A Study of Safety and Effectiveness of Golimumab in Parti... | NCT00361335 | Trialant
NCT00361335
Sponsor
Centocor, Inc.
Status
Completed
Last Update Posted
Jul 29, 2014Estimated
Enrollment
643Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
Golimumab
Methotrexate
Placebo
Countries
United States
Argentina
Australia
Colombia
Germany
Hungary
Latvia
Lithuania
Malaysia
Malta
Mexico
New Zealand
Peru
Poland
Ukraine
Protocol Section
Identification Module
NCT ID
NCT00361335
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR012781
Secondary IDs
ID
Type
Description
Link
C0524T12
Other Identifier
Centocor, Inc.
2005-003232-21
EudraCT Number
Brief Title
A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Acronym
Not provided
Organization
Centocor, Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2006
Primary Completion Date
Dec 2007Actual
Completion Date
Sep 2009Actual
First Submitted Date
Aug 4, 2006
First Submission Date that Met QC Criteria
Aug 4, 2006
First Posted Date
Aug 8, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 24, 2010
Results First Submitted that Met QC Criteria
Jul 23, 2012
Results First Posted Date
Aug 24, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 23, 2014
Last Update Posted Date
Jul 29, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Centocor, Inc.INDUSTRY
Collaborators
Name
Class
Schering-Plough
INDUSTRY
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 assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.
Detailed Description
This is a Phase III, double blind (neither investigator nor participant knows the treatment received), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), multicenter, 5-arm (treatment groups) study of golimumab at 2 doses (given with or without MTX over a period of 30 minutes) for at least 48 weeks in patients with active RA despite concurrent MTX therapy. The study consists of a treatment period of golimumab IV infusions (IV Period) which ranges from 48 weeks to approximately 140 weeks, assuming an enrollment period of approximately 92 weeks, and a long-term optional extension period (Extension Study) in which golimumab SC injections will be given for 24 weeks. The end of study will be the time the last participant completes the Week E-40 visit (Extension Study) for safety follow-up assessments. For the IV Period, participants will be randomly assigned to 1 of the 5 treatment groups in a 1:1:1:1:1 ratio (approximately 125 patients per group). At Week 16 and Week 24, joint assessment results will be used to allow participants to enter early escape and dose regimen adjustment, respectively, in a blinded fashion. Treatment will be unblinded after the 48-week database lock and participants will be given the option to participate in the Extension Study and receive SC injections of 50mg golimumab (with or without MTX) every 4 weeks for an additional 24 weeks. Safety will be monitored throughout the study. The entire study duration (IV Period plus Extension Study) for each participant will range from 88 weeks up to 192 weeks, assuming an enrollment period of approximately 92 weeks.
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis
Golimumab
Methotrexate
Tumor Necrosis Factor-alpha
Immunology
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
643Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group I: 2mg/kg Golimumab + MTX
Experimental
Intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (an additional 2mg/kg IV infusion of golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive methotrexate (MTX) at the same dose as that before study entry
Drug: Golimumab
Drug: Methotrexate
Group II: 2mg/kg Golimumab only
Experimental
IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (addition of MTX) and dose regimen adjustment (addition of MTX or switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive placebo (sham MTX) capsules
Drug: Golimumab
Drug: Placebo
Group III: 4mg/kg Golimumab + MTX
Experimental
IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive MTX at the same dose as that before study entry.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Golimumab
Drug
2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes
Group I: 2mg/kg Golimumab + MTX
Group II: 2mg/kg Golimumab only
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14
An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).
Week 0 to Week 14
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
- Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender joints for at least 3 months prior to screening - Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
Exclusion Criteria:
- Participants having known hypersensitivity (severe allergy) to human immunoglobulin proteins or other components of golimumab - Having known clinically serious adverse reaction to a biologic anti-TNF agent - Have had history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening
George MD, Ostergaard M, Conaghan PG, Emery P, Baker DG, Baker JF. Obesity and rates of clinical remission and low MRI inflammation in rheumatoid arthritis. Ann Rheum Dis. 2017 Oct;76(10):1743-1746. doi: 10.1136/annrheumdis-2017-211569. Epub 2017 Jun 12.
