A Study of Effectiveness and Safety of CNTO 136 in Patien... | NCT00718718 | Trialant
NCT00718718
Sponsor
Centocor, Inc.
Status
Completed
Last Update Posted
Jan 23, 2018Actual
Enrollment
187Actual
Phase
Phase 2
Conditions
Arthritis, Rheumatoid
Interventions
CNTO 136 100 mg
CNTO 136 50 mg
CNTO 136 25 mg
Placebo
Methotrexate
Countries
United States
Hungary
Japan
Mexico
Poland
Russia
South Korea
Protocol Section
Identification Module
NCT ID
NCT00718718
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR015214
Secondary IDs
ID
Type
Description
Link
C1377T04
Other Identifier
Centocor
2007-006603-20
EudraCT Number
Brief Title
A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official Title
A Phase 2, 2-Part, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept, Dose-finding Study Evaluating the Efficacy and Safety of CNTO 136 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Acronym
Not provided
Organization
Centocor, Inc.INDUSTRY
Status Module
Record Verification Date
Dec 2017
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
Aug 11, 2008Actual
Primary Completion Date
Mar 3, 2011Actual
Completion Date
Mar 3, 2011Actual
First Submitted Date
Jul 17, 2008
First Submission Date that Met QC Criteria
Jul 17, 2008
First Posted Date
Jul 21, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 22, 2017
Results First Submitted that Met QC Criteria
Oct 22, 2017
Results First Posted Date
Dec 4, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 15, 2011
Certification/Extension First Submitted that Passed QC Review
Sep 15, 2011
Certification/Extension First Posted Date
Sep 21, 2011Estimated
Last Update Submitted Date
Dec 22, 2017
Last Update Posted Date
Jan 23, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Centocor, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
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
The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate (MTX) therapy.
Detailed Description
This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study) study. This study will be conducted in 2 parts (Part A and Part B). Each part consists of 3 phases: screening (approximately 1 month prior to the start of study medication), treatment phase (Part A: 22 weeks and Part B: 24 weeks), and follow-up phase (approximately 4 months after the last administration of study medication). In Part A, participants will be randomly assigned to 2 groups to receive CNTO 136 100 mg and placebo for 22 weeks. All participants in Part A, will be crossed over at Week 12 from placebo to CNTO 136 (for Group 1) and from CNTO 136 to placebo (for Group 2). In Part B, participants will be randomly assigned to 5 groups to receive placebo and/or 1 of 3 doses of CNTO 136 (100mg, 50mg or 25mg) for 24 weeks. Participants in Part B, Group 1 will be crossed over at Week 12 from placebo to CNTO 136. All participants should be maintained on a stable dose of MTX for at least 6 weeks prior to the start of study medication through Week 24. Safety will be evaluated by the assessment of adverse events, vital signs, clinical findings, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for a participant will be approximately 42 weeks.
Conditions Module
Conditions
Arthritis, Rheumatoid
Keywords
Arthritis, Rheumatoid
Rheumatoid Arthritis
Active Rheumatoid Arthritis
CNTO 136
Interleukin-6
Anti-interleukin-6 monoclonal antibody
Methotrexate
Placebo
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
187Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A, Group 1
Experimental
Participants will receive placebo (Week 0 to Week 10) and later CNTO 136 100 mg (Week 12 to Week 22) every 2 weeks. Stable dose of methotrexate will be maintained through Week 24.
Drug: CNTO 136 100 mg
Drug: Placebo
Drug: Methotrexate
Part A, Group 2
Experimental
Participants will receive CNTO 136 100 mg (Week 0 to Week 10) and later placebo (Week 12 to Week 22) every 2 weeks. Stable dose of methotrexate will be maintained through Week 24.
Drug: CNTO 136 100 mg
Drug: Placebo
Drug: Methotrexate
Part B, Group 1
Experimental
Participants will receive placebo (Week 0 to Week 10) and later CNTO 136 100 mg (Week 12 to Week 24) every 2 weeks. Stable dose of methotrexate will be maintained through Week 24.
Drug: CNTO 136 100 mg
Drug: Placebo
Drug: Methotrexate
Part B, Group 2
Experimental
Participants will receive CNTO 136 100 mg (Week 0 to Week 24) every 2 weeks. Stable dose of methotrexate will be maintained through Week 24.
