Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT00634933
• Recruitment Status: Terminated
• First Posted: March 13, 2008
• Results First Posted: March 11, 2013
• Last Update Posted: March 11, 2013
• Sponsor: Pfizer
• Collaborator: Trubion Pharmaceuticals/Emergent BioSolutions Inc.
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Arthritis, Rheumatoid
• Interventions: Drug: TRU-015; Drug: Methylprednisolone; Drug: Prednisone
• Enrollment: 222

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose	Placebo/TRU-015 Single Dose	Placebo/TRU-015 Induction Dose
Arm/Group Description	Placebo infusion, matched to TRU-015 (800 milligram [mg]), intravenously (IV) along with methylprednisolone 100 mg IV 1 hour (hr) prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 800 mg, IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
Period Title: Part A: Baseline to Week 24
Started	74	75	73	0	0
Completed	63	57	55	0	0
Not Completed	11	18	18	0	0
Reason Not Completed
Adverse Event	4	4	8	0	0
Death	1	0	0	0	0
Failed to Return	1	0	0	0	0
Investigator Request	1	1	1	0	0
Lost to Follow-up	0	1	1	0	0
Withdrawal by Subject	0	3	3	0	0
Lack of Efficacy	3	1	0	0	0
Other	1	8	5	0	0
Period Title: Between Part A and Part B
Started	0	57	55	31	32
Completed	0	56	55	31	32
Not Completed	0	1	0	0	0
Reason Not Completed
Physician Decision	0	1	0	0	0
Period Title: Part B: Week 24 to Week 52
Started	0	56	55	31	32
Completed	0	42	33	25	22
Not Completed	0	14	22	6	10
Reason Not Completed
Adverse Event	0	1	1	1	0
Discontinuation of Study by Sponsor	0	11	14	3	7
Physician Decision	0	1	1	0	0
Protocol Violation	0	0	0	0	1
Withdrawal by Subject	0	0	0	2	1
Lack of Efficacy	0	1	1	0	0
Other	0	0	5	0	1

Baseline Characteristics

Arm/Group Title		Placebo	TRU-015 Single Dose	TRU-015 Induction Dose	Total
Arm/Group Description		Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	Total of all reporting groups
Overall Number of Baseline Participants		74	75	73	222
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	74 participants	75 participants	73 participants	222 participants
		50.62 (11.07)	52.99 (11.33)	52.55 (13.00)	52.05 (11.81)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	74 participants	75 participants	73 participants	222 participants
	Female	64 86.5%	62 82.7%	59 80.8%	185 83.3%
	Male	10 13.5%	13 17.3%	14 19.2%	37 16.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
Description	ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Modified intent-to-treat (mITT) population included all randomized participants who received any portion of test article. Last observation carried forward (LOCF) method was used to impute missing values.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Measure Type: Number; Unit of Measure: percentage of participants
	16.2	29.3	27.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	A 2-sided Cochran-Mantel-Haenszel test (CMH), stratified by prior anti-tumor necrosis factor (anti-TNF) use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.061
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.120
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Description	ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.
Time Frame	Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Measure Type: Number; Unit of Measure: percentage of participants
Week 2	17.6	21.3	26.0
Week 4	31.1	34.7	34.2
Week 8	31.1	44.0	42.5
Week 12	31.1	52.0	49.3
Week 16	41.9	64.0	61.6
Week 20	47.3	62.7	64.4
Week 24	43.2	61.3	67.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.570
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.200
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.616
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.671
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.108
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.174
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.010
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.029
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.021
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.062
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.049
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.030
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.005
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Description	ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.
Time Frame	Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 20 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Measure Type: Number; Unit of Measure: percentage of participants
Week 2	0.0	8.0	6.8
Week 4	6.8	8.0	6.8
Week 8	12.2	10.7	8.2
Week 12	14.9	16.0	13.7
Week 16	16.2	30.7	31.5
Week 20	16.2	28.0	28.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.014
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.025
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.794
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.966
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.770
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.456
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.880
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.814
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.042
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.035
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.086
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.082
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

