A Study Comparing Sirukumab (CNTO 136) Monotherapy With A... | NCT02019472 | Trialant
NCT02019472
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Oct 26, 2017Actual
Enrollment
559Actual
Phase
Phase 3
Conditions
Arthritis, Rheumatoid
Interventions
adalimumab 40 mg
sirukumab 100 mg
sirukumab 50 mg
Placebo
Countries
United States
Bulgaria
Chile
Colombia
Germany
Hungary
Lithuania
Mexico
Moldova
Poland
Romania
Russia
Serbia
South Africa
Spain
Ukraine
Protocol Section
Identification Module
NCT ID
NCT02019472
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR103111
Secondary IDs
ID
Type
Description
Link
CNTO136ARA3005
Other Identifier
Janssen Research & Development, LLC
2013-001417-32
EudraCT Number
Brief Title
A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis
Official Title
A Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA® Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis
Acronym
SIRROUND-H
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Sep 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
Apr 4, 2014Actual
Primary Completion Date
Aug 17, 2016Actual
Completion Date
Aug 17, 2016Actual
First Submitted Date
Dec 18, 2013
First Submission Date that Met QC Criteria
Dec 18, 2013
First Posted Date
Dec 24, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 16, 2017
Results First Submitted that Met QC Criteria
Aug 16, 2017
Results First Posted Date
Sep 14, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 4, 2016
Certification/Extension First Submitted that Passed QC Review
Jul 4, 2016
Certification/Extension First Posted Date
Jul 6, 2016Estimated
Last Update Submitted Date
Sep 25, 2017
Last Update Posted Date
Oct 26, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Name
Class
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
No
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 primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate.
Detailed Description
This is a randomized, double-blind, parallel-group, global, multicenter study of subcutaneous (SC) sirukumab monotherapy compared with adalimumab monotherapy in subjects with active rheumatoid arthritis. Approximately 510 subjects will be randomly assigned in a 1:1:1 ratio to receive treatment with adalimumab 40 mg SC every 2 weeks, sirukumab 100 mg SC every 2 weeks, or 50 mg SC every 4 weeks, with approximately 170 subjects per treatment group. At Week 16, subjects in all treatment groups who have < 20% improvement from baseline in both swollen and tender joint counts will qualify for early escape. The expected duration of the study is 68 weeks. This includes 52 weeks of treatment with study agent and 16 weeks of safety follow-up after the last study agent administration. The study will end when the last subject completes the last scheduled visit (Week 68 visit or completes the 16 week safety follow-up, whichever is later). Subject safety will be monitored through the end of the study.
Conditions Module
Conditions
Arthritis, Rheumatoid
Keywords
Rheumatoid arthritis
CNTO 136
Sirukumab
Adalimumab
HUMIRA®
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
559Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1 (adalimumab 40 mg)
Experimental
Adalimumab 40 mg SC at Weeks 0, 2, and every 2 weeks through Week 52. At Week 16, subjects who have < 20% improvement from baseline in both swollen and tender joint counts will early escape in a blinded fashion and receive adalimumab 40 mg every week through Week 52.
Biological: adalimumab 40 mg
Group 2 (sirukumab 100 mg)
Experimental
Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks through Week 52. Subjects may meet the early escape criteria at Week 16 (< 20% improvement from baseline in both swollen and tender joint counts) but no sirukumab dose adjustments will made for these subjects. However, these subjects will receive placebo injections every 2 weeks between the sirukumab injections (ie, subjects that early escape will receive a weekly injection of alternating sirukumab and placebo, to preserve the blind).
Biological: sirukumab 100 mg
Drug: Placebo
Group 3 (sirukumab 50 mg)
Experimental
Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. Between sirukumab injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks through Week 50. At Week 16, subjects who have < 20% improvement from baseline in both swollen and tender joint counts will early escape in a blinded fashion and receive sirukumab 100 mg every 2 weeks through Week 52 and placebo injections every 2 weeks between the sirukumab injections (ie, subjects that early escape will receive a weekly injection of alternating sirukumab and placebo, to preserve the blind).
Biological: sirukumab 50 mg
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
adalimumab 40 mg
Biological
SC injections
Group 1 (adalimumab 40 mg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24
The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of "0-10", with the minimum score= 0 (best) to maximum score= 10 (worst).
