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A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis (GO-REVEAL)

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: NCT00265096
Recruitment Status : Completed
First Posted : December 14, 2005
Results First Posted : April 16, 2012
Last Update Posted : July 19, 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, Psoriatic
Interventions Biological: golimumab
Biological: Placebo; golimumab
Enrollment 407
Recruitment Details 405 patients were randomized at 57 centers: 35 in North America (17 in the United States and 18 in Canada) and 22 in Europe (5 in Belgium, 10 in Poland, 3 in Spain, and 4 in the United Kingdom). The first patient was enrolled on 12 Dec 2005. The date of the last patient visit for the week (Wk) 24 reporting period was 14 May 2007.
Pre-assignment Details  
Arm/Group Title Group 1: Placebo Group 2: Golimumab 50 mg Group 3: Golimumab 100 mg
Hide Arm/Group Description Group 1: Placebo Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg. Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg. Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
Period Title: Overall Study
Started 113 146 146
Completed 77 [1] 95 [1] 107 [1]
Not Completed 36 51 39
Reason Not Completed
Adverse Event             14             18             18
Lost to Follow-up             2             5             3
Death             0             1             2
Unsatisfactory therapeutic effect             9             8             6
Not Specified             11             19             10
[1]
Indicates number of patients that were continuing SC study agent at Wk 24
Arm/Group Title Group 1: Placebo Group 2: Golimumab 50 mg Group 3: Golimumab 100 mg Total
Hide Arm/Group Description Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg. Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg. Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs. Total of all reporting groups
Overall Number of Baseline Participants 113 146 146 405
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 146 participants 146 participants 405 participants
47  (10.56) 45.7  (10.7) 48.2  (10.93) 47  (10.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 146 participants 146 participants 405 participants
Female
44
  38.9%
57
  39.0%
60
  41.1%
161
  39.8%
Male
69
  61.1%
89
  61.0%
86
  58.9%
244
  60.2%
1.Primary Outcome
Title American College of Rheumatology (ACR) 20 Response at Week 14
Hide Description ACR 20 response is an improvement of >= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])
Time Frame Baseline (Week 0), Week 4, Week 8 and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components at Week 14 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 Group II: Golimumab 50 mg Group III: Golimumab 100 mg Combined: Group II & III
Hide Arm/Group Description:
Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Overall Number of Participants Analyzed 113 146 146 292
Measure Type: Number
Unit of Measure: Participants
10 74 66 140
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Combined: Group II & III
Comments Null Hypothesis: No difference in ACR 20 response comparing Groups I vs II and Groups I vs III. Sample size (n=396; 110 placebo, 286 combined golimumab) provided >98% power to detect a significant difference (alpha=0.05) in ACR 20 response between treatment groups, assuming equal proportions of subjects receiving methotrexate (MTX) at baseline and the difference in ACR 20 response of 27% in subjects without MTX and 17-27% in subjects with MTX, between placebo and combined golimumab groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise conparisons at 0.05 level.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Golimumab 50 mg
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 Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group III: Golimumab 100 mg
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 Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).
2.Primary Outcome
Title Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24
Hide Description Summary of change from baseline in total van der Heijde-Sharp (vdH-S) score of the hands and feet, as modified for psoriatic arthritis, at Week 24. The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 to 528 with higher scores indicating more joint damage. For the change from baseline, positive values show an increase in damage.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis.
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Group III: Golimumab 100 mg Combined: Group II & III
Hide Arm/Group Description:
Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Overall Number of Participants Analyzed 113 146 146 292
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.27  (1.259) -0.16  (1.309) -0.02  (1.322) -0.09  (1.315)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Combined: Group II & III
Comments Null Hypothesis: There is no difference in change from baseline among 3 treatment groups. Sample size (n=396, 110 placebo, 286 combined golimumab) provided >93% power to detect a significant difference (alpha=0.05) in change from baseline between treatment groups, assuming 50% of subjects received MTX at baseline, and mean change from baseline for combined golimumab of 0, and a mean increase for placebo of 0.1 in subjects who received MTX at baseline and 0.6 in subjects who did not receive MTX
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments The test was not to be performed if the test of ACR 20 at Week 24 was not significant.