Baker JF, Conaghan PG, Smolen JS, Aletaha D, Shults J, Emery P, Baker DG, Ostergaard M. Development and validation of modified disease activity scores in rheumatoid arthritis: superior correlation with magnetic resonance imaging-detected synovitis and radiographic progression. Arthritis Rheumatol. 2014 Apr;66(4):794-802. doi: 10.1002/art.38304.
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 643 participants were randomized in the IV Period (Main Study). A total of 508 participants were randomized in the SC Period (Extension Study); participation in the SC Period was optional.
Recruitment Details
The study was conducted at 86 investigational sites. The study population included 643 randomized participants from 15 countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
2mg/kg Golimumab+ MTX
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (addition of MTX) and dose regimen adjustment (addition of MTX), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive placebo (sham MTX) capsules.
Drug: Golimumab
Drug: Placebo
Group V: IV Placebo + MTX
Placebo Comparator
IV infusions of placebo at Week 0 and Week 12 with early escape (switch to 4mg/kg IV golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (placebo plus golimumab) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition patients will receive MTX at the same dose as that before study entry. Participants still receiving placebo injections at Week 48 are not eligible to enter the Extension Study.
Drug: Methotrexate
Drug: Placebo
Group III: 4mg/kg Golimumab + MTX
Group IV: 4mg/kg Golimumab only
Methotrexate
Drug
Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.
Group I: 2mg/kg Golimumab + MTX
Group III: 4mg/kg Golimumab + MTX
Group V: IV Placebo + MTX
Placebo
Drug
Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.
Group II: 2mg/kg Golimumab only
Group IV: 4mg/kg Golimumab only
Group V: IV Placebo + MTX
sham MTX
Week 0 to Week 24
Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity [based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities] and CRP blood test to measure inflammation).
Week 0 to Week 14
Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14
DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A "Good" response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A "Moderate" response is defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >1.2 or a DAS28 score of <= 5.1 and improvement from baseline in DAS28 score of >0.6 to 1.2
Week 0 to Week 14
Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14
The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.
Taylor PC, Ritchlin C, Mendelsohn A, Baker D, Kim L, Xu Z, Mack M, Kremer J. Maintenance of efficacy and safety with subcutaneous golimumab among patients with active rheumatoid arthritis who previously received intravenous golimumab. J Rheumatol. 2011 Dec;38(12):2572-80. doi: 10.3899/jrheum.110570. Epub 2011 Nov 15.
Kremer J, Ritchlin C, Mendelsohn A, Baker D, Kim L, Xu Z, Han J, Taylor P. Golimumab, a new human anti-tumor necrosis factor alpha antibody, administered intravenously in patients with active rheumatoid arthritis: Forty-eight-week efficacy and safety results of a phase III randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2010 Apr;62(4):917-28. doi: 10.1002/art.27348.
FG001
2mg/kg Golimumab Only
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
FG002
4mg/kg Golimumab + MTX
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
FG003
4mg/kg Golimumab Only
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
FG004
IV Placebo + MTX
Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
FG005
EE/DRA -> 2mg/kg Golimumab + MTX
At Week 16 and Week 24 participants entered early escape (EE) and dose regimen adjustment (DRA), respectively, depending on joint assessment results and received IV infusions of 2mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
FG006
EE/DRA -> 4mg/kg Golimumab + MTX
At Week 16 and Week 24 participants entered EE and DRA, respectively, depending on joint assessment results and received IV infusions of 4mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
FG000129 subjects
FG001128 subjects
FG002128 subjects
FG003129 subjects
FG004129 subjects
FG0050 subjects"0" in column indicates this reporting group is not relevant to the IV Period.
FG0060 subjects"0" in column indicates this reporting group is not relevant to the IV Period.