4. Secondary Outcome

Title	Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Description	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.
Time Frame	Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Measure Type: Number; Unit of Measure: percentage of participants
Week 2	0.0	1.3	1.4
Week 4	1.4	1.3	0.0
Week 8	1.4	2.7	1.4
Week 12	1.4	2.7	2.7
Week 16	6.8	8.0	6.8
Week 20	2.7	6.7	6.8
Week 24	2.7	9.3	9.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.325
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.338
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.983
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.296
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.575
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	1.000
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.573
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.563
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.768
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.977
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.249
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.268
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.089
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.079
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

5. Secondary Outcome

Title	Number of Tender Joints
Description	The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Time Frame	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Mean (Standard Deviation); Unit of Measure: tender joints
Baseline	17.0 (6.1)	16.8 (7.0)	17.7 (6.2)
Week 2	13.6 (7.0)	11.9 (7.4)	13.0 (7.7)
Week 4	11.9 (7.0)	10.7 (7.7)	11.6 (7.7)
Week 8	11.7 (8.4)	9.8 (6.7)	10.1 (7.4)
Week 12	11.0 (7.9)	8.8 (6.9)	9.6 (7.7)
Week 16	9.4 (7.9)	7.3 (7.0)	8.4 (7.2)
Week 20	9.0 (7.2)	7.6 (7.3)	7.6 (7.1)
Week 24	9.4 (7.5)	8.1 (7.6)	7.6 (7.4)

6. Secondary Outcome

Title	Number of Swollen Joints
Description	The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Time Frame	Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Mean (Standard Deviation); Unit of Measure: swollen joints
Baseline	12.2 (4.4)	12.3 (6.0)	13.9 (5.7)
Week 2	9.5 (5.7)	9.0 (6.5)	10.2 (6.2)
Week 4	7.8 (5.3)	8.5 (6.4)	9.0 (6.2)
Week 8	7.0 (5.7)	6.9 (5.2)	7.7 (5.6)
Week 12	7.6 (5.8)	6.0 (4.9)	7.1 (5.5)
Week 16	6.1 (5.4)	5.1 (5.2)	5.9 (4.7)
Week 20	6.0 (5.4)	4.8 (4.6)	5.1 (4.9)
Week 24	6.2 (5.5)	4.7 (4.6)	5.0 (5.0)

7. Secondary Outcome

Title	Duration of Morning Stiffness
Description	Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).
Time Frame	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

8. Secondary Outcome

Title	Visual Analogue Scale for Pain (VAS-pain)
Description	100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.
Time Frame	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Mean (Standard Deviation); Unit of Measure: mm
Baseline	65.4 (17.9)	62.5 (20.7)	61.6 (23.0)
Week 2	53.0 (21.2)	47.7 (25.2)	49.6 (24.6)
Week 4	53.6 (20.3)	48.9 (25.9)	49.0 (24.2)
Week 8	56.4 (23.0)	45.8 (24.0)	47.0 (24.5)
Week 12	54.3 (21.6)	42.3 (24.1)	44.8 (25.4)
Week 16	51.1 (24.2)	39.3 (24.4)	40.8 (25.2)
Week 20	51.1 (21.6)	39.5 (24.2)	39.1 (25.7)
Week 24	49.2 (22.2)	39.2 (25.0)	43.9 (28.3)

9. Secondary Outcome

Title	Physician Global Assessment (PGA) of Disease Activity
Description	Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.
Time Frame	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	6.8 (1.3)	6.4 (1.6)	6.6 (1.7)
Week 2	5.5 (1.5)	5.1 (2.2)	5.2 (1.9)
Week 4	5.0 (1.9)	5.0 (2.3)	4.9 (2.1)
Week 8	5.0 (2.2)	4.1 (2.1)	4.4 (2.1)
Week 12	4.8 (2.1)	4.1 (2.1)	4.3 (2.3)
Week 16	4.6 (2.4)	3.7 (2.1)	3.6 (2.1)
Week 20	4.4 (2.1)	3.8 (1.8)	3.6 (2.2)
Week 24	4.3 (2.2)	3.7 (2.1)	3.6 (2.4)