Method ANOVA
Comments Analysis of Variance (ANOVA) on van der Waerden scores with 2 factors: treatment group and participant's baseline methotrexate (MTX) usage
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Golimumab 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments The test was not to be performed if the test of ACR 20 at Week 24 was not significant
Method ANOVA
Comments ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group III: Golimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments The test was not to be performed if the test of ACR 20 at Week 24 was not significant
Method ANOVA
Comments ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage
3.Secondary Outcome
Title Psoriasis Area and Severity Index (PASI) 75 Response at Week 14 in a Subset of Patients With ≥ 3 Percent Body Surface Area (BSA) Psoriasis Skin Involvement at Baseline
Hide Description Number of patients (randomized patients with >= 3 percent Body Surface Area [BSA] psoriasis skin involvement at baseline) with Psoriasis Area and Severity Index (PASI) 75 response at Week 14. PASI is the widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 to 72. Zero (0) means no disease and 72 means maximal disease. PASI 75 Response at Week 14 means reduction in PASI score by 75 percent at Week 14.
Time Frame Baseline, Week 4, Week 8 and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
In a subset of patients with ≥ 3 percent body surface area (BSA) psoriasis skin involvement at baseline. Missing scores were imputed by Last Observation Carried Forward (LOCF).
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Group III: Golimumab 100 mg Combined: Group II & III
Hide Arm/Group Description:
Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Overall Number of Participants Analyzed 79 109 108 217
Measure Type: Number
Unit of Measure: Participants
2 44 63 107
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Combined: Group II & III
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 Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Golimumab 50 mg
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 Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group III: Golimumab 100 mg
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 Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)
4.Secondary Outcome
Title Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24
Hide Description Summary of improvement from baseline in Health Assessment Questionnaire (HAQ) score at Week (Wk) 24. This 20-question instrument 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, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.
Time Frame Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). Missing scores were imputed by LOCF. Week (Wk) 16 scores were used for patients with change in study treatment. Week 16 HAQ scores were used for patients with change in study treatment.
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Group III: Golimumab 100 mg Combined: Group II & III
Hide Arm/Group Description:
Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Overall Number of Participants Analyzed 113 146 146 292
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
0.0000
(-0.2500 to 0.2500)
0.2500
(0.0000 to 0.6250)
0.3750
(0.0000 to 0.6250)
0.2500
(0.0000 to 0.6250)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Combined: Group II & III
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 on van der Waerden normal scores
Comments With 2 factors (treatment group and subject’s baseline Methotrexate (MTX) usage)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Golimumab 50 mg
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 on van der Waerden normal scores
Comments With 2 factors (treatment group and subject’s baseline MTX usage)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group III: Golimumab 100 mg
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 on van der Waerden normal scores
Comments With 2 factors (treatment group and subject’s baseline MTX usage)
5.Secondary Outcome
Title Change From Baseline in the Physical Component Summary Score of the 36-item Short Form Health Survey at Week 14
Hide Description The short form health survey (SF-36) is a well-validated and widely used quality-of-life instrument employed in numerous disease states. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.
Time Frame Baseline and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). Missing scores were imputed by Last Observation Carried Forward (LOCF).
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Group III: Golimumab 100 mg Combined: Group II & III
Hide Arm/Group Description:
Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Overall Number of Participants Analyzed 113 146 146 292
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.63  (7.676) 6.53  (8.882) 7.85  (9.547) 7.19  (9.229)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Combined: Group II & III
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 on van der Waerden normal scores
Comments With 2 factors (treatment and subject’s baseline Methotrexate (MTX) usage)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Golimumab 50 mg
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 on van der Waerden normal scores
Comments With 2 factors (with treatment and subject’s baseline MTX usage)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group III: Golimumab 100 mg
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 on van der Waerden normal scores
Comments With 2 factors (treatment and subject’s baseline MTX usage)
6.Secondary Outcome
Title American College of Rheumatology 20 at Week 24
Hide Description

Number of Patients who achieved an American College of Rheumatology (ACR) 20 response at Week (Wk) 24.

ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])

Time Frame Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Patients considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. Wk 16 ACR response was used for patients with change in study treatment.
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Group III: Golimumab 100 mg Combined: Group II & III
Hide Arm/Group Description:
Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Overall Number of Participants Analyzed 113 146 146 292
Measure Type: Number
Unit of Measure: P a r t i c ip an t s
14 76 89 165
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Combined: Group II & III
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 Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline Methotrexate (MTX) usage)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Golimumab 50 mg
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 Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group III: Golimumab 100 mg
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 Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)
Time Frame [Not Specified]
Adverse Event Reporting Description The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
 
Arm/Group Title Group 1: Golimumab 50 mg Group 2: Golimumab 100 mg Group 3: Golimumab 50 and 100 mg
Hide Arm/Group Description Subjects who were treated with Golimumab and received Golimumab 50 mg injections only. Subjects who were treated with Golimumab and received Golimumab 100 mg injections only. Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
All-Cause Mortality
Group 1: Golimumab 50 mg Group 2: Golimumab 100 mg Group 3: Golimumab 50 and 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Golimumab 50 mg Group 2: Golimumab 100 mg Group 3: Golimumab 50 and 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/139 (20.86%)   25/109 (22.94%)   29/146 (19.86%) 
Blood and lymphatic system disorders       
Thrombocytopenia * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Cardiac disorders       
Acute Left Ventricular Failure * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Acute Myocardial Infarction * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Cardiac Failure Congestive * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Coronary Artery Disease * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Coronary Artery Occlusion * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Myocardial Infarction * 1  4/139 (2.88%)  0/109 (0.00%)  1/146 (0.68%) 
Myocardial Ischaemia * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Gastrointestinal disorders       
Abdominal Pain * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Abdominal Pain Upper * 1  0/139 (0.00%)  1/109 (0.92%)  1/146 (0.68%) 
Dysphagia * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Erosive Oesophagitis * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Irritable Bowel Syndrome * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Oesophageal Pain * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Vomiting * 1  1/139 (0.72%)  0/109 (0.00%)  1/146 (0.68%) 
General disorders       
Accidental Death * 1  1/139 (0.72%)  1/109 (0.92%)  0/146 (0.00%) 
Chest Pain * 1  0/139 (0.00%)  0/109 (0.00%)  2/146 (1.37%) 
Death * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Hepatobiliary disorders       
Cholecystitis Acute * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Cholelithiasis * 1  1/139 (0.72%)  2/109 (1.83%)  0/146 (0.00%) 
Infections and infestations       
Abscess * 1  2/139 (1.44%)  0/109 (0.00%)  0/146 (0.00%) 
Arthritis Bacterial * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Bartholin's Abscess * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Cellulitis * 1  0/139 (0.00%)  1/109 (0.92%)  1/146 (0.68%) 
Eye Infection Toxoplasmal * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Histoplasmosis * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Lung Abscess * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Pneumonia * 1  0/139 (0.00%)  0/109 (0.00%)  2/146 (1.37%) 
