Osteoarthritis, Knee / Osteoarthritis, Hip
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMT-5547
Solution for injection in pre-filled syringe
DRUGMT-5547-matching placebo
Solution for injection in pre-filled syringe
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Additional screening criteria check may apply for qualification: * Male and female Japanese patients, 40 years to 85 years at the time written informed consent is obtained. * Patients who have been diagnosed with osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology (ACR) criteria. * Patients with an evaluated joint (knee or hip) with a K-L (Kellgren-Lawrence) score of ≥2 based on the X-ray test performed. * Moderate to severe pain in the evaluated joint, defined as a WOMAC pain score of ≥4 (mean of the 5 items), on the WOMAC assessments. * Patients who satisfy both 1) and 2) below. 1. Inadequate OA pain relief from at least 1 oral NSAID. 2. Intolerance to or inadequate OA pain relief from at least 1 opioid (including combination drugs), or unwillingness to take opioid therapy. * Patients who agree to not change their current lifestyle (daily living activities and exercise) throughout the study. * Patients who are able to complete post-operative follow-up for any joint replacement surgery that is performed during the study. * Body mass index at screening ≤39. * Patient who are able to understand and answer endpoint questions used in the study.
Exclusion criteria
Additional screening criteria check may apply for qualification: * Presence of symptoms of carpal tunnel syndrome within 6 months before screening. * Patients who cannot undergo MRI. * Trauma to the index joint within 3 months prior to screening. * Presence or history of inflammatory joint diseases other than OA, Paget's disease of the spine, pelvis or femur, multiple sclerosis, fibromyalgia, vertebral tumors or infections, or renal osteodystrophy. * Presence or history, confirmed by imaging, of arthropathy, neuropathic joint arthropathy, hip dislocation, knee dislocation, extensive subchondral cyst, marked bone destruction or bone loss, or pathologic fractures. * Autonomic neuropathy diagnosed in the assessment of autonomic nerve symptoms performed at screening, or baseline. * Presence or history of orthostatic hypotension at the orthostatic hypotension assessments performed at screening, prerandomization, or baseline. * Presence or history of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy such as reflex sympathetic dystrophy at screening. * Presence or history of chronic familial dysautonomia. * Intolerance to naproxen. * Systemic (excluding topical, intranasal, ophthalmic, and inhaled formulations) corticosteroids within 4 weeks prior to screening. * Intra-articular corticosteroids in the evaluated joint within 12 weeks prior to screening, or in any other joint within 4 weeks prior to screening. * Received an intra-articular injection of hyaluronic acid in any joint within the period specified for each medicine prior to screening. * Resting heart rate of \<50 bpm or \>100 bpm at screening, or baseline. * Presence or history of 2nd or 3rd degree heart block, 1st degree heart block with abnormal QRS, or bifascicular block by ECG assessment at screening. * Non-compliance with the Numerical rating scale (NRS) recording (average pain on walking in the evaluated joint over 1 day) during the pre-treatment observation period. * Women who are pregnant, breast-feeding, or may be pregnant. * Use of an anti-Nerve growth factor (anti-NGF) antibody in the past, or apparent hypersensitivity or intolerance to anti-NGF antibodies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Pain Score (Change From Baseline at Week 16) | Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Baseline to Week 68 | 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. |
| WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Baseline to Week 68 | 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. |
| WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Baseline to Week 68 | 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. |
| WOMAC Physical Function Score (Change From Baseline at Week 16) | Baseline to 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. |
| Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Baseline to Week 68 | 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). |
| Number of Participants With Adverse Events and Adverse Drug Reactions | Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) | — |
| Number of Participants With a Joint Replacement Procedure is Scheduled | Baseline to Week 68 | 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. |
| WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Baseline to Week 68 | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pooled Placebo This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment.
Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44.
Naproxen oral was received from the day after the Week 16 until Week 48. | 204 |
| Pooled MT-5547 1 mg q4w This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment.
Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44.
