A Phase 2 Study of E6011 in Subjects With Rheumatoid Arth... | NCT02960490 | Trialant
NCT02960490
Sponsor
Eisai Co., Ltd.
Status
Completed
Last Update Posted
Aug 23, 2021Actual
Enrollment
66Actual
Phase
Phase 2
Conditions
Rheumatoid Arthritis
Interventions
E6011
Placebo
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT02960490
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
E6011-J081-202
Secondary IDs
Not provided
Brief Title
A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics
Official Title
A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics
Acronym
Not provided
Organization
Eisai Inc.INDUSTRY
Status Module
Record Verification Date
Dec 2019
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
Nov 26, 2016Actual
Primary Completion Date
May 16, 2018Actual
Completion Date
Nov 25, 2019Actual
First Submitted Date
Nov 3, 2016
First Submission Date that Met QC Criteria
Nov 7, 2016
First Posted Date
Nov 9, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 28, 2021
Results First Submitted that Met QC Criteria
Jul 28, 2021
Results First Posted Date
Aug 23, 2021Actual
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
Jul 28, 2021
Last Update Posted Date
Aug 23, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eisai Co., Ltd.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study in rheumatoid arthritis participants inadequately responding to biologics.
Detailed Description
Not provided
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
E6011
rheumatoid arthritis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
66Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
E6011 400 mg/E6011 200 mg
Experimental
In the Treatment Phase (24 weeks), participants will receive E6011 400 milligrams (mg) at Weeks 0, 1, and 2, and then every 2 weeks subsequently until Week 10, and will then receive E6011 200 mg every 2 weeks between Weeks 12 and 22 in a double-blind manner. Participants who complete evaluations at Week 24 of the Treatment Phase will enter the Extension Phase (conducted up to Week 104 from the start of the study treatment), in which they will receive open-label E6011 200 mg every 2 weeks until Week 102.
Drug: E6011
E6011 400 mg/E6011 400 mg
Experimental
In the Treatment Phase (24 weeks), participants will receive E6011 400 mg at Weeks 0, 1, and 2, and then every 2 weeks subsequently until Week 10, and will then receive E6011 400 mg every 2 weeks between Weeks 12 and 22 in a double-blind manner. Participants who complete evaluations at Week 24 of the Treatment Phase will enter the Extension Phase (conducted up to Week 104 from the start of the study treatment), in which they will receive open-label E6011 200 mg every 2 weeks until Week 102.
Drug: E6011
Placebo/E6011 200 mg
Experimental
In the Treatment Phase (24 weeks), participants will receive placebo at Weeks 0, 1, and 2, and then every 2 weeks subsequently until Week 10, and will then receive E6011 200 mg every 2 weeks between Weeks 12 and 22 in a double-blind manner. Participants who complete evaluations at Week 24 of the Treatment Phase will enter the Extension Phase (conducted up to Week 104 from the start of the study treatment), in which they will receive open-label E6011 200 mg every 2 weeks until Week 102.
Drug: E6011
Drug: Placebo
Placebo/E6011 400 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
E6011
Drug
subcutaneous administration
E6011 400 mg/E6011 200 mg
E6011 400 mg/E6011 400 mg
Placebo/E6011 200 mg
Placebo/E6011 400 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI)
The ACR20 response was defined as if the following 3 criteria (ACR components) were met: Greater than or equal to (>=) 20 percent (%) reduction from baseline in the tender joint count (TJC) in 68 joints (TJC68); >=20% reduction from baseline in the swollen joint count (SJC) in 66 joints (SJC66); >=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (visual analog scale [VAS]), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), Health Assessment Questionnaire disability index (HAQ-DI), and C-reactive protein (CRP).
