Efficacy and Safety of MT-5547 in Patients With Osteoarth... | NCT03245008 | Trialant
NCT03245008
Sponsor
Tanabe Pharma Corporation
Status
Completed
Last Update Posted
Jan 7, 2026Actual
Enrollment
626Actual
Phase
Phase 2Phase 3
Conditions
Osteoarthritis, Knee / Osteoarthritis, Hip
Interventions
MT-5547
MT-5547-matching placebo
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT03245008
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MT-5547-J01
Secondary IDs
Not provided
Brief Title
Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
Official Title
A Phase 2/3 (Placebo-Controlled, Double-Blind, Comparative) Study on MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
Acronym
Not provided
Organization
Tanabe Pharma CorporationINDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 8, 2017Actual
Primary Completion Date
Dec 14, 2019Actual
Completion Date
Mar 9, 2021Actual
First Submitted Date
Aug 7, 2017
First Submission Date that Met QC Criteria
Aug 7, 2017
First Posted Date
Aug 10, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Mar 8, 2023
Results First Submitted that Met QC Criteria
Apr 23, 2023
Results First Posted Date
May 17, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 15, 2025
Last Update Posted Date
Jan 7, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Tanabe Pharma CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
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.
MT-5547-matching placebo SC dosing. Naproxen oral after Week 16.
Drug: MT-5547-matching placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MT-5547
Drug
Solution for injection in pre-filled syringe
MT-5547 dosing regimen 1
MT-5547 dosing regimen 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Baseline to Week 16
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Inadequate OA pain relief from at least 1 oral NSAID.
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
40 Years
Maximum Age
85 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
General Manager
Tanabe Pharma Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Investigational Site
Aichi
Japan
Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
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.
Baseline to Week 68
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point)
The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.
Baseline to Week 68
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point)
The WOMAC stiffness subscale score was defined as the average of 2 items(after first waking and later in the day). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where higher scores indicated worse stiffness.
Baseline to Week 68
WOMAC Total Score (Change From Baseline at Each Assessment Time Point)
The WOMAC total subscale score was defined as the average of 24 items(5 pain subscale items, 17 physical functioning subscale items, and 2 stiffness subscale items). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where smaller values being better.
Baseline to Week 68
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point)
Patient Global Assessment(PGA) was a measure whereby the participant assessed global improvement in OA using the 5-level scale(1=very well; 2=well; 3=fair; 4=poor; and 5=very poor).
Baseline to Week 68
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
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.
Baseline to Week 68
Aomori
Japan
Investigational Site
Chiba
Japan
Investigational Site
Ehime
Japan
Investigational Site
Fukui
Japan
Investigational Site
Fukuoka
Japan
Investigational Site
Fukushima
Japan
Investigational Site
Gunma
Japan
Investigational Site
Hiroshima
Japan
Investigational Site
Hokkaido
Japan
Investigational Site
Hyōgo
Japan
Investigational Site
Ibaraki
Japan
Investigational Site
Kagoshima
Japan
Investigational Site
Kanagawa
Japan
Investigational Site
Kumamoto
Japan
Investigational Site
Kyoto
Japan
Investigational Site
Mie
Japan
Investigational Site
Miyagi
Japan
Investigational Site
Miyazaki
Japan
Investigational Site
Osaka
Japan
Investigational Site
Ōita
Japan
Investigational Site
Saitama
Japan
Investigational Site
Shiga
Japan
Investigational Site
Shizuoka
Japan
Investigational Site
Tokyo
Japan
Investigational Site
Yamagata
Japan
Investigational Site
Yamaguchi
Japan
FG001
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.
FG002
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.
FG003
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.
FG004
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.
FG000204 subjects
FG001203 subjects
FG002162 subjects
FG00328 subjects
FG00429 subjects
COMPLETED
FG000164 subjects
FG001159 subjects
FG002132 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00040 subjects
FG00144 subjects
FG00230 subjects
FG00328 subjects
FG00429 subjects
Type
Comment
Reasons
Adverse Event
FG00015 subjects
FG00118 subjects
FG00215 subjects
FG0030 subjects
FG0041 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0001 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00020 subjects
FG00119 subjects
FG00211 subjects
FG0030 subjects
FG004
Discontinuation of 3 mg q4w and 6 mg q8w doses
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00327 subjects
Failure to meet randomization criteria
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
The pooled placebo group (N=204) and the pooled MT-5547 1 mg q4w group (N=203) showed the total number of participants randomized to each group before and after the protocol amendment.