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. | 203 |
| After the Amendment MT-5547 1 mg q8w This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. | 162 |
| MT-5547 3 mg q4w This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44.
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. | 28 |
| MT-5547 6 mg q8w This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44.
Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. | 29 |
| Total | 626 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 15 | 18 | 15 | 0 | 1 |
| Overall Study | Discontinuation of 3 mg q4w and 6 mg q8w doses | 0 | 0 | 0 | 27 | 27 |
| Overall Study | Failure to meet randomization criteria | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 4 | 1 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 1 | 3 | 4 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 20 | 19 | 11 | 0 | 0 |
Baseline characteristics
| Characteristic | Pooled Placebo | Total | MT-5547 6 mg q8w | MT-5547 3 mg q4w | After the Amendment MT-5547 1 mg q8w | Pooled MT-5547 1 mg q4w |
|---|---|---|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 9.4 | 66.6 years STANDARD_DEVIATION 9.3 | 65.2 years STANDARD_DEVIATION 7.4 | 68.6 years STANDARD_DEVIATION 7.6 | 66.6 years STANDARD_DEVIATION 9.4 | 66.1 years STANDARD_DEVIATION 9.7 |
| BMI | 26.6 kg/㎡ STANDARD_DEVIATION 4.3 | 26.8 kg/㎡ STANDARD_DEVIATION 4.3 | 27.3 kg/㎡ STANDARD_DEVIATION 4.5 | 24.8 kg/㎡ STANDARD_DEVIATION 3.4 | 26.8 kg/㎡ STANDARD_DEVIATION 4.2 | 27.0 kg/㎡ STANDARD_DEVIATION 4.4 |
| Index Joint Hip | 15 Participants | 45 Participants | 3 Participants | 2 Participants | 12 Participants | 13 Participants |
| Index Joint Knee | 189 Participants | 581 Participants | 26 Participants | 26 Participants | 150 Participants | 190 Participants |
| K-L Score 1 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| K-L Score 2 | 39 Participants | 104 Participants | 3 Participants | 2 Participants | 24 Participants | 36 Participants |
| K-L Score 3 | 95 Participants | 304 Participants | 15 Participants | 15 Participants | 82 Participants | 97 Participants |
| K-L Score 4 | 70 Participants | 218 Participants | 11 Participants | 11 Participants | 56 Participants | 70 Participants |
| Race/Ethnicity, Customized Japanese | 204 Participants | 626 Participants | 29 Participants | 28 Participants | 162 Participants | 203 Participants |
| Sex: Female, Male Female | 163 Participants | 494 Participants | 25 Participants | 20 Participants | 126 Participants | 160 Participants |
| Sex: Female, Male Male | 41 Participants | 132 Participants | 4 Participants | 8 Participants | 36 Participants | 43 Participants |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | 5.93 units on a scale STANDARD_DEVIATION 1.33 | 6.02 units on a scale STANDARD_DEVIATION 1.35 | 6.34 units on a scale STANDARD_DEVIATION 1.29 | 6.32 units on a scale STANDARD_DEVIATION 1.51 | 6.02 units on a scale STANDARD_DEVIATION 1.39 | 6.01 units on a scale STANDARD_DEVIATION 1.31 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 204 | 0 / 162 | 0 / 203 | 0 / 28 | 0 / 29 | 0 / 204 | 0 / 162 | 0 / 203 | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 108 / 204 | 85 / 162 | 118 / 203 | 4 / 28 | 11 / 29 | 51 / 204 | 37 / 162 | 65 / 203 | 12 / 28 | 7 / 29 |
| serious Total, serious adverse events | 6 / 204 | 4 / 162 | 9 / 203 | 0 / 28 | 0 / 29 | 5 / 204 | 3 / 162 | 7 / 203 | 3 / 28 | 3 / 29 |
Outcome results
Primary
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
Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week treatment period dataset, 24-week treatment period dataset, and 68-week treatment period dataset. The results in this section are presented in the 16-week treatment period dataset.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Week 16) | -1.74 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Week 16) | -2.96 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Week 16) | -1.78 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Week 16) | -2.12 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Week 16) | -2.79 units on a scale | Standard Error 0.18 |
p-value: <0.00195% CI: [-1.57, -0.86]Mixed Models Analysis
p-value: 0.10395% CI: [-0.76, 0.07]Mixed Models Analysis
Secondary
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)
Population: The analysis was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants~* participants who did not receive study drug even once~* participants for whom absolutely no post-randomization safety data are available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one AE (Treatment Period) | 174 Participants |
| Pooled Placebo | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one adverse drug reaction (treatment period) | 14 Participants |
| Pooled Placebo | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one AE (post-treatment period) | 115 Participants |
| Pooled Placebo | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one adverse drug reaction (post-treatment period) | 3 Participants |
| Pooled MT-5547 1 mg q4w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one AE (Treatment Period) | 136 Participants |
| Pooled MT-5547 1 mg q4w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one adverse drug reaction (post-treatment period) | 4 Participants |
| Pooled MT-5547 1 mg q4w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one adverse drug reaction (treatment period) | 20 Participants |
| Pooled MT-5547 1 mg q4w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one AE (post-treatment period) | 83 Participants |
| After the Amendment Placebo | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one adverse drug reaction (post-treatment period) | 14 Participants |
| After the Amendment Placebo | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one adverse drug reaction (treatment period) | 25 Participants |
| After the Amendment Placebo | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one AE (post-treatment period) | 117 Participants |
| After the Amendment Placebo | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one AE (Treatment Period) | 168 Participants |
| After the Amendment MT-5547 1 mg q8w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one AE (Treatment Period) | 11 Participants |
| After the Amendment MT-5547 1 mg q8w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one adverse drug reaction (treatment period) | 1 Participants |
| After the Amendment MT-5547 1 mg q8w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one adverse drug reaction (post-treatment period) | 2 Participants |
