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Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

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ClinicalTrials.gov Identifier: NCT01004432
Recruitment Status : Completed
First Posted : October 30, 2009
Results First Posted : May 13, 2014
Last Update Posted : April 30, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Janssen Biotech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Interventions Drug: Golimumab 50 mg SC
Drug: Golimumab 2 mg/kg IV
Drug: Methotrexate (MTX)
Drug: Placebo SC
Drug: Placebo IV
Enrollment 433
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX OL Group 1: Golimumab 50 mg SC + MTX Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX OL Study Extension Group: Golimumab 50 mg SC + MTX
Hide Arm/Group Description All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12. Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48. Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44. Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48. Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
Period Title: Open-label (OL) Period (Week 0 - 16)
Started 433 0 0 0 0
Completed 350 [1] 0 0 0 0
Not Completed 83 0 0 0 0
Reason Not Completed
Adverse Event             20             0             0             0             0
Protocol Violation             29             0             0             0             0
Withdrawal by Subject             17             0             0             0             0
Lack of Efficacy             15             0             0             0             0
Lost to Follow-up             2             0             0             0             0
[1]
1 Participant died after completing open-label period. Discontinuation was noted as adverse event.
Period Title: OL/Double-Blind (DB) Period (Week 16-52)
Started 0 75 91 184 0
Completed 0 65 54 126 0
Not Completed 0 10 37 58 0
Reason Not Completed
Adverse Event             0             1             5             6             0
Protocol Violation             0             3             3             4             0
Withdrawal by Subject             0             1             4             7             0
Death             0             0             0             1             0
Lack of Efficacy             0             2             24             37             0
Lost to Follow-up             0             3             1             3             0
Period Title: OL Study Extension (Week 52 - 76)
Started 0 0 0 0 212
Completed 0 0 0 0 194
Not Completed 0 0 0 0 18
Reason Not Completed
Adverse Event             0             0             0             0             2
Protocol Violation             0             0             0             0             4
Withdrawal by Subject             0             0             0             0             2
Lack of Efficacy             0             0             0             0             10
Arm/Group Title OL Overall Group: Golimumab 50 mg SC + MTX
Hide Arm/Group Description All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
Overall Number of Baseline Participants 433
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 433 participants
55.7  (11.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 433 participants
Female
358
  82.7%
Male
75
  17.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 433 participants
Austria 1
Belgium 9
Canada 37
Germany 7
Greece 8
Italy 12
Sweden 1
United Kingdom 9
United States 349
1.Primary Outcome
Title Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14
Hide Description Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.
Arm/Group Title OL Overall Group: Golimumab 50 mg SC + MTX
Hide Arm/Group Description:
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
Overall Number of Participants Analyzed 433
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.9
(30.4 to 39.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OL Overall Group: Golimumab 50 mg SC + MTX
Comments null hypothesis: proportion <=0.2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments One sided test adjusting for conducting one interim analysis
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage achive ACR 20 response
Estimated Value 34.9
Confidence Interval (2-Sided) 95%
30.4 to 39.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2
Hide Description Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
Time Frame Within 2 weeks of initiating therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.
Arm/Group Title OL Overall Group: Golimumab 50 mg SC + MTX
Hide Arm/Group Description:
All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
Overall Number of Participants Analyzed 433
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.5
(20.4 to 28.5)
3.Secondary Outcome
Title Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52
Hide Description Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (<=) 3.2 at a given visit and improvement from Baseline was >1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, is reported.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label modified Intent To Treat (mITT) population included all participants, who received at least 1 open-label golimumab 50 mg SC injection during the continued open-label/ double-blind treatment period.
Arm/Group Title OL Group 1: Golimumab 50 mg SC + MTX
Hide Arm/Group Description:
Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
Overall Number of Participants Analyzed 75
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.7
(13.2 to 32.1)
4.Secondary Outcome
Title Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16
Hide Description Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, is reported.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind modified Intent To Treat (mITT) population included participants who were randomized at Week 16 to SC or IV golimumab (Groups 2a and 2b) and received at least 1 dose of study drug after randomization.
Arm/Group Title DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
Hide Arm/Group Description:
Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
Overall Number of Participants Analyzed 91 184
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.2
(6.2 to 20.1)
9.2
(5.1 to 13.4)
5.Secondary Outcome
Title Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16
Hide Description Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, is reported.