Drug: CNTO 136 100 mg
Drug: Methotrexate
Part B, Group 3
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CNTO 136 100 mg
Drug
CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.
Part A, Group 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B)
An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: participant's assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and serum C-reactive protein (CRP).
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B)
The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosed with rheumatoid arthritis (RA) for at least 4 months prior to screening
Have been treated and having an inadequate response with the tolerated dose of methotrexate (MTX) (at least 15mg/week) for at least 4 months prior to screening. MTX doses of 10 or 12.5 mg/week are allowed if participant had intolerance of 15 mg/week
MTX route of administration and dose (not to exceed 25 mg/week) should be stable for at least 6 weeks prior to the start of the study medication
Have active RA as defined by persistent disease activity with at least 6 swollen and 6 tender joints, at the time of screening and baseline, and either anti-cyclic citrullinated peptide antibody-positive or rheumatoid factor positive at screening
C-reactive protein greater than or equal to 1.0 mg/dL (10 mg/L)
Agree to use one of the contraception methods defined in the protocol
Exclusion Criteria:
Have inflammatory diseases other than RA that might confound the evaluation of the benefit of CNTO 136 therapy in arthritis
Family history of/ have long QT syndrome; or a history of second or third-degree heart block
Received systemic immunosuppressives or disease modifying antirheumatic drug other than MTX, sulfasalazine, hydroxychloroquine or chloroquine within 4 weeks prior to the start of study medication
Received intra articular (into joints), intramuscular, or intravenous corticosteroids within 4 weeks prior to the start of study medication
Positive human immunodeficiency virus test, hepatitis B or hepatitis C
History of / have chronic or recurrent infectious disease, history of / active tuberculosis
Have serious infection within 2 months prior to start of study medication
Smolen JS, Weinblatt ME, Sheng S, Zhuang Y, Hsu B. Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2014 Sep;73(9):1616-25. doi: 10.1136/annrheumdis-2013-205137. Epub 2014 Apr 3.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A - Placebo (Wk 0-Wk 12)
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks.
FG001
Part A - Placebo Then Sirukumab (Wk 12 to End of Study)
Periods
Title
Milestones
Reasons Not Completed
Prior to Week 12
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Taiwan
Ukraine
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
Crossover 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
ParticipantCare ProviderInvestigator
Participants will receive CNTO 136 100 mg (Week 0 to Week 24) every 4 weeks and placebo at interim visits (Weeks 2, 6, 10, 14, 18, and 22). Stable dose of methotrexate will be maintained through Week 24.
Drug: CNTO 136 100 mg
Drug: Placebo
Drug: Methotrexate
Part B, Group 4
Experimental
Participants will receive CNTO 136 50 mg (Week 0 to Week 24) every 4 weeks and placebo at interim visits (Weeks 2, 6,10, 14, 18, and 22). Stable dose of methotrexate will be maintained through Week 24.
Drug: CNTO 136 50 mg
Drug: Placebo
Drug: Methotrexate
Part B, Group 5
Experimental
Participants will receive CNTO 136 25 mg (Week 0 to Week 24) every 4 weeks and placebo at interim visits (Weeks 2, 6,10, 14, 18, and 22). Stable dose of methotrexate will be maintained through Week 24.
Drug: CNTO 136 25 mg
Drug: Placebo
Drug: Methotrexate
Part A, Group 2
Part B, Group 1
Part B, Group 2
Part B, Group 3
Sirukumab
CNTO 136 50 mg
Drug
CNTO 136 50 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.
Part B, Group 4
Sirukumab
CNTO 136 25 mg
Drug
CNTO 136 25 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.
Part B, Group 5
Sirukumab
Placebo
Drug
Placebo will be adminstered subcutaneously as per the appropriate randomized arm.
Part A, Group 1
Part A, Group 2
Part B, Group 1
Part B, Group 3
Part B, Group 4
Part B, Group 5
Methotrexate
Drug
Stable dose of methotrexate will be maintained through Week 24.
Part A, Group 1
Part A, Group 2
Part B, Group 1
Part B, Group 2
Part B, Group 3
Part B, Group 4
Part B, Group 5
Baseline, Week 12
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A)
An ACR 50 response is defined as >= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP.
Week 12
Serum Sirukumab Concentrations Through Week 38 (Part A)
Sirukumab Concentrations in serum were measured.
Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38
Serum Sirukumab Concentrations Through Week 38 (Part B)
Sirukumab Concentrations in serum were measured.
Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38
Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B)
Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement.
Baseline, Week 2
Lexington
Kentucky
United States
Frederick
Maryland
United States
Kalamazoo
Michigan
United States
Charlotte
North Carolina
United States
Winston-Salem
North Carolina
United States
Duncansville
Pennsylvania
United States
Anderson
South Carolina
United States
Budapest
Hungary
Győr
Hungary
Kecskemét
Hungary
Goshogawara
Japan
Hitachi
Japan
Kawagoe
Japan
Kitakyushu
Japan
Miyazaki
Japan
Sasebo
Japan
Shinjuku-Ku
Japan
Tomigusuku
Japan
Guadalajara
Mexico
Mexico City
Mexico
México
Mexico
Bialystok
Poland
Bydgoszcz
Poland
Elblag
Poland
Gdynia
Poland
Krakow
Poland
Lublin
Poland
Poznan
Poland
Warsaw
Poland
Kemerovo
Russia
Moscow
Russia
Novosibirsk
Russia
Saint Petersburg
Russia
Busan
South Korea
Daegu
South Korea
Daejeon
South Korea
Seoul
South Korea
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
FG002
Part A - Sirukumab (Wk 0-Wk 12)
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
FG003
Part A - Sirukumab Then Placebo (Wk 12 to End of Study)
Participants received placebo at Weeks 12 and q2w through Week 22.
FG004
Part B - Placebo (Wk 0-Wk 12)
Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
FG005
Part B - Placebo Then Sirukumab 100 mg q2 Weeks
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24.
FG006
Part B - Sirukumab 100mg q2w
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
FG007
Part B - Sirukumab 100mg q4w
Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
FG008
Part B - Sirukumab 50mg q4w
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
FG009
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
FG00019 subjects
FG0010 subjects
FG00217 subjects
FG0030 subjects
FG00430 subjects
FG0050 subjects
FG00630 subjects
FG00730 subjects
FG00830 subjects
FG00931 subjects
COMPLETED
FG00018 subjects
FG0010 subjects
FG00216 subjects
FG0030 subjects
FG00427 subjects
FG0050 subjects
FG00629 subjects
FG00728 subjects
FG00828 subjects
FG00931 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0061 subjects
FG0072 subjects
FG0082 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Week 12 to End of Study
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00118 subjects
FG0020 subjects
FG00316 subjects
FG0040 subjects
FG00527 subjects
FG00629 subjects
FG00728 subjects
FG00828 subjects
FG00931 subjects
Treated
FG0000 subjects
FG00118 subjects
FG0020 subjects
FG00316 subjects
FG004
COMPLETED
FG0000 subjects
FG00117 subjects
FG0020 subjects
FG00315 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Placebo
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
BG001
Part A: Sirukumab 100 mg q2 Weeks
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Week 12 and q2w through week 22.
BG002
Part B: Placebo
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
BG003
Part B: Sirukumab 100 mg q2 Weeks
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
BG004
Part B: Sirukumab 100 mg q4 Weeks
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
BG005
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
BG006
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00019
BG00117
BG00230
BG00330
BG00430
BG00530
BG00631
BG007187
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
BG00046.2± 10.24
BG00150.1± 10.72
BG00254.1± 12.72
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG00114
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Hungary
Title
Measurements
BG0000
BG0010
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
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B)
An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: participant's assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and serum C-reactive protein (CRP).
Population analyzed included all randomized participants in Part B.
Posted
Number
Percentage of Participants
Week 12
ID
Title
Description
OG000
Part B: Placebo
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
OG001
Part B: Sirukumab 100 mg q2 Weeks
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
OG002
Part B: Sirukumab 100 mg q4 Weeks
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
OG003
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
OG004
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.3
OG00126.7
OG00223.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.026
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
0.052
Secondary
Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B)
The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline.
Population analyzed included randomized subjects in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
OG001
Part A: Sirukumab 100 mg q2 Weeks
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
Secondary
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A)
An ACR 50 response is defined as >= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP.
Population analyzed included all randomized participants in Part A (excluding a site based on sponsor audit for data integrity). Here 'N'(number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Number
Percentage of Participants
Week 12
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
OG001
Part A: Sirukumab 100 mg q2 Weeks
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
Secondary
Serum Sirukumab Concentrations Through Week 38 (Part A)
Sirukumab Concentrations in serum were measured.
Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part A (excluding a site based on sponsor audit for data integrity). Here 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure whereas 'n' signifies participants evaluable at specific time points, for each arm, respectively.
Posted
Mean
Standard Deviation
Microgram per milliliter
Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
OG001
Part A: Sirukumab 100 mg q2 Weeks
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
Units
Counts
Secondary
Serum Sirukumab Concentrations Through Week 38 (Part B)
Sirukumab Concentrations in serum were measured.
Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure whereas 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.
Posted
Mean
Standard Deviation
Microgram per milliliter
Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38
ID
Title
Description
OG000
Part B: Placebo
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
OG001
Part B: Sirukumab 100 mg q2 Weeks
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
OG002
Part B: Sirukumab 100 mg q4 Weeks
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Secondary
Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B)
Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement.
Population analyzed included randomized participants in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Percent change
Baseline, Week 2
ID
Title
Description
OG000
Part B: Placebo
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
OG001
Part B: Sirukumab 100 mg q2 Weeks
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
OG002
Part B: Sirukumab 100 mg q4 Weeks
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Time Frame
Screening up to Week 38
Description
Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
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
Part A - Placebo (Wk 0-Wk 12)
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks
0
19
12
19
EG001
Part A - Placebo Then Sirukumab (Wk 12 to End of Study)
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
0
18
18
18
EG002
Part A - Sirukumab (Wk 0-Wk 12)
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
1
17
12
17
EG003
Part A - Sirukumab Then Placebo (Wk 12 to End of Study)
Participants received placebo at Weeks 12 and q2w through Week 22.
0
16
10
16
EG004
Part B - Placebo (Wk 0-Wk 12)
Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
4
30
15
30
EG005
Part B - Placebo Then Sirukumab 100 mg q2 Weeks
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24.
2
26
11
26
EG006
Part B - Sirukumab 100mg q2w
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
2
30
20
30
EG007
Part B - Sirukumab 100mg q4w
Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
5
30
18
30
EG008
Part B - Sirukumab 50mg q4w
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
1
30
25
30
EG009
Part B - Sirukumab 25mg q4w
Participants received 25 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
3
31
23
31
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Blindness
Eye disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG0030 affected16 at risk
EG0041 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
Appendicitis
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Arthritis Bacterial
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Bursitis Infective
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cellulitis Staphylococcal
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pelvic Inflammatory Disease
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pneumonia
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Transaminases Increased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Rheumatoid Arthritis
Musculoskeletal and connective tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Fibrosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Facial Paresis
Nervous system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Intracranial Aneurysm
Nervous system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Subarachnoid Haemorrhage
Nervous system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Vertebral Artery Occlusion
Nervous system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Uterine Polyp
Reproductive system and breast disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Haemorrhagic Diathesis
Blood and lymphatic system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG0030 affected16 at risk
EG004
Leukopenia
Blood and lymphatic system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0012 affected18 at risk
EG0020 affected17 at risk
EG003
Bundle Branch Block Left
Cardiac disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Eye Pain
Eye disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Uveitis
Eye disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Vision Blurred
Eye disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Aphthous Stomatitis
Gastrointestinal disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0010 affected18 at risk
EG0023 affected17 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Periodontitis
Gastrointestinal disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Fatigue
General disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Injection Site Erythema
General disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0014 affected18 at risk
EG0026 affected17 at risk
EG003
Injection Site Pain
General disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0011 affected18 at risk
EG0024 affected17 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0022 affected17 at risk
EG003
Injection Site Rash
General disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Injection Site Swelling
General disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0022 affected17 at risk
EG003
Injection Site Urticaria
General disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Injection Site Warmth
General disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pyrexia
General disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Acute Tonsillitis
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Bronchitis
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0002 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Lymphangitis
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0012 affected18 at risk
EG0022 affected17 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pneumonia
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Rhinitis
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Sinusitis
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Staphylococcal Skin Infection
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0002 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Synovial Rupture
Injury, poisoning and procedural complications
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0014 affected18 at risk
EG0022 affected17 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0022 affected17 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Blood Cholesterol Increased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blood Glucose Increased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blood Insulin Increased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blood Potassium Decreased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Insulin Resistance Test
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Intraocular Pressure Increased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Transaminases Increased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0011 affected18 at risk
EG0025 affected17 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Rheumatoid Arthritis
Musculoskeletal and connective tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0002 affected19 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Spinal Column Stenosis
Musculoskeletal and connective tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Tendon Pain
Musculoskeletal and connective tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Dizziness
Nervous system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Headache
Nervous system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0001 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Migraine
Nervous system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Sciatica
Nervous system disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Upper Respiratory Tract Inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Haematoma
Vascular disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypertension
Vascular disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA: 13.0,13.1
Non-systematic Assessment
EG0000 affected19 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Point of Contact
Title
Organization
Phone
Extension
Email
Associate Director
Janssen Research & Development, LLC
ClinicalTrialDisclosure@its.jnj.com
ID
Term
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C568922
sirukumab
D008727
Methotrexate
Ancestor Terms
ID
Term
D000630
Aminopterin
D011622
Pterins
D011621
Pteridines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
3 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG00526 subjects
FG00629 subjects
FG00728 subjects
FG00828 subjects
FG00931 subjects
0 subjects
FG00524 subjects
FG00627 subjects
FG00727 subjects
FG00827 subjects
FG00931 subjects
0 subjects
FG0053 subjects
FG0062 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
53.8
± 13.02
BG00452± 11
BG00550.9± 10.29
BG00652.8± 9.41
BG00751.8± 11.26
25
BG00327
BG00427
BG00526
BG00623
BG007153
Male
BG0008
BG0013
BG0025
BG0033
BG0043
BG0054
BG0068
BG00734
2
BG0035
BG0043
BG0053
BG0064
BG00717
Japan
Title
Measurements
BG0000
BG0010
BG0025
BG0035
BG0045
BG0056
BG0066
BG00727
Mexico
Title
Measurements
BG0000
BG0010
BG0025
BG0033
BG0044
BG0055
BG0066
BG00723
Poland
Title
Measurements
BG00013
BG00112
BG0029
BG00310
BG0046
BG0055
BG0067
BG00762
Republic of Korea
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0041
BG0052
BG0061
BG0075
Russian Federation
Title
Measurements
BG0000
BG0010
BG0029
BG0036
BG00410
BG0059
BG0067
BG00741
United States
Title
Measurements
BG0006
BG0015
BG0020
BG0030
BG0041
BG0050
BG0060
BG00712
30
OG00431
26.7
OG00419.4
Superiority or Other
OG000
OG003
Cochran-Mantel-Haenszel
0.026
Superiority or Other
OG000
OG004
Cochran-Mantel-Haenszel
0.104
Superiority or Other
OG002
Part B: Placebo
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
OG003
Part B: Sirukumab 100 mg q2 Weeks
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
OG004
Part B: Sirukumab 100 mg q4 Weeks
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
OG005
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
OG006
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Units
Counts
Participants
OG00019
OG00117
OG00230
OG00330
OG00430
OG00530
OG00631
Title
Denominators
Categories
Baseline
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00229
ParticipantsOG00330
ParticipantsOG00430
ParticipantsOG00529
ParticipantsOG00631
Title
Measurements
OG0006.341± 0.9034
OG0015.919± 0.9676
OG0025.908± 0.7332
OG003
Change at Week 12
ParticipantsOG00017
ParticipantsOG00114
ParticipantsOG00229
ParticipantsOG00330
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
Van Der Waerden ANOVA
< 0.001
Superiority or Other
OG002
OG003
Van Der Waerden ANOVA
< 0.001
Superiority or Other
OG002
OG004
Van Der Waerden ANOVA
< 0.001
Superiority or Other
OG002
OG005
Van Der Waerden ANOVA
< 0.001
Superiority or Other
OG002
OG006
Van Der Waerden ANOVA
< 0.001
Superiority or Other
Units
Counts
Participants
OG00017
OG00114
Title
Denominators
Categories
Title
Measurements
OG0005.9
OG00128.6
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
Cochran-Mantel-Haenszel
0.148
Superiority or Other
Participants
OG00017
OG00114
Title
Denominators
Categories
Week 0
ParticipantsOG00017
ParticipantsOG00114
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below lower limit of quantification (LLOQ) (0.0977 microgram per milliliter).
