Statistics |
Baseline (n=394) |
Week 1 (n=394) |
Week 4 (n=394) |
Week 12 (n=394) |
Week 26 (n=394) |
Week 39†
(n=388) |
Week 52†
(n=388) |
Improvement of WOMAC A1 Sub-Score
from Baseline |
Mean±SD |
– |
-11.8±16.5 |
-18.5±18.4 |
-25.1±19.1 |
-28.0±19.9 |
-30.1±21.4 |
-32.7±20.0 |
p value* |
– |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
Change of WOMAC A Score from
Baseline |
Mean±SD |
– |
-10.2±13.9 |
-17.6±16.2 |
-23.1±17.7 |
-25.7±18.6 |
-26.3±20.1 |
-29.2±19.2 |
p value* |
– |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
Change of WOMAC B Score from
Baseline |
Mean±SD |
– |
-9.61±16.4 |
-15.3±19.4 |
-20.9±21.9 |
-22.9±22.0 |
-23.6±22.9 |
-25.7±22.0 |
p value* |
– |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
Change of WOMAC C Score from
Baseline |
Mean±SD |
– |
-9.5±13.1 |
-15.7±15.8 |
-20.9±18.5 |
-22.6±19.8 |
-23.3±20.5 |
-25.7±19.5 |
p value* |
– |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
Proportion of Patients in Each PTGA
Score Rating, n (%) |
Very well |
5 (1.3) |
9 (2.3) |
22 (5.6) |
37 (9.4) |
54 (13.7) |
70 (18.0) |
82 (21.1) |
Well |
54 (13.7) |
94 (23.9) |
126 (32.0) |
165 (41.9) |
179 (45.4) |
178 (45.9) |
175 (45.1) |
Fair |
124 (31.5) |
199 (50.5) |
202 (51.3) |
165 (41.9) |
127 (32.2) |
118 (30.4) |
90 (23.2) |
Poor |
183 (46.4) |
89 (22.6) |
40 (10.2) |
26 (6.6) |
32 (8.1) |
21 (5.4) |
40 (10.3) |
Very poor |
25 (6.3) |
3 (0.8) |
4 (1.0) |
1 (0.3) |
2 (0.5) |
1 (0.3) |
1 (0.3) |
Missing |
3 (0.8) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
p value **
|
– |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
Proportion of Patients in Each COGA
Score Rating, n (%) |
Very well |
9 (2.3) |
15 (3.8) |
28 (7.1) |
38 (9.6) |
56 (14.2) |
68 (17.5) |
77 (19.8) |
Well |
55 (14.0) |
102 (25.9) |
142 (36.0) |
181 (45.9) |
181 (45.9) |
179 (46.1) |
177 (45.6) |
Fair |
153 (38.8) |
190 (48.2) |
190 (48.2) |
150 (38.1) |
129 (32.7) |
119 (30.7) |
98 (25.3) |
Poor |
172 (43.7) |
84 (21.3) |
33 (8.4) |
24 (6.1) |
27 (6.9) |
21 (5.4) |
35 (9.0) |
Very poor |
5 (1.3) |
3 (0.8) |
1 (0.3) |
1 (0.3) |
1 (0.3) |
1 (0.3) |
1 (0.3) |
p value **
|
– |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
Statistics |
|
Week 1
(n=390) |
Week 4
(n=390) |
Week 12
(n=378) |
Week 26
(n=372) |
Week 39†
(n=362) |
Week 52†
(n=369) |
Proportion of Patients in Each Group
of Concomitant OA Treatment and Medication, n (%) |
Increased therapy |
– |
24 (6.2) |
12 (3.1) |
16 (4.2) |
10 (2.7) |
7 (1.9) |
5 (1.4) |
Decreased therapy |
– |
59 (15.1) |
57 (14.6) |
33 (8.7) |
33 (8.9) |
3 (0.8) |
2 (0.5) |
No change in therapy |
– |
307 (78.7) |
321 (82.3) |
329 (87.0) |
329 (88.4) |
352 (97.2) |
36362 (98.1) |
* p value was calculated using paired t-test.
* p value was calculated using McNemar-Bowkers test.
† Last Observation Carried Forward methodology was used. At Week 26, six patients received repeat treatment, which with LOCF, allowed data for 388 patients.