A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

• Sponsor: Centocor, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00361335
• Collaborator: Schering-Plough (Industry)
• Enrollment: 643
• Locations: 72
• Arms: 5
• Duration (Months): 36
• Patients Per Site: 8.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Golimumab; Drug: Methotrexate; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 643 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I: 2mg/kg Golimumab + MTX 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; 2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes; Drug: Methotrexate; 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.
Experimental: Group II: 2mg/kg Golimumab only 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; 2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes; Drug: Placebo; 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.; Other Names: sham MTX
Experimental: Group III: 4mg/kg Golimumab + MTX 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.	Drug: Golimumab; 2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes; Drug: Methotrexate; 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.
Experimental: Group IV: 4mg/kg Golimumab only 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; 2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes; Drug: Placebo; 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.; Other Names: sham MTX
Placebo Comparator: Group V: IV Placebo + MTX 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; 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.; Drug: Placebo; 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.; Other Names: sham MTX

Outcome Measures

Primary Outcome Measures

1. Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 [Week 0 to 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).

Secondary Outcome Measures

1. Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24 [Week 0 to 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).

2. Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 [Week 0 to 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).

3. Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14 [Week 0 to 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

4. Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14 [Weeks 0 to 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Peoria	Arizona	United States
2		Aventura	Florida	United States
3		Orlando	Florida	United States
4		Tampa	Florida	United States
5		Atlanta	Georgia	United States
6		Lincoln	Nebraska	United States
7		Omaha	Nebraska	United States
8		Voorhees	New Jersey	United States
9		Albany	New York	United States
10		Roslyn	New York	United States
11		Charlotte	North Carolina	United States
12		Oklahoma City	Oklahoma	United States
13		Duncansville	Pennsylvania	United States
14		Norristown	Pennsylvania	United States
15		West Reading	Pennsylvania	United States
16		Willow Grove	Pennsylvania	United States
17		Amarillo	Texas	United States
18		Fort Worth	Texas	United States
19		Lubbock	Texas	United States
20		Spokane	Washington	United States
21		Buenos Aires		Argentina
22		Cordoba		Argentina
23		Rosario		Argentina
24		San Juan		Argentina
25		San Miguel De Tucuman		Argentina
26		Santa Fe		Argentina
27		Fitzroy		Australia
28		Heidelberg		Australia
29		Maroochydore		Australia
30		Melbourne		Australia
31		Perth		Australia
32		Woodville		Australia
33		Barranquilla		Colombia
34		Bogota		Colombia
35		Bucaramanga		Colombia
36		Floridablanca		Colombia
37		Erlangen		Germany
38		Hamburg		Germany
39		Magdeburg		Germany
40		München		Germany
41		Budapest		Hungary
42		Szolnok		Hungary
43		Daugavpils		Latvia
44		Riga		Latvia
45		Kaunas		Lithuania
46		Klaipeda		Lithuania
47		Siauliai		Lithuania
48		Vilnius		Lithuania
49		Ipoh		Malaysia
50		Kuching		Malaysia
51		Precinct 7		Malaysia
52		Selangor Darul Ehasan		Malaysia
53		Msd06 Gwardiamangia		Malta
54		Col. Del Valle		Mexico
55		Guadalajara Jalisco		Mexico
56		Guadalajara N/A		Mexico
57		Monterrey		Mexico
58		Christchurch		New Zealand
59		Dunedin		New Zealand
60		Rotorua		New Zealand
61		Takapuna Auckland		New Zealand
62		Timaru		New Zealand
63		Lima		Peru
64		Bialystok		Poland
65		Elblag		Poland
66		Krakow		Poland
67		Warszawa		Poland
68		Wloszczowa		Poland
69		Kiev		Ukraine
70		Kyiv		Ukraine
71		Symferpol		Ukraine
72		Zhaporizhzhya		Ukraine

Sponsors and Collaborators

• Centocor, Inc.
• Schering-Plough

Investigators

• Study Director: Centocor, Inc. Clinical Trial, Centocor, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centocor, Inc.
• ClinicalTrials.gov Identifier: NCT00361335
• Other Study ID Numbers: CR012781; C0524T12; 2005-003232-21
• First Posted: Aug 8, 2006
• Last Update Posted: Jul 29, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Centocor, Inc.: Rheumatoid arthritis; Golimumab; Methotrexate; Tumor Necrosis Factor-alpha; Immunology
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Golimumab; Methotrexate

Study Results

Participant Flow

Recruitment Details	The study was conducted at 86 investigational sites. The study population included 643 randomized participants from 15 countries.
Pre-assignment Detail	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.

