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A Study of Golimumab in Participants With Active Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02181673
Recruitment Status : Completed
First Posted : July 4, 2014
Results First Posted : December 21, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Arthritis, Psoriatic
Interventions Drug: Placebo
Drug: Golimumab
Enrollment 480
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo (Week 0-24) Placebo Then Golimumab 2 mg/kg (Week 24-60) Golimumab 2 mg/kg (Week 0-60)
Hide Arm/Group Description Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20. Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52. Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
Period Title: Up to Week 24
Started 239 0 241
Treated 239 0 240
Completed 222 0 230
Not Completed 17 0 11
Reason Not Completed
Adverse Event             2             0             3
Death             1             0             0
Lack of Efficacy             1             0             0
Lost to Follow-up             1             0             0
Physician Decision             0             0             3
Withdrawal by Subject             10             0             1
Other             2             0             3
Randomized not Treated             0             0             1
Period Title: Week 24-Week 60
Started 0 222 230
Treated 0 220 230
Completed 0 214 213
Not Completed 0 8 17
Reason Not Completed
Adverse Event             0             4             10
Other             0             2             1
Withdrawal by Subject             0             2             2
Pregnancy             0             0             1
Lack of Efficacy             0             0             1
Lost to Follow-up             0             0             1
Physician Decision             0             0             1
Arm/Group Title Placebo (Week 0-24) Golimumab 2 mg/kg Total
Hide Arm/Group Description Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20. Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind. Total of all reporting groups
Overall Number of Baseline Participants 239 241 480
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 241 participants 480 participants
<=18 years
2
   0.8%
0
   0.0%
2
   0.4%
Between 18 and 65 years
216
  90.4%
228
  94.6%
444
  92.5%
>=65 years
21
   8.8%
13
   5.4%
34
   7.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 239 participants 241 participants 480 participants
46.7  (12.53) 45.7  (11.25) 46.2  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 241 participants 480 participants
Female
118
  49.4%
113
  46.9%
231
  48.1%
Male
121
  50.6%
128
  53.1%
249
  51.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 241 participants 480 participants
Belarus
14
   5.9%
8
   3.3%
22
   4.6%
Canada
1
   0.4%
0
   0.0%
1
   0.2%
Germany
3
   1.3%
1
   0.4%
4
   0.8%
Hungary
13
   5.4%
9
   3.7%
22
   4.6%
Lithuania
13
   5.4%
17
   7.1%
30
   6.3%
Poland
43
  18.0%
34
  14.1%
77
  16.0%
Romania
3
   1.3%
1
   0.4%
4
   0.8%
Russian Federation
79
  33.1%
74
  30.7%
153
  31.9%
Spain
1
   0.4%
2
   0.8%
3
   0.6%
Ukraine
61
  25.5%
86
  35.7%
147
  30.6%
United States
8
   3.3%
9
   3.7%
17
   3.5%
1.Primary Outcome
Title Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14
Hide Description The ACR 20 response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 239 241
Measure Type: Number
Unit of Measure: Percentage of Participants
21.8 75.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Golimumab
Comments [Not Specified]
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]
Method of Estimation Estimation Parameter Percent Difference
Estimated Value 53.4
Confidence Interval (2-Sided) 95%
45.80 to 60.90
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14
Hide Description The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). 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 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized. Here "N" (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 222 233
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.12  (0.466) -0.60  (0.530)
3.Secondary Outcome
Title Percentage of Participants Who Achieved an ACR 50 Response at Week 14
Hide Description The ACR 50 response is defined as: greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 239 241
Measure Type: Number
Unit of Measure: Percentage of Participants
6.3 43.6
4.Secondary Outcome
Title Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set included randomized participants with greater than or equal to (>=) 3 percent (%) body surface area (BSA) Psoriasis Skin Involvement at Baseline.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 198 196
Measure Type: Number
Unit of Measure: Percentage of participants
13.6 59.2
5.Secondary Outcome
Title Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
Hide Description The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS for structural damage endpoints (FAS-SD) defined as participants in the FAS who were treated and had a non-missing baseline total modified vdH-S score for the analysis.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 237 237
Mean (Standard Error)
Unit of Measure: units on a scale
1.95  (0.264) -0.36  (0.144)
6.Secondary Outcome
Title Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline
Hide Description Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all randomized participants with Enthesitis at Baseline. Here "N" (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 173 182
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (1.98) -1.8  (1.75)
7.Secondary Outcome
Title Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline
Hide Description Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all Randomized participants With Dactylitis (Score >0) at Baseline. Here "N" (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 115 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.8  (7.03) -7.8  (8.57)
8.Secondary Outcome
Title Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14
Hide Description The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized. Here "N" (number of participants analyzed) signifies the number of participants evaluable for this outcome measure.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 222 233
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.69  (5.920) 8.65  (7.602)
9.Secondary Outcome
Title Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
Hide Description The ACR 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 239 241
Measure Type: Number
Unit of Measure: Percentage of participants
6.3 53.5
10.Secondary Outcome
Title Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14
Hide Description The ACR 70 response is defined as greater than or equal to (>=) 70 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=70% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 239 241
Measure Type: Number
Unit of Measure: Percentage of participants
2.1 24.5
11.Secondary Outcome
Title Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14
Hide Description The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized. Here "N" (number of participants analyzed) signifies the number of participants evaluable for this outcome measure.
