A Study of the Effectiveness and Safety of Ustekinumab (S... | NCT01645280 | Trialant
NCT01645280
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
May 12, 2016Estimated
Enrollment
274Actual
Phase
Phase 2
Conditions
Arthritis, Rheumatoid
Interventions
Placebo + methotrexate (MTX) (Group 1)
Ustekinumab + MTX (Group 2)
Ustekinumab + MTX (Group 3)
CNTO 1959 + MTX (Group 4)
CNTO 1959 + MTX (Group 5)
Countries
United States
Argentina
Bulgaria
Chile
Colombia
Czechia
Hungary
Poland
Russia
Singapore
Ukraine
Protocol Section
Identification Module
NCT ID
NCT01645280
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR100736
Secondary IDs
ID
Type
Description
Link
CNTO1275ARA2001
Other Identifier
Janssen Research & Development, LLC
2011-001122-18
EudraCT Number
Brief Title
A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
May 2016
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 2012
Primary Completion Date
Dec 2013Actual
Completion Date
May 2014Actual
First Submitted Date
Jun 6, 2012
First Submission Date that Met QC Criteria
Jul 17, 2012
First Posted Date
Jul 20, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 12, 2014
Results First Submitted that Met QC Criteria
Dec 12, 2014
Results First Posted Date
Dec 19, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 10, 2016
Last Update Posted Date
May 12, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.
Detailed Description
This is a randomized (patients assigned to treatment by chance), double-blind (study personnel and patients will not know what treatment is being assigned to patients), multicenter, placebo-controlled (a placebo is a treatment identical in appearance to the study agent, but containing no active ingredient), dose-ranging study. Approximately 250 patients will be randomly assigned to 1 of 5 treatment groups. The maximum length of study participation is 54 weeks, including a 6-week screening period. The end of the study will be the last follow-up visit of the last patient. Study visits and evaluations will occur, and patient safety will be monitored throughout the study.
Conditions Module
Conditions
Arthritis, Rheumatoid
Keywords
Active rheumatoid arthritis
Ustekinumab
STELARA
CNTO 1959
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
274Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1
Placebo Comparator
Drug: Placebo + methotrexate (MTX) (Group 1)
Group 2
Experimental
Drug: Ustekinumab + MTX (Group 2)
Group 3
Experimental
Drug: Ustekinumab + MTX (Group 3)
Group 4
Experimental
Drug: CNTO 1959 + MTX (Group 4)
Group 5
Experimental
Drug: CNTO 1959 + MTX (Group 5)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo + methotrexate (MTX) (Group 1)
Drug
Placebo: form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28
The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).
Week 28
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28
The DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, CRP (mG/L) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have had RA for at least 6 months prior to screening
Have a diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association - Be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening
Have been treated with and tolerated MTX for at least 6 months prior to screening, and have a MTX dose of >= 10 mg and <= 25 mg per week and stable for at least 12 weeks prior to first administration of study agent
Have active RA, defined as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints at the time of screening and baseline; serum C-reactive protein (CRP) >= 0.80 mg/dL at screening. The investigator may consider the patient eligible if the CRP value is at least 0.80 mg/dL in a single repeat testing during the screening period
If using oral corticosteroids, must be on a stable dose of <= 10 mg/day of prednisone or an equipotent dose of another oral corticosteroid for at least 2 weeks prior to the first administration of study agent. If not using corticosteroids at Week 0, the patient must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent
If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics regularly for RA, the patient must have been on a stable dose for at least 2 weeks prior to the first administration of study agent. If not using NSAIDs or other analgesics for RA at Week 0, the patient must have not received NSAIDs or other analgesics for RA for at least 2 weeks prior to the first administration of study agent
Exclusion Criteria:
Has other inflammatory diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease, that might confound the evaluation of the benefit of study agent therapy
Has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled
Has any known malignancy or history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent)
Has a history of lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location, or clinically significant splenomegaly
Has known allergies, hypersensitivity, or intolerance to ustekinumab or CNTO 1959 or its inactive ingredients
Has ever received any approved or investigational biologic agent
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
Smolen JS, Agarwal SK, Ilivanova E, Xu XL, Miao Y, Zhuang Y, Nnane I, Radziszewski W, Greenspan A, Beutler A, Baker D. A randomised phase II study evaluating the efficacy and safety of subcutaneously administered ustekinumab and guselkumab in patients with active rheumatoid arthritis despite treatment with methotrexate. Ann Rheum Dis. 2017 May;76(5):831-839. doi: 10.1136/annrheumdis-2016-209831. Epub 2017 Jan 13.
