The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.
The blind will be maintained, including for the study sponsor, until the key code is opened after the data have been fixed for all subjects in Week 24. In addition, in order to eliminate any bias that could affect the study assessments, to the extent possible, the blind will be maintained with respect to the study site and the subject even after the opening of the study sponsor key code.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
626
Solution for injection in pre-filled syringe
Solution for injection in pre-filled syringe
Investigational Site
Aichi, Japan
Investigational Site
Aomori, Japan
WOMAC Pain Score (Change From Baseline at Week 16)
The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.
Time frame: Baseline to Week 16
WOMAC Physical Function Score (Change From Baseline at Week 16)
The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.
Time frame: Baseline to Week 16
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point)
The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.
Time frame: Baseline to Week 68
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point)
The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.
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Investigational Site
Chiba, Japan
Investigational Site
Ehime, Japan
Investigational Site
Fukui, Japan
Investigational Site
Fukuoka, Japan
Investigational Site
Fukushima, Japan
Investigational Site
Gunma, Japan
Investigational Site
Hiroshima, Japan
Investigational Site
Hokkaido, Japan
...and 17 more locations
Time frame: Baseline to Week 68
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point)
The WOMAC stiffness subscale score was defined as the average of 2 items(after first waking and later in the day). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where higher scores indicated worse stiffness.
Time frame: Baseline to Week 68
WOMAC Total Score (Change From Baseline at Each Assessment Time Point)
The WOMAC total subscale score was defined as the average of 24 items(5 pain subscale items, 17 physical functioning subscale items, and 2 stiffness subscale items). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where smaller values being better.
Time frame: Baseline to Week 68
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point)
Patient Global Assessment(PGA) was a measure whereby the participant assessed global improvement in OA using the 5-level scale(1=very well; 2=well; 3=fair; 4=poor; and 5=very poor).
Time frame: Baseline to Week 68
Number of Participants With Adverse Events and Adverse Drug Reactions
Time frame: Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks)
Number of Participants With a Joint Replacement Procedure is Scheduled
All the Joint Replacement surgeries that were performed within 20 weeks from the day after the end date of the treatment period were reported and tabulated in this study in order to assess the outcome of joint damage regardless of the presence or absence of related adjudicated arthropathy. The subjects who were going to undergo JR surgery were to be withdrawn from study treatment.
Time frame: Baseline to Week 68