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Trial record 1 of 1 for:    NCT00207714
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An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00207714
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : August 7, 2012
Last Update Posted : October 18, 2012
Sponsor:
Collaborator:
Centocor BV
Information provided by:
Centocor, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Golimumab
Drug: MTX
Drug: Placebo
Drug: Infliximab
Enrollment 172
Recruitment Details A total of 172 participants were randomly assigned to treatments at 33 sites: 16 in North America (13 in the US and 3 in Canada), 12 in Europe (3 in Belgium, 4 in the UK, 5 in Germany), and 5 in Australia. The study period extended from 01 Dec 2003 to 21 Feb 2006.
Pre-assignment Details  
Arm/Group Title Group I: Placebo Crossover to Infliximab Group II: Golimumab 50 mg Every 4 Weeks Group III: Golimumab 50 mg Every 2 or 4 Weeks Group IV: Golibumab 100 mg Every 4 Weeks Group V: Golimumab 100 mg Every 2 or 4 Weeks
Hide Arm/Group Description Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks. Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks. Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks. Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
Period Title: Overall Study
Started 35 35 34 34 34
Completed 21 [1] 28 [1] 24 [1] 26 [1] 29 [1]
Not Completed 14 7 10 8 5
Reason Not Completed
Adverse Event             6             2             4             3             1
Unsatisfactory therapeutic effect             5             3             1             4             4
Other             3             2             5             1             0
[1]
Indicates number of participants who continued subcutaneous study agent at Wk 16
Arm/Group Title Group I: Placebo Crossover to Infliximab Group II: Golimumab 50 mg Every 4 Weeks Group III: Golimumab 50 mg Every 2 or 4 Weeks Group IV: Golibumab 100 mg Every 4 Weeks Group V: Golimumab 100 mg Every 2 or 4 Weeks Total
Hide Arm/Group Description Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks. Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks. Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks. Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks. Total of all reporting groups
Overall Number of Baseline Participants 35 35 34 34 34 172
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 34 participants 34 participants 34 participants 172 participants
53.8  (12.9) 56.1  (10.5) 50.4  (13.1) 56.3  (12.1) 54.1  (14.1) 54.2  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 34 participants 34 participants 34 participants 172 participants
Female
26
  74.3%
30
  85.7%
23
  67.6%
26
  76.5%
27
  79.4%
132
  76.7%
Male
9
  25.7%
5
  14.3%
11
  32.4%
8
  23.5%
7
  20.6%
40
  23.3%
1.Primary Outcome
Title Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16
Hide Description ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT). Participants considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.
Arm/Group Title Group I: Placebo Crossover to Infliximab Group II: Golimumab 50 mg Every 4 Weeks Group III: Golimumab 50 mg Every 2 or 4 Weeks Group IV: Golibumab 100 mg Every 4 Weeks Group V: Golimumab 100 mg Every 2 or 4 Weeks Combined: Groups II, III, IV & V
Hide Arm/Group Description:
Placebo SC injections every 2 weeks (Wks) from week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
Golimumab (CNTO148) 50 mg SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 Wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 Wks).
Overall Number of Participants Analyzed 35 35 34 34 34 137
Measure Type: Number
Unit of Measure: Participants
13 21 17 19 27 84
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo Crossover to Infliximab, Combined: Groups II, III, IV & V
Comments Null hypothesis: No difference in ACR 20 response at Week 16 between combined golimumab groups and Placebo +MTX group. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25 % response in Placebo +MTX.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo Crossover to Infliximab, Group II: Golimumab 50 mg Every 4 Weeks
Comments Null hypothesis: No difference in ACR 20 response at Wk 16 between golimumab 50 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo Crossover to Infliximab, Group III: Golimumab 50 mg Every 2 or 4 Weeks
Comments Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 50 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.281
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group I: Placebo Crossover to Infliximab, Group IV: Golibumab 100 mg Every 4 Weeks
Comments Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group I: Placebo Crossover to Infliximab, Group V: Golimumab 100 mg Every 2 or 4 Weeks
Comments Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.
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 Summary of ACR-N, Index of Improvement at Week 16
Hide Description The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient's assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient's global assessment of disease activity (VAS 0-10); c. Physician's global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) and missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. The joint evaluability rules were also applied.