| After the Amendment MT-5547 1 mg q8w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one AE (post-treatment period) | 19 Participants |
| After the Amendment MT-5547 1 mg q4w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one adverse drug reaction (post-treatment period) | 4 Participants |
| After the Amendment MT-5547 1 mg q4w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one AE (post-treatment period) | 16 Participants |
| After the Amendment MT-5547 1 mg q4w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one adverse drug reaction (treatment period) | 3 Participants |
| After the Amendment MT-5547 1 mg q4w | Number of Participants With Adverse Events and Adverse Drug Reactions | Participants with at least one AE (Treatment Period) | 14 Participants |
Secondary
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
Population: The analysis was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants~* participants who did not receive study drug even once~* participants for whom absolutely no post-randomization safety data are available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With a Joint Replacement Procedure is Scheduled | 4 Participants |
| Pooled MT-5547 1 mg q4w | Number of Participants With a Joint Replacement Procedure is Scheduled | 5 Participants |
| After the Amendment Placebo | Number of Participants With a Joint Replacement Procedure is Scheduled | 10 Participants |
| After the Amendment MT-5547 1 mg q8w | Number of Participants With a Joint Replacement Procedure is Scheduled | 1 Participants |
| After the Amendment MT-5547 1 mg q4w | Number of Participants With a Joint Replacement Procedure is Scheduled | 0 Participants |
Secondary
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
Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.3 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 24 | -1.2 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 36 | -1.2 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 28 | -1.0 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 60 | -0.9 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 32 | -1.1 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 4 | -0.5 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 52 | -0.9 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 8 | -0.6 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 68 | -0.9 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 48 | -1.1 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 12 | -0.8 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.5 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 44 | -1.2 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 16 | -0.8 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 40 | -1.1 units on a scale | Standard Error 0.1 |
| Pooled Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 20 | -1.1 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.2 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 48 | -1.1 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 24 | -1.1 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 60 | -0.5 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.8 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 32 | -1.2 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 40 | -1.2 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 28 | -1.3 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.1 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.7 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 44 | -1.1 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.0 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 68 | -0.5 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 52 | -0.9 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 36 | -1.2 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 20 | -1.2 units on a scale | Standard Error 0.1 |
| Pooled MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 8 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 36 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.4 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.5 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 4 | -0.5 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 8 | -0.7 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 12 | -0.8 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 16 | -0.9 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 20 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 24 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 28 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 32 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 40 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 44 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 48 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 52 | -0.9 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 60 | -1.0 units on a scale | Standard Error 0.1 |
| After the Amendment Placebo | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 68 | -1.0 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 24 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 20 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 36 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 40 | -1.0 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 44 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 8 | -0.9 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.7 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 48 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 4 | -0.9 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 52 | -0.9 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.9 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 68 | -0.8 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 28 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 60 | -0.8 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q8w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 32 | -1.0 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 32 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 48 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.0 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 36 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 28 | -1.3 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 60 | -0.5 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 68 | -0.6 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 40 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 20 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.7 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 52 | -0.9 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 44 | -1.1 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 8 | -1.2 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.8 units on a scale | Standard Error 0.1 |