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI
The ACR20 response was defined as if the following 3 criteria (ACR components) were met: >=20% reduction from baseline in the TJC in 68 joints (TJC68); >=20% reduction from baseline in the SJC in 66 joints (SJC66); >=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged ≥18 and <75 years old at the time of informed consent
Diagnosed with rheumatoid arthritis (RA) under the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) criteria ≥12 weeks before informed consent
Received biologics treatment under approved dosage and administration for ≥12 weeks but discontinued it before screening because of inadequate response
History of biologics treatment should be limited to 2 agents among adalimumab, infliximab, golimumab, certolizumab pegol, etanercept, tocilizumab, and abatacept (including biosimilars)
Presented ≥6 tender joints (out of 68 joints) and ≥6 swollen joints (out of 66 joints) in the Screening and Observation Phases
Can continue stable dose regimen of methotrexate at 6 to 16 milligrams (mg)/week from 4 weeks before starting the study treatment until completion of the Extension Phase (or until study discontinuation)
C-reactive protein (CRP) level ≥0.6 mg/deciliter (dL) or erythrocyte sedimentation rate (ESR) ≥28 millimeters per hour (mm/hr) in the Screening Phase
Weighs ≥30 kilograms (kg) and ≤100 kg in the Screening Phase
Has voluntarily consented, in writing, to participate in this study. If a participant is below the age of 20, also consented, in writing by a legally acceptable representative
Has been thoroughly briefed on the conditions for participation in the study, is able to understand, and is willing and able to comply with all aspects of the protocol
Exclusion Criteria:
Any history or complication of inflammatory arthritic disorder other than RA or Sjogren's syndrome
Meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class IV in the Screening Phase
Received immunoglobulin preparations or blood products within 24 weeks before starting the study treatment
Received a live vaccine within 12 weeks before starting the study treatment, or is planning to receive
Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, or renal disease) that could affect the participant's safety or interfere with the study assessments in the opinion of the investigator or subinvestigator
Complication of uncontrolled disorders such as acute cardiac infarction, unstable angina, brain infarct, or symptomatic intracerebral hemorrhage
History of severe allergy (shock or anaphylactoid symptoms)
History or current clinical condition of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease, except for skin carcinoma (epithelial carcinoma or basal cell carcinoma) and cervix carcinoma which has completely excised and without metastasis or recurrence for more than 5 years before informed consent
Immunodeficiency or history of human immunodeficiency virus (HIV) infection
Infection requiring hospitalization or intravenous administration of antibiotics or disease requiring administration of antivirus drugs (e.g., herpes zoster) within 4 weeks before starting the study treatment
History of tuberculosis or current complication of active tuberculosis
History of clinically important vasculitis
Tested positive for any of the following in the Screening Phase: HIV, hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus core antibody (HBc antibody), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus antibody (HCV antibody), human T-lymphotrophic virus Type I antibody (HTLV-1 antibody), or syphilis
Positive in tuberculosis test (QuantiFERON Tuberculosis Gold Test or T-SPOT Tuberculosis Test) in the Screening Phase
Findings indicating a history of tuberculosis on chest x-ray in the Screening Phase
Neurological findings such as paralysis, visual impairment, or language disorder in the Screening Phase
Females of childbearing potential who have a positive pregnancy test in the Screening or Observation Phase or are breastfeeding
Females of childbearing potential who:
Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation
Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from being sexually active during the study period or for 28 days after study drug discontinuation
Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
(NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause] or have been sterilized surgically [i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]).
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation.
Scheduled for surgery during the study
Currently enrolled in another clinical study or used any investigational drug or device within 28 days (or 5× the half-life, whichever is longer) before informed consent
Has been treated with E6011 or any biologics for use in RA that has not been approved
Use of a psychotropic agent as recreational purpose other than therapeutic purpose
Any history of a medical condition or a concomitant medical condition that in the opinion of the investigator or subinvestigator would compromise the participant's ability to safely complete the study
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Eisai Trial Site #1
Yotsukaidō
Chiba
Japan
Eisai Trial Site #1
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
A total of 93 participants were screened, of which 66 were randomized to receive study treatment. This study has a Core Treatment Phase (Treatment Phase: 12 Weeks; Entire Treatment Phase [Re-randomized Participants]: 12 Weeks) and an Extension Phase: 80 Weeks.
