protein ranged from 0 to 28, with the normal range being <10; (6)the disease activity score based on 44 joints rages from 0 to 10; (7)the visual analog scale for pain ranges from 0 to 10; (8)the physician global assessment scale ranges from 0 to 10; (9)patients reported the mean number of analgesic pills taken during the previous week, ranged from 0 to 50; (10)number of self-reported arthritic flares during the previous month; (11)the clinical presentation was based on the maximum number of swollen joints during the three- month treatment period; (12)the persistence of symptoms was based on the assessment of the enrolling physician. This information was not always recorded (missing in eight patients). MTX, methotrexate; PBO, placebo; CRP, C-reactive protein; DAS44, disease activity score based on 44 joints; VAS, visual analog scale.