| After the Amendment MT-5547 1 mg q4w | Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) | Week 24 | -1.2 units on a scale | Standard Error 0.1 |
Secondary
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
Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.63 units on a scale | Standard Error 0.14 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.54 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.66 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.50 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.53 units on a scale | Standard Error 0.2 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.62 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.03 units on a scale | Standard Error 0.15 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.35 units on a scale | Standard Error 0.19 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -1.29 units on a scale | Standard Error 0.16 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.49 units on a scale | Standard Error 0.2 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.75 units on a scale | Standard Error 0.19 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.62 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.80 units on a scale | Standard Error 0.15 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.72 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.75 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.68 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.43 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -2.97 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -3.17 units on a scale | Standard Error 0.19 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -3.04 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.02 units on a scale | Standard Error 0.2 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.80 units on a scale | Standard Error 0.15 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -3.29 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -3.28 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -3.19 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -2.77 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -1.52 units on a scale | Standard Error 0.14 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -3.25 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -2.10 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.05 units on a scale | Standard Error 0.21 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.80 units on a scale | Standard Error 0.2 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -3.16 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -3.06 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -2.65 units on a scale | Standard Error 0.16 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.72 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.58 units on a scale | Standard Error 0.14 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.78 units on a scale | Standard Error 0.15 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -0.98 units on a scale | Standard Error 0.16 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -1.26 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.61 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.76 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.38 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.52 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.48 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.63 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.70 units on a scale | Standard Error 0.19 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.74 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.75 units on a scale | Standard Error 0.19 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.43 units on a scale | Standard Error 0.2 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.61 units on a scale | Standard Error 0.21 |
| After the Amendment Placebo | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.60 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.39 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.54 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.84 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -2.10 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.74 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -2.27 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -3.03 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -1.76 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -1.22 units on a scale | Standard Error 0.15 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.77 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.68 units on a scale | Standard Error 0.16 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.42 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.55 units on a scale | Standard Error 0.15 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.38 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.83 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.32 units on a scale | Standard Error 0.21 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.60 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -3.13 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.99 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.90 units on a scale | Standard Error 0.16 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.99 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -2.77 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -3.05 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -1.78 units on a scale | Standard Error 0.21 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -1.84 units on a scale | Standard Error 0.21 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -3.08 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -2.56 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.85 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -1.40 units on a scale | Standard Error 0.14 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.56 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -3.03 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -2.45 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.65 units on a scale | Standard Error 0.15 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.90 units on a scale | Standard Error 0.19 |
Secondary
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.
