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

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ClinicalTrials.gov Identifier: NCT00634933
Recruitment Status : Terminated (The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.)
First Posted : March 13, 2008
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
Sponsor:
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
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
Hide 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
Arm/Group Title Placebo TRU-015 Single Dose TRU-015 Induction Dose Total
Hide 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
Hide 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%
1.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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]
Show Statistical Analysis 3 Hide 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]
Show Statistical Analysis 4 Hide 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]
Show Statistical Analysis 5 Hide 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]
Show Statistical Analysis 6 Hide 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]
Show Statistical Analysis 7 Hide 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]
Show Statistical Analysis 8 Hide 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]
Show Statistical Analysis 9 Hide 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]
Show Statistical Analysis 10 Hide 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]
Show Statistical Analysis 11 Hide 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]
Show Statistical Analysis 12 Hide 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]
Show Statistical Analysis 13 Hide 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]
Show Statistical Analysis 14 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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]
Show Statistical Analysis 3 Hide 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]
Show Statistical Analysis 4 Hide 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]
Show Statistical Analysis 5 Hide 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]
Show Statistical Analysis 6 Hide 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]
Show Statistical Analysis 7 Hide 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]
Show Statistical Analysis 8 Hide 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]
Show Statistical Analysis 9 Hide 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]
Show Statistical Analysis 10 Hide 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]
Show Statistical Analysis 11 Hide 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]
Show Statistical Analysis 12 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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]
Show Statistical Analysis 3 Hide 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]
Show Statistical Analysis 4 Hide 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]
Show Statistical Analysis 5 Hide 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]
Show Statistical Analysis 6 Hide 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]
Show Statistical Analysis 7 Hide 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]
Show Statistical Analysis 8 Hide 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]
Show Statistical Analysis 9 Hide 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]
Show Statistical Analysis 10 Hide 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]
Show Statistical Analysis 11 Hide 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]
Show Statistical Analysis 12 Hide 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]
Show Statistical Analysis 13 Hide 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]
Show Statistical Analysis 14 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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]
Show Statistical Analysis 3 Hide 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]
Show Statistical Analysis 4 Hide 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]
Show Statistical Analysis 5 Hide 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]
Show Statistical Analysis 6 Hide 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]
Show Statistical Analysis 7 Hide 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]
Show Statistical Analysis 8 Hide 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]
Show Statistical Analysis 9 Hide 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]
Show Statistical Analysis 10 Hide 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]
Show Statistical Analysis 11 Hide 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]
Show Statistical Analysis 12 Hide 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]
Show Statistical Analysis 13 Hide 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]
Show Statistical Analysis 14 Hide 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]
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)
Hide 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   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
As the results of the primary analysis did not meet the predefined efficacy criteria, the development of TRU-015 was discontinued.
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00634933     History of Changes
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