Table 7 Change in clinical secondary outcome on the FAS population (LOCF approach)

LI

Treatment group (N = 40)

12.5 ± 3.8

8.3 ± 4.1

8.2 ± 4.3

6.8 ± 4.9

ANOVA

Placebo group (N = 41)

12.5 ± 3.4

9.0 ± 5.0

8.9 ± 5.5

8.1 ± 5.5

P value

0.9500

0.4983

0.5466

0.3395

Change in pain (VAS)

Treatment group (N = 40)

65.7 ± 11.6

35.9 ± 21.5

31.4 ± 24.2

27.9 ± 23.2

ANOVA

Placebo group (N = 41)

66.4 ± 9.8

38.6 ± 21.6

36.2 ± 25.6

30.8 ± 23.9

P value

0.7719

0.5659

0.3939

0.5738

Change in pain intensity adjusted to basal value (VAS)

Treatment group (N = 40)

–

−30.1 ± 3.4

−34.8 ± 3.9

−38.2 ± 3.7

ANOVA

Placebo group (N = 41)

–

−27.5 ± 3.4

−29.7 ± 3.8

−35.2 ± 3.7

P value

–

0.5925

0.3543

0.5576

Change in pain intensity responder 30% (VAS)

Treatment group (N = 40)

–

60.0%

70.0%

72.5%

Chi-square test

Placebo group (N = 41)

–

61.0%

65.9%

75.6%

P value

–

0.9284

0.6894

0.7495

Change in pain intensity responder 50% (VAS)

Treatment group (N = 40)

–

50.0%

50.0%

57.5%

Chi-square test

Placebo group (N = 41)

–

43.9%

43.9%

63.4%

P value

–

0.5825

0.5825

0.5862

%OMERACT -OARSI responders/non-responders

Treatment group (N = 40)

–

70.0%

70.0%

67.5%

Chi-square test

Placebo group (N = 41)

–

70.7%

65.9%

61.0%

P value

–

0.9425

0.1597

0.3750

Patient global assessment on disease activity

Treatment group (N = 40)

6.6 ± 1.3

3.6 ± 1.9

3.4 ± 2.5

2.9 ± 2.1

ANOVA

Placebo group (N = 41)

6.4 ± 1.3

4.0 ± 2.1

4.1 ± 2.5

3.5 ± 2.4

P value

0.6411

0.447

0.2052

0.2444