Time frame: Baseline to Week 68
Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.44 units on a scale | Standard Error 0.14 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.22 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.31 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.18 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.18 units on a scale | Standard Error 0.19 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.22 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -0.73 units on a scale | Standard Error 0.15 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.03 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -0.97 units on a scale | Standard Error 0.15 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.14 units on a scale | Standard Error 0.19 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.38 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.26 units on a scale | Standard Error 0.16 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.56 units on a scale | Standard Error 0.14 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.35 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.40 units on a scale | Standard Error 0.16 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.29 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.02 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -2.66 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.83 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.74 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -1.75 units on a scale | Standard Error 0.19 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.55 units on a scale | Standard Error 0.14 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -3.00 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.91 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.90 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -2.43 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -1.23 units on a scale | Standard Error 0.14 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.90 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.81 units on a scale | Standard Error 0.15 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -1.71 units on a scale | Standard Error 0.2 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.51 units on a scale | Standard Error 0.19 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.84 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.74 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -2.34 units on a scale | Standard Error 0.16 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.33 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.4 units on a scale | Standard Error 0.14 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.52 units on a scale | Standard Error 0.14 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -0.71 units on a scale | Standard Error 0.15 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -0.94 units on a scale | Standard Error 0.16 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.22 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.40 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -1.95 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.17 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.15 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.23 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.29 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.37 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.35 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.06 units on a scale | Standard Error 0.19 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.22 units on a scale | Standard Error 0.2 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.22 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.02 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.20 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.47 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.84 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.46 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.94 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.67 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -1.48 units on a scale | Standard Error 0.16 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.98 units on a scale | Standard Error 0.14 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.46 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.38 units on a scale | Standard Error 0.15 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.10 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.25 units on a scale | Standard Error 0.14 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.10 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.41 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -1.98 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.23 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.83 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.61 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.64 units on a scale | Standard Error 0.15 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.67 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -2.49 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.76 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -1.52 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -1.51 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.71 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -2.23 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.53 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -1.12 units on a scale | Standard Error 0.14 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.26 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.69 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -2.17 units on a scale | Standard Error 0.16 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.41 units on a scale | Standard Error 0.14 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.61 units on a scale | Standard Error 0.18 |
Secondary
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
Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week treatment period dataset, 24-week treatment period dataset, and 68-week treatment period dataset. The results in this section are presented in the 16-week treatment period dataset.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | WOMAC Physical Function Score (Change From Baseline at Week 16) | -1.38 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Week 16) | -2.64 units on a scale | Standard Error 0.16 |
| After the Amendment Placebo | WOMAC Physical Function Score (Change From Baseline at Week 16) | -1.44 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Physical Function Score (Change From Baseline at Week 16) | -1.88 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Physical Function Score (Change From Baseline at Week 16) | -2.53 units on a scale | Standard Error 0.17 |
p-value: <0.00195% CI: [-1.6, -0.92]Mixed Models Analysis
95% CI: [-0.84, -0.05]
Secondary
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
Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.24 units on a scale | Standard Error 0.15 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.13 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.16 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.02 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.06 units on a scale | Standard Error 0.21 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.22 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -0.58 units on a scale | Standard Error 0.16 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -1.83 units on a scale | Standard Error 0.2 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -0.72 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.09 units on a scale | Standard Error 0.21 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.27 units on a scale | Standard Error 0.19 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -0.99 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.42 units on a scale | Standard Error 0.16 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.29 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.21 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.16 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -1.93 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -2.63 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.87 units on a scale | Standard Error 0.19 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.80 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -1.51 units on a scale | Standard Error 0.21 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.55 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.94 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.97 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.96 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -2.36 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -1.21 units on a scale | Standard Error 0.15 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -3.01 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.78 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -1.49 units on a scale | Standard Error 0.21 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.51 units on a scale | Standard Error 0.2 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.91 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.74 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -2.29 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.23 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.24 units on a scale | Standard Error 0.15 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.45 units on a scale | Standard Error 0.16 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -0.62 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -0.75 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.01 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.24 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -1.95 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.16 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.01 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.31 units on a scale | Standard Error 0.19 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.24 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.38 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.34 units on a scale | Standard Error 0.19 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -1.93 units on a scale | Standard Error 0.2 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.17 units on a scale | Standard Error 0.21 |