Baseline and Week 24
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
The ACR 50 Response is defined as greater than or equal to (>=) 50 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >= 50% improvement in 3 of following 5 assessments: subject's assessment of pain using Visual Analog Scale (VAS) (0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), 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 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 24
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24
The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of "0-10", with the minimum score= 0 (best) to maximum score= 10 (worst). The DAS28 (ESR) remission is defined as a DAS28 (ESR) value of less than 2.6 at a visit.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening
Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline
Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or an inadequate responder to methotrexate
Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent
C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening
Exclusion Criteria:
Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept
Has ever used tofacitinib therapy or any other JAK inhibitor
Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration
Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
Taylor PC, Schiff MH, Wang Q, Jiang Y, Zhuang Y, Kurrasch R, Daga S, Rao R, Tak PP, Hsu B. Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naive patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study. Ann Rheum Dis. 2018 May;77(5):658-666. doi: 10.1136/annrheumdis-2017-212496. Epub 2018 Feb 26.
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
A total of 559 participants were randomized and treated. All participants received at least one administration of study treatment.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Adalimumab 40 mg
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
The ACR 20 Response is defined as >= 20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement in 3 of following 5 assessments: subject's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, subject's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum CRP.
Week 24
Phoenix
Arizona
United States
Arvin
California
United States
El Cajon
California
United States
Huntington Beach
California
United States
Pleasanton
California
United States
Thousand Oaks
California
United States
Tustin
California
United States
Whittier
California
United States
Newark
Delaware
United States
Aventura
Florida
United States
Dunedin
Florida
United States
Miami
Florida
United States
New Port Richey
Florida
United States
Palm Harbor
Florida
United States
Plantation
Florida
United States
Tampa
Florida
United States
Kansas City
Kansas
United States
Elizabethtown
Kentucky
United States
Paducah
Kentucky
United States
Frederick
Maryland
United States
Wheaton
Maryland
United States
St Louis
Missouri
United States
Las Vegas
Nevada
United States
Salisbury
North Carolina
United States
Wilmington
North Carolina
United States
Dayton
Ohio
United States
Portland
Oregon
United States
Duncansville
Pennsylvania
United States
Wexford
Pennsylvania
United States
Wyomissing
Pennsylvania
United States
Jackson
Tennessee
United States
Nashville
Tennessee
United States
Austin
Texas
United States
Carrollton
Texas
United States
Corpus Christi
Texas
United States
Cypress
Texas
United States
Lubbock
Texas
United States
McKinney
Texas
United States
Mesquite
Texas
United States
Chesapeake
Virginia
United States
Clarksburg
West Virginia
United States
Rousse
Bulgaria
Sofia
Bulgaria
Port Montt
Chile
Temuco
Chile
Barranquilla
Colombia
Bogotá
Colombia
Bucaramanga
Colombia
Bad Doberan
Germany
Berlin
Germany
Cologne
Germany
Ratingen
Germany
Vogelsang-Gommern
Germany
Debrecen
Hungary
Gödöllő
Hungary
KlaipÄ—da
Lithuania
Å iauliai
Lithuania
Vilnius
Lithuania
Chihuahua City
Mexico
Guadalajara
Mexico
Jalisco
Mexico
Mexicali
Mexico
Chisinau
Moldova
Bydgoszcz
Poland
Bytom
Poland
Krakow
Poland
Lublin
Poland
Nadarzyn
Poland
Poznan
Poland
Warsaw
Poland
Wroclaw
Poland
Bucharest
Romania
Constanța
Romania
PloieÅŸti
Romania
Arkhangelsk
Russia
Kazan'
Russia
Kemerovo
Russia
Kursk
Russia
Moscow
Russia
Novosibirsk
Russia
Petrozavodsk
Russia
Ryazan
Russia
Saint Petersburg
Russia
Tomsk
Russia
Tver'
Russia
Vladimir
Russia
Yaroslavl
Russia
Belgrade
Serbia
Novi Sad
Serbia
Zemun
Serbia
Cape Town
South Africa
Durban
South Africa
Kempton Park
South Africa
Stellenbosch
South Africa
A Coruña
Spain
Madrid
Spain
Chernihiv
Ukraine
Kryvyi Rih
Ukraine
Kyiv
Ukraine
Lviv
Ukraine
Odesa
Ukraine
Poltava
Ukraine
Sumy
Ukraine
Ternopil
Ukraine
Vinnytsia
Ukraine
Zaporizhzhia
Ukraine
FG001
Sirukumab 50 mg
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
FG002
Sirukumab 100 mg
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
FG000186 subjects
FG001186 subjects
FG002187 subjects
COMPLETED
FG000149 subjects
FG001134 subjects
FG002145 subjects
NOT COMPLETED
FG00037 subjects
FG00152 subjects
FG00242 subjects
Type
Comment
Reasons
Adverse Event
FG00014 subjects
FG00123 subjects
FG00217 subjects
Death
FG0000 subjects
FG0011 subjects
FG0021 subjects
Lack of Efficacy
FG0007 subjects
FG0014 subjects
FG0024 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0021 subjects
Physician Decision
FG0001 subjects
FG0012 subjects
FG0020 subjects
Pregnancy
FG0001 subjects
FG0012 subjects
FG0022 subjects
Withdrawal by Subject
FG00011 subjects
FG00110 subjects
FG00211 subjects
Other
FG0003 subjects
FG0018 subjects
FG0026 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Adalimumab 40 mg
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
BG001
Sirukumab 50 mg
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
BG002
Sirukumab 100 mg
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000186
BG001186
BG002187
BG003559
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00052.6± 12.15
BG00152.5± 12.46
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000156
BG001157
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Bulgaria
Title
Measurements
BG0001
BG0011
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
Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24
The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of "0-10", with the minimum score= 0 (best) to maximum score= 10 (worst).
Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent. Participants with missing DAS28 (ESR) at baseline were excluded from the analysis.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 24
ID
Title
Description
OG000
Adalimumab 40 mg
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
OG001
Sirukumab 50 mg
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
OG002
Sirukumab 100 mg
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
Units
Counts
Participants
OG000186
OG001185
OG002185
Title
Denominators
Categories
Baseline
Title
Measurements
OG0006.89± 0.851
OG0016.90± 0.881
OG0026.91± 0.863
Change from Baseline at Week 24
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
OG002
ANCOVA
< 0.001
LS mean difference
-0.76
2-Sided
95
-1.07
-0.46
Superiority or Other
OG000
OG001
ANCOVA
=0.013
Primary
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
The ACR 50 Response is defined as greater than or equal to (>=) 50 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >= 50% improvement in 3 of following 5 assessments: subject's assessment of pain using Visual Analog Scale (VAS) (0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), 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 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).
Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Adalimumab 40 mg
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
OG001
Secondary
Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24
The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of "0-10", with the minimum score= 0 (best) to maximum score= 10 (worst). The DAS28 (ESR) remission is defined as a DAS28 (ESR) value of less than 2.6 at a visit.
Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Adalimumab 40 mg
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
OG001
Sirukumab 50 mg
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
Secondary
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
The ACR 20 Response is defined as >= 20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement in 3 of following 5 assessments: subject's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, subject's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum CRP.
Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Adalimumab 40 mg
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
OG001
Sirukumab 50 mg
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
Time Frame
Screening, up to Week 68
Description
Safety population included all participants who were randomized, received at least 1 (partial or complete) dose of double-blind study agent, and contributed any safety data after the start of study treatment.
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
Adalimumab 40 mg q2w Only
Participants received 40 mg of adalimumab subcutaneously q2w for 52 weeks.
15
173
71
173
EG001
Adalimumab 40 mg q2w Then 40 mg q1w
Participants received 40 mg adalimumab subcutaneously q2w until Week 16 and received 40 mg adalimumab subcutaneously weekly (q1w) (due to EE) through Week 52.
1
13
3
13
EG002
Adalimumab 40 mg
Participants received 40 milligram (mg) of adalimumab subcutaneously once every 2 weeks (q2w) for 52 weeks. Participants who met early escape (EE) criteria (had less than 20 percent improvement from baseline in swollen and tender joint counts) at Week 16 received adalimumab 40 mg once every week (q1w) through Week 52.
16
186
74
186
EG003
Sirukumab 50 mg q4w Only
Participants received 50 mg of sirukumab subcutaneously every four weeks (q4w) for 52 weeks.
23
160
79
160
EG004
Sirukumab 50 mg q4w Then 100 mg q2w
Participants received 50 mg sirukumab until Week 16 and received 100 mg sirukumab subcutaneously q4w (due to EE or inadvertently) through Week 52.