Recruitment Details
Participants took part in the study at 46 investigative sites in Japan from 26 November 2016 to 25 November 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Core Treatment Phase: Placebo
During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
FG001
Core Treatment Phase: E6011 400 mg
Periods
Title
Milestones
Reasons Not Completed
Treatment Phase(Double-blind): 12 Weeks
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 31, 2019
Jul 23, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Experimental
In the Treatment Phase (24 weeks), participants will receive placebo at Weeks 0, 1, and 2, and then every 2 weeks subsequently until Week 10, and will then receive E6011 400 mg every 2 weeks between Weeks 12 and 22 in a double-blind manner. Participants who complete evaluations at Week 24 of the Treatment Phase will enter the Extension Phase (conducted up to Week 104 from the start of the study treatment), in which they will receive open-label E6011 200 mg every 2 weeks until Week 102.
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI
The ACR50 response was defined as if the following 3 criteria (ACR components) were met: >=50% reduction from baseline in the TJC in 68 joints (TJC68); >=50% reduction from baseline in the SJC in 66 joints (SJC66); >=50% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI
The ACR70 response was defined as if the following 3 criteria (ACR components) were met: >=70% reduction from baseline in the TJC in 68 joints (TJC68); >=70% reduction from baseline in the SJC in 66 joints (SJC66); >=70% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF)
A total of 28 joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Tender joints were marked with tick or cross in corresponding frames of the Assessment Sheet for Tender Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF
A total of 28 joints were examined for swollen joints. Swollen joints were marked with open circles in corresponding frames of the Assessment Sheet for Swollen Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF
Intensity and severity of pain associated with rheumatoid arthritis (RA) were indicated by the participant on a score sheet, Pain/disease activity assessments reported by the participant, by placing a mark on a 100 millimeter (mm) horizontal VAS. Pain assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF
Participants were evaluated on their disease activity of RA, and entered the result on the score sheet, disease activity assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF
The Physician's Global Assessment of Disease Activity was recorded using the 100 mm horizontal VAS. Physician rated participant's RA disease activity on a scale ranged from 0-100 mm, where 0 indicated no disease activity (no arthritis) and 100 represented maximum disease activity (maximum arthritis). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF
Degree of disability was self-evaluated by participant using HAQ-DI.Assessment was made based on activities capable without any aids/devices.20-question instrument assessed degree of difficulty person had in accomplishing tasks in 8 functional areas(dressing,arising,eating,walking,hygiene,reaching,gripping,and activities of daily living).Responses in each functional area were scored from 0(indicated no difficulty)to 3(indicated inability to perform task in that area).Overall score computed as: sum of domain scores and divided by number of domains answered.Total possible score range:0-3 where 0=least difficulty and 3=extreme difficulty.Data for Core Treatment Phase from Week 0-10 is reported according to participant re-randomization in 4 arms at Week 12.Data reported for Extension Phase from Baseline to Week 24,is same data for Core Treatment Phase,but excluding participants who received at least 1 dose of drug and had at least 1 postdose primary efficacy measurement after Week 24-72.