The number of participants who were randomized to the placebo group (N=165) and the MT-5547 1 mg q4w group (N=165) after the protocol amendment were not shown in the table below because they are included in the respective pooled groups. A total of 626 participants were enrolled into this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000204
BG001203
BG002162
BG00328
BG00429
BG005626
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00067.1± 9.4
BG00166.1± 9.7
BG00266.6± 9.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000163
BG001160
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Japanese
Title
Measurements
BG000204
BG001203
BG002
BMI
Mean
Standard Deviation
kg/㎡
Title
Denominators
Categories
Title
Measurements
BG00026.6± 4.3
BG00127.0± 4.4
BG002
Index Joint
The index joint was the joint (knee or hip) that was judged to have a K-L score of ≥2 in the X-ray (centralized assessment) and the joint with the highest WOMAC pain subscale score (mean of 5 items).
Count of Participants
Participants
Title
Denominators
Categories
Knee
Title
Measurements
BG000189
BG001
K-L Score
Kellgren-Lawrence category. Osteoarthritis staging category based on simple X-ray; a 5-level scale from 0 to 4. Higher scores indicated worse.
Count of Participants
Participants
Title
Denominators
Categories
1
Title
Measurements
BG0000
BG0010
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
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.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0005.93± 1.33
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
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.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline to Week 16
ID
Title
Description
OG000
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.
OG001
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.
OG002
After the Amendment Placebo
Participants in this group were randomized to Placebo group after 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. These participants were included in the Pooled Placebo group.
OG003
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.
OG004
After the Amendment MT-5547 1 mg q4w
Participants in this group were randomized to MT-5547 1mg q4w group after 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.
These participants were included in the pooled MT-5547 1mg q4w group.
Units
Counts
Participants
OG000204
OG001203
OG002165
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.74± 0.17
OG001-2.96± 0.17
OG002-1.78± 0.18
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<0.001
Adjusted P-value
Least Squares Mean Difference
-1.22
Standard Error of the Mean
0.18
2-Sided
95
-1.57
-0.86
Superiority
OG002
OG003
Mixed Models Analysis
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.
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.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline to Week 16
ID
Title
Description
OG000
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.
OG001
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.
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.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline to Week 68
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline to Week 68
ID
Title
Description
OG000
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.
OG001
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.
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.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline to Week 68
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline to Week 68
ID
Title
Description
OG000
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.
OG001
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.
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).
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.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline to Week 68
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Number of Participants With Adverse Events and Adverse Drug Reactions
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
Posted
Count of Participants
Participants
Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks)
ID
Title
Description
OG000
Placebo
Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo 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.
OG001
MT-5547 1 mg q8w
MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w.
Participants randomized to the After the amendment MT-5547 1 mg q8w 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.
OG002
MT-5547 1mg q4w
MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w 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.
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.
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
Posted
Count of Participants
Participants
Baseline to Week 68
ID
Title
Description
OG000
Placebo
Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo 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.
OG001
MT-5547 1 mg q8w
MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w.
Participants randomized to the After the amendment MT-5547 1 mg q8w 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.
Time Frame
Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks)
Description
The analysis of safety 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 Reported AEs & deaths are treatment emergent.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo, On-treatment Period
Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo 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.
0
204
6
204
108
204
EG001
MT-5547 1 mg q8w, On-treatment Period
MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w.
Participants randomized to the After the amendment MT-5547 1 mg q8w 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.
0
162
4
162
85
162
EG002
MT-5547 1mg q4w, On-treatment Period
MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w 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.
0
203
9
203
118
203
EG003
MT-5547 3 mg q4w, On-treatment Period
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.
0
28
0
28
4
28
EG004
MT-5547 6 mg q8w, On-treatment Period
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.
0
29
0
29
11
29
EG005
Placebo, Post-treatment Observation Period
Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo 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.
0
204
5
204
51
204
EG006
MT-5547 1 mg q8w, Post-treatment Observation Period
MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w.
Participants randomized to the After the amendment MT-5547 1 mg q8w 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.