Arm/Group Title	2mg/kg Golimumab+ MTX	2mg/kg Golimumab Only	4mg/kg Golimumab + MTX	4mg/kg Golimumab Only	IV Placebo + MTX	EE/DRA -> 2mg/kg Golimumab + MTX	EE/DRA -> 4mg/kg Golimumab + MTX
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.
Period Title: IV Period: Baseline to E0
STARTED	129	128	128	129	129	0	0
COMPLETED	109	99	107	102	105	0	0
NOT COMPLETED	20	29	21	27	24	0	0
Period Title: IV Period: Baseline to E0
STARTED	82	59	104	63	3	24	173
COMPLETED	80	56	99	59	3	23	164
NOT COMPLETED	2	3	5	4	0	1	9

Baseline Characteristics

Arm/Group Title	2mg/kg Golimumab+ MTX	2mg/kg Golimumab Only	4mg/kg Golimumab + MTX	4mg/kg Golimumab Only	IV Placebo + MTX	Total
Arm/Group Description	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.	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.	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.	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.	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.	Total of all reporting groups
Overall Participants	129	128	128	129	129	643
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.7 (11.10)	49.9 (11.86)	49.6 (10.96)	48.4 (12.66)	50.2 (11.28)	49.4 (11.65)
Sex: Female, Male (Count of Participants)
Female	99 76.7%	107 83.6%	103 80.5%	105 81.4%	103 79.8%	517 80.4%
Male	30 23.3%	21 16.4%	25 19.5%	24 18.6%	26 20.2%	126 19.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14
Description	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).
Time Frame	Week 0 to Week 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I: 2mg/kg Golimumab+ MTX	Group II: 2mg/kg Golimumab Only	Group III: 4mg/kg Golimumab + MTX	Group IV: 4mg/kg Golimumab Only	Group V: IV Placebo + MTX	Group VI: Combined Groups I and III	Group VII: Combined Groups II and IV
Arm/Group Description	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.	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.	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.	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.	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.	Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)	Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
Measure Participants	129	128	128	129	129	257	257
Number [Participants]	28 21.7%	16 12.5%	27 21.1%	25 19.4%	17 13.2%	55 8.6%	41 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group V: IV Placebo + MTX, Group VI: Combined Groups I and III
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.051
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group I: 2mg/kg Golimumab+ MTX, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.073
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group III: 4mg/kg Golimumab + MTX, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.093
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group V: IV Placebo + MTX, Group VII: Combined Groups II and IV
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.465
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Group II: 2mg/kg Golimumab Only, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.872
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Group IV: 4mg/kg Golimumab Only, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.175
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

2. Secondary Outcome

Title	Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
Description	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).
Time Frame	Week 0 to Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I: 2mg/kg Golimumab+ MTX	Group II: 2mg/kg Golimumab Only	Group III: 4mg/kg Golimumab + MTX	Group IV: 4mg/kg Golimumab Only	Group V: IV Placebo + MTX	Group VI: Combined Groups I and III	Group VII: Combined Groups II and IV
Arm/Group Description	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.	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.	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.	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.	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.	Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)	Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
Measure Participants	129	128	128	129	129	257	257
Number [Participants]	24 18.6%	11 8.6%	32 25%	15 11.6%	12 9.3%	56 8.7%	26 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group V: IV Placebo + MTX, Group VI: Combined Groups I and III
	Comments	Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VI at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group I: 2mg/kg Golimumab+ MTX, Group V: IV Placebo + MTX
	Comments	Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups I vs V at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.032
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group III: 4mg/kg Golimumab + MTX, Group V: IV Placebo + MTX
	Comments	Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups III vs V at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group V: IV Placebo + MTX, Group VII: Combined Groups II and IV
	Comments	Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VII at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.795
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Group II: 2mg/kg Golimumab Only, Group V: IV Placebo + MTX
	Comments	Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups II vs V at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.844
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Group IV: 4mg/kg Golimumab Only, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.540
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