Time Frame Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
Study extension mITT population included all participants, who were enrolled into the 24-week study extension period at Week 52, and received at least 1 golimumab SC injection during the study extension period. Participants reported in other groups are subgroups of 'Study Extension OL Group' by treatment received in the OL/DB phase (Weeks 16-52).
Arm/Group Title OL Group 1: Golimumab 50 mg SC + MTX DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX OL Study Extension Group: Golimumab 50 mg SC + MTX
Hide Arm/Group Description:
Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
Overall Number of Participants Analyzed 63 47 102 212
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
ESR-based ACR 20 Response
7.9
(1.3 to 14.6)
8.5
(0.5 to 16.5)
15.7
(8.6 to 22.7)
11.8
(7.5 to 16.1)
CRP-based ACR 20 Response
7.9
(1.3 to 14.6)
8.5
(0.5 to 16.5)
17.6
(10.2 to 25.0)
12.7
(8.2 to 17.2)
6.Secondary Outcome
Title Change in ESR-based DAS28 Score at Week 76 Relative to Week 52
Hide Description Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESR-based DAS28 score range: 0 to 9.4, higher score=more disease activity.
Time Frame Week 52, 76
Hide Outcome Measure Data
Hide Analysis Population Description
Study extension mITT population. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time point for each arm, respectively. Participants reported in other groups are subgroups of 'Study Extension OL Group' by treatment received in the OL/DB phase (Weeks 16-52).
Arm/Group Title OL Group 1: Golimumab 50 mg SC + MTX DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX OL Study Extension Group: Golimumab 50 mg SC + MTX
Hide Arm/Group Description:
Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
Overall Number of Participants Analyzed 61 40 95 196
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 52 (n = 61, 40, 95, 196) 3.182  (1.1109) 4.070  (0.8037) 4.394  (1.2389) 3.950  (1.2379)
Change at Week 76 (n = 57, 33, 84, 174) -0.136  (1.2095) 0.209  (1.2253) -0.017  (1.0518) -0.013  (1.1386)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OL Overall Group: Golimumab 50 mg SC + MTX OL Group 1: Golimumab 50 mg SC + MTX Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX OL Study Extension Group: Golimumab 50 mg SC + MTX
Hide Arm/Group Description All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12. Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48. Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44. Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48. Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
All-Cause Mortality
OL Overall Group: Golimumab 50 mg SC + MTX OL Group 1: Golimumab 50 mg SC + MTX Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX OL Study Extension Group: Golimumab 50 mg SC + MTX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
OL Overall Group: Golimumab 50 mg SC + MTX OL Group 1: Golimumab 50 mg SC + MTX Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX OL Study Extension Group: Golimumab 50 mg SC + MTX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/433 (4.62%)   2/75 (2.67%)   4/91 (4.40%)   10/184 (5.43%)   10/212 (4.72%) 
Cardiac disorders           
Bradycardia * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  1/184 (0.54%)  0/212 (0.00%) 
Cardiac failure congestive * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  1/184 (0.54%)  0/212 (0.00%) 
Coronary artery disease * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  1/184 (0.54%)  1/212 (0.47%) 
Acute myocardial infarction * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Gastrointestinal disorders           
Oesophagitis haemorrhagic * 1  0/433 (0.00%)  0/75 (0.00%)  1/91 (1.10%)  0/184 (0.00%)  0/212 (0.00%) 
Small intestinal obstruction * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Upper gastrointestinal haemorrhage * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
General disorders           
Chest pain * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  3/184 (1.63%)  1/212 (0.47%) 
Pyrexia * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Infections and infestations           
Appendicitis * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Cellulitis * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Diverticulitis * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Gastroenteritis * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Gastroenteritis viral * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Pneumonia * 1  1/433 (0.23%)  0/75 (0.00%)  1/91 (1.10%)  2/184 (1.09%)  0/212 (0.00%) 
Sepsis * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  1/184 (0.54%)  0/212 (0.00%) 
Urinary tract infection * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  1/184 (0.54%)  0/212 (0.00%) 
Urosepsis * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Wound infection staphylococcal * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Hepatitis C * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Injury, poisoning and procedural complications           
