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A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

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ClinicalTrials.gov Identifier: NCT01645280
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : December 19, 2014
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: Placebo + methotrexate (MTX) (Group 1)
Drug: Ustekinumab + MTX (Group 2)
Drug: Ustekinumab + MTX (Group 3)
Drug: CNTO 1959 + MTX (Group 4)
Drug: CNTO 1959 + MTX (Group 5)
Enrollment 274
Recruitment Details  
Pre-assignment Details A total of 274 subjects were enrolled into the study and 273 were treated. One participant in the Ustekinumab 90 milligram (mg) every 8 weeks group did not receive the treatment due to an adverse event before dosing.
Arm/Group Title Placebo Ustekinumab 90 mg Every 8 Weeks Ustekinumab 90 mg Every 12 Weeks CNTO1959 200 mg Every 8 Weeks CNTO1959 50 mg Every 8 Weeks
Hide Arm/Group Description Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab. Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate. Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Period Title: Overall Study
Started 55 [1] 54 55 54 55
Completed 49 51 49 48 47
Not Completed 6 3 6 6 8
Reason Not Completed
Death             0             1             0             0             0
Withdrawal by Subject             4             0             2             4             5
Lost to Follow-up             0             0             0             2             1
Other             1             1             2             0             0
Treatment not completed/Completed f/u             1             1             2             0             2
[1]
16 participants in placebo group early escaped to receive Ustekinmab; included in safety population.
Arm/Group Title Placebo Ustekinumab 90 mg Every 8 Weeks Ustekinumab 90 mg Every 12 Weeks CNTO1959 200 mg Every 8 Weeks CNTO1959 50 mg Every 8 Weeks Total
Hide Arm/Group Description Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab. Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate. Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. Total of all reporting groups
Overall Number of Baseline Participants 55 55 55 54 55 274
Hide Baseline Analysis Population Description
Analysis population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 55 participants 55 participants 54 participants 55 participants 274 participants
51.1  (10.57) 50.8  (13.01) 51.4  (13.59) 54.6  (11.34) 49.9  (12.85) 51.5  (12.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 55 participants 54 participants 55 participants 274 participants
Female
48
  87.3%
46
  83.6%
47
  85.5%
42
  77.8%
45
  81.8%
228
  83.2%
Male
7
  12.7%
9
  16.4%
8
  14.5%
12
  22.2%
10
  18.2%
46
  16.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 55 participants 54 participants 55 participants 274 participants
Argentina 1 5 6 5 6 23
Bulgaria 2 2 2 2 1 9
CZ Rep 0 0 1 0 0 1
Chile 1 1 1 1 2 6
Colombia 10 9 8 6 10 43
Hungary 6 5 2 4 3 20
Poland 5 8 6 7 9 35
Russia 20 15 18 19 14 86
Singapore 1 1 0 2 0 4
USA 0 0 1 0 0 1
Ukraine 9 9 10 8 10 46
1.Primary Outcome
Title Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28
Hide Description The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient’s assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants. For early escape, data at or prior to Week 16 were carried forward through Week 28.
Arm/Group Title Placebo Ustekinumab 90 mg Every 8 Weeks Ustekinumab 90 mg Every 12 Weeks CNTO1959 200 mg Every 8 Weeks CNTO1959 50 mg Every 8 Weeks
Hide Arm/Group Description:
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Overall Number of Participants Analyzed 55 55 55 54 55
Measure Type: Number
Unit of Measure: percentage of participants
40.0 52.7 54.5 44.4 38.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.184
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 mg Every 12 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 200 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.642
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 50 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.832
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
2.Secondary Outcome
Title Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28
Hide Description The DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, CRP (mG/L) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame From Baseline to Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The modified-ITT population included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.
Arm/Group Title Placebo Ustekinumab 90 mg Every 8 Weeks Ustekinumab 90 mg Every 12 Weeks CNTO1959 200 mg Every 8 Weeks CNTO1959 50 mg Every 8 Weeks
Hide Arm/Group Description:
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Overall Number of Participants Analyzed 55 54 55 54 55
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
-0.94  (0.174) -1.52  (0.185) -1.49  (0.183) -1.21  (0.170) 6.07  (0.821)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 mg Every 12 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method ANCOVA
Comments Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 200 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.248
Comments [Not Specified]
Method ANCOVA
Comments Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 50 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method ANCOVA
Comments Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
3.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12
Hide Description The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 2) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 3) Physician's Global Assessment of Disease Activity-Visual Analog Scale, 4) Patient’s Assessment of Physical Function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI), 5) C-reactive Protein (CRP).