Pneumonia Legionella * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Pyelonephritis Acute * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Sepsis * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Streptococcal Sepsis * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Tuberculosis * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Urinary Tract Infection * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Injury, poisoning and procedural complications       
Ankle Fracture * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Delayed Recovery from Anaesthesia * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Limb Injury * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Tendon Injury * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Tibia Fracture * 1  0/139 (0.00%)  0/109 (0.00%)  2/146 (1.37%) 
Investigations       
Alanine Aminotransferase Increased * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Hepatic Enzyme Increased * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Metabolism and nutrition disorders       
Diabetes Mellitus * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Arthritis * 1  1/139 (0.72%)  1/109 (0.92%)  0/146 (0.00%) 
Foot Deformity * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Intervertebral Disc Degeneration * 1  1/139 (0.72%)  1/109 (0.92%)  0/146 (0.00%) 
Intervertebral Disc Disorder * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Intervertebral Disc Protrusion * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Musculoskeletal Pain * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Osteoarthritis * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Psoriatic Arthropathy * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Spinal Column Stenosis * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal Cell Carcinoma * 1  3/139 (2.16%)  4/109 (3.67%)  3/146 (2.05%) 
Bladder Cancer * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Bladder Transitional Cell Carcinoma Stage I * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Breast Cancer * 1  2/139 (1.44%)  0/109 (0.00%)  0/146 (0.00%) 
Colon Adenoma * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Colon Cancer * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Colon Cancer Metastatic * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Colon Cancer Stage 0 * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Oesophageal Cancer Metastatic * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Prostate Cancer * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Renal Adenoma * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Small Cell Lung Cancer Metastatic * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Small Cell Lung Cancer Stage Unspecified * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Squamous Cell Carcinoma of Skin * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Uterine Leiomyoma * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Nervous system disorders       
Aphasia * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Balance Disorder * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Carotid Artery Stenosis * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Cervical Myelopathy * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Myelopathy * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion Spontaneous * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Psychiatric disorders       
Alcoholism * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Depression * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Disorientation * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Suicidal Ideation * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Renal and urinary disorders       
Calculus Urinary * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Haematuria * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Renal Colic * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Renal Failure * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Reproductive system and breast disorders       
Ovarian Cyst * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Chronic Obstructive Pulmonary Disease * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Haemothorax * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Pulmonary Embolism * 1  1/139 (0.72%)  0/109 (0.00%)  0/146 (0.00%) 