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF
CRP of each participants was measured as a part of blood biochemical tests. A normal CRP value is less than (<) 10 milligram per deciliter (mg/dL). A test result showing a CRP level greater than 10 mg/dL is a sign of chronic disease. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF
ESR were a type of blood test. An ESR was used to monitor the arthritis condition. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF
The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above=high disease activity, a value greater than (>) 3.2 and less than or equal to (<=) 5.1=moderate disease activity and value <=3.2=low disease activity, value <2.6=disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF
The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 4.1 or above=high disease activity, a value >2.7 and <=4.1=moderate disease activity and a value <=2.7=low disease activity, value <2.3=disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF
The SDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), physician global assessment of disease activity score (score range as 0-10), and CRP value (score range as 0-10). Total score ranged between 0-86. SDAI score of 26 or above=high disease activity, a value >11 and <=26=moderate disease activity and value <=11=low disease activity, value <=3.3=disease remission. Higher scores indicated higher disease activity. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF
The CDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10) and physician global assessment of disease activity (score range as 0-10). Total score ranged between 0-76. CDAI score of 22 or above=high disease activity, a value >10 and <=22=moderate disease activity, a value <=10=low disease activity, and a value <=2.8=disease remission. Higher scores indicated higher disease activity. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI
The Disease Activity Score Based on 28-joints Count-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to <=5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI
The Disease Activity Score Based on 28-joints Count-CRP based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to <=5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI
The SDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), physician global assessment of disease activity score (score range as 0-10), and CRP value (score range as 0-10). Total score ranged between 0-86. SDAI score of 86 or above=high disease activity, a value >11 and <=26=moderate disease activity, a value >=3.4 and <=11=low disease activity. Higher scores indicated higher disease activity. SDAI Remission was defined as SDAI score <=3.3. Data for Core Treatment Phase from Week 0-10 is reported according to participant's re-randomization in four arms at Week 12. Data reported for Extension Phase from Week 2 to Week 24, is same data for Core Treatment Phase, but excluding participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI
The CDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), and physician global assessment of disease activity score (score range as 0-10). Total score ranged between 0-76. CDAI score of 76 or above=high disease activity, a value >10 and <=22=moderate disease activity, a value >2.9 and <=10=low disease activity. Higher scores indicated higher disease activity. CDAI Remission was defined as CDAI score <=2.8. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI
Boolean remission criteria was defined as: tender joint count 68 <=1; swollen joint count 66 <=1; CRP <=1 mg/dL; and disease activity assessments VAS (mm) by participants <=10. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
During the Core Treatment Phase, participants received E6011 400 milligram (mg), infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
FG002
Core Treatment Phase: Placebo Then E6011 200 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
FG003
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
FG004
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
FG005
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
FG006
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
FG007
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
FG008
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
FG009
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
FG00034 subjects
FG00132 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Treated
FG00033 subjects
FG00131 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Full Analysis Set (FAS)
FG00033 subjects
FG00131 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Safety Analysis Set (SAS)
FG00033 subjects
FG00131 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG00029 subjects
FG00126 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0005 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0003 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease Progression
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Not treated
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Re-randomized Participants: 12 Weeks
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00215 subjects
FG00314 subjects
FG00414 subjects
FG00512 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Treated
FG0000 subjects
FG0010 subjects
FG00215 subjects
FG00314 subjects
FG004
FAS
FG0000 subjects
FG0010 subjects
FG00215 subjects
FG00314 subjects
FG004
SAS
FG0000 subjects
FG0010 subjects
FG00215 subjects
FG00314 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG00213 subjects
FG00312 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Extension Phase(Open-label): 80 Weeks
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00613 subjects
FG00711 subjectsOne Participant who completed Core Treatment Phase (Placebo Then E6011 400 mg arm) had inadequate therapeutic effect at Week 24, hence did not started Extension phase.
FG00813 subjects
FG00910 subjects
Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
FAS
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
SAS
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Core Treatment Phase: Placebo
During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10. Participants who continued the study beyond Week 12 in the Core Treatment Phase (Placebo) received E6011 200 mg or 400 mg, infusion, subcutaneously every 2 weeks between weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
BG001
Core Treatment Phase: E6011 400 mg
During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10. Participants who continued the study beyond Week 12 in the Core Treatment Phase (E6011 400 mg) received E6011 200 mg or 400 mg, infusion, subcutaneously every 2 weeks between weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00033
BG00131
BG00264
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
BG00049.6± 10.64
BG00153.5± 11.30
BG00251.5± 11.05
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00028
BG00122
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Japanese
Title
Measurements
BG00033
BG00131
BG002
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
Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI)
The ACR20 response was defined as if the following 3 criteria (ACR components) were met: Greater than or equal to (>=) 20 percent (%) reduction from baseline in the tender joint count (TJC) in 68 joints (TJC68); >=20% reduction from baseline in the swollen joint count (SJC) in 66 joints (SJC66); >=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (visual analog scale [VAS]), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), Health Assessment Questionnaire disability index (HAQ-DI), and C-reactive protein (CRP).
