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Table 3 Results of the interim analysis to select the most effective JTA formulation (Full Analysis Set)

From: Safety and efficacy of a single intra-articular injection of a novel enhanced protein solution (JTA-004) compared to hylan G-F 20 in symptomatic knee osteoarthritis: a randomized, double-blind, controlled phase II/III study

Difference between each JTA and the reference group in adjusted mean change from baseline in WOMAC Pain Subscale Score

JTA-100/2

JTA-200/2

JTA-200/4

Month 3

 N

28

24

29

 Adjusted Mean (SE)

−11.79 (6.32)

−9.50 (6.60)

−16.50 (6.28)

 Adjusted CI (a)

−26.87, 3.29

−25.25, 6.24

−31.48, − 1.53

 p-value

0.160

0.344

0.027

Month 6

 N

22

19

24

 Adjusted Mean (SE)

−8.10 (7.03)

−11.22 (7.29)

−7.37 (6.94)

 Adjusted CI (a)

−24.94, 8.74

− 28.68, 6.24

−24.01, 9.27

 p-value

0.526

0.295

0.588

  1. CI confidence interval, JTA-100/2 group of patients receiving an injection of JTA-004 with 100 μg clonidine and 20 mg hyaluronic acid, JTA-200/2 group of patients receiving an injection of JTA-004 with 200 μg clonidine and 20 mg hyaluronic acid, JTA-200/4 group of patients receiving an injection of JTA-004 with 200 μg clonidine and 40 mg hyaluronic acid, N total number of patients, SE standard error, WOMAC Western Ontario McMaster Universities
  2. (a) calculated using the Dunnett’s test procedure (overall type-I error rate of 0.05)
  3. Differences in adjusted mean change from baseline in WOMAC Pain Subscale Score were evaluated using an ANCOVA model with treatment group as fixed factor and baseline value of WOMAC Pain Subscale Score as covariate