OG0010.01± 0.030
Day 2
ParticipantsOG00016
ParticipantsOG00112
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Day 5
ParticipantsOG00014
ParticipantsOG00110
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Day 8
ParticipantsOG00017
ParticipantsOG00112
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Day 11
ParticipantsOG00016
ParticipantsOG00114
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Week 2
ParticipantsOG00014
ParticipantsOG00113
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Week 4
ParticipantsOG00017
ParticipantsOG00113
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Week 6
ParticipantsOG00015
ParticipantsOG00112
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Week 8
ParticipantsOG00016
ParticipantsOG00111
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Week 10
ParticipantsOG00016
ParticipantsOG00111
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Week 10 Day 4
ParticipantsOG00012
ParticipantsOG0018
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Week 10 Day 7
ParticipantsOG00013
ParticipantsOG00110
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Week 12
ParticipantsOG00012
ParticipantsOG0018
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG001
Week 14
ParticipantsOG00016
ParticipantsOG00110
Title
Measurements
OG0004.78± 1.779
OG001
Week 18
ParticipantsOG00014
ParticipantsOG0019
Title
Measurements
OG0008.52± 4.338
OG001
Week 22
ParticipantsOG00014
ParticipantsOG0018
Title
Measurements
OG00010.79± 5.830
OG001
Week 24
ParticipantsOG00013
ParticipantsOG0017
Title
Measurements
OG00011.37± 6.177
OG001
Week 38
ParticipantsOG0009
ParticipantsOG0016
Title
Measurements
OG0000.41± 0.525
OG001
OG003
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
OG004
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Units
Counts
Participants
OG00026
OG00130
OG00230
OG00330
OG00431
Title
Denominators
Categories
Week 0
ParticipantsOG00025
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00330
ParticipantsOG00431
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG0010.03± 0.087
OG0020.00± 0.000
OG003
Day 5
ParticipantsOG00015
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00315
Day 8
ParticipantsOG00022
ParticipantsOG00126
ParticipantsOG00228
ParticipantsOG00326
Day 11
ParticipantsOG00014
ParticipantsOG00120
ParticipantsOG00218
ParticipantsOG00313
Week 2
ParticipantsOG00020
ParticipantsOG00124
ParticipantsOG00225
ParticipantsOG00325
Week 4
ParticipantsOG00025
ParticipantsOG00127
ParticipantsOG00226
ParticipantsOG00325
Week 8
ParticipantsOG00024
ParticipantsOG00123
ParticipantsOG00220
ParticipantsOG00318
Week 12
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00219
ParticipantsOG00318
Week 16
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00214
ParticipantsOG00314
Week 20
ParticipantsOG00020
ParticipantsOG00121
ParticipantsOG00215
ParticipantsOG00315
Week 24
ParticipantsOG00018
ParticipantsOG00117
ParticipantsOG00214
ParticipantsOG00313
Week 24 Day 4
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG00212
ParticipantsOG0039
Week 24 Day 7
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
ParticipantsOG00311
Week 26
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG0037
Week 28
ParticipantsOG00016
ParticipantsOG00115
ParticipantsOG00213
ParticipantsOG00314
Week 30
ParticipantsOG00017
ParticipantsOG00116
ParticipantsOG00213
ParticipantsOG00314
Week 34
ParticipantsOG00014
ParticipantsOG00116
ParticipantsOG00214
ParticipantsOG00312
Week 38
ParticipantsOG00016
ParticipantsOG00115
ParticipantsOG00214
ParticipantsOG00313
OG003
Part B: Sirukumab 50 mg q4 Weeks
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
OG004
Part B: Sirukumab 25 mg q4 Weeks
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
OG005
Part A: Placebo
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
OG006
Part A: Sirukumab 100 mg q2 Weeks
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
OG00431
OG00517
OG00614
Title
Denominators
Categories
Title
Measurements
OG000-49.31± 246.040
OG00181.46± 25.000
OG00288.53± 12.675
OG00385.42± 18.242
OG00481.22± 24.484
OG00519.97± 41.232
OG00691.19± 4.812
0 affected
16 at risk
EG0041 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0061 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0061 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0053 affected26 at risk
EG0064 affected30 at risk
EG0074 affected30 at risk
EG0085 affected30 at risk
EG0093 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0061 affected30 at risk
EG0072 affected30 at risk
EG0082 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0061 affected30 at risk
EG0071 affected30 at risk
EG0080 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0061 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0062 affected30 at risk
EG0071 affected30 at risk
EG0081 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0082 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0062 affected30 at risk
EG0071 affected30 at risk
EG0081 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0093 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0051 affected26 at risk