6
26
13
26
EG005
Sirukumab 50 mg
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
29
186
92
186
EG006
Sirukumab 100 mg
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
22
187
86
187
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pancytopenia
Blood and lymphatic system disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG0031 affected160 at risk
EG004
Atrial fibrillation
Cardiac disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected13 at risk
EG0021 affected186 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Gastrointestinal perforation
Gastrointestinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Peripheral swelling
General disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0002 affected173 at risk
EG0010 affected13 at risk
EG0022 affected186 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Bursitis infective
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Erysipelas
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Gastrointestinal bacterial infection
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Herpes ophthalmic
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Tongue abscess
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Gliomatosis cerebri
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected13 at risk
EG0021 affected186 at risk
EG003
Essential hypertension
Vascular disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Vasculitis
Vascular disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected13 at risk
EG0020 affected186 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0004 affected173 at risk
EG0010 affected13 at risk
EG0024 affected186 at risk
EG00316 affected160 at risk
EG0041 affected26 at risk
EG00517 affected186 at risk
EG00611 affected187 at risk
Injection site erythema
General disorders
MedDRA Version 17.0
Non-systematic Assessment
EG00013 affected173 at risk
EG0010 affected13 at risk
EG00213 affected186 at risk
EG003
Injection site pruritus
General disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0008 affected173 at risk
EG0010 affected13 at risk
EG0028 affected186 at risk
EG003
Injection site swelling
General disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0004 affected173 at risk
EG0010 affected13 at risk
EG0024 affected186 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG0004 affected173 at risk
EG0010 affected13 at risk
EG0024 affected186 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG00016 affected173 at risk
EG0010 affected13 at risk
EG00216 affected186 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 17.0
Non-systematic Assessment
EG00010 affected173 at risk
EG0010 affected13 at risk
EG00210 affected186 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 17.0
Non-systematic Assessment
EG00012 affected173 at risk
EG0010 affected13 at risk
EG00212 affected186 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA Version 17.0
Non-systematic Assessment
EG00011 affected173 at risk
EG0010 affected13 at risk
EG00211 affected186 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 17.0
Non-systematic Assessment
EG00017 affected173 at risk
EG0010 affected13 at risk
EG00217 affected186 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0009 affected173 at risk
EG0012 affected13 at risk
EG00211 affected186 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 17.0
Non-systematic Assessment
EG0009 affected173 at risk
EG0011 affected13 at risk
EG00210 affected186 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-Cilag International N.V.
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
D000068879
Adalimumab
C568922
sirukumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0
Between 18 and 65 years
BG000163
BG001159
BG002164
BG003486
>=65 years
BG00023
BG00127
BG00223
BG00373
49.8
± 12.31
BG00351.6± 12.36
154
BG003467
Male
BG00030
BG00129
BG00233
BG00392
0
BG0032
Chile
Title
Measurements
BG0005
BG0012
BG0023
BG00310
Colombia
Title
Measurements
BG0007
BG0016
BG0021
BG00314
Germany
Title
Measurements
BG0005
BG0011
BG0025
BG00311
Hungary
Title
Measurements
BG0000
BG0011
BG0022
BG0033
Lithuania
Title
Measurements
BG00012
BG00115
BG0029
BG00336
Mexico
Title
Measurements
BG0003
BG0015
BG0023
BG00311
Moldova
Title
Measurements
BG0002
BG0016
BG0024
BG00312
Poland
Title
Measurements
BG00021
BG00117
BG00220
BG00358
Romania
Title
Measurements
BG0004
BG0015
BG0024
BG00313
Russian Federation
Title
Measurements
BG00030
BG00129
BG00233
BG00392
Serbia
Title
Measurements
BG00020
BG00119
BG00226
BG00365
South Africa
Title
Measurements
BG0008
BG0019
BG0027
BG00324
Spain
Title
Measurements
BG0001
BG0011
BG0020
BG0032
Ukraine
Title
Measurements
BG00042
BG00137
BG00239
BG003118
United States
Title
Measurements
BG00025
BG00132
BG00231
BG00388
Title
Measurements
OG000-2.19± 1.437
OG001-2.58± 1.524
OG002-2.96± 1.58
Least Square (LS) mean difference
-0.39
2-Sided
95
-0.69
-0.08
Superiority or Other
Sirukumab 50 mg
Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 52 weeks and in between placebo SC injections was received at Weeks 2, 6, 10 and 14. Participants who met EE criteria at Week 16 received 100 mg sirukumab every 2 weeks (q2w) from Week 16 through Week 52 and placebo SC injections q2w between the sirukumab injections from Week 16 through Week 50.
OG002
Sirukumab 100 mg
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
Units
Counts
Participants
OG000186
OG001186
OG002187
Title
Denominators
Categories
Title
Measurements
OG00031.7
OG00126.9
OG00235.3
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
0.306
Percentage Difference
-4.8
2-Sided
95
-14.1
4.4
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
0.464
Percentage Difference
3.6
2-Sided
95
-6
13.1
Superiority or Other
OG002
Sirukumab 100 mg
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.
Units
Counts
Participants
OG000186
OG001186
OG002187
Title
Denominators
Categories
Title
Measurements
OG0007.5
OG00112.9
OG00220.3
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
0.086
Percentage Difference
5.4
2-Sided
95
-0.7
11.4
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
< 0.001
Percentage Difference
12.8
2-Sided
95
5.9
19.7
Superiority or Other
OG002
Sirukumab 100 mg
Participants received 100 mg of sirukumab subcutaneous injections at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Participants who met EE criteria at Week 16 received placebo injections q2w in between the sirukumab injections through Week 52.