10. Secondary Outcome

Title	Patient Global Assessment (PtGA) of Disease Activity
Description	Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.
Time Frame	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	7.3 (1.6)	6.9 (1.9)	7.0 (2.3)
Week 2	6.2 (2.1)	5.6 (2.4)	5.6 (2.3)
Week 4	6.0 (1.8)	5.4 (2.4)	5.6 (2.4)
Week 8	6.2 (2.1)	5.2 (2.4)	5.3 (2.3)
Week 12	5.9 (2.1)	4.8 (2.3)	5.2 (2.4)
Week 16	6.6 (9.2)	4.4 (2.3)	4.6 (2.5)
Week 20	5.5 (2.1)	4.5 (2.3)	4.5 (2.4)
Week 24	5.3 (2.0)	4.6 (2.3)	4.7 (2.7)

11. Secondary Outcome

Title	General Health Visual Analog Scale (VAS)
Description	100 mm line (VAS) marked by participant. Participants were asked, "How do you feel concerning your arthritis?" Total possible score range, 0 mm = very well to 100 mm = extremely bad.
Time Frame	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

12. Secondary Outcome

Title	Health Assessment Questionnaire Disability Index (HAQ-DI)
Description	HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	1.8 (0.6)	1.7 (0.6)	1.6 (0.7)
Week 2	1.5 (0.6)	1.4 (0.7)	1.3 (0.6)
Week 4	1.4 (0.7)	1.4 (0.7)	1.3 (0.7)
Week 8	1.5 (0.7)	1.3 (0.6)	1.2 (0.7)
Week 12	1.5 (0.7)	1.3 (0.6)	1.1 (0.7)
Week 16	1.4 (0.7)	1.2 (0.6)	1.1 (0.7)
Week 20	1.4 (0.7)	1.2 (0.7)	1.0 (0.8)
Week 24	1.4 (0.6)	1.2 (0.7)	1.0 (0.8)

13. Secondary Outcome

Title	Disease Activity Score Based on 28-joints Count (DAS28)
Description	DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity.
Time Frame	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	6.1 (0.7)	5.8 (0.9)	6.1 (1.0)
Week 2	5.4 (1.0)	5.1 (1.3)	5.3 (1.3)
Week 4	5.2 (1.1)	4.9 (1.4)	5.0 (1.4)
Week 8	5.1 (1.3)	4.6 (1.3)	4.7 (1.3)
Week 12	5.0 (1.3)	4.3 (1.3)	4.6 (1.4)
Week 16	4.7 (1.5)	3.9 (1.4)	4.3 (1.4)
Week 20	4.7 (1.4)	4.0 (1.3)	4.1 (1.4)
Week 24	4.7 (1.4)	4.1 (1.3)	4.0 (1.5)

14. Secondary Outcome

Title	36-Item Short-Form Health Survey (SF-36)
Description	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame	Baseline, Week 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

15. Secondary Outcome

Title	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Baseline, Week 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

16. Secondary Outcome

Title	Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time Frame	Baseline, Week 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

17. Secondary Outcome

Title	Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
Description	FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Time Frame	Baseline, Week 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

18. Secondary Outcome

Title	Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score
Description	WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.
Time Frame	Baseline, Week 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description

Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

19. Secondary Outcome

Title	Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
Description	The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.
Time Frame	Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.