3. Secondary Outcome

Title	Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
Description	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).
Time Frame	Week 0 to Week 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I: 2mg/kg Golimumab+ MTX	Group II: 2mg/kg Golimumab Only	Group III: 4mg/kg Golimumab + MTX	Group IV: 4mg/kg Golimumab Only	Group V: IV Placebo + MTX	Group VI: Combined Groups I and III	Group VII: Combined Groups II and IV
Arm/Group Description	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.	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.	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.	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.	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.	Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)	Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
Measure Participants	129	128	128	129	129	257	257
Number [Participants]	71 55%	51 39.8%	66 51.6%	62 48.1%	36 27.9%	137 21.3%	113 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group V: IV Placebo + MTX, Group VI: Combined Groups I and III
	Comments	Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group I: 2mg/kg Golimumab+ MTX, Group V: IV Placebo + MTX
	Comments	Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs V at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group III: 4mg/kg Golimumab + MTX, Group V: IV Placebo + MTX
	Comments	Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups III vs V at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group V: IV Placebo + MTX, Group VII: Combined Groups II and IV
	Comments	Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VII at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Group II: 2mg/kg Golimumab Only, Group V: IV Placebo + MTX
	Comments	Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups II vs V at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.043
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Group IV: 4mg/kg Golimumab Only, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

4. Secondary Outcome

Title	Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14
Description	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
Time Frame	Week 0 to Week 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I: 2mg/kg Golimumab+ MTX	Group II: 2mg/kg Golimumab Only	Group III: 4mg/kg Golimumab + MTX	Group IV: 4mg/kg Golimumab Only	Group V: IV Placebo + MTX	Group VI: Combined Groups I and III	Group VII: Combined Groups II and IV
Arm/Group Description	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.	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.	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.	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.	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.	Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)	Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
Measure Participants	129	128	128	129	129	257	257
Number [Participants]	89 69%	80 62.5%	94 73.4%	83 64.3%	57 44.2%	183 28.5%	163 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group V: IV Placebo + MTX, Group VI: Combined Groups I and III
	Comments	Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VI at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group I: 2mg/kg Golimumab+ MTX, Group V: IV Placebo + MTX
	Comments	Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups I vs V at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group III: 4mg/kg Golimumab + MTX, Group V: IV Placebo + MTX
	Comments	Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups III vs V at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group V: IV Placebo + MTX, Group VII: Combined Groups II and IV
	Comments	Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VII at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Group II: 2mg/kg Golimumab Only, Group V: IV Placebo + MTX
	Comments	Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups II vs V at 0.05 level of significance.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Group IV: 4mg/kg Golimumab Only, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	2-sided Cochran-Mantel-Haenszel
	Comments	No adjustments were made to control for multiplicity

5. Secondary Outcome

Title	Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14
Description	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.
Time Frame	Weeks 0 to Week 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group I: 2mg/kg Golimumab+ MTX	Group II: 2mg/kg Golimumab Only	Group III: 4mg/kg Golimumab + MTX	Group IV: 4mg/kg Golimumab Only	Group V: IV Placebo + MTX	Group VI: Combined Groups I and III	Group VII: Combined Groups II and IV
Arm/Group Description	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.	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.	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.	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.	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.	Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)	Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
Measure Participants	129	128	128	129	129	257	257
Mean (Standard Deviation) [Units on a scale]	6.92 (9.175)	4.03 (7.462)	6.76 (8.252)	5.14 (9.674)	4.27 (7.216)	6.84 (8.702)	4.58 (8.644)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group V: IV Placebo + MTX, Group VI: Combined Groups I and III
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	2-sided ANOVA on van der Waerden
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group I: 2mg/kg Golimumab+ MTX, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	2-sided ANOVA on van der Waerden
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group III: 4mg/kg Golimumab + MTX, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	2-sided ANOVA on van der Waerden
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group I: 2mg/kg Golimumab+ MTX, Group VII: Combined Groups II and IV
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.996
	Comments
	Method	2-sided ANOVA on van der Waerden
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Group II: 2mg/kg Golimumab Only, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.738
	Comments
	Method	2-sided ANOVA on van der Waerden
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Group IV: 4mg/kg Golimumab Only, Group V: IV Placebo + MTX
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.788
	Comments	No adjustments were made to control for multiplicity
	Method	2-sided ANOVA on van der Waerden
	Comments