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The m-ITT population included participants who received at least 1 (partial or complete) dose of study agent.
Arm/Group Title Placebo Ustekinumab 90 mg Every 8 Weeks Ustekinumab 90 mg Every 12 Weeks CNTO1959 200 mg Every 8 Weeks CNTO1959 50 mg Every 8 Weeks
Hide Arm/Group Description:
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Overall Number of Participants Analyzed 55 54 55 54 55
Measure Type: Number
Unit of Measure: percentage of participants
29.1 37.0 34.5 33.3 20.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 mg Every 12 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.543
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 200 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.629
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 50 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.273
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.
4.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28
Hide Description The Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Baseline and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The m-ITT included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.
Arm/Group Title Placebo Ustekinumab 90 mg Every 8 Weeks Ustekinumab 90 mg Every 12 Weeks CNTO1959 200 mg Every 8 Weeks CNTO1959 50 mg Every 8 Weeks
Hide Arm/Group Description:
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Overall Number of Participants Analyzed 55 54 55 54 55
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
-0.30  (0.074) -0.48  (0.072) -0.44  (0.071) -0.41  (0.075) -0.39  (0.076)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments [Not Specified]
Method ANCOVA
Comments Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 mg Every 12 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method ANCOVA
Comments Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 200 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.280
Comments [Not Specified]
Method ANCOVA
Comments Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, CNTO1959 50 mg Every 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.345
Comments [Not Specified]
Method ANCOVA
Comments Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.
Time Frame Week 0 to 48
Adverse Event Reporting Description Safety population included all participants who received at least 1 dose of study drug.
 
Arm/Group Title Placebo Placebo (Early Escape) Ustekinumab 90 mg Every 8 Weeks Ustekinumab 90 mg Every 12 Weeks CNTO1959 200 mg Every 8 Weeks CNTO1959 50 mg Every 8 Weeks
Hide Arm/Group Description Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab. Participants who early escaped at Week 16 and received ustekinumab 90 milligram (mg) subcutaneously at Week 16, 20 and 28 along with methotrexate. Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate. Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
All-Cause Mortality
Placebo Placebo (Early Escape) Ustekinumab 90 mg Every 8 Weeks Ustekinumab 90 mg Every 12 Weeks CNTO1959 200 mg Every 8 Weeks CNTO1959 50 mg Every 8 Weeks
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 Placebo (Early Escape) Ustekinumab 90 mg Every 8 Weeks Ustekinumab 90 mg Every 12 Weeks CNTO1959 200 mg Every 8 Weeks CNTO1959 50 mg Every 8 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/55 (5.45%)   1/16 (6.25%)   4/54 (7.41%)   3/55 (5.45%)   3/54 (5.56%)   0/55 (0.00%) 
Blood and lymphatic system disorders             
Anaemia * 1  0/55 (0.00%)  0/16 (0.00%)  1/54 (1.85%)  0/55 (0.00%)  0/54 (0.00%)  0/55 (0.00%) 
Cardiac disorders             
Angina Unstable * 1  1/55 (1.82%)  0/16 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  0/54 (0.00%)  0/55 (0.00%) 
Gastrointestinal disorders             
Ileus * 1  0/55 (0.00%)  0/16 (0.00%)  0/54 (0.00%)  1/55 (1.82%)  0/54 (0.00%)  0/55 (0.00%) 
Infections and infestations             
Appendicitis * 1  1/55 (1.82%)  0/16 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  0/54 (0.00%)  0/55 (0.00%) 