Arm/Group Title Group I: Placebo Crossover to Infliximab Group II: Golimumab 50 mg Every 4 Weeks Group III: Golimumab 50 mg Every 2 or 4 Weeks Group IV: Golibumab 100 mg Every 4 Weeks Group V: Golimumab 100 mg Every 2 or 4 Weeks Combined: Groups II, III, IV & V
Hide Arm/Group Description:
Placebo SC injections every 2 wks from Wk 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 wks thru Wk 44. Continue stable dose of MTX throughout the study.
Golimumab (CNTO148) 50 mg SC injections every 4 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
Golimumab 50 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
Golimumab 100 mg SC injections every 4 wks thru Wk 18 plus MTX (Weeks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Weeks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
Golimumab 100 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 wks).
Overall Number of Participants Analyzed 35 35 34 34 34 137
Median (Inter-Quartile Range)
Unit of Measure: Scores on scale
0.0
(-12.5 to 28.6)
37.4
(0.0 to 54.4)
19.4
(-1.0 to 49.0)
22.3
(0.0 to 55.6)
35.6
(20.0 to 56.6)
33.3
(0.0 to 54.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo Crossover to Infliximab, Combined: Groups II, III, IV & V
Comments No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and combined golimumab groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA on van der Waerden normal scores.
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo Crossover to Infliximab, Group II: Golimumab 50 mg Every 4 Weeks
Comments No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 4 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANOVA on van der Waerden normal scores.
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo Crossover to Infliximab, Group III: Golimumab 50 mg Every 2 or 4 Weeks
Comments No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 2 or 4 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method ANOVA on van der Waerden normal scores.
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group I: Placebo Crossover to Infliximab, Group IV: Golibumab 100 mg Every 4 Weeks
Comments No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golibumab 100 mg every 4 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANOVA on van der Waerden normal scores.
Comments ANOVA on van der Waerden normal scores
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group I: Placebo Crossover to Infliximab, Group V: Golimumab 100 mg Every 2 or 4 Weeks
Comments No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golimumab 100 mg every 2 or 4 Weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA on van der Waerden normal scores.
Comments [Not Specified]
Time Frame Baseline to Week 52
Adverse Event Reporting Description Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
 
Arm/Group Title Group I: Placebo Crossover to Infliximab Group II: Golimumab 50 mg Every 4 Weeks Group III: Golimumab 50 mg Every 2 or 4 Weeks Group IV: Golibumab 100 mg Every 4 Weeks Group V: Golimumab 100 mg Every 2 or 4 Weeks
Hide Arm/Group Description Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. Golimumab (CNTO148) 50 milligram (mg) subcutaneous (SC) injections every 4 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks. Golimumab 50 miligram (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks. Golimumab 100 mg subcutaneous (SC) injections every 4 weeks (Wks) thru Week (Wk) 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks. Golimumab 100 milligrams (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