Adverse Events

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.
Adverse Event Reporting 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.
Arm/Group Title	IV Period: 2mg/kg Golimumab+ MTX		IV Period: 2mg/kg Golimumab Only		IV Period: 4mg/kg Golimumab + MTX		IV Period: 4mg/kg Golimumab Only		IV Period: Placebo + MTX		SC Period: 50mg Golimumab + MTX		SC Period: 50mg Golimumab Only
Arm/Group Description	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		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.		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.		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.		Participants who received IV placebo and MTX only. Follow-up time was counted in this group until the participant started to receive IV golimumab.		Participants who received 50mg SC golimumab and MTX.		Participants who received 50mg golimumab only. Participants must not have received any MTX while receiving 50mg SC golimumab.
All Cause Mortality
	IV Period: 2mg/kg Golimumab+ MTX		IV Period: 2mg/kg Golimumab Only		IV Period: 4mg/kg Golimumab + MTX		IV Period: 4mg/kg Golimumab Only		IV Period: Placebo + MTX		SC Period: 50mg Golimumab + MTX		SC Period: 50mg Golimumab Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	IV Period: 2mg/kg Golimumab+ MTX		IV Period: 2mg/kg Golimumab Only		IV Period: 4mg/kg Golimumab + MTX		IV Period: 4mg/kg Golimumab Only		IV Period: Placebo + MTX		SC Period: 50mg Golimumab + MTX		SC Period: 50mg Golimumab Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/182 (13.7%)		17/128 (13.3%)		47/336 (14%)		8/127 (6.3%)		7/129 (5.4%)		38/419 (9.1%)		8/117 (6.8%)
Blood and lymphatic system disorders
Haemorrhagic anaemia	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Pancytopenia	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Anaemia	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Cardiac disorders
Myocardial infarction	1/182 (0.5%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		1/117 (0.9%)
Acute myocardial infarction	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		1/117 (0.9%)
Angina unstable	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Coronary artery disease	0/182 (0%)		0/128 (0%)		0/336 (0%)		1/127 (0.8%)		1/129 (0.8%)		0/419 (0%)		3/117 (2.6%)
Myocardial ischaemia	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Ventricular tachycardia	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Atrial fibrillation	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Ear and labyrinth disorders
Vertigo positional	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Endocrine disorders
Adrenal insufficiency	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		1/117 (0.9%)
Eye disorders
Keratitis	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Gastrointestinal disorders
Abdominal pain	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Gastritis	1/182 (0.5%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Nausea	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Vomiting	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Abdominal pain lower	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Abdominal hernia obstructive	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Appendix disorder	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
General disorders
Chest pain	1/182 (0.5%)		1/128 (0.8%)		0/336 (0%)		1/127 (0.8%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Death	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Oedema	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Hepatobiliary disorders
Cholecystitis	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Cholecystitis acute	0/182 (0%)		0/128 (0%)		0/336 (0%)		1/127 (0.8%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Immune system disorders
Anaphylactic shock	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Infections and infestations
Pneumonia	1/182 (0.5%)		3/128 (2.3%)		3/336 (0.9%)		1/127 (0.8%)		1/129 (0.8%)		5/419 (1.2%)		0/117 (0%)
Cellulitis	0/182 (0%)		1/128 (0.8%)		4/336 (1.2%)		0/127 (0%)		0/129 (0%)		2/419 (0.5%)		0/117 (0%)
Diverticulitis	0/182 (0%)		1/128 (0.8%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Lower respiratory tract infection	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		1/127 (0.8%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Urinary tract infection	0/182 (0%)		0/128 (0%)		3/336 (0.9%)		0/127 (0%)		0/129 (0%)		2/419 (0.5%)		0/117 (0%)
Appendicitis	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Arthritis bacterial	1/182 (0.5%)		0/128 (0%)		2/336 (0.6%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Cervicitis	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Eye abcess	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Herpes zoster	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Localised infection	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Osteomyelitis	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Pneumonia bacterial	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Pulmonary tuberculosis	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Pyelonephritis	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		1/127 (0.8%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Subcutaneous abscess	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Infection	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		1/129 (0.8%)		0/419 (0%)		0/117 (0%)