FAS included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Core Treatment Phase: Placebo
During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
OG001
Core Treatment Phase: E6011 400 mg
During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
Units
Counts
Participants
OG00033
OG00131
Title
Denominators
Categories
Title
Measurements
OG00027.3(12.08 to 42.47)
OG00122.6(7.86 to 37.30)
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
Regression, Logistic
0.621
Difference from Placebo
-4.7
2-Sided
95
-25.85
16.46
Superiority
Secondary
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI
The ACR20 response was defined as if the following 3 criteria (ACR components) were met: >=20% reduction from baseline in the TJC in 68 joints (TJC68); >=20% reduction from baseline in the SJC in 66 joints (SJC66); >=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI
The ACR50 response was defined as if the following 3 criteria (ACR components) were met: >=50% reduction from baseline in the TJC in 68 joints (TJC68); >=50% reduction from baseline in the SJC in 66 joints (SJC66); >=50% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI
The ACR70 response was defined as if the following 3 criteria (ACR components) were met: >=70% reduction from baseline in the TJC in 68 joints (TJC68); >=70% reduction from baseline in the SJC in 66 joints (SJC66); >=70% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF)
A total of 28 joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Tender joints were marked with tick or cross in corresponding frames of the Assessment Sheet for Tender Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF
A total of 28 joints were examined for swollen joints. Swollen joints were marked with open circles in corresponding frames of the Assessment Sheet for Swollen Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG001
Secondary
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF
Intensity and severity of pain associated with rheumatoid arthritis (RA) were indicated by the participant on a score sheet, Pain/disease activity assessments reported by the participant, by placing a mark on a 100 millimeter (mm) horizontal VAS. Pain assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF
Participants were evaluated on their disease activity of RA, and entered the result on the score sheet, disease activity assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF
The Physician's Global Assessment of Disease Activity was recorded using the 100 mm horizontal VAS. Physician rated participant's RA disease activity on a scale ranged from 0-100 mm, where 0 indicated no disease activity (no arthritis) and 100 represented maximum disease activity (maximum arthritis). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF
Degree of disability was self-evaluated by participant using HAQ-DI.Assessment was made based on activities capable without any aids/devices.20-question instrument assessed degree of difficulty person had in accomplishing tasks in 8 functional areas(dressing,arising,eating,walking,hygiene,reaching,gripping,and activities of daily living).Responses in each functional area were scored from 0(indicated no difficulty)to 3(indicated inability to perform task in that area).Overall score computed as: sum of domain scores and divided by number of domains answered.Total possible score range:0-3 where 0=least difficulty and 3=extreme difficulty.Data for Core Treatment Phase from Week 0-10 is reported according to participant re-randomization in 4 arms at Week 12.Data reported for Extension Phase from Baseline to Week 24,is same data for Core Treatment Phase,but excluding participants who received at least 1 dose of drug and had at least 1 postdose primary efficacy measurement after Week 24-72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF
CRP of each participants was measured as a part of blood biochemical tests. A normal CRP value is less than (<) 10 milligram per deciliter (mg/dL). A test result showing a CRP level greater than 10 mg/dL is a sign of chronic disease. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF
ESR were a type of blood test. An ESR was used to monitor the arthritis condition. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Secondary
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF
The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above=high disease activity, a value greater than (>) 3.2 and less than or equal to (<=) 5.1=moderate disease activity and value <=3.2=low disease activity, value <2.6=disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF
The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 4.1 or above=high disease activity, a value >2.7 and <=4.1=moderate disease activity and a value <=2.7=low disease activity, value <2.3=disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF
The SDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), physician global assessment of disease activity score (score range as 0-10), and CRP value (score range as 0-10). Total score ranged between 0-86. SDAI score of 26 or above=high disease activity, a value >11 and <=26=moderate disease activity and value <=11=low disease activity, value <=3.3=disease remission. Higher scores indicated higher disease activity. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF
The CDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10) and physician global assessment of disease activity (score range as 0-10). Total score ranged between 0-76. CDAI score of 22 or above=high disease activity, a value >10 and <=22=moderate disease activity, a value <=10=low disease activity, and a value <=2.8=disease remission. Higher scores indicated higher disease activity. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Secondary
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI
The Disease Activity Score Based on 28-joints Count-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to <=5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI
The Disease Activity Score Based on 28-joints Count-CRP based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to <=5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI
The SDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), physician global assessment of disease activity score (score range as 0-10), and CRP value (score range as 0-10). Total score ranged between 0-86. SDAI score of 86 or above=high disease activity, a value >11 and <=26=moderate disease activity, a value >=3.4 and <=11=low disease activity. Higher scores indicated higher disease activity. SDAI Remission was defined as SDAI score <=3.3. Data for Core Treatment Phase from Week 0-10 is reported according to participant's re-randomization in four arms at Week 12. Data reported for Extension Phase from Week 2 to Week 24, is same data for Core Treatment Phase, but excluding participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI
The CDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), and physician global assessment of disease activity score (score range as 0-10). Total score ranged between 0-76. CDAI score of 76 or above=high disease activity, a value >10 and <=22=moderate disease activity, a value >2.9 and <=10=low disease activity. Higher scores indicated higher disease activity. CDAI Remission was defined as CDAI score <=2.8. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI
Boolean remission criteria was defined as: tender joint count 68 <=1; swollen joint count 66 <=1; CRP <=1 mg/dL; and disease activity assessments VAS (mm) by participants <=10. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed "n" were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
Time Frame
From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104)
Description
SAS included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
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
Core Treatment Phase: Placebo
During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
0
33
1
33
19
33
EG001
Core Treatment Phase: E6011 400 mg
During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10.
0
31
0
31
14
31
EG002
Core Treatment Phase: Placebo Then E6011 200 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
0
15
0
15
12
15
EG003
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
0
14
1
14
13
14
EG004
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
0
14
0
14
13
14
EG005
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
0
12
0
12
9
12
EG006
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
1
13
2
13
13
13
EG007
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
0
11
2
11
11
11
EG008
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
0
13
2
13
13
13
EG009
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
0
10
0
10
9
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cholecystitis acute
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG0030 affected14 at risk
EG0040 affected14 at risk
EG0050 affected12 at risk
EG0060 affected13 at risk
EG0070 affected11 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Oesophageal achalasia
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Sudden death
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Joint destruction
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG0030 affected14 at risk
EG0041 affected14 at risk
EG0050 affected12 at risk
EG0061 affected13 at risk
EG0071 affected11 at risk
EG0082 affected13 at risk
EG0091 affected10 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG003
Eustachian tube patulous
Ear and labyrinth disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0012 affected31 at risk
EG0020 affected15 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0022 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Injection site erythema
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0012 affected31 at risk
EG0020 affected15 at risk
EG003
Injection site reaction
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG003
Face oedema
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Injection site pain
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Injection site warmth
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0011 affected31 at risk
EG0022 affected15 at risk
EG003
Breast abscess
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0021 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Cystitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0011 affected31 at risk
EG0021 affected15 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0012 affected31 at risk
EG0020 affected15 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG003
Cell marker increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG003
Liver function test increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected31 at risk
EG0020 affected15 at risk
EG003
Joint destruction
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Dry eye
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Injection site swelling
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Otitis media
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Periodontitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Amylase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Syncope
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Skin erosion
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Hypertension
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0021 affected15 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Dental necrosis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0009 affected33 at risk
EG0014 affected31 at risk
EG0022 affected15 at risk
EG003
Paronychia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Influenza
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Atypical mycobacterial infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Bacterial diarrhoea
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Dermatophytosis of nail
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Dislocation of vertebra
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Hypovitaminosis
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Intervertebral disc compression
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected31 at risk