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 274 subjects were enrolled into the study and 273 were treated. One participant in the Ustekinumab 90 milligram (mg) every 8 weeks group did not receive the treatment due to an adverse event before dosing.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
FG001
Ustekinumab 90 mg Every 8 Weeks
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Mexico
Peru
South Korea
Turkey (Türkiye)
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Group 1
Ustekinumab + MTX (Group 2)
Drug
Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)
Group 2
Ustekinumab + MTX (Group 3)
Drug
Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose)
Group 3
CNTO 1959 + MTX (Group 4)
Drug
CNTO 1959: type = exact number, unit = mg, number = 200, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)
Group 4
CNTO 1959 + MTX (Group 5)
Drug
CNTO 1959: type = exact number, unit = mg, number = 50, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose)
Group 5
From Baseline to Week 28
Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12
The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 2) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 3) Physician's Global Assessment of Disease Activity-Visual Analog Scale, 4) Patient's Assessment of Physical Function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI), 5) C-reactive Protein (CRP).
Week 12
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28
The Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Baseline and Week 28
Rock Island
Illinois
United States
St Louis
Missouri
United States
Buenos Aires
Argentina
San Juan
Argentina
San Miguel de Tucumán
Argentina
Plovdiv
Bulgaria
Sofia
Bulgaria
Osorno
Chile
Bogotá
Colombia
Bucaramanga
Colombia
Cali
Colombia
Chía
Colombia
Medellín
Colombia
Hlučín
Czechia
Kladno
Czechia
Uherské Hradiště
Czechia
Budapest
Hungary
Gödöllő
Hungary
Székesfehérvár
Hungary
Szombathely
Hungary
Veszprém
Hungary
Bialystok
Poland
Elblag
Poland
Krakow
Poland
Poznan
Poland
Sopot
Poland
Sosnowiec
Poland
Warsaw
Poland
Kazan'
Russia
Moscow
Russia
Novosibirsk
Russia
Petrozavodsk
Russia
Saint Petersburg
Russia
Saratov
Russia
Ufa
Russia
Ulyanovsk
Russia
Yaroslavl
Russia
Singapore
Singapore
Donetsk
Ukraine
Ivano-Frankivsk
Ukraine
Kharkiv
Ukraine
Kiev
Ukraine
Simferopol
Ukraine
Ternopil
Ukraine
Uzhhorod
Ukraine
Vinnitsa
Ukraine
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
FG002
Ustekinumab 90 mg Every 12 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
FG003
CNTO1959 200 mg Every 8 Weeks
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
FG004
CNTO1959 50 mg Every 8 Weeks
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
FG00055 subjects16 participants in placebo group early escaped to receive Ustekinmab; included in safety population.
FG00154 subjects
FG00255 subjects
FG00354 subjects
FG00455 subjects
COMPLETED
FG00049 subjects
FG00151 subjects
FG00249 subjects
FG00348 subjects
FG00447 subjects
NOT COMPLETED
FG0006 subjects
FG0013 subjects
FG0026 subjects
FG0036 subjects
FG0048 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Withdrawal by Subject
FG0004 subjects
FG0010 subjects
FG0022 subjects
FG0034 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Other
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Treatment not completed/Completed f/u
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Analysis population included all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
BG001
Ustekinumab 90 mg Every 8 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
BG002
Ustekinumab 90 mg Every 12 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
BG003
CNTO1959 200 mg Every 8 Weeks
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
BG004
CNTO1959 50 mg Every 8 Weeks
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00055
BG00155
BG00255
BG00354
BG00455
BG005274
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
BG00051.1± 10.57
BG00150.8± 13.01
BG00251.4± 13.59
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00048
BG00146
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Argentina
Title
Measurements
BG0001
BG0015
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 American College of Rheumatology 20 (ACR 20) Response at Week 28
The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).
