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Trial record 1 of 1 for:    NCT00973479
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An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy

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ClinicalTrials.gov Identifier: NCT00973479
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : October 14, 2013
Last Update Posted : December 25, 2013
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor, Inc.

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: Golimumab
Other: Placebo
Drug: methotrexate (MTX)
Enrollment 592
Recruitment Details This study evaluated the efficacy and safety of intravenous administration of Golimumab 2mg/kg + methotrexate (MTX) in patients with Active Rheumatoid Arthritis despite treatment with MTX therapy. It was conducted between 14 September 2009 and 08 February 2013 and recruited participants at 92 sites in 13 countries worldwide.
Pre-assignment Details 592 participants were randomly allocated to 2 treatment arms. At Week 16 some participants in Placebo arm switched to Golimumab earlier than the rest at Week 24. Thus, the Adverse Events are presented based upon the time when participants began to receive Golimumab in the following manner: Golimumab from Day 0, from Week 16 and from Week 24.
Arm/Group Title Group I: Placebo + Methotrexate (MTX) Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
Hide Arm/Group Description Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count. Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
Period Title: Overall Study
Started 197 395
Completed 160 326
Not Completed 37 69
Reason Not Completed
Lost to Follow-up             0             3
Death             2             2
Withdrawal by Subject             15             16
Lack of Efficacy             5             7
Adverse Event             12             32
Protocol Violation             2             2
Not Specified             1             7
Arm/Group Title Group I: Placebo + Methotrexate (MTX) Group II: Golimumab 2 mg/kg + Methotrexate (MTX) Total
Hide Arm/Group Description Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count. Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind. Total of all reporting groups
Overall Number of Baseline Participants 197 395 592
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 197 participants 395 participants 592 participants
51.4  (11.26) 51.9  (12.55) 51.8  (12.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants 395 participants 592 participants
Female
157
  79.7%
326
  82.5%
483
  81.6%
Male
40
  20.3%
69
  17.5%
109
  18.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 197 participants 395 participants 592 participants
Argentina 28 54 82
Australia 3 6 9
Columbia 12 25 37
Hungary 10 21 31
Korea, Republic of 4 12 16
Lithuania 20 44 64
Malaysia 8 18 26
Mexico 13 25 38
New Zealand 2 4 6
Poland 36 65 101
Russian Federation 23 46 69
Ukraine 32 58 90
United States 6 17 23
1.Primary Outcome
Title Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
Hide Description An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 20 percentage improvement in at least 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS), (0 [no pain] to 10 [worst pain]) b. Participant's global assessment of disease activity by VAS c. Physician's global assessment of disease activity by VAS d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C-reactive protein.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.
Arm/Group Title Group I: Placebo + Methotrexate (MTX) Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
Hide Arm/Group Description:
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
Overall Number of Participants Analyzed 197 395
Measure Type: Number
Unit of Measure: Percentage of Participants
24.9 58.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo + Methotrexate (MTX), Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
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]
2.Secondary Outcome
Title Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14
Hide Description DAS28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis combining tender joints (28 joints), swollen joints (28 joints), CRP, and participant’s global assessment of disease activity. The DAS28 score ranges from 0 (best) to 10 (worst). DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Higher scores indicate worsening. A decrease in DAS28 score >1.2 is being referred to as a "good response" and a decrease of 0.6-1.2 as a "moderate response".
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.
Arm/Group Title Group I: Placebo + Methotrexate (MTX) Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
Hide Arm/Group Description:
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
Overall Number of Participants Analyzed 197 395
Measure Type: Number
Unit of Measure: Percentage of Participants
40.1 81.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo + Methotrexate (MTX), Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
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]
3.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14
Hide Description The HAQ is 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 (no difficulty), to 3 (inability to perform a task in that area). HAQscore on a scale ranges from 0 (no disability) to 3 (completely disabled). Higher scores indicate worsening.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.
Arm/Group Title Group I: Placebo + Methotrexate (MTX) Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
Hide Arm/Group Description:
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
Overall Number of Participants Analyzed 197 395
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.1250  (0.55770) 0.5000  (0.57706)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo + Methotrexate (MTX), Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
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 ANOVA of van der Waerden scores
Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24
Hide Description An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm) b. Participant's global assessment of disease activity by VAS (0-10 cm) c. Physician's global assessment of disease activity by VAS (0-10 cm) d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.
Arm/Group Title Group I: Placebo + Methotrexate (MTX) Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
Hide Arm/Group Description:
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
Overall Number of Participants Analyzed 197 395
Measure Type: Number
Unit of Measure: Percentage of Participants
13.2 34.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo + Methotrexate (MTX), Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
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]
5.Secondary Outcome
Title Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24.
Hide Description Total vdH-S score is sum of joint erosion score and joint-space narrowing (JSN) score. Joint erosion score summarizes erosion severity in 32 joints of hands and 12 joints of feet. Each joint scored from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Maximal erosion score is 280. JSN score summarizes severity of JSN in 30 joints of hands and 12 joints of feet. Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). Maximal JSN score is 168. Thus, the worst possible vdH-S score is 448.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.