EG0020 affected15 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Response at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG00013.3(0.00 to 30.54)
OG0017.1(0.00 to 20.63)
OG0027.1(0.00 to 20.63)
OG003
Response at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Response at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG0000.0(0.00 to 0.00)
OG0010.0(0.00 to 0.00)
OG0020.0(0.00 to 0.00)
OG003
Response at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Response at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG0000.0(0.00 to 0.00)
OG0010.0(0.00 to 0.00)
OG0020.0(0.00 to 0.00)
OG003
Response at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Response at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Response at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG0009.7± 6.88
OG00111.7± 7.74
OG0029.9± 4.80
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG0007.1± 2.91
OG0019.5± 6.14
OG0028.9± 3.47
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG00056.7± 32.02
OG00155.9± 30.33
OG00256.9± 33.07
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG00056.2± 31.20
OG00154.9± 32.83
OG00255.6± 34.74
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG00063.3± 29.63
OG00157.9± 22.02
OG00262.4± 19.41
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG0000.90± 0.816
OG0011.04± 0.770
OG0020.88± 0.744
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG0001.08± 1.299
OG0012.50± 4.012
OG0023.09± 3.186
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG00033.1± 19.55
OG00144.4± 25.70
OG00251.8± 34.26
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG0005.479± 1.2520
OG0015.870± 1.3037
OG0025.951± 1.1584
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG0004.842± 1.2628
OG0015.194± 1.2869
OG0025.305± 1.1055
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG00029.767± 13.8824
OG00134.986± 16.9418
OG00233.750± 11.5847
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Baseline
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG00028.687± 13.2790
OG00132.486± 15.4890
OG00230.657± 9.4928
OG003
Change at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Change at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Change at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
EULAR Response at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
Good Response
OG0000
OG0010
OG0020
OG003
EULAR Response at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR Response at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR Response at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR Response at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR Response at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR Response at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR Response at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR Response at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
EULAR response at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
Good response
OG0000
OG0010
OG0020
OG003
EULAR response at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR response at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR response at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR response at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR response at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR response at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
EULAR response at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
EULAR response at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Remission at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG0000.0(0.00 to 0.00)
OG0010.0(0.00 to 0.00)
OG0020.0(0.00 to 0.00)
OG003
Remission at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
Units
Counts
Participants
OG00015
OG00114
OG00214
OG00312
OG00413
OG00511
OG00613
OG00710
Title
Denominators
Categories
Remission at Week 2
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG00710
Title
Measurements
OG0000.0(0.00 to 0.00)
OG0010.0(0.00 to 0.00)
OG0020.0(0.00 to 0.00)
OG003
Remission at Week 4
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 8
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 12
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 16
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 20
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 24
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00312
Remission at Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 52
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 56
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 60
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 64
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 68
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Remission at Week 72
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Core Treatment Phase: Placebo Then E6011 400 mg
Participants who received Placebo and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG002
Core Treatment Phase: E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 200 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG003
Core Treatment Phase: E6011 400 mg Then E6011 400 mg
Participants who received E6011 400 mg and completed Week 10 evaluations were re-randomized at Week 12 in the Core Treatment Phase to receive E6011 400 mg, infusion, subcutaneously every 2 weeks between Weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase.
OG004
Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG005
Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg
Participants who received Placebo up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG006
Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 200 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.
OG007
Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg
Participants who received E6011 400 mg up to Week 10 followed by E6011 400 mg from Weeks 12 to 22 during the Core Treatment Phase continued receiving E6011 200 mg, infusion, subcutaneously every 2 weeks up to Week 102 in the Extension Phase.