COMPLETED
FG000109 subjects
FG00199 subjects
FG002107 subjects
FG003102 subjects
FG004105 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00020 subjects
FG00129 subjects
FG00221 subjects
FG00327 subjects
FG00424 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0009 subjects
FG0014 subjects
FG0025 subjects
FG0039 subjects
FG0048 subjects
FG0050 subjects
FG0060 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Death
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Discontinued oral study agent
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Protocol-prohibited medications
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Worsening of RA
FG0000 subjects
FG0015 subjects
FG0021 subjects
FG0034 subjects
FG004
Other
FG0002 subjects
FG0019 subjects
FG0029 subjects
FG0033 subjects
FG004
Lack of Efficacy
FG0005 subjects
FG0019 subjects
FG0023 subjects
FG0037 subjects
FG004
SC Period: Week E0 to Week E24
Type
Comment
Milestone Data
STARTED
FG00082 subjectsReporting groups in the SC Period are determined by treatment assignment at Week 24
FG00159 subjectsReporting groups in the SC Period are determined by treatment assignment at Week 24
FG002104 subjectsReporting groups in the SC Period are determined by treatment assignment at Week 24
FG00363 subjectsReporting groups in the SC Period are determined by treatment assignment at Week 24
FG0043 subjectsReporting groups in the SC Period are determined by treatment assignment at Week 24
FG00524 subjectsReporting groups in the SC Period are determined by treatment assignment at Week 24
FG006173 subjectsReporting groups in the SC Period are determined by treatment assignment at Week 24
COMPLETED
FG00080 subjects
FG00156 subjects
FG00299 subjects
FG00359 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0025 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
2mg/kg Golimumab+ MTX
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
BG001
2mg/kg Golimumab Only
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
BG002
4mg/kg Golimumab + MTX
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
BG003
4mg/kg Golimumab Only
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
BG004
IV Placebo + MTX
Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000129
BG001128
BG002128
BG003129
BG004129
BG005643
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049.7± 11.10
BG00149.9± 11.86
BG00249.6± 10.96
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00099
BG001107
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
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14
An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).
Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.
Posted
Number
Participants
Week 0 to Week 14
ID
Title
Description
OG000
Group I: 2mg/kg Golimumab+ MTX
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
OG001
Group II: 2mg/kg Golimumab Only
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
OG002
Group III: 4mg/kg Golimumab + MTX
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
OG003
Group IV: 4mg/kg Golimumab Only
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
OG004
Group V: IV Placebo + MTX
Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
OG005
Group VI: Combined Groups I and III
Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
OG006
Group VII: Combined Groups II and IV
Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
Units
Counts
Participants
OG000129
OG001128
OG002128
OG003
Title
Denominators
Categories
Title
Measurements
OG00028
OG00116
OG00227
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
OG004
OG005
Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31 percentage response in the Group VI at α = 0.05.
2-sided Cochran-Mantel-Haenszel
0.051
95
No
Superiority or Other
Secondary
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).
Posted
Number
Participants
Week 0 to Week 24
ID
Title
Description
OG000
Group I: 2mg/kg Golimumab+ MTX
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
OG001
Group II: 2mg/kg Golimumab Only
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
OG002
Group III: 4mg/kg Golimumab + MTX
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
Secondary
Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity [based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities] and CRP blood test to measure inflammation).
Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.
Posted
Number
Participants
Week 0 to Week 14
ID
Title
Description
OG000
Group I: 2mg/kg Golimumab+ MTX
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
OG001
Group II: 2mg/kg Golimumab Only
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
Secondary
Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14
DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A "Good" response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A "Moderate" response is defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >1.2 or a DAS28 score of <= 5.1 and improvement from baseline in DAS28 score of >0.6 to 1.2
Intent to treat. Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing components were imputed by the median component value of all patients in the same stratum unless all components are missing in which case considered non-responders.
Posted
Number
Participants
Week 0 to Week 14
ID
Title
Description
OG000
Group I: 2mg/kg Golimumab+ MTX
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
OG001
Group II: 2mg/kg Golimumab Only
Secondary
Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14
The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.