Post procedural infection	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		1/129 (0.8%)		0/419 (0%)		0/117 (0%)
Abscess	0/182 (0%)		0/128 (0%)		0/336 (0%)		1/127 (0.8%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Anogenital warts	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Breast cellulitis	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Bronchiectasis	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Chronic sinusitis	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Endophthalmitis	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Lymph node tuberculosis	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Septic shock	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Sinusitis	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Upper respiratory tract infection	0/182 (0%)		0/128 (0%)		0/336 (0%)		1/127 (0.8%)		0/129 (0%)		0/419 (0%)		1/117 (0.9%)
Urinary tract infection bacterial	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		1/117 (0.9%)
Abdominal abscess	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Arthritis infective	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Intevertebral discitis	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		1/117 (0.9%)
Respiratory tract infection	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Soft tissue infection	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Staphylococcal sepsis	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Viral infection	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Injury, poisoning and procedural complications
Concussion	1/182 (0.5%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Collapse of lung	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Complicated fracture	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Femur fracture	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Head injury	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Hip fracture	0/182 (0%)		0/128 (0%)		0/336 (0%)		1/127 (0.8%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Stress fracture	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Synovial rupture	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Tendon rupture	2/182 (1.1%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Spinal compression fracture	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Narcotic intoxication	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Investigations
Haemoglobin decreased	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Metabolism and nutrition disorders
Fluid overload	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Hyponatraemia	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Obesity	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis	1/182 (0.5%)		1/128 (0.8%)		2/336 (0.6%)		0/127 (0%)		1/129 (0.8%)		3/419 (0.7%)		0/117 (0%)
Arthralgia	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Back pain	0/182 (0%)		1/128 (0.8%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Osteoarthritis	1/182 (0.5%)		0/128 (0%)		2/336 (0.6%)		0/127 (0%)		0/129 (0%)		2/419 (0.5%)		0/117 (0%)
Spinal osteoarthritis	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Foot deformity	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Osteochondrosis	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Osteonecrosis	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Rheumatoid nodule	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Atlantoaxial instability	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		1/117 (0.9%)
Spinal column stenosis	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Colon cancer	0/182 (0%)		0/128 (0%)		0/336 (0%)		1/127 (0.8%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Ovarian low malignant potential tumour	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Basal cell carcinoma	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		1/129 (0.8%)		0/419 (0%)		0/117 (0%)
Benign salivary gland neoplasm	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Cervix carcinoma	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Lung neoplasm malignant	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Metastases to central nervous system	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Ovarian adenoma	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Thyroid cancer	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Carcinoid tumour	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Neoplasm	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Prostate cancer	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Squamous cell carcinoma	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Tongue neoplasm malignant stage unspecified	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Nervous system disorders
Headache	1/182 (0.5%)		1/128 (0.8%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Syringomyelia	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Neuralgia	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		1/129 (0.8%)		0/419 (0%)		0/117 (0%)
Syncope	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		1/129 (0.8%)		1/419 (0.2%)		1/117 (0.9%)
Cerebral ischaemia	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Brain oedema	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		1/117 (0.9%)
Cervical cord compression	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		1/117 (0.9%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Psychiatric disorders