Skin and subcutaneous tissue disorders       
Psoriasis * 1  0/139 (0.00%)  1/109 (0.92%)  0/146 (0.00%) 
Vascular disorders       
Haematoma * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Hypotension * 1  0/139 (0.00%)  0/109 (0.00%)  1/146 (0.68%) 
Thrombophlebitis Superficial * 1  1/139 (0.72%)  1/109 (0.92%)  0/146 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Golimumab 50 mg Group 2: Golimumab 100 mg Group 3: Golimumab 50 and 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   107/139 (76.98%)   91/109 (83.49%)   113/146 (77.40%) 
Eye disorders       
Conjunctivitis * 1  8/139 (5.76%)  3/109 (2.75%)  2/146 (1.37%) 
Gastrointestinal disorders       
Abdominal Pain * 1  6/139 (4.32%)  9/109 (8.26%)  6/146 (4.11%) 
Diarrhoea * 1  11/139 (7.91%)  15/109 (13.76%)  13/146 (8.90%) 
Dyspepsia * 1  11/139 (7.91%)  4/109 (3.67%)  6/146 (4.11%) 
Nausea * 1  6/139 (4.32%)  7/109 (6.42%)  9/146 (6.16%) 
General disorders       
Fatigue * 1  4/139 (2.88%)  8/109 (7.34%)  11/146 (7.53%) 
Injection Site Erythema * 1  12/139 (8.63%)  13/109 (11.93%)  7/146 (4.79%) 
Oedema Peripheral * 1  5/139 (3.60%)  6/109 (5.50%)  8/146 (5.48%) 
Infections and infestations       
Bronchitis * 1  18/139 (12.95%)  11/109 (10.09%)  18/146 (12.33%) 
Cellulitis * 1  7/139 (5.04%)  1/109 (0.92%)  6/146 (4.11%) 
Ear Infection * 1  2/139 (1.44%)  8/109 (7.34%)  8/146 (5.48%) 
Gastroenteritis * 1  8/139 (5.76%)  8/109 (7.34%)  6/146 (4.11%) 
Influenza * 1  10/139 (7.19%)  7/109 (6.42%)  8/146 (5.48%) 
Nasopharyngitis * 1  23/139 (16.55%)  28/109 (25.69%)  31/146 (21.23%) 
Oral Herpes * 1  9/139 (6.47%)  5/109 (4.59%)  4/146 (2.74%) 
Pharyngitis * 1  7/139 (5.04%)  5/109 (4.59%)  13/146 (8.90%) 
Rhinitis * 1  5/139 (3.60%)  6/109 (5.50%)  7/146 (4.79%) 
Sinusitis * 1  18/139 (12.95%)  13/109 (11.93%)  20/146 (13.70%) 
Upper Respiratory Tract Infection * 1  44/139 (31.65%)  34/109 (31.19%)  41/146 (28.08%) 
Urinary Tract Infection * 1  10/139 (7.19%)  12/109 (11.01%)  6/146 (4.11%) 
Injury, poisoning and procedural complications       
Ligament Sprain * 1  3/139 (2.16%)  5/109 (4.59%)  11/146 (7.53%) 
Muscle Strain * 1  3/139 (2.16%)  6/109 (5.50%)  4/146 (2.74%) 
Investigations       
Alanine Aminotransferase Increased * 1  17/139 (12.23%)  8/109 (7.34%)  11/146 (7.53%) 
Aspartate Aminotransferase Increased * 1  11/139 (7.91%)  5/109 (4.59%)  10/146 (6.85%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  15/139 (10.79%)  10/109 (9.17%)  14/146 (9.59%) 
Back Pain * 1  18/139 (12.95%)  18/109 (16.51%)  22/146 (15.07%) 
Muscle Spasms * 1  2/139 (1.44%)  6/109 (5.50%)  2/146 (1.37%) 
Pain in Extremity * 1  6/139 (4.32%)  7/109 (6.42%)  6/146 (4.11%) 
Psoriatic Arthropathy * 1  15/139 (10.79%)  13/109 (11.93%)  12/146 (8.22%) 
Tendonitis * 1  11/139 (7.91%)  3/109 (2.75%)  5/146 (3.42%) 
Nervous system disorders       
Headache * 1  21/139 (15.11%)  14/109 (12.84%)  12/146 (8.22%) 
Sciatica * 1  2/139 (1.44%)  6/109 (5.50%)  4/146 (2.74%) 
Psychiatric disorders       
Anxiety * 1  7/139 (5.04%)  2/109 (1.83%)  2/146 (1.37%) 
Depression * 1  8/139 (5.76%)  7/109 (6.42%)  4/146 (2.74%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  10/139 (7.19%)  8/109 (7.34%)  12/146 (8.22%) 
Oropharyngeal Pain * 1  7/139 (5.04%)  8/109 (7.34%)  6/146 (4.11%) 
Skin and subcutaneous tissue disorders       
Night Sweats * 1  8/139 (5.76%)  1/109 (0.92%)  1/146 (0.68%) 
Pruritus * 1  8/139 (5.76%)  0/109 (0.00%)  3/146 (2.05%) 
Psoriasis * 1  11/139 (7.91%)  6/109 (5.50%)  15/146 (10.27%) 
Rash * 1  5/139 (3.60%)  6/109 (5.50%)  9/146 (6.16%) 
Vascular disorders       
Hypertension * 1  12/139 (8.63%)  16/109 (14.68%)  24/146 (16.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
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 PI 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 and Development, 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: NCT00265096     History of Changes
Other Study ID Numbers: CR006340
C0524T08 ( Other Identifier: Centocor )
First Submitted: December 12, 2005
First Posted: December 14, 2005
Results First Submitted: May 21, 2009
Results First Posted: April 16, 2012
Last Update Posted: July 19, 2013