0
162
3
162
37
162
EG007
MMT-5547 1mg q4w, Post-treatment Observation Period
MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w 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.
0
203
7
203
65
203
EG008
MT-5547 3 mg q4w, Post-treatment Observation Period
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.
0
28
3
28
12
28
EG009
MT-5547 6 mg q8w, Post-treatment Observation Period
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.
0
29
3
29
7
29
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cataract
Eye disorders
MedDRA Version 20.1
Systematic Assessment
EG0001 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG0030 affected28 at risk
EG0040 affected29 at risk
EG0050 affected204 at risk
EG0060 affected162 at risk
EG0070 affected203 at risk
EG0080 affected28 at risk
EG0090 affected29 at risk
Colitis ischaemic
Gastrointestinal disorders
MedDRA Version 20.1
Systematic Assessment
EG0001 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA Version 20.1
Systematic Assessment
EG0001 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0021 affected203 at risk
EG003
Pyrexia
General disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0021 affected203 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0021 affected203 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0021 affected203 at risk
EG003
Encephalitis viral
Infections and infestations
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA Version 20.1
Systematic Assessment
EG0001 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Heat illness
Injury, poisoning and procedural complications
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0021 affected203 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0011 affected162 at risk
EG0020 affected203 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0021 affected203 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0021 affected203 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0021 affected203 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0011 affected162 at risk
EG0020 affected203 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0021 affected203 at risk
EG003
Rapidly progressive osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 20.1
Systematic Assessment
EG0001 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Thymoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 20.1
Systematic Assessment
EG0000 affected204 at risk
EG0010 affected162 at risk
EG0020 affected203 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
OG002
After the Amendment Placebo
Participants in this group were randomized to Placebo group after 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. These participants were included in the Pooled Placebo group.
OG003
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.
OG004
After the Amendment MT-5547 1 mg q4w
Participants in this group were randomized to MT-5547 1mg q4w group after 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.
These participants were included in the pooled MT-5547 1mg q4w group.
Units
Counts
Participants
OG000204
OG001203
OG002165
OG003162
OG004165
Title
Denominators
Categories
Title
Measurements
OG000-1.38± 0.16
OG001-2.64± 0.16
OG002-1.44± 0.17
OG003-1.88± 0.17
OG004-2.53± 0.17
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<0.001
Adjusted P-value
Least Squares Mean Difference
-1.26
Standard Error of the Mean
0.17
2-Sided
95
-1.60
-0.92
Superiority
OG002
OG003
Least Squares Mean Difference
-0.45
Standard Error of the Mean
0.20
2-Sided
95
-0.84
-0.05
Superiority
OG002
After the Amendment Placebo
Participants in this group were randomized to Placebo group after 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. These participants were included in the Pooled Placebo group.
OG003
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.
OG004
After the Amendment MT-5547 1 mg q4w
Participants in this group were randomized to MT-5547 1mg q4w group after 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.
These participants were included in the pooled MT-5547 1mg q4w group.
Units
Counts
Participants
OG000204
OG001203
OG002165
OG003162
OG004165
Title
Denominators
Categories
Week 1
ParticipantsOG000203
ParticipantsOG001203
ParticipantsOG002165
ParticipantsOG003162
ParticipantsOG004165
Title
Measurements
OG000-0.63± 0.14
OG001-1.52± 0.14
OG002-0.58± 0.14
OG003
Week 2
ParticipantsOG000201
ParticipantsOG001200
ParticipantsOG002162
ParticipantsOG003162
Week 4
ParticipantsOG000201
ParticipantsOG001201
ParticipantsOG002163
ParticipantsOG003162
Week 8
ParticipantsOG000199
ParticipantsOG001200
ParticipantsOG002161
ParticipantsOG003160
Week 12
ParticipantsOG000193
ParticipantsOG001197
ParticipantsOG002155
ParticipantsOG003158
Week 16
ParticipantsOG000190
ParticipantsOG001189
ParticipantsOG002152
ParticipantsOG003158
Week 20
ParticipantsOG000189
ParticipantsOG001185
ParticipantsOG002151
ParticipantsOG003157
Week 24
ParticipantsOG000186
ParticipantsOG001180
ParticipantsOG002148
ParticipantsOG003149
Week 28
ParticipantsOG000184
ParticipantsOG001177
ParticipantsOG002146
ParticipantsOG003143
Week 32
ParticipantsOG000180
ParticipantsOG001175
ParticipantsOG002142
ParticipantsOG003142
Week 36
ParticipantsOG000173
ParticipantsOG001173
ParticipantsOG002135
ParticipantsOG003136
Week 40
ParticipantsOG000170
ParticipantsOG001171
ParticipantsOG002133
ParticipantsOG003133
Week 44
ParticipantsOG000170
ParticipantsOG001162
ParticipantsOG002133
ParticipantsOG003134
Week 48
ParticipantsOG000170
ParticipantsOG001161
ParticipantsOG002133
ParticipantsOG003132
Week 52
ParticipantsOG000167
ParticipantsOG001160
ParticipantsOG002131
ParticipantsOG003133
Week 60
ParticipantsOG000163
ParticipantsOG001156
ParticipantsOG002127
ParticipantsOG003131
Week 68
ParticipantsOG000162
ParticipantsOG001151
ParticipantsOG002126
ParticipantsOG003130
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.