Depression	2/182 (1.1%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Generalized anxiety disorder	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Major depression	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Renal and urinary disorders
Renal failure	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Stress urinary incontinence	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Calculus ureteric	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		1/129 (0.8%)		0/419 (0%)		0/117 (0%)
Renal colic	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Reproductive system and breast disorders
Endometrial hyperplasia	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Menorrhagia	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Metrorrhagia	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Uterine cervical squamous metaplasia	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Cystocele	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Pelvic prolapse	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Uterine haemorrhage	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Vaginal prolapse	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Amenorrhoea	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Epistaxis	0/182 (0%)		1/128 (0.8%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Pleural effusion	1/182 (0.5%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Pulmonary fibrosis	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Pulmonary oedema	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		1/129 (0.8%)		0/419 (0%)		0/117 (0%)
Respiratory failure	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Acute respiratory distress syndrome	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		1/117 (0.9%)
Asthma	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Chronic obstructive pulmonary disease	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Laryngeal oedema	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		1/117 (0.9%)
Pulmonary infarction	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Skin and subcutaneous tissue disorders
Skin lesion	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Vascular disorders
Aortic stenosis	1/182 (0.5%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Deep vein thrombosis	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		0/419 (0%)		0/117 (0%)
Hypertension	0/182 (0%)		0/128 (0%)		1/336 (0.3%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Aortic aneurysm	0/182 (0%)		0/128 (0%)		0/336 (0%)		0/127 (0%)		0/129 (0%)		1/419 (0.2%)		0/117 (0%)
Other (Not Including Serious) Adverse Events
	IV Period: 2mg/kg Golimumab+ MTX		IV Period: 2mg/kg Golimumab Only		IV Period: 4mg/kg Golimumab + MTX		IV Period: 4mg/kg Golimumab Only		IV Period: Placebo + MTX		SC Period: 50mg Golimumab + MTX		SC Period: 50mg Golimumab Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	109/182 (59.9%)		71/128 (55.5%)		190/336 (56.5%)		70/127 (55.1%)		65/129 (50.4%)		94/419 (22.4%)		26/117 (22.2%)
Gastrointestinal disorders
Diarrhoea	15/182 (8.2%)		4/128 (3.1%)		14/336 (4.2%)		7/127 (5.5%)		2/129 (1.6%)		15/419 (3.6%)		4/117 (3.4%)
Nausea	20/182 (11%)	129	4/128 (3.1%)	128	36/336 (10.7%)	128	7/127 (5.5%)	129	9/129 (7%)	129	10/419 (2.4%)	129	1/117 (0.9%)	129
Dyspepsia	12/182 (6.6%)		3/128 (2.3%)		17/336 (5.1%)		4/127 (3.1%)		2/129 (1.6%)		6/419 (1.4%)		0/117 (0%)
Vomiting	8/182 (4.4%)		2/128 (1.6%)		11/336 (3.3%)		4/127 (3.1%)		8/129 (6.2%)		6/419 (1.4%)		2/117 (1.7%)
Infections and infestations
Upper respiratory tract infection	22/182 (12.1%)		14/128 (10.9%)		41/336 (12.2%)		16/127 (12.6%)		12/129 (9.3%)		30/419 (7.2%)		10/117 (8.5%)
Bronchitis	14/182 (7.7%)		10/128 (7.8%)		26/336 (7.7%)		8/127 (6.3%)		7/129 (5.4%)		22/419 (5.3%)		2/117 (1.7%)
Nasopharyngitis	13/182 (7.1%)		9/128 (7%)		13/336 (3.9%)		8/127 (6.3%)		7/129 (5.4%)		19/419 (4.5%)		9/117 (7.7%)
Influenza	6/182 (3.3%)		10/128 (7.8%)		10/336 (3%)		5/127 (3.9%)		1/129 (0.8%)		15/419 (3.6%)		3/117 (2.6%)
Urinary tract infection	8/182 (4.4%)		5/128 (3.9%)		21/336 (6.3%)		7/127 (5.5%)		2/129 (1.6%)		7/419 (1.7%)		4/117 (3.4%)
Sinusitis	11/182 (6%)		3/128 (2.3%)		24/336 (7.1%)		7/127 (5.5%)		6/129 (4.7%)		15/419 (3.6%)		3/117 (2.6%)
Investigations
Alanine aminotransferase increased	15/182 (8.2%)		3/128 (2.3%)		19/336 (5.7%)		3/127 (2.4%)		8/129 (6.2%)		18/419 (4.3%)		3/117 (2.6%)
Aspartate aminotransferase increased	7/182 (3.8%)		1/128 (0.8%)		11/336 (3.3%)		0/127 (0%)		8/129 (6.2%)		10/419 (2.4%)		3/117 (2.6%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis	12/182 (6.6%)		20/128 (15.6%)		19/336 (5.7%)		12/127 (9.4%)		6/129 (4.7%)		29/419 (6.9%)		6/117 (5.1%)
Arthralgia	8/182 (4.4%)		6/128 (4.7%)		20/336 (6%)		6/127 (4.7%)		7/129 (5.4%)		6/419 (1.4%)		1/117 (0.9%)
Nervous system disorders
Headache	17/182 (9.3%)		8/128 (6.3%)		26/336 (7.7%)		8/127 (6.3%)		13/129 (10.1%)		20/419 (4.8%)		2/117 (1.7%)
Respiratory, thoracic and mediastinal disorders
Cough	8/182 (4.4%)		7/128 (5.5%)		18/336 (5.4%)		5/127 (3.9%)		5/129 (3.9%)		7/419 (1.7%)		2/117 (1.7%)
Skin and subcutaneous tissue disorders
Rash	8/182 (4.4%)		9/128 (7%)		9/336 (2.7%)		6/127 (4.7%)		2/129 (1.6%)		5/419 (1.2%)		2/117 (1.7%)
Vascular disorders
Hypertension	14/182 (7.7%)		8/128 (6.3%)		15/336 (4.5%)		4/127 (3.1%)		5/129 (3.9%)		7/419 (1.7%)		1/117 (0.9%)

Limitations/Caveats

The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <=5% of patients.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.