EG0062 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0092 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0052 affected26 at risk
EG0063 affected30 at risk
EG0072 affected30 at risk
EG0084 affected30 at risk
EG0096 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0082 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0061 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0061 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0072 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0065 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0092 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0062 affected30 at risk
EG0071 affected30 at risk
EG0082 affected30 at risk
EG0092 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0082 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0073 affected30 at risk
EG0083 affected30 at risk
EG0092 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0051 affected26 at risk
EG0064 affected30 at risk
EG0077 affected30 at risk
EG00810 affected30 at risk
EG0096 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0051 affected26 at risk
EG0063 affected30 at risk
EG0074 affected30 at risk
EG0086 affected30 at risk
EG0093 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0072 affected30 at risk
EG0080 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0073 affected30 at risk
EG0081 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0061 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0083 affected30 at risk
EG0090 affected31 at risk
2 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0042 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0083 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0051 affected26 at risk
EG0061 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0092 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0092 affected31 at risk
2 affected
16 at risk
EG0041 affected30 at risk
EG0050 affected26 at risk
EG0065 affected30 at risk
EG0071 affected30 at risk
EG0082 affected30 at risk
EG0094 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0092 affected31 at risk
1 affected
16 at risk
EG0041 affected30 at risk
EG0051 affected26 at risk
EG0062 affected30 at risk
EG0071 affected30 at risk
EG0081 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0081 affected30 at risk
EG0091 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0062 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0072 affected30 at risk
EG0080 affected30 at risk
EG0091 affected31 at risk
2 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0083 affected30 at risk
EG0091 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0043 affected30 at risk
EG0051 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0042 affected30 at risk
EG0051 affected26 at risk
EG0062 affected30 at risk
EG0071 affected30 at risk
EG0081 affected30 at risk
EG0092 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0041 affected30 at risk
EG0052 affected26 at risk
EG0060 affected30 at risk
EG0071 affected30 at risk
EG0081 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0062 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0091 affected31 at risk
1 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0060 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
1 affected
16 at risk
EG0042 affected30 at risk
EG0050 affected26 at risk
EG0062 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0093 affected31 at risk
0 affected
16 at risk
EG0040 affected30 at risk
EG0050 affected26 at risk
EG0062 affected30 at risk
EG0070 affected30 at risk
EG0080 affected30 at risk
EG0090 affected31 at risk
5.755
± 0.9706
OG0046.190± 0.6829
OG0056.051± 0.8791
OG0065.688± 0.9529
ParticipantsOG00430
ParticipantsOG00529
ParticipantsOG00631
Title
Measurements
OG000-0.619± 0.8541
OG001-2.075± 0.7979
OG002-1.073± 0.9766
OG003-2.248± 1.2050
OG004-2.011± 0.8843
OG005-2.198± 0.8550
OG006-1.964± 0.9532
3.73
± 2.581
7.40
± 3.402
6.01
± 2.861
5.42
± 1.866
4.78
± 1.549
8.83
± 3.251
10.49
± 3.327
12.36
± 3.133
13.49
± 3.670
19.07
± 4.630
18.71
± 4.111
14.31
± 3.438
7.07
± 2.544
2.74
± 1.737
1.18
± 0.816
0.88
± 0.599
0.02
± 0.051
0.02
± 0.076
OG0040.01± 0.048
Participants
OG004
22
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG0016.75± 3.212
OG0026.21± 2.933
OG0032.66± 1.447
OG0041.59± 0.808
Participants
OG004
31
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG0015.67± 2.398
OG0025.85± 2.774
OG0032.61± 1.339
OG0041.49± 0.556
Participants
OG004
18
Title
Measurements
OG0000.02± 0.063
OG0014.50± 2.307
OG0024.68± 2.539
OG0032.54± 1.233
OG0041.26± 0.516
Participants
OG004
28
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG0014.30± 2.265
OG0023.81± 1.934
OG0031.97± 0.916
OG0041.16± 0.426
Participants
OG004
28
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG0017.16± 3.290
OG0022.02± 1.073
OG0030.97± 0.470
OG0040.85± 1.167
Participants
OG004
24
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
OG00110.54± 5.008
OG0023.08± 1.806
OG0031.45± 0.764
OG0040.99± 0.560
Participants
OG004
24
Title
Measurements
OG000NA± NAData could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).