OG002
After the Amendment Placebo
Participants in this group were randomized to Placebo group after 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. These participants were included in the Pooled Placebo group.
OG003
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.
OG004
After the Amendment MT-5547 1 mg q4w
Participants in this group were randomized to MT-5547 1mg q4w group after 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.
These participants were included in the pooled MT-5547 1mg q4w group.
Units
Counts
Participants
OG000204
OG001203
OG002165
OG003162
OG004165
Title
Denominators
Categories
Week 1
ParticipantsOG000203
ParticipantsOG001203
ParticipantsOG002165
ParticipantsOG003162
ParticipantsOG004165
Title
Measurements
OG000-0.44± 0.14
OG001-1.23± 0.14
OG002-0.4± 0.14
OG003
Week 2
ParticipantsOG000201
ParticipantsOG001200
ParticipantsOG002162
ParticipantsOG003162
Week 4
ParticipantsOG000201
ParticipantsOG001201
ParticipantsOG002163
ParticipantsOG003162
Week 8
ParticipantsOG000199
ParticipantsOG001200
ParticipantsOG002161
ParticipantsOG003160
Week 12
ParticipantsOG000193
ParticipantsOG001197
ParticipantsOG002155
ParticipantsOG003158
Week 16
ParticipantsOG000190
ParticipantsOG001189
ParticipantsOG002152
ParticipantsOG003158
Week 20
ParticipantsOG000189
ParticipantsOG001185
ParticipantsOG002151
ParticipantsOG003157
Week 24
ParticipantsOG000186
ParticipantsOG001180
ParticipantsOG002148
ParticipantsOG003149
Week 28
ParticipantsOG000184
ParticipantsOG001177
ParticipantsOG002146
ParticipantsOG003143
Week 32
ParticipantsOG000180
ParticipantsOG001175
ParticipantsOG002142
ParticipantsOG003142
Week 36
ParticipantsOG000173
ParticipantsOG001173
ParticipantsOG002135
ParticipantsOG003136
Week 40
ParticipantsOG000170
ParticipantsOG001171
ParticipantsOG002133
ParticipantsOG003133
Week 44
ParticipantsOG000170
ParticipantsOG001162
ParticipantsOG002133
ParticipantsOG003134
Week 48
ParticipantsOG000170
ParticipantsOG001161
ParticipantsOG002133
ParticipantsOG003132
Week 52
ParticipantsOG000167
ParticipantsOG001160
ParticipantsOG002131
ParticipantsOG003133
Week 60
ParticipantsOG000163
ParticipantsOG001156
ParticipantsOG002127
ParticipantsOG003131
Week 68
ParticipantsOG000162
ParticipantsOG001151
ParticipantsOG002126
ParticipantsOG003130
OG002
After the Amendment Placebo
Participants in this group were randomized to Placebo group after 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. These participants were included in the Pooled Placebo group.
OG003
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.
OG004
After the Amendment MT-5547 1 mg q4w
Participants in this group were randomized to MT-5547 1mg q4w group after 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.
These participants were included in the pooled MT-5547 1mg q4w group.