Intent to treat (ITT). Missing components were imputed by the median component value of all patients in the same Stratum at baseline, and last observation carried forward (LOCF) at Week 14
Posted
Mean
Standard Deviation
Units on a scale
Weeks 0 to Week 14
ID
Title
Description
OG000
Group I: 2mg/kg Golimumab+ MTX
Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
OG001
Group II: 2mg/kg Golimumab Only
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
OG002
Group III: 4mg/kg Golimumab + MTX
Time Frame
IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.
Description
The number of participants reported at risk for AEs in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
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
IV Period: 2mg/kg Golimumab+ MTX
Participants who received 2mg/kg IV golimumab and methotrexate (MTX). Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 2mg/kg IV golimumab and before receiving 4mg/kg IV golimumab
25
182
109
182
EG001
IV Period: 2mg/kg Golimumab Only
Participants who received 2mg/kg IV golimumab only. Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 2mg/kg IV golimumab.
17
128
71
128
EG002
IV Period: 4mg/kg Golimumab + MTX
Participants who received at least one 4 mg/kg IV golimumab dose and MTX. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 4mg/kg IV golimumab.
47
336
190
336
EG003
IV Period: 4mg/kg Golimumab Only
Participants who received at least one 4mg/kg IV golimumab dose. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 4mg/kg IV golimumab.
8
127
70
127
EG004
IV Period: Placebo + MTX
Participants who received IV placebo and MTX only. Follow-up time was counted in this group until the participant started to receive IV golimumab.
7
129
65
129
EG005
SC Period: 50mg Golimumab + MTX
Participants who received 50mg SC golimumab and MTX.
38
419
94
419
EG006
SC Period: 50mg Golimumab Only
Participants who received 50mg golimumab only. Participants must not have received any MTX while receiving 50mg SC golimumab.
8
117
26
117
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0013 affected128 at risk
EG0023 affected336 at risk
EG0031 affected127 at risk
EG0041 affected129 at risk
EG0055 affected419 at risk
EG0060 affected117 at risk
Cellulitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0024 affected336 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0021 affected336 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0023 affected336 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0022 affected336 at risk
EG003
Cervicitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Eye abcess
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Localised infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Collapse of lung
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Complicated fracture
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Synovial rupture
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0002 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0011 affected128 at risk
EG0022 affected336 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0021 affected336 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0022 affected336 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Ovarian low malignant potential tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Headache
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0011 affected128 at risk
EG0021 affected336 at risk
EG003
Syringomyelia
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Syncope
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Depression
Psychiatric disorders
MedDRA (11.0)
Systematic Assessment
EG0002 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Generalized anxiety disorder
Psychiatric disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Major depression
Psychiatric disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Uterine cervical squamous metaplasia
Reproductive system and breast disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Haemorrhagic anaemia
Blood and lymphatic system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Keratitis
Eye disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Chest pain
General disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Abscess
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Anogenital warts
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Breast cellulitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Bronchiectasis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Endophthalmitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Lymph node tuberculosis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Septic shock
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Osteochondrosis
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Rheumatoid nodule
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Benign salivary gland neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Ovarian adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Pelvic prolapse
Reproductive system and breast disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Vaginal prolapse
Reproductive system and breast disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Death
General disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Hypertension
Vascular disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0011 affected128 at risk
EG0020 affected336 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0021 affected336 at risk
EG003
Abdominal hernia obstructive