Arm/Group Title Group I: Placebo + Methotrexate (MTX) Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
Hide Arm/Group Description:
Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
Overall Number of Participants Analyzed 197 395
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.09  (3.194) 0.03  (1.899)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo + Methotrexate (MTX), Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
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 ANOVA of van der Waerden scores
Comments [Not Specified]
Time Frame Adverse events data were collected for the duration of study (100 weeks) and follow-up (12 weeks).
Adverse Event Reporting Description The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table is based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
 
Arm/Group Title Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16 Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24 Golimumab 2 mg/kg + MTX Combined Golimumab
Hide Arm/Group Description Participants received placebo only through Week 16 and met early escape criteria or subjects who received first placebo and later inadvertently received Golimumab prior or at Week 16. The follow-up period for this treatment group begins once a participant switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses. Participants received placebo only through Week 24 or subjects who received first placebo and later inadvertently received Golimumab after Week 16 through Week 24. The follow-up period for this treatment group begins once a participants switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses. Participants were assigned to Golimumab 2 mg/kg + MTX and received at least one 2 mg/kg Golimumab. The follow-up period for this treatment group begins with the first dose of Golimumab 2 mg/kg. Participants may have missed one or more Golimumab doses. Participants in the reporting groups: Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16, Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24, and Golimumab 2 mg/kg + MTX.
All-Cause Mortality
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16 Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24 Golimumab 2 mg/kg + MTX Combined Golimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16 Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24 Golimumab 2 mg/kg + MTX Combined Golimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/68 (16.18%)   17/121 (14.05%)   78/395 (19.75%)   106/584 (18.15%) 
Blood and lymphatic system disorders         
Anaemia  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Lymphadenopathy  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Cardiac disorders         
Acute coronary syndrome  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Acute myocardial infarction  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Angina pectoris  1  1/68 (1.47%)  0/121 (0.00%)  1/395 (0.25%)  2/584 (0.34%) 
Angina unstable  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Atrial fibrillation  1  1/68 (1.47%)  0/121 (0.00%)  1/395 (0.25%)  2/584 (0.34%) 
Cor pulmonale chronic  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Myocardial infarction  1  1/68 (1.47%)  0/121 (0.00%)  1/395 (0.25%)  2/584 (0.34%) 
Myocardial ischaemia  1  0/68 (0.00%)  1/121 (0.83%)  2/395 (0.51%)  3/584 (0.51%) 
Sick sinus syndrome  1  1/68 (1.47%)  0/121 (0.00%)  0/395 (0.00%)  1/584 (0.17%) 
Ear and labyrinth disorders         
Vertigo  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Endocrine disorders         
Hyperthyroidism  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Eye disorders         
Cataract  1  0/68 (0.00%)  0/121 (0.00%)  3/395 (0.76%)  3/584 (0.51%) 
Gastrointestinal disorders         
Abdominal pain upper  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Acute abdomen  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Diverticulum intestinal  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Duodenogastric reflux  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Gastric disorder  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Gastritis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Gastrooesophageal reflux disease  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Haemorrhoids  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Hiatus hernia  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Pancreatitis acute  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Pancreatitis chronic  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
General disorders         
Cyst  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Pyrexia  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Sudden death  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Hepatobiliary disorders         
Bile duct stone  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Cholecystitis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Cholecystitis acute  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Cholelithiasis  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Hepatitis toxic  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Jaundice  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Infections and infestations         
Appendicitis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Arthritis bacterial  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Bacteraemia  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Bronchitis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Cellulitis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Device related infection  1  1/68 (1.47%)  0/121 (0.00%)  0/395 (0.00%)  1/584 (0.17%) 
Empyema  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Endophthalmitis  1  1/68 (1.47%)  0/121 (0.00%)  0/395 (0.00%)  1/584 (0.17%) 
Erysipelas  1  0/68 (0.00%)  0/121 (0.00%)  2/395 (0.51%)  2/584 (0.34%) 
Gastroenteritis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Infective spondylitis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Intervertebral discitis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Lobar pneumonia  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Lung abscess  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Pelvic inflammatory disease  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Pharyngitis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Pneumonia  1  1/68 (1.47%)  0/121 (0.00%)  4/395 (1.01%)  5/584 (0.86%) 
Pneumonia cryptococcal  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Rectal abscess  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Sepsis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Sepsis syndrome  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Septic shock  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Tuberculosis  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Tuberculous pleurisy  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Upper respiratory tract infection  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Urinary tract infection  1  0/68 (0.00%)  1/121 (0.83%)  3/395 (0.76%)  4/584 (0.68%) 
