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

Table 4 Difference in adjusted mean change from baseline in WOMAC Total Score (Full Analysis Set)

Difference between each JTA and the reference group in adjusted mean change from baseline in WOMAC Total Score	JTA-100/2*	JTA-200/2*	JTA-200/4*
Month 3
Change from Baseline
N	38	34	41
Adjusted Mean (SE)	−23.2 (3.9)	−22.3 (3.8)	− 28.9 (3.6)
Difference between treatments (JTA-004 minus reference) in Change from Baseline
Adjusted Mean (SE)	−4.34 (5.44)	−2.94 (5.30)	−10.55 (5.05)
Adjusted CI (a)	−18.21, 9.54	−16.52, 10.65	−23.42, 2.32
p-value	0.878	0.972	0.143
Month 6
Change from Baseline
N	36	35	40
Adjusted Mean (SE)	−27.3 (4.2)	−23.7 (4.3)	−25.6 (4.0)
Difference between treatments (JTA-004 minus reference) in Change from Baseline
Adjusted Mean (SE)	−11.49 (5.84)	−7.17 (5.96)	−10.11 (5.68)
Adjusted CI (a)	−26.29, 3.32	−22.28, 7.94	−24.47, 4.24
p-value	0.177	0.599	0.246

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. *N = 41 in each group
(a) Calculated using Dunnett-corrected t-value
Changes from baseline in WOMAC Total Score over time were evaluated using a Mixed-effect Model for Repeated Measurements with absolute change from baseline to the visit in WOMAC Total Score as response variable, treatment group and visit as factors, baseline WOMAC Total Score as covariate and treatment group-visit interaction

ISSN: 1471-2474