Units
Counts
Participants
OG000204
OG001203
OG002165
OG003162
OG004165
Title
Denominators
Categories
Week 1
ParticipantsOG000203
ParticipantsOG001203
ParticipantsOG002165
ParticipantsOG003162
ParticipantsOG004165
Title
Measurements
OG000-0.24± 0.15
OG001-1.21± 0.15
OG002-0.24± 0.15
OG003
Week 2
ParticipantsOG000201
ParticipantsOG001200
ParticipantsOG002162
ParticipantsOG003162
Week 4
ParticipantsOG000201
ParticipantsOG001201
ParticipantsOG002163
ParticipantsOG003162
Week 8
ParticipantsOG000199
ParticipantsOG001200
ParticipantsOG002161
ParticipantsOG003160
Week 12
ParticipantsOG000193
ParticipantsOG001197
ParticipantsOG002155
ParticipantsOG003158
Week 16
ParticipantsOG000190
ParticipantsOG001189
ParticipantsOG002152
ParticipantsOG003158
Week 20
ParticipantsOG000189
ParticipantsOG001185
ParticipantsOG002151
ParticipantsOG003157
Week 24
ParticipantsOG000186
ParticipantsOG001180
ParticipantsOG002148
ParticipantsOG003149
Week 28
ParticipantsOG000184
ParticipantsOG001177
ParticipantsOG002146
ParticipantsOG003143
Week 32
ParticipantsOG000180
ParticipantsOG001175
ParticipantsOG002142
ParticipantsOG003142
Week 36
ParticipantsOG000173
ParticipantsOG001173
ParticipantsOG002135
ParticipantsOG003136
Week 40
ParticipantsOG000170
ParticipantsOG001171
ParticipantsOG002133
ParticipantsOG003133
Week 44
ParticipantsOG000170
ParticipantsOG001162
ParticipantsOG002133
ParticipantsOG003134
Week 48
ParticipantsOG000170
ParticipantsOG001161
ParticipantsOG002133
ParticipantsOG003132
Week 52
ParticipantsOG000167
ParticipantsOG001160
ParticipantsOG002131
ParticipantsOG003133
Week 60
ParticipantsOG000163
ParticipantsOG001156
ParticipantsOG002127
ParticipantsOG003131
Week 68
ParticipantsOG000162
ParticipantsOG001151
ParticipantsOG002126
ParticipantsOG003130
OG002
After the Amendment Placebo
Participants in this group were randomized to Placebo group after 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. These participants were included in the Pooled Placebo group.
OG003
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.
OG004
After the Amendment MT-5547 1 mg q4w
Participants in this group were randomized to MT-5547 1mg q4w group after 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.
These participants were included in the pooled MT-5547 1mg q4w group.
Units
Counts
Participants
OG000204
OG001203
OG002165
OG003162
OG004165
Title
Denominators
Categories
Week 1
ParticipantsOG000203
ParticipantsOG001203
ParticipantsOG002165
ParticipantsOG003162
ParticipantsOG004165
Title
Measurements
OG000-0.46± 0.13
OG001-1.29± 0.13
OG002-0.42± 0.13
OG003
Week 2
ParticipantsOG000201
ParticipantsOG001200
ParticipantsOG002162
ParticipantsOG003162
Week 4
ParticipantsOG000201
ParticipantsOG001201
ParticipantsOG002163
ParticipantsOG003162
Week 8
ParticipantsOG000199
ParticipantsOG001200
ParticipantsOG002161
ParticipantsOG003160
Week 12
ParticipantsOG000193
ParticipantsOG001197
ParticipantsOG002155
ParticipantsOG003158
Week 16
ParticipantsOG000190
ParticipantsOG001189
ParticipantsOG002152
ParticipantsOG003158
Week 20
ParticipantsOG000189
ParticipantsOG001185
ParticipantsOG002151
ParticipantsOG003157
Week 24
ParticipantsOG000186
ParticipantsOG001180
ParticipantsOG002148
ParticipantsOG003149
Week 28
ParticipantsOG000184
ParticipantsOG001177
ParticipantsOG002146
ParticipantsOG003143
Week 32
ParticipantsOG000180
ParticipantsOG001175
ParticipantsOG002142
ParticipantsOG003142
Week 36
ParticipantsOG000173
ParticipantsOG001173
ParticipantsOG002135
ParticipantsOG003136
Week 40
ParticipantsOG000170
ParticipantsOG001171
ParticipantsOG002133
ParticipantsOG003133
Week 44
ParticipantsOG000170
ParticipantsOG001162
ParticipantsOG002133
ParticipantsOG003134
Week 48
ParticipantsOG000170
ParticipantsOG001161
ParticipantsOG002133
ParticipantsOG003132
Week 52
ParticipantsOG000167
ParticipantsOG001160
ParticipantsOG002131
ParticipantsOG003133
Week 60
ParticipantsOG000163
ParticipantsOG001156
ParticipantsOG002127
ParticipantsOG003131
Week 68
ParticipantsOG000162
ParticipantsOG001151
ParticipantsOG002126
ParticipantsOG003130
OG002
After the Amendment Placebo
Participants in this group were randomized to Placebo group after 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. These participants were included in the Pooled Placebo group.