Urosepsis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Vestibular neuronitis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Injury, poisoning and procedural complications         
Ankle fracture  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Concussion  1  1/68 (1.47%)  0/121 (0.00%)  0/395 (0.00%)  1/584 (0.17%) 
Contusion  1  1/68 (1.47%)  0/121 (0.00%)  0/395 (0.00%)  1/584 (0.17%) 
Dislocation of vertebra  1  1/68 (1.47%)  0/121 (0.00%)  0/395 (0.00%)  1/584 (0.17%) 
Femoral neck fracture  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Femur fracture  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Hand fracture  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Head injury  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Humerus fracture  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Laceration  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Meniscus lesion  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Rib fracture  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Road traffic accident  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Spinal compression fracture  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Upper limb fracture  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Metabolism and nutrition disorders         
Dehydration  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Electrolyte imbalance  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Hyponatraemia  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Foot deformity  1  0/68 (0.00%)  1/121 (0.83%)  1/395 (0.25%)  2/584 (0.34%) 
Intervertebral disc protrusion  1  1/68 (1.47%)  0/121 (0.00%)  2/395 (0.51%)  3/584 (0.51%) 
Muscular weakness  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Osteoarthritis  1  1/68 (1.47%)  1/121 (0.83%)  1/395 (0.25%)  3/584 (0.51%) 
Osteonecrosis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Rheumatoid arthritis  1  2/68 (2.94%)  0/121 (0.00%)  10/395 (2.53%)  12/584 (2.05%) 
Synovitis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Bowen's disease  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Breast cancer  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Cervix carcinoma stage 0  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Chronic lymphocytic leukaemia  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Fibroadenoma of breast  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Lung neoplasm  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Salivary gland adenoma  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Thyroid neoplasm  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Nervous system disorders         
Carotid artery stenosis  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Cerebral infarction  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Cerebral ischaemia  1  0/68 (0.00%)  1/121 (0.83%)  1/395 (0.25%)  2/584 (0.34%) 
Iiird nerve paresis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Ischaemic stroke  1  0/68 (0.00%)  0/121 (0.00%)  2/395 (0.51%)  2/584 (0.34%) 
Lacunar infarction  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Radiculopathy  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Subarachnoid haemorrhage  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Syncope  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Renal and urinary disorders         
Calculus ureteric  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Nephrolithiasis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Nephropathy  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Renal colic  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Reproductive system and breast disorders         
Bartholinitis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Breast disorder  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Metrorrhagia  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Uterine prolapse  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Respiratory, thoracic and mediastinal disorders         
Acute pulmonary oedema  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Asthma  1  0/68 (0.00%)  0/121 (0.00%)  2/395 (0.51%)  2/584 (0.34%) 
Dyspnoea  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Hypoxia  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Interstitial lung disease  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Pleurisy  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Respiratory failure  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Skin and subcutaneous tissue disorders         
Rash  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Vascular disorders         
Arterial rupture  1  0/68 (0.00%)  1/121 (0.83%)  0/395 (0.00%)  1/584 (0.17%) 
Deep vein thrombosis  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Hypotension  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Peripheral vascular disorder  1  0/68 (0.00%)  0/121 (0.00%)  1/395 (0.25%)  1/584 (0.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16 Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24 Golimumab 2 mg/kg + MTX Combined Golimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/68 (50.00%)   38/121 (31.40%)   199/395 (50.38%)   271/584 (46.40%) 
Infections and infestations         
Bronchitis  1  6/68 (8.82%)  9/121 (7.44%)  37/395 (9.37%)  52/584 (8.90%) 
Nasopharyngitis  1  3/68 (4.41%)  8/121 (6.61%)  28/395 (7.09%)  39/584 (6.68%) 
Pharyngitis  1  0/68 (0.00%)  7/121 (5.79%)  26/395 (6.58%)  33/584 (5.65%) 
Upper respiratory tract infection  1  5/68 (7.35%)  8/121 (6.61%)  54/395 (13.67%)  67/584 (11.47%) 
Urinary tract infection  1  3/68 (4.41%)  7/121 (5.79%)  26/395 (6.58%)  36/584 (6.16%) 
Investigations         
Alanine aminotransferase increased  1  8/68 (11.76%)  3/121 (2.48%)  27/395 (6.84%)  38/584 (6.51%) 
Aspartate aminotransferase increased  1  5/68 (7.35%)  2/121 (1.65%)  18/395 (4.56%)  25/584 (4.28%) 
Hepatic enzyme increased  1  4/68 (5.88%)  0/121 (0.00%)  6/395 (1.52%)  10/584 (1.71%) 
Musculoskeletal and connective tissue disorders         
Rheumatoid arthritis  1  9/68 (13.24%)  3/121 (2.48%)  33/395 (8.35%)  45/584 (7.71%) 
Nervous system disorders         
Headache  1  5/68 (7.35%)  2/121 (1.65%)  27/395 (6.84%)  34/584 (5.82%) 
Vascular disorders         
Hypertension  1  8/68 (11.76%)  4/121 (3.31%)  27/395 (6.84%)  39/584 (6.68%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director Clinical Research
Organization: Centocor, Inc.
Phone: 1-800-457-6399
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00973479     History of Changes
Other Study ID Numbers: CR015784
CNTO148ART3001 ( Other Identifier: Centocor, Inc )
2008-006064-11 ( EudraCT Number )
First Submitted: September 4, 2009
First Posted: September 9, 2009
Results First Submitted: August 8, 2013
Results First Posted: October 14, 2013
Last Update Posted: December 25, 2013