Fall * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Intentional overdose * 1  0/433 (0.00%)  1/75 (1.33%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Upper limb fracture * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Femur fracture * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Metabolism and nutrition disorders           
Diabetic ketoacidosis * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Dehydration * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Hypokalaemia * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Musculoskeletal and connective tissue disorders           
Back pain * 1  2/433 (0.46%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Joint effusion * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Muscular weakness * 1  0/433 (0.00%)  1/75 (1.33%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Osteoarthritis * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Pain in extremity * 1  0/433 (0.00%)  1/75 (1.33%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Polymyalgia rheumatica * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Tenosynovitis * 1  0/433 (0.00%)  0/75 (0.00%)  1/91 (1.10%)  0/184 (0.00%)  0/212 (0.00%) 
Arthralgia * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Rheumatoid arthritis * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast cancer * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  1/184 (0.54%)  0/212 (0.00%) 
Breast cancer stage III * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Essential thrombocythaemia * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Nervous system disorders           
Carotid artery occlusion * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  1/184 (0.54%)  0/212 (0.00%) 
Cerebral haemorrhage * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Intracranial aneurysm * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  1/184 (0.54%)  0/212 (0.00%) 
Polyneuropathy * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Renal and urinary disorders           
Renal failure acute * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  1/184 (0.54%)  0/212 (0.00%) 
Asthma * 1  2/433 (0.46%)  0/75 (0.00%)  1/91 (1.10%)  1/184 (0.54%)  0/212 (0.00%) 
Emphysema * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Pulmonary embolism * 1  0/433 (0.00%)  0/75 (0.00%)  1/91 (1.10%)  0/184 (0.00%)  1/212 (0.47%) 
Respiratory distress * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Pneumothorax * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
Vascular disorders           
Deep vein thrombosis * 1  1/433 (0.23%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  0/212 (0.00%) 
Hypotension * 1  0/433 (0.00%)  0/75 (0.00%)  0/91 (0.00%)  0/184 (0.00%)  1/212 (0.47%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OL Overall Group: Golimumab 50 mg SC + MTX OL Group 1: Golimumab 50 mg SC + MTX Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX OL Study Extension Group: Golimumab 50 mg SC + MTX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   123/433 (28.41%)   21/75 (28.00%)   30/91 (32.97%)   54/184 (29.35%)   61/212 (28.77%) 
Infections and infestations           
Bronchitis * 1  12/433 (2.77%)  2/75 (2.67%)  6/91 (6.59%)  11/184 (5.98%)  4/212 (1.89%) 
Sinusitis * 1  17/433 (3.93%)  4/75 (5.33%)  4/91 (4.40%)  13/184 (7.07%)  12/212 (5.66%) 
Upper respiratory tract infection * 1  29/433 (6.70%)  7/75 (9.33%)  5/91 (5.49%)  15/184 (8.15%)  13/212 (6.13%) 
Urinary tract infection * 1  24/433 (5.54%)  3/75 (4.00%)  2/91 (2.20%)  11/184 (5.98%)  13/212 (6.13%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  20/433 (4.62%)  2/75 (2.67%)  8/91 (8.79%)  8/184 (4.35%)  11/212 (5.19%) 
Rheumatoid arthritis * 1  13/433 (3.00%)  2/75 (2.67%)  9/91 (9.89%)  9/184 (4.89%)  11/212 (5.19%) 
Nervous system disorders           
Headache * 1  24/433 (5.54%)  0/75 (0.00%)  1/91 (1.10%)  5/184 (2.72%)  3/212 (1.42%) 
Psychiatric disorders           
Depression * 1  7/433 (1.62%)  4/75 (5.33%)  3/91 (3.30%)  2/184 (1.09%)  5/212 (2.36%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Since participants assigned to the double blind groups were non-responders to at least 2 anti-Tumor Necrosis Factors (TNF), thus comprising a very difficult group to treat.
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: Study Director
Organization: Janssen Scientific Affairs, LLC
Phone: 215-325-4209
EMail: rdehorat@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01004432    
Other Study ID Numbers: CR016663
CNTO148ART3002 ( Other Identifier: Janssen Biotech Inc. )
2009-010582-23 ( EudraCT Number )
GO SAVE ( Other Identifier: Janssen Biotech Inc. )
First Submitted: October 29, 2009
First Posted: October 30, 2009
Results First Submitted: March 13, 2014
Results First Posted: May 13, 2014
Last Update Posted: April 30, 2015