| After the Amendment Placebo | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.23 units on a scale | Standard Error 0.21 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -1.86 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.21 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.53 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.78 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.44 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.94 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.56 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -1.47 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.97 units on a scale | Standard Error 0.15 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.34 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.37 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -1.98 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.26 units on a scale | Standard Error 0.16 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -1.90 units on a scale | Standard Error 0.21 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.31 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -1.85 units on a scale | Standard Error 0.21 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.19 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.86 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.81 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.73 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.87 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -2.58 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.89 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -1.45 units on a scale | Standard Error 0.21 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -1.44 units on a scale | Standard Error 0.22 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.92 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -2.30 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.65 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -1.21 units on a scale | Standard Error 0.15 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.44 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.93 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -2.24 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.56 units on a scale | Standard Error 0.16 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.74 units on a scale | Standard Error 0.19 |
Secondary
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
Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.46 units on a scale | Standard Error 0.13 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.28 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.37 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.23 units on a scale | Standard Error 0.16 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.24 units on a scale | Standard Error 0.19 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.30 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -0.78 units on a scale | Standard Error 0.14 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.08 units on a scale | Standard Error 0.18 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -1.02 units on a scale | Standard Error 0.15 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.20 units on a scale | Standard Error 0.19 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.45 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.31 units on a scale | Standard Error 0.16 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.60 units on a scale | Standard Error 0.14 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.42 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.46 units on a scale | Standard Error 0.16 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.36 units on a scale | Standard Error 0.17 |
| Pooled Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.10 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -2.72 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.91 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.81 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -1.79 units on a scale | Standard Error 0.19 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.60 units on a scale | Standard Error 0.14 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -3.06 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.99 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.97 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -2.49 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -1.29 units on a scale | Standard Error 0.13 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.98 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.87 units on a scale | Standard Error 0.15 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -1.76 units on a scale | Standard Error 0.19 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.57 units on a scale | Standard Error 0.18 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.91 units on a scale | Standard Error 0.17 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.81 units on a scale | Standard Error 0.16 |
| Pooled MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -2.40 units on a scale | Standard Error 0.15 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.39 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -0.42 units on a scale | Standard Error 0.13 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -0.56 units on a scale | Standard Error 0.14 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -0.75 units on a scale | Standard Error 0.15 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -0.98 units on a scale | Standard Error 0.15 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -1.28 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.45 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.03 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.24 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.20 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.31 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.36 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.44 units on a scale | Standard Error 0.17 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.42 units on a scale | Standard Error 0.18 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.11 units on a scale | Standard Error 0.19 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.29 units on a scale | Standard Error 0.2 |
| After the Amendment Placebo | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.29 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.08 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.27 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.55 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -1.89 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.51 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -2.01 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.73 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -1.54 units on a scale | Standard Error 0.16 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -1.03 units on a scale | Standard Error 0.14 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.51 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.44 units on a scale | Standard Error 0.15 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.15 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.31 units on a scale | Standard Error 0.14 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -2.14 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.49 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -2.04 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q8w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.30 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 32 | -2.89 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 48 | -2.70 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 4 | -1.70 units on a scale | Standard Error 0.15 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 36 | -2.75 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 16 | -2.56 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 28 | -2.83 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 60 | -1.57 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 68 | -1.57 units on a scale | Standard Error 0.2 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 40 | -2.80 units on a scale | Standard Error 0.18 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 12 | -2.31 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 20 | -2.60 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 1 | -1.18 units on a scale | Standard Error 0.13 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 52 | -2.33 units on a scale | Standard Error 0.19 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 44 | -2.78 units on a scale | Standard Error 0.17 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 8 | -2.23 units on a scale | Standard Error 0.15 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 2 | -1.47 units on a scale | Standard Error 0.14 |
| After the Amendment MT-5547 1 mg q4w | WOMAC Total Score (Change From Baseline at Each Assessment Time Point) | Week 24 | -2.68 units on a scale | Standard Error 0.18 |