Arm/Group Title Placebo Golimumab
Hide Arm/Group Description:
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
Overall Number of Participants Analyzed 222 233
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.97  (7.644) 5.33  (9.948)
Time Frame Up to 60 Weeks
Adverse Event Reporting Description Safety Population included all participants who received at least 1 dose of study agent.
 
Arm/Group Title Placebo (Week 0-24) Placebo Then Golimumab 2 mg/kg (Week 24-60) Golimumab 2 mg/kg (Week 0-60)
Hide Arm/Group Description Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20. Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52. Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
All-Cause Mortality
Placebo (Week 0-24) Placebo Then Golimumab 2 mg/kg (Week 24-60) Golimumab 2 mg/kg (Week 0-60)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Week 0-24) Placebo Then Golimumab 2 mg/kg (Week 24-60) Golimumab 2 mg/kg (Week 0-60)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/239 (3.35%)   5/220 (2.27%)   19/240 (7.92%) 
Cardiac disorders       
Cardiac failure acute * 1  1/239 (0.42%)  0/220 (0.00%)  0/240 (0.00%) 
Myocardial ischaemia * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Eye disorders       
Cataract * 1  1/239 (0.42%)  0/220 (0.00%)  0/240 (0.00%) 
Gastrointestinal disorders       
Oedematous pancreatitis * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Hepatobiliary disorders       
Drug-induced liver injury * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Hepatitis acute * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Hepatitis chronic active * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Infections and infestations       
Empyema * 1  0/239 (0.00%)  1/220 (0.45%)  0/240 (0.00%) 
Infected dermal cyst * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Periodontitis * 1  0/239 (0.00%)  1/220 (0.45%)  0/240 (0.00%) 
Pneumonia * 1  1/239 (0.42%)  1/220 (0.45%)  2/240 (0.83%) 
Pulmonary tuberculosis * 1  0/239 (0.00%)  0/220 (0.00%)  2/240 (0.83%) 
Pyelonephritis acute * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Urinary tract infection * 1  0/239 (0.00%)  1/220 (0.45%)  0/240 (0.00%) 
Injury, poisoning and procedural complications       
Epidural haemorrhage * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Facial bones fracture * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Humerus fracture * 1  1/239 (0.42%)  0/220 (0.00%)  1/240 (0.42%) 
Radius fracture * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Skull fracture * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Investigations       
Gene mutation identification test positive * 1  0/239 (0.00%)  1/220 (0.45%)  0/240 (0.00%) 
Laboratory test abnormal * 1  0/239 (0.00%)  1/220 (0.45%)  0/240 (0.00%) 
Liver function test abnormal * 1  1/239 (0.42%)  0/220 (0.00%)  1/240 (0.42%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Gastric cancer * 1  0/239 (0.00%)  1/220 (0.45%)  0/240 (0.00%) 
Meningioma benign * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Non-small cell lung cancer * 1  1/239 (0.42%)  0/220 (0.00%)  0/240 (0.00%) 
Oesophageal neoplasm * 1  1/239 (0.42%)  0/220 (0.00%)  0/240 (0.00%) 
Pleomorphic adenoma * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Nervous system disorders       
Cerebral haematoma * 1  1/239 (0.42%)  0/220 (0.00%)  0/240 (0.00%) 
Headache * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Neuritis * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Paraesthesia * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Renal and urinary disorders       
Calculus urinary * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Renal failure * 1  1/239 (0.42%)  0/220 (0.00%)  0/240 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pneumonia aspiration * 1  1/239 (0.42%)  0/220 (0.00%)  0/240 (0.00%) 
Skin and subcutaneous tissue disorders       
Pustular psoriasis * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Vascular disorders       
Deep vein thrombosis * 1  1/239 (0.42%)  0/220 (0.00%)  0/240 (0.00%) 
Hypertension * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
Hypertensive crisis * 1  0/239 (0.00%)  0/220 (0.00%)  1/240 (0.42%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Week 0-24) Placebo Then Golimumab 2 mg/kg (Week 24-60) Golimumab 2 mg/kg (Week 0-60)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/239 (7.95%)   25/220 (11.36%)   40/240 (16.67%) 
Infections and infestations       
Nasopharyngitis * 1  13/239 (5.44%)  9/220 (4.09%)  14/240 (5.83%) 
Investigations       
Alanine aminotransferase increased * 1  5/239 (2.09%)  13/220 (5.91%)  25/240 (10.42%) 
Aspartate aminotransferase increased * 1  5/239 (2.09%)  12/220 (5.45%)  19/240 (7.92%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 19.1
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.
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 in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: Senior Director Clinical Development
Organization: Janssen Research & Development, LLC
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02181673     History of Changes
Other Study ID Numbers: CR103796
2014-000242-30 ( EudraCT Number )
CNTO148PSA3001 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: July 2, 2014
First Posted: July 4, 2014
Results First Submitted: November 10, 2017
Results First Posted: December 21, 2017
Last Update Posted: December 21, 2017