Arm/Group Title	Placebo	TRU-015 Single Dose	TRU-015 Induction Dose
Arm/Group Description:	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
Overall Number of Participants Analyzed	74	75	73
Measure Type: Number; Unit of Measure: percentage of participants
Week 2: good response	1.4	6.7	2.7
Week 2: moderate response	33.8	38.7	39.7
Week 2: no response	64.9	54.7	57.5
Week 4: good response	5.4	14.7	8.2
Week 4: moderate response	39.2	41.3	45.2
Week 4: no response	55.4	44.0	46.6
Week 8: good response	8.1	14.7	12.3
Week 8: moderate response	44.6	44.0	53.4
Week 8: no response	47.3	41.3	34.2
Week 12: good response	9.5	21.3	16.4
Week 12: moderate response	39.2	53.3	52.1
Week 12: no response	51.4	25.3	31.5
Week 16: good response	18.9	34.7	20.5
Week 16: moderate response	40.5	41.3	56.2
Week 16: no response	40.5	24.0	23.3
Week 20: good response	17.6	29.3	26.0
Week 20: moderate response	37.8	52.0	54.8
Week 20: no response	44.6	18.7	19.2
Week 24: good response	14.9	26.7	30.1
Week 24: moderate response	44.6	46.7	50.7
Week 24: no response	40.5	26.7	19.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.106
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.322
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 4 Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.059
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 4: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.250
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.255
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.105
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.019
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.011
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.113
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Single Dose
	Comments	Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.034
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, TRU-015 Induction Dose
	Comments	Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Placebo (Part A)	TRU-015 Single Dose (Part A)	TRU-015 Induction Dose (Part A)	TRU-015 Single Dose (Part B)	TRU-015 Induction Dose (Part B)	Placebo/TRU-015 Single Dose (Part B)	Placebo/TRU-015 Induction Dose (Part B)
Arm/Group Description	Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-SD in the Part B of the study.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-ID in the Part B of the study.	TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 800 mg, IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.	TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
All-Cause Mortality
	Placebo (Part A)	TRU-015 Single Dose (Part A)	TRU-015 Induction Dose (Part A)	TRU-015 Single Dose (Part B)	TRU-015 Induction Dose (Part B)	Placebo/TRU-015 Single Dose (Part B)	Placebo/TRU-015 Induction Dose (Part B)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events
	Placebo (Part A)	TRU-015 Single Dose (Part A)	TRU-015 Induction Dose (Part A)	TRU-015 Single Dose (Part B)	TRU-015 Induction Dose (Part B)	Placebo/TRU-015 Single Dose (Part B)	Placebo/TRU-015 Induction Dose (Part B)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	7/74 (9.46%)	4/75 (5.33%)	7/73 (9.59%)	2/56 (3.57%)	2/55 (3.64%)	0/31 (0.00%)	0/32 (0.00%)
Blood and lymphatic system disorders
Anaemia * 1	1/74 (1.35%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Cardiac disorders
Atrial fibrillation * 1	0/74 (0.00%)	0/75 (0.00%)	1/73 (1.37%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Cardiac failure congestive * 1	0/74 (0.00%)	1/75 (1.33%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Tachycardia * 1	1/74 (1.35%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Gastrointestinal disorders
Oesophageal ulcer * 1	0/74 (0.00%)	1/75 (1.33%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Hepatobiliary disorders
Cholecystitis acute * 1	0/74 (0.00%)	1/75 (1.33%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Cholecystitis chronic * 1	2/74 (2.70%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Cholelithiasis * 1	0/74 (0.00%)	1/75 (1.33%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Infections and infestations
Bronchitis * 1	0/74 (0.00%)	0/75 (0.00%)	2/73 (2.74%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Influenza * 1	1/74 (1.35%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Pneumonia * 1	1/74 (1.35%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Appendicitis * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	1/56 (1.79%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
H1N1 influenza * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	1/55 (1.82%)	0/31 (0.00%)	0/32 (0.00%)