OG003
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.
OG004
After the Amendment MT-5547 1 mg q4w
Participants in this group were randomized to MT-5547 1mg q4w group after 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.
These participants were included in the pooled MT-5547 1mg q4w group.
Units
Counts
Participants
OG000204
OG001203
OG002165
OG003162
OG004165
Title
Denominators
Categories
Week 1
ParticipantsOG000203
ParticipantsOG001203
ParticipantsOG002165
ParticipantsOG003162
ParticipantsOG004165
Title
Measurements
OG000-0.3± 0.1
OG001-0.7± 0.1
OG002-0.4± 0.1
OG003
Week 2
ParticipantsOG000201
ParticipantsOG001200
ParticipantsOG002162
ParticipantsOG003162
Week 4
ParticipantsOG000201
ParticipantsOG001201
ParticipantsOG002163
ParticipantsOG003162
Week 8
ParticipantsOG000199
ParticipantsOG001200
ParticipantsOG002161
ParticipantsOG003160
Week 12
ParticipantsOG000194
ParticipantsOG001197
ParticipantsOG002156
ParticipantsOG003158
Week 16
ParticipantsOG000190
ParticipantsOG001189
ParticipantsOG002152
ParticipantsOG003158
Week 20
ParticipantsOG000189
ParticipantsOG001185
ParticipantsOG002151
ParticipantsOG003157
Week 24
ParticipantsOG000186
ParticipantsOG001180
ParticipantsOG002148
ParticipantsOG003149
Week 28
ParticipantsOG000184
ParticipantsOG001177
ParticipantsOG002146
ParticipantsOG003143
Week 32
ParticipantsOG000180
ParticipantsOG001175
ParticipantsOG002142
ParticipantsOG003142
Week 36
ParticipantsOG000173
ParticipantsOG001173
ParticipantsOG002135
ParticipantsOG003136
Week 40
ParticipantsOG000170
ParticipantsOG001171
ParticipantsOG002133
ParticipantsOG003133
Week 44
ParticipantsOG000170
ParticipantsOG001162
ParticipantsOG002133
ParticipantsOG003134
Week 48
ParticipantsOG000170
ParticipantsOG001161
ParticipantsOG002133
ParticipantsOG003132
Week 52
ParticipantsOG000167
ParticipantsOG001160
ParticipantsOG002131
ParticipantsOG003133
Week 60
ParticipantsOG000163
ParticipantsOG001156
ParticipantsOG002127
ParticipantsOG003131
Week 68
ParticipantsOG000162
ParticipantsOG001151
ParticipantsOG002126
ParticipantsOG003130
OG003
MT-5547 3 mg q4w
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.
OG004
MT-5547 6 mg q8w
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.
Units
Counts
Participants
OG000204
OG001162
OG002203
OG00328
OG00429
Title
Denominators
Categories
Participants with at least one AE (Treatment Period)
Title
Measurements
OG000174
OG001136
OG002168
OG00311
OG00414
Participants with at least one adverse drug reaction (treatment period)
Title
Measurements
OG00014
OG00120
OG00225
OG003
Participants with at least one AE (post-treatment period)
Title
Measurements
OG000115
OG00183
OG002117
OG003
Participants with at least one adverse drug reaction (post-treatment period)
Title
Measurements
OG0003
OG0014
OG00214
OG003
OG002
MT-5547 1mg q4w
MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w 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.
OG003
MT-5547 3 mg q4w
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.
OG004
MT-5547 6 mg q8w
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.