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Appendix disorder
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Oedema
General disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Intevertebral discitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Viral infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Narcotic intoxication
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Atlantoaxial instability
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Carcinoid tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Tongue neoplasm malignant stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Cervical cord compression
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Pulmonary infarction
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA (11.0)
Systematic Assessment
EG0000 affected182 at risk
EG0010 affected128 at risk
EG0020 affected336 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Upper respiratory tract infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG00022 affected182 at risk
EG00114 affected128 at risk
EG00241 affected336 at risk
EG00316 affected127 at risk
EG004
Bronchitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG00014 affected182 at risk
EG00110 affected128 at risk
EG00226 affected336 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG00013 affected182 at risk
EG0019 affected128 at risk
EG00213 affected336 at risk
EG003
Influenza
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0006 affected182 at risk
EG00110 affected128 at risk
EG00210 affected336 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0008 affected182 at risk
EG0015 affected128 at risk
EG00221 affected336 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG00012 affected182 at risk
EG00120 affected128 at risk
EG00219 affected336 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0008 affected182 at risk
EG0016 affected128 at risk
EG00220 affected336 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG00015 affected182 at risk
EG0014 affected128 at risk
EG00214 affected336 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG000129 events20 affected182 at risk
EG001128 events4 affected128 at risk
EG002128 events36 affected336 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG00012 affected182 at risk
EG0013 affected128 at risk
EG00217 affected336 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0008 affected182 at risk
EG0012 affected128 at risk
EG00211 affected336 at risk
EG003
Headache
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG00017 affected182 at risk
EG0018 affected128 at risk
EG00226 affected336 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0008 affected182 at risk
EG0019 affected128 at risk
EG0029 affected336 at risk
EG003
Hypertension
Vascular disorders
MedDRA (11.0)
Systematic Assessment
EG00014 affected182 at risk
EG0018 affected128 at risk
EG00215 affected336 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (11.0)
Systematic Assessment
EG00015 affected182 at risk
EG0013 affected128 at risk
EG00219 affected336 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (11.0)
Systematic Assessment
EG0007 affected182 at risk
EG0011 affected128 at risk
EG00211 affected336 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG00011 affected182 at risk
EG0013 affected128 at risk
EG00224 affected336 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0008 affected182 at risk
EG0017 affected128 at risk
EG00218 affected336 at risk
EG003
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <=5% of patients.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Director Clinical Research
Centocor, Inc.
1-800-457-6399
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
C529000
golimumab
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
2 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
2 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
2 subjects
FG0050 subjects
FG0060 subjects
2 subjects
FG0050 subjects
FG0060 subjects
8 subjects
FG0050 subjects
FG0060 subjects
3 subjects
FG00523 subjects
FG006164 subjects
0 subjects
FG0051 subjects
FG0069 subjects
2 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Worsening of RA
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
48.4
± 12.66
BG00450.2± 11.28
BG00549.4± 11.65
103
BG003105
BG004103
BG005517
Male
BG00030
BG00121
BG00225
BG00324
BG00426
BG005126
129
OG004129
OG005257
OG006257
25
OG00417
OG00555
OG00641
OG000
OG004
Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups I vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31% response in the Group I at α = 0.05.
2-sided Cochran-Mantel-Haenszel
0.073
95
No
Superiority or Other
OG002
OG004
Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups III vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31 percentage response in the Group III at α = 0.05.
2-sided Cochran-Mantel-Haenszel
0.093
95
No
Superiority or Other
OG004
OG006
Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups VII vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31 percentage response in the Group VII at α = 0.05.
2-sided Cochran-Mantel-Haenszel
0.465
95
No
Superiority or Other
OG001
OG004
Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups II vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31 percentage response in the Group II at α = 0.05.
2-sided Cochran-Mantel-Haenszel
0.872
95
No
Superiority or Other
OG003
OG004
Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31 percentage response in the combined group (I and III) at α = 0.05.