The intent-to-treat (ITT) population included all randomized participants. For early escape, data at or prior to Week 16 were carried forward through Week 28.
Posted
Number
percentage of participants
Week 28
ID
Title
Description
OG000
Placebo
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
OG001
Ustekinumab 90 mg Every 8 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
OG002
Ustekinumab 90 mg Every 12 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
OG003
CNTO1959 200 mg Every 8 Weeks
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
OG004
CNTO1959 50 mg Every 8 Weeks
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Units
Counts
Participants
OG00055
OG00155
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG00040.0
OG00152.7
OG00254.5
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
Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
0.184
No
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28
The DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, CRP (mG/L) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
The modified-ITT population included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.
Posted
Least Squares Mean
Standard Error
units on scale
From Baseline to Week 28
ID
Title
Description
OG000
Placebo
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
OG001
Ustekinumab 90 mg Every 8 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
OG002
Secondary
Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12
The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 2) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 3) Physician's Global Assessment of Disease Activity-Visual Analog Scale, 4) Patient's Assessment of Physical Function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI), 5) C-reactive Protein (CRP).
The m-ITT population included participants who received at least 1 (partial or complete) dose of study agent.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
OG001
Ustekinumab 90 mg Every 8 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
OG002
Ustekinumab 90 mg Every 12 Weeks
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28
The Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
The m-ITT included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.
Posted
Least Squares Mean
Standard Error
units on scale
Baseline and Week 28
ID
Title
Description
OG000
Placebo
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
OG001
Ustekinumab 90 mg Every 8 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Time Frame
Week 0 to 48
Description
Safety population included all participants who received at least 1 dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
3
55
13
55
EG001
Placebo (Early Escape)
Participants who early escaped at Week 16 and received ustekinumab 90 milligram (mg) subcutaneously at Week 16, 20 and 28 along with methotrexate.
1
16
6
16
EG002
Ustekinumab 90 mg Every 8 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
4
54
15
54
EG003
Ustekinumab 90 mg Every 12 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
3
55
15
55
EG004
CNTO1959 200 mg Every 8 Weeks
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
3
54
18
54
EG005
CNTO1959 50 mg Every 8 Weeks
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
0
55
14
55
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina Unstable
Cardiac disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected16 at risk
EG0020 affected54 at risk
EG0030 affected55 at risk
EG0040 affected54 at risk
EG0050 affected55 at risk
Ileus
Gastrointestinal disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0020 affected54 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 11.0
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected16 at risk
EG0020 affected54 at risk
EG003
Lobar Pneumonia
Infections and infestations
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0020 affected54 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0021 affected54 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0021 affected54 at risk
EG003
Rheumatoid Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0001 affected55 at risk
EG0011 affected16 at risk
EG0020 affected54 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0021 affected54 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0020 affected54 at risk
EG003
Shock
Vascular disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0021 affected54 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0021 affected54 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0020 affected54 at risk
EG003
Breast Cancer Stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0020 affected54 at risk
EG003
Squamous Cell Carcinoma of Lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected16 at risk
EG0020 affected54 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Influenza
Infections and infestations
MedDRA Version 11.0
Non-systematic Assessment
EG0003 affected55 at risk
EG0010 affected16 at risk
EG0021 affected54 at risk
EG0033 affected55 at risk
EG0043 affected54 at risk
EG0053 affected55 at risk
Nasopharyngitis
Infections and infestations
MedDRA Version 11.0
Non-systematic Assessment
EG0003 affected55 at risk
EG0011 affected16 at risk
EG0025 affected54 at risk
EG003
Rheumatoid Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected16 at risk
EG0022 affected54 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0003 affected55 at risk
EG0011 affected16 at risk
EG0022 affected54 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0003 affected55 at risk