Lobar Pneumonia * 1  0/55 (0.00%)  0/16 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  1/54 (1.85%)  0/55 (0.00%) 
Urinary Tract Infection * 1  0/55 (0.00%)  0/16 (0.00%)  1/54 (1.85%)  0/55 (0.00%)  0/54 (0.00%)  0/55 (0.00%) 
Gastroenteritis * 1  0/55 (0.00%)  0/16 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  1/54 (1.85%)  0/55 (0.00%) 
Injury, poisoning and procedural complications             
Concussion * 1  0/55 (0.00%)  0/16 (0.00%)  1/54 (1.85%)  0/55 (0.00%)  0/54 (0.00%)  0/55 (0.00%) 
Musculoskeletal and connective tissue disorders             
Rheumatoid Arthritis * 1  1/55 (1.82%)  1/16 (6.25%)  0/54 (0.00%)  0/55 (0.00%)  0/54 (0.00%)  0/55 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Breast Cancer Stage I * 1  0/55 (0.00%)  0/16 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  1/54 (1.85%)  0/55 (0.00%) 
Squamous Cell Carcinoma of Lung * 1  0/55 (0.00%)  0/16 (0.00%)  0/54 (0.00%)  1/55 (1.82%)  0/54 (0.00%)  0/55 (0.00%) 
Nervous system disorders             
Sciatica * 1  0/55 (0.00%)  0/16 (0.00%)  1/54 (1.85%)  0/55 (0.00%)  0/54 (0.00%)  0/55 (0.00%) 
Transient Ischaemic Attack * 1  0/55 (0.00%)  0/16 (0.00%)  0/54 (0.00%)  1/55 (1.82%)  0/54 (0.00%)  0/55 (0.00%) 
Vascular disorders             
Shock * 1  0/55 (0.00%)  0/16 (0.00%)  1/54 (1.85%)  0/55 (0.00%)  0/54 (0.00%)  0/55 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Placebo (Early Escape) Ustekinumab 90 mg Every 8 Weeks Ustekinumab 90 mg Every 12 Weeks CNTO1959 200 mg Every 8 Weeks CNTO1959 50 mg Every 8 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/55 (23.64%)   6/16 (37.50%)   15/54 (27.78%)   15/55 (27.27%)   18/54 (33.33%)   14/55 (25.45%) 
Blood and lymphatic system disorders             
Anaemia * 1  1/55 (1.82%)  0/16 (0.00%)  2/54 (3.70%)  0/55 (0.00%)  3/54 (5.56%)  1/55 (1.82%) 
Gastrointestinal disorders             
Dyspepsia * 1  1/55 (1.82%)  1/16 (6.25%)  0/54 (0.00%)  0/55 (0.00%)  0/54 (0.00%)  0/55 (0.00%) 
General disorders             
Asthenia * 1  0/55 (0.00%)  1/16 (6.25%)  2/54 (3.70%)  1/55 (1.82%)  1/54 (1.85%)  1/55 (1.82%) 
Infections and infestations             
Influenza * 1  3/55 (5.45%)  0/16 (0.00%)  1/54 (1.85%)  3/55 (5.45%)  3/54 (5.56%)  3/55 (5.45%) 
Nasopharyngitis * 1  3/55 (5.45%)  1/16 (6.25%)  5/54 (9.26%)  4/55 (7.27%)  4/54 (7.41%)  3/55 (5.45%) 
Bronchitis * 1  1/55 (1.82%)  0/16 (0.00%)  2/54 (3.70%)  2/55 (3.64%)  4/54 (7.41%)  2/55 (3.64%) 
Pharyngitis * 1  0/55 (0.00%)  1/16 (6.25%)  0/54 (0.00%)  1/55 (1.82%)  0/54 (0.00%)  1/55 (1.82%) 
Urinary Tract Infection * 1  0/55 (0.00%)  1/16 (6.25%)  0/54 (0.00%)  1/55 (1.82%)  0/54 (0.00%)  0/55 (0.00%) 
Investigations             
Aspartate Aminotransferase Increased * 1  1/55 (1.82%)  1/16 (6.25%)  0/54 (0.00%)  1/55 (1.82%)  0/54 (0.00%)  1/55 (1.82%) 
Musculoskeletal and connective tissue disorders             
Rheumatoid Arthritis * 1  1/55 (1.82%)  0/16 (0.00%)  2/54 (3.70%)  5/55 (9.09%)  4/54 (7.41%)  2/55 (3.64%) 
Back Pain * 1  1/55 (1.82%)  0/16 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  1/54 (1.85%)  3/55 (5.45%) 
Nervous system disorders             
Headache * 1  3/55 (5.45%)  1/16 (6.25%)  2/54 (3.70%)  5/55 (9.09%)  3/54 (5.56%)  2/55 (3.64%) 
Skin and subcutaneous tissue disorders             
Photosensitivity Reaction * 1  0/55 (0.00%)  1/16 (6.25%)  0/54 (0.00%)  0/55 (0.00%)  0/54 (0.00%)  0/55 (0.00%) 
Vascular disorders             
Hypertension * 1  3/55 (5.45%)  1/16 (6.25%)  4/54 (7.41%)  2/55 (3.64%)  1/54 (1.85%)  1/55 (1.82%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Name/Title: Senior Director Clin Development
Organization: Janssen Pharmaceuticals
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01645280     History of Changes
Other Study ID Numbers: CR100736
CNTO1275ARA2001 ( Other Identifier: Janssen Research & Development, LLC )
2011-001122-18 ( EudraCT Number )
First Submitted: June 6, 2012
First Posted: July 20, 2012
Results First Submitted: December 12, 2014
Results First Posted: December 19, 2014
Last Update Posted: May 12, 2016