Injury, poisoning and procedural complications
Hip fracture * 1	0/74 (0.00%)	0/75 (0.00%)	1/73 (1.37%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Joint sprain * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	1/56 (1.79%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Musculoskeletal and connective tissue disorders
Bursitis * 1	0/74 (0.00%)	0/75 (0.00%)	1/73 (1.37%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Rheumatoid arthritis * 1	1/74 (1.35%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Osteoarthritis * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	1/55 (1.82%)	0/31 (0.00%)	0/32 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma * 1	1/74 (1.35%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Pregnancy, puerperium and perinatal conditions
Pregnancy * 1	0/74 (0.00%)	1/75 (1.33%)	1/73 (1.37%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Respiratory, thoracic and mediastinal disorders
Haemoptysis * 1	1/74 (1.35%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Pulmonary fibrosis * 1	1/74 (1.35%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Skin and subcutaneous tissue disorders
Angioedema * 1	0/74 (0.00%)	0/75 (0.00%)	1/73 (1.37%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 13.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo (Part A)	TRU-015 Single Dose (Part A)	TRU-015 Induction Dose (Part A)	TRU-015 Single Dose (Part B)	TRU-015 Induction Dose (Part B)	Placebo/TRU-015 Single Dose (Part B)	Placebo/TRU-015 Induction Dose (Part B)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	25/74 (33.78%)	27/75 (36.00%)	25/73 (34.25%)	22/56 (39.29%)	12/55 (21.82%)	18/31 (58.06%)	14/32 (43.75%)
Blood and lymphatic system disorders
Anaemia * 1	4/74 (5.41%)	1/75 (1.33%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	1/31 (3.23%)	2/32 (6.25%)
Gastrointestinal disorders
Diarrhoea * 1	2/74 (2.70%)	3/75 (4.00%)	4/73 (5.48%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Nausea * 1	4/74 (5.41%)	0/75 (0.00%)	4/73 (5.48%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
General disorders
Infusion related reaction * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	1/55 (1.82%)	2/31 (6.45%)	0/32 (0.00%)
Oedema peripheral * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	1/56 (1.79%)	1/55 (1.82%)	1/31 (3.23%)	2/32 (6.25%)
Infections and infestations
Bronchitis * 1	4/74 (5.41%)	2/75 (2.67%)	0/73 (0.00%)	1/56 (1.79%)	1/55 (1.82%)	2/31 (6.45%)	0/32 (0.00%)
Pharyngitis * 1	0/74 (0.00%)	4/75 (5.33%)	2/73 (2.74%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Urinary tract infection * 1	5/74 (6.76%)	6/75 (8.00%)	5/73 (6.85%)	8/56 (14.29%)	3/55 (5.45%)	6/31 (19.35%)	4/32 (12.50%)
Gastroenteritis * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	2/31 (6.45%)	0/32 (0.00%)
Nasopharyngitis * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	3/56 (5.36%)	3/55 (5.45%)	1/31 (3.23%)	1/32 (3.13%)
Upper respiratory tract infection * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	4/56 (7.14%)	1/55 (1.82%)	2/31 (6.45%)	3/32 (9.38%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	4/56 (7.14%)	0/55 (0.00%)	3/31 (9.68%)	1/32 (3.13%)
Back pain * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	2/56 (3.57%)	3/55 (5.45%)	1/31 (3.23%)	0/32 (0.00%)
Pain in extremity * 1	0/74 (0.00%)	0/75 (0.00%)	0/73 (0.00%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	2/32 (6.25%)
Nervous system disorders
Headache * 1	7/74 (9.46%)	4/75 (5.33%)	6/73 (8.22%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	4/74 (5.41%)	5/75 (6.67%)	0/73 (0.00%)	2/56 (3.57%)	1/55 (1.82%)	1/31 (3.23%)	3/32 (9.38%)
Skin and subcutaneous tissue disorders
Pruritus * 1	2/74 (2.70%)	7/75 (9.33%)	5/73 (6.85%)	1/56 (1.79%)	0/55 (0.00%)	1/31 (3.23%)	3/32 (9.38%)
Rash * 1	0/74 (0.00%)	4/75 (5.33%)	10/73 (13.70%)	3/56 (5.36%)	2/55 (3.64%)	3/31 (9.68%)	2/32 (6.25%)
Urticaria * 1	1/74 (1.35%)	1/75 (1.33%)	5/73 (6.85%)	0/56 (0.00%)	0/55 (0.00%)	0/31 (0.00%)	0/32 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 13.1

Limitations and Caveats

As the results of the primary analysis did not meet the predefined efficacy criteria, the development of TRU-015 was discontinued.

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00634933
• Obsolete Identifiers: NCT01616706
• Other Study ID Numbers: 3206K1-2203; B2051001
• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Results First Submitted: December 27, 2012
• Results First Posted: March 11, 2013
• Last Update Posted: March 11, 2013