EG0011 affected16 at risk
EG0024 affected54 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected16 at risk
EG0022 affected54 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 11.0
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected16 at risk
EG0022 affected54 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected16 at risk
EG0020 affected54 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0001 affected55 at risk
EG0011 affected16 at risk
EG0020 affected54 at risk
EG003
Asthenia
General disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected16 at risk
EG0022 affected54 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected16 at risk
EG0020 affected54 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected16 at risk
EG0020 affected54 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 11.0
Non-systematic Assessment
EG0001 affected55 at risk
EG0011 affected16 at risk
EG0020 affected54 at risk
EG003
Photosensitivity Reaction
Skin and subcutaneous tissue disorders
MedDRA Version 11.0
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected16 at risk
EG0020 affected54 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
If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Director Clin Development
Janssen Pharmaceuticals
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
D008727
Methotrexate
D000069549
Ustekinumab
C000588857
guselkumab
Ancestor Terms
ID
Term
D000630
Aminopterin
D011622
Pterins
D011621
Pteridines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
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
5 subjects
1 subjects
0 subjects
2 subjects
54.6
± 11.34
BG00449.9± 12.85
BG00551.5± 12.34
47
BG00342
BG00445
BG005228
Male
BG0007
BG0019
BG0028
BG00312
BG00410
BG00546
6
BG0035
BG0046
BG00523
Bulgaria
Title
Measurements
BG0002
BG0012
BG0022
BG0032
BG0041
BG0059
CZ Rep
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
Chile
Title
Measurements
BG0001
BG0011
BG0021
BG0031
BG0042
BG0056
Colombia
Title
Measurements
BG00010
BG0019
BG0028
BG0036
BG00410
BG00543
Hungary
Title
Measurements
BG0006
BG0015
BG0022
BG0034
BG0043
BG00520
Poland
Title
Measurements
BG0005
BG0018
BG0026
BG0037
BG0049
BG00535
Russia
Title
Measurements
BG00020
BG00115
BG00218
BG00319
BG00414
BG00586
Singapore
Title
Measurements
BG0001
BG0011
BG0020
BG0032
BG0040
BG0054
USA
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
Ukraine
Title
Measurements
BG0009
BG0019
BG00210
BG0038
BG00410
BG00546
54
OG00455
44.4
OG00438.2
Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
0.130
No
Superiority or Other
OG000
OG003
Cochran-Mantel-Haenszel
Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
0.642
No
Superiority or Other
OG000
OG004
Cochran-Mantel-Haenszel
Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
0.832
No
Superiority or Other
Ustekinumab 90 mg Every 12 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
OG003
CNTO1959 200 mg Every 8 Weeks
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
OG004
CNTO1959 50 mg Every 8 Weeks
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Units
Counts
Participants
OG00055
OG00154
OG00255
OG00354
OG00455
Title
Denominators
Categories
Title
Measurements
OG000-0.94± 0.174
OG001-1.52± 0.185
OG002-1.49± 0.183
OG003-1.21± 0.170
OG0046.07± 0.821
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
ANCOVA
Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
0.019
No
Superiority or Other
OG000
OG002
ANCOVA
Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
0.025
No
Superiority or Other
OG000
OG003
ANCOVA
Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
0.248
No
Superiority or Other
OG000
OG004
ANCOVA
Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
0.045
No
Superiority or Other
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
OG003
CNTO1959 200 mg Every 8 Weeks
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
OG004
CNTO1959 50 mg Every 8 Weeks
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Units
Counts
Participants
OG00055
OG00154
OG00255
OG00354
OG00455
Title
Denominators
Categories
Title
Measurements
OG00029.1
OG00137.0
OG00234.5
OG00333.3
OG00420.0
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
Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
0.381
No
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
0.543
No
Superiority or Other
OG000
OG003
Cochran-Mantel-Haenszel
Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
0.629
No
Superiority or Other
OG000
OG004
Cochran-Mantel-Haenszel
Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
0.273
No
Superiority or Other
OG002
Ustekinumab 90 mg Every 12 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
OG003
CNTO1959 200 mg Every 8 Weeks
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
OG004
CNTO1959 50 mg Every 8 Weeks
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Units
Counts
Participants
OG00055
OG00154
OG00255
OG00354
OG00455
Title
Denominators
Categories
Title
Measurements
OG000-0.30± 0.074
OG001-0.48± 0.072
OG002-0.44± 0.071
OG003-0.41± 0.075
OG004-0.39± 0.076
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
ANCOVA
Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
0.060
No
Superiority or Other
OG000
OG002
ANCOVA
Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
0.134
No
Superiority or Other
OG000
OG003
ANCOVA
Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
0.280
No
Superiority or Other
OG000
OG004
ANCOVA
Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.