All-Cause Mortality
Group I: Placebo Crossover to Infliximab Group II: Golimumab 50 mg Every 4 Weeks Group III: Golimumab 50 mg Every 2 or 4 Weeks Group IV: Golibumab 100 mg Every 4 Weeks Group V: Golimumab 100 mg Every 2 or 4 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Group I: Placebo Crossover to Infliximab Group II: Golimumab 50 mg Every 4 Weeks Group III: Golimumab 50 mg Every 2 or 4 Weeks Group IV: Golibumab 100 mg Every 4 Weeks Group V: Golimumab 100 mg Every 2 or 4 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/34 (5.88%)   7/37 (18.92%)   5/32 (15.63%)   5/33 (15.15%)   5/35 (14.29%) 
Cardiac disorders           
Angina unstable  1  0/34 (0.00%)  0/37 (0.00%)  1/32 (3.13%)  0/33 (0.00%)  0/35 (0.00%) 
Cardiac failure congestive  1  0/34 (0.00%)  1/37 (2.70%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Cardiac tamponade  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  1/35 (2.86%) 
Coronary artery stenosis  1  0/34 (0.00%)  1/37 (2.70%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Gastrointestinal disorders           
Inguinal hernia  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  1/35 (2.86%) 
Enterocolitis  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
General disorders           
Chest pain  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  1/33 (3.03%)  0/35 (0.00%) 
Infections and infestations           
Bronchopneumonia  1  0/34 (0.00%)  1/37 (2.70%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Pneumonia  1  0/34 (0.00%)  0/37 (0.00%)  1/32 (3.13%)  0/33 (0.00%)  0/35 (0.00%) 
Pneumonia legionella  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  1/33 (3.03%)  0/35 (0.00%) 
Septic shock  1  0/34 (0.00%)  0/37 (0.00%)  1/32 (3.13%)  0/33 (0.00%)  0/35 (0.00%) 
Sinusitis  1  0/34 (0.00%)  0/37 (0.00%)  1/32 (3.13%)  0/33 (0.00%)  0/35 (0.00%) 
Listeria sepsis  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Lower respiratory tract infection  1  1/34 (2.94%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Injury, poisoning and procedural complications           
Femur fracture  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  1/35 (2.86%) 
Fractured coccyx  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  1/35 (2.86%) 
Medical device complication  1  0/34 (0.00%)  1/37 (2.70%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Metabolism and nutrition disorders           
Hyperglycaemia  1  0/34 (0.00%)  1/37 (2.70%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Musculoskeletal and connective tissue disorders           
Rheumatoid arthritis  1  2/34 (5.88%)  1/37 (2.70%)  1/32 (3.13%)  1/33 (3.03%)  0/35 (0.00%) 
Back pain  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  1/35 (2.86%) 
Fracture delayed union  1  0/34 (0.00%)  1/37 (2.70%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Intervertebral disc protrusion  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Basal cell carcinoma  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  1/33 (3.03%)  0/35 (0.00%) 
Lung adenocarcinoma  1  0/34 (0.00%)  0/37 (0.00%)  1/32 (3.13%)  0/33 (0.00%)  0/35 (0.00%) 
Squamous cell carcinoma  1  0/34 (0.00%)  0/37 (0.00%)  1/32 (3.13%)  0/33 (0.00%)  0/35 (0.00%) 