2-sided Cochran-Mantel-Haenszel
0.175
95
No
Superiority or Other
OG003
Group IV: 4mg/kg Golimumab Only
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
OG004
Group V: IV Placebo + MTX
Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
OG005
Group VI: Combined Groups I and III
Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
OG006
Group VII: Combined Groups II and IV
Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
Units
Counts
Participants
OG000129
OG001128
OG002128
OG003129
OG004129
OG005257
OG006257
Title
Denominators
Categories
Title
Measurements
OG00024
OG00111
OG00232
OG00315
OG00412
OG00556
OG00626
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
OG004
OG005
Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VI at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
0.002
95
No
Superiority or Other
OG000
OG004
Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups I vs V at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
0.032
95
No
Superiority or Other
OG002
OG004
Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups III vs V at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
<0.001
95
No
Superiority or Other
OG004
OG006
Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VII at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
0.795
95
No
Superiority or Other
OG001
OG004
Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups II vs V at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
0.844
95
No
Superiority or Other
OG003
OG004
Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
0.540
95
No
Superiority or Other
OG002
Group III: 4mg/kg Golimumab + MTX
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
OG003
Group IV: 4mg/kg Golimumab Only
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
OG004
Group V: IV Placebo + MTX
Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
OG005
Group VI: Combined Groups I and III
Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
OG006
Group VII: Combined Groups II and IV
Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
Units
Counts
Participants
OG000129
OG001128
OG002128
OG003129
OG004129
OG005257
OG006257
Title
Denominators
Categories
Title
Measurements
OG00071
OG00151
OG00266
OG00362
OG00436
OG005137
OG006113
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
OG004
OG005
Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
<0.001
95
No
Superiority or Other
OG000
OG004
Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs V at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
<0.001
95
No
Superiority or Other
OG002
OG004
Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups III vs V at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
<0.001
95
No
Superiority or Other
OG004
OG006
Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VII at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
0.002
95
No
Superiority or Other
OG001
OG004
Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups II vs V at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
0.043
95
No
Superiority or Other
OG003
OG004
Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
<0.001
95
No
Superiority or Other
Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
OG002
Group III: 4mg/kg Golimumab + MTX
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
OG003
Group IV: 4mg/kg Golimumab Only
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
OG004
Group V: IV Placebo + MTX
Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
OG005
Group VI: Combined Groups I and III
Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
OG006
Group VII: Combined Groups II and IV
Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
Units
Counts
Participants
OG000129
OG001128
OG002128
OG003129
OG004129
OG005257
OG006257
Title
Denominators
Categories
Title
Measurements
OG00089
OG00180
OG00294
OG00383
OG00457
OG005183
OG006163
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
OG004
OG005
Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VI at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
<0.001
95
No
Superiority or Other
OG000
OG004
Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups I vs V at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
<0.001
95
No
Superiority or Other
OG002
OG004
Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups III vs V at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
<0.001
95
No
Superiority or Other
OG004
OG006
Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VII at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
<0.001
95
No
Superiority or Other
OG001
OG004
Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups II vs V at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
0.003
95
No
Superiority or Other
OG003
OG004
Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.
2-sided Cochran-Mantel-Haenszel
No adjustments were made to control for multiplicity
0.001
95
No
Superiority or Other
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
OG003
Group IV: 4mg/kg Golimumab Only
Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
OG004
Group V: IV Placebo + MTX
Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
OG005
Group VI: Combined Groups I and III
Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
OG006
Group VII: Combined Groups II and IV
Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
Units
Counts
Participants
OG000129
OG001128
OG002128
OG003129
OG004129
OG005257
OG006257
Title
Denominators
Categories
Title
Measurements
OG0006.92± 9.175
OG0014.03± 7.462
OG0026.76± 8.252
OG0035.14± 9.674
OG0044.27± 7.216
OG0056.84± 8.702
OG0064.58± 8.644
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
OG004
OG005
Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs VI at 0.05 level of significance.
2-sided ANOVA on van der Waerden
0.005
95
No
Superiority or Other
OG000
OG004
Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I vs V at 0.05 level of significance.
2-sided ANOVA on van der Waerden
0.014
95
No
Superiority or Other
OG002
OG004
Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups III vs V at 0.05 level of significance.
2-sided ANOVA on van der Waerden
0.014
95
No
Superiority or Other
OG000
OG006
Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I and VII at 0.05 level of significance.
2-sided ANOVA on van der Waerden
0.996
95
No
Superiority or Other
OG001
OG004
Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups II vs V at 0.05 level of significance.
2-sided ANOVA on van der Waerden
0.738
95
No
Superiority or Other
OG003
OG004
Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.
2-sided ANOVA on van der Waerden
0.788
No adjustments were made to control for multiplicity