Nervous system disorders           
Nerve root compression  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Reproductive system and breast disorders           
Benign prostatic hyperplasia  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive airways disease exacerbated  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  1/33 (3.03%)  0/35 (0.00%) 
Vascular disorders           
Thrombophlebitis superficial  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  1/35 (2.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group I: Placebo Crossover to Infliximab Group II: Golimumab 50 mg Every 4 Weeks Group III: Golimumab 50 mg Every 2 or 4 Weeks Group IV: Golibumab 100 mg Every 4 Weeks Group V: Golimumab 100 mg Every 2 or 4 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/34 (82.35%)   34/37 (91.89%)   29/32 (90.63%)   29/33 (87.88%)   33/35 (94.29%) 
Blood and lymphatic system disorders           
Eosinophilia  1  0/34 (0.00%)  0/37 (0.00%)  2/32 (6.25%)  0/33 (0.00%)  0/35 (0.00%) 
Ear and labyrinth disorders           
Vertigo  1  1/34 (2.94%)  0/37 (0.00%)  2/32 (6.25%)  1/33 (3.03%)  2/35 (5.71%) 
Tinnitus  1  0/34 (0.00%)  1/37 (2.70%)  0/32 (0.00%)  2/33 (6.06%)  0/35 (0.00%) 
Eye disorders           
Dry eye  1  1/34 (2.94%)  0/37 (0.00%)  0/32 (0.00%)  2/33 (6.06%)  1/35 (2.86%) 
Conjunctivitis  1  1/34 (2.94%)  2/37 (5.41%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Gastrointestinal disorders           
Nausea  1  2/34 (5.88%)  5/37 (13.51%)  8/32 (25.00%)  7/33 (21.21%)  8/35 (22.86%) 
Diarrhoea  1  4/34 (11.76%)  5/37 (13.51%)  3/32 (9.38%)  3/33 (9.09%)  6/35 (17.14%) 
Vomiting  1  2/34 (5.88%)  5/37 (13.51%)  0/32 (0.00%)  2/33 (6.06%)  5/35 (14.29%) 
Abdominal pain upper  1  4/34 (11.76%)  2/37 (5.41%)  2/32 (6.25%)  3/33 (9.09%)  1/35 (2.86%) 
Abdominal pain  1  0/34 (0.00%)  0/37 (0.00%)  1/32 (3.13%)  2/33 (6.06%)  1/35 (2.86%) 
Constipation  1  1/34 (2.94%)  2/37 (5.41%)  1/32 (3.13%)  0/33 (0.00%)  1/35 (2.86%) 
Dyspepsia  1  0/34 (0.00%)  4/37 (10.81%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Mouth ulceration  1  0/34 (0.00%)  2/37 (5.41%)  0/32 (0.00%)  0/33 (0.00%)  1/35 (2.86%) 
Gingival pain  1  0/34 (0.00%)  2/37 (5.41%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Toothache  1  0/34 (0.00%)  0/37 (0.00%)  2/32 (6.25%)  0/33 (0.00%)  0/35 (0.00%) 
General disorders           
Injection site erythema  1  4/34 (11.76%)  5/37 (13.51%)  5/32 (15.63%)  4/33 (12.12%)  10/35 (28.57%) 
Fatigue  1  0/34 (0.00%)  2/37 (5.41%)  4/32 (12.50%)  2/33 (6.06%)  3/35 (8.57%) 
Pyrexia  1  1/34 (2.94%)  3/37 (8.11%)  1/32 (3.13%)  4/33 (12.12%)  2/35 (5.71%) 
Injection site pain  1  0/34 (0.00%)  1/37 (2.70%)  2/32 (6.25%)  3/33 (9.09%)  2/35 (5.71%) 
Oedema peripheral  1  0/34 (0.00%)  3/37 (8.11%)  3/32 (9.38%)  1/33 (3.03%)  1/35 (2.86%) 
Chest pain  1  0/34 (0.00%)  0/37 (0.00%)  2/32 (6.25%)  1/33 (3.03%)  3/35 (8.57%) 
Injection site pruritus  1  0/34 (0.00%)  1/37 (2.70%)  0/32 (0.00%)  1/33 (3.03%)  3/35 (8.57%) 
Chills  1  2/34 (5.88%)  0/37 (0.00%)  1/32 (3.13%)  2/33 (6.06%)  1/35 (2.86%) 
Injection site induration  1  0/34 (0.00%)  1/37 (2.70%)  1/32 (3.13%)  0/33 (0.00%)  2/35 (5.71%) 
Malaise  1  0/34 (0.00%)  2/37 (5.41%)  0/32 (0.00%)  1/33 (3.03%)  1/35 (2.86%) 
Injection site haemorrhage  1  1/34 (2.94%)  0/37 (0.00%)  2/32 (6.25%)  1/33 (3.03%)  0/35 (0.00%) 
Infections and infestations           
Nasopharyngitis  1  3/34 (8.82%)  8/37 (21.62%)  3/32 (9.38%)  2/33 (6.06%)  8/35 (22.86%) 
Upper respiratory tract infection  1  7/34 (20.59%)  6/37 (16.22%)  6/32 (18.75%)  5/33 (15.15%)  4/35 (11.43%) 
Influenza  1  0/34 (0.00%)  4/37 (10.81%)  2/32 (6.25%)  2/33 (6.06%)  1/35 (2.86%) 
Sinusitis  1  2/34 (5.88%)  3/37 (8.11%)  3/32 (9.38%)  2/33 (6.06%)  1/35 (2.86%) 
Bronchitis  1  1/34 (2.94%)  3/37 (8.11%)  0/32 (0.00%)  0/33 (0.00%)  5/35 (14.29%) 
Herpes simplex  1  1/34 (2.94%)  3/37 (8.11%)  2/32 (6.25%)  1/33 (3.03%)  1/35 (2.86%) 
Urinary tract infection  1  2/34 (5.88%)  2/37 (5.41%)  0/32 (0.00%)  3/33 (9.09%)  1/35 (2.86%) 
Gastroenteritis viral  1  1/34 (2.94%)  1/37 (2.70%)  1/32 (3.13%)  2/33 (6.06%)  1/35 (2.86%) 
Lower respiratory tract infection  1  3/34 (8.82%)  1/37 (2.70%)  0/32 (0.00%)  3/33 (9.09%)  1/35 (2.86%) 
Respiratory tract infection  1  1/34 (2.94%)  3/37 (8.11%)  1/32 (3.13%)  1/33 (3.03%)  0/35 (0.00%) 
Viral infection  1  0/34 (0.00%)  2/37 (5.41%)  1/32 (3.13%)  1/33 (3.03%)  1/35 (2.86%) 
Pharyngitis  1  0/34 (0.00%)  2/37 (5.41%)  0/32 (0.00%)  1/33 (3.03%)  1/35 (2.86%) 
Rhinitis  1  0/34 (0.00%)  0/37 (0.00%)  1/32 (3.13%)  0/33 (0.00%)  3/35 (8.57%) 
Nail infection  1  0/34 (0.00%)  0/37 (0.00%)  2/32 (6.25%)  1/33 (3.03%)  0/35 (0.00%) 
Ear infection  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  2/33 (6.06%)  0/35 (0.00%) 
Fungal rash  1  0/34 (0.00%)  0/37 (0.00%)  2/32 (6.25%)  0/33 (0.00%)  0/35 (0.00%) 
Gingival infection  1  0/34 (0.00%)  0/37 (0.00%)  2/32 (6.25%)  0/33 (0.00%)  0/35 (0.00%) 
Injury, poisoning and procedural complications           
Contusion  1  0/34 (0.00%)  0/37 (0.00%)  2/32 (6.25%)  2/33 (6.06%)  2/35 (5.71%) 
Thermal burn  1  0/34 (0.00%)  0/37 (0.00%)  2/32 (6.25%)  1/33 (3.03%)  2/35 (5.71%) 
Excoriation  1  1/34 (2.94%)  1/37 (2.70%)  0/32 (0.00%)  2/33 (6.06%)  0/35 (0.00%) 
Arthropod bite  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  2/33 (6.06%)  0/35 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  0/34 (0.00%)  1/37 (2.70%)  4/32 (12.50%)  3/33 (9.09%)  1/35 (2.86%) 
Aspartate aminotransferase increased  1  0/34 (0.00%)  1/37 (2.70%)  3/32 (9.38%)  3/33 (9.09%)  1/35 (2.86%) 
Blood cholesterol increased  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  1/33 (3.03%)  2/35 (5.71%) 
Blood pressure increased  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  2/33 (6.06%)  0/35 (0.00%) 
Liver function test abnormal  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  2/33 (6.06%)  0/35 (0.00%) 
Musculoskeletal and connective tissue disorders           
Rheumatoid arthritis  1  5/34 (14.71%)  8/37 (21.62%)  7/32 (21.88%)  4/33 (12.12%)  7/35 (20.00%) 
Arthralgia  1  0/34 (0.00%)  3/37 (8.11%)  5/32 (15.63%)  2/33 (6.06%)  5/35 (14.29%) 
Back pain  1  1/34 (2.94%)  3/37 (8.11%)  3/32 (9.38%)  2/33 (6.06%)  2/35 (5.71%) 
Muscle spasms  1  1/34 (2.94%)  3/37 (8.11%)  2/32 (6.25%)  1/33 (3.03%)  2/35 (5.71%) 
Pain in extremity  1  2/34 (5.88%)  1/37 (2.70%)  3/32 (9.38%)  1/33 (3.03%)  3/35 (8.57%) 
Osteoarthritis  1  0/34 (0.00%)  3/37 (8.11%)  0/32 (0.00%)  0/33 (0.00%)  2/35 (5.71%) 
Joint swelling  1  0/34 (0.00%)  2/37 (5.41%)  1/32 (3.13%)  0/33 (0.00%)  1/35 (2.86%) 
Neck pain  1  0/34 (0.00%)  1/37 (2.70%)  2/32 (6.25%)  0/33 (0.00%)  1/35 (2.86%) 
Arthritis  1  0/34 (0.00%)  1/37 (2.70%)  0/32 (0.00%)  0/33 (0.00%)  2/35 (5.71%) 
Bursitis  1  0/34 (0.00%)  2/37 (5.41%)  1/32 (3.13%)  0/33 (0.00%)  0/35 (0.00%) 
Myalgia  1  0/34 (0.00%)  0/37 (0.00%)  3/32 (9.38%)  0/33 (0.00%)  0/35 (0.00%) 
Shoulder pain  1  0/34 (0.00%)  0/37 (0.00%)  1/32 (3.13%)  0/33 (0.00%)  2/35 (5.71%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Benign breast neoplasm  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  2/33 (6.06%)  0/35 (0.00%) 
Nervous system disorders           
Headache  1  7/34 (20.59%)  8/37 (21.62%)  6/32 (18.75%)  9/33 (27.27%)  3/35 (8.57%) 
Dizziness  1  6/34 (17.65%)  1/37 (2.70%)  3/32 (9.38%)  4/33 (12.12%)  3/35 (8.57%) 
Paraesthesia  1  0/34 (0.00%)  3/37 (8.11%)  2/32 (6.25%)  1/33 (3.03%)  0/35 (0.00%) 
Hypoaesthesia  1  0/34 (0.00%)  1/37 (2.70%)  1/32 (3.13%)  1/33 (3.03%)  2/35 (5.71%) 
Sciatica  1  0/34 (0.00%)  3/37 (8.11%)  0/32 (0.00%)  1/33 (3.03%)  0/35 (0.00%) 
Balance disorder  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  2/35 (5.71%) 
Psychiatric disorders           
Insomnia  1  0/34 (0.00%)  0/37 (0.00%)  2/32 (6.25%)  0/33 (0.00%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  1/34 (2.94%)  3/37 (8.11%)  5/32 (15.63%)  4/33 (12.12%)  4/35 (11.43%) 
Dyspnoea  1  0/34 (0.00%)  2/37 (5.41%)  2/32 (6.25%)  3/33 (9.09%)  2/35 (5.71%) 
Pharyngolaryngeal pain  1  2/34 (5.88%)  2/37 (5.41%)  3/32 (9.38%)  2/33 (6.06%)  1/35 (2.86%) 
Nasal congestion  1  0/34 (0.00%)  2/37 (5.41%)  1/32 (3.13%)  0/33 (0.00%)  0/35 (0.00%) 
Rhinitis seasonal  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  2/35 (5.71%) 
Skin and subcutaneous tissue disorders           
Pruritus  1  3/34 (8.82%)  2/37 (5.41%)  0/32 (0.00%)  1/33 (3.03%)  3/35 (8.57%) 
Rash  1  3/34 (8.82%)  2/37 (5.41%)  1/32 (3.13%)  1/33 (3.03%)  2/35 (5.71%) 
Dermatitis  1  0/34 (0.00%)  3/37 (8.11%)  1/32 (3.13%)  0/33 (0.00%)  0/35 (0.00%) 
Ecchymosis  1  0/34 (0.00%)  1/37 (2.70%)  2/32 (6.25%)  1/33 (3.03%)  0/35 (0.00%) 
Hyperhidrosis  1  1/34 (2.94%)  0/37 (0.00%)  3/32 (9.38%)  0/33 (0.00%)  1/35 (2.86%) 
Rash pruritic  1  0/34 (0.00%)  2/37 (5.41%)  1/32 (3.13%)  0/33 (0.00%)  0/35 (0.00%) 
Increased tendency to bruise  1  0/34 (0.00%)  0/37 (0.00%)  0/32 (0.00%)  0/33 (0.00%)  2/35 (5.71%) 
Skin exfoliation  1  0/34 (0.00%)  2/37 (5.41%)  0/32 (0.00%)  0/33 (0.00%)  0/35 (0.00%) 
Urticaria  1  2/34 (5.88%)  0/37 (0.00%)  0/32 (0.00%)  1/33 (3.03%)  0/35 (0.00%) 
Vascular disorders           
Hypertension  1  1/34 (2.94%)  4/37 (10.81%)  3/32 (9.38%)  1/33 (3.03%)  2/35 (5.71%) 
Hot flush  1  2/34 (5.88%)  1/37 (2.70%)  2/32 (6.25%)  1/33 (3.03%)  0/35 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.
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.
Generally, the only disclosure restriction on the Principal Investigator is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director Clinical Research
Organization: Centocor Research & Development, Inc.
Phone: 1-800-457-6399
Layout table for additonal information
Responsible Party: DIRECTOR CLINICAL RESEARCH, Janssen R&D US
ClinicalTrials.gov Identifier: NCT00207714    
Other Study ID Numbers: CR005263
C0524T02 ( Other Identifier: Centocor )
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: May 21, 2009
Results First Posted: August 7, 2012
Last Update Posted: October 18, 2012