A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s) - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Arthritis, Rheumatoid
Interventions:	Drug: placebo; golimumab Biological: golimumab

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
101 investigative sites received study agent and 86 sites enrolled patients (obtained informed consent) in this study. Sixty sites were in North America and 41 were in Europe/Australia/New Zealand. Consent was obtained from the first patient on 21 Feb 2006 and the last patient completed the 24-week reporting period on 26 Sep 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Group I: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group II: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group III: Golimumab 100 mg	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.

Participant Flow: Overall Study

	Group I: Placebo	Group II: Golimumab 50 mg	Group III: Golimumab 100 mg
STARTED	155	153	153
COMPLETED	124 ^[1]	141 ^[1]	139 ^[1]
NOT COMPLETED	31	12	14
Adverse Event	10	4	2
Unsastisfactory therapeutic effect	11	6	5
Lost to Follow-up	0	0	2
Death	1	0	0
Not specified	9	2	5

[1]	Indicates number of patients who continued subcutaneous study agent at Wk 24

Baseline Characteristics

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Reporting Groups

	Description
Group I: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group II: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group III: Golimumab 100 mg	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Total	Total of all reporting groups

Baseline Measures

	Group I: Placebo	Group II: Golimumab 50 mg	Group III: Golimumab 100 mg	Total
Number of Participants [units: participants]	155	153	153	461
Age ^[1] [units: years] Mean ± Standard Deviation	54.8 ± 13.07	53.9 ± 11.47	53.7 ± 12.26	54.1 ± 12.27
Gender [units: participants]
Female	132	113	122	367
Male	23	40	31	94

[1]	>= 18 years

Outcome Measures

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1. Primary:

American College of Rheumatology 20 Response at Week 14. [ Time Frame: Week 14 ]

Measure Type	Primary
Measure Title	American College of Rheumatology 20 Response at Week 14.
Measure Description	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 visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)
Time Frame	Week 14
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent 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 were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.

Reporting Groups

	Description
Group I: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group II: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group III: Golimumab 100 mg	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combined: Groups II & III	Combined Group II (golimumab 50 mg) and Group III (golimumab 100 mg).

Measured Values

	Group I: Placebo	Group II: Golimumab 50 mg	Group III: Golimumab 100 mg	Combined: Groups II & III
Number of Participants Analyzed [units: participants]	155	153	153	306
American College of Rheumatology 20 Response at Week 14. [units: participants]	28	54	58	112

Statistical Analysis 1 for American College of Rheumatology 20 Response at Week 14.

Groups ^[1]	Group I: Placebo vs. Combined: Groups II & III
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Group I vs. Combined Groups II and III. A sample size of 140 patients per group provides a >90% power assuming 50% of patients used Methotrexate (MTX) at baseline and 30% ACR 20 response in placebo and 40~55% ACR 20 response in golimumab groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	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.

Statistical Analysis 2 for American College of Rheumatology 20 Response at Week 14.

Groups ^[1]	Group I: Placebo vs. Group II: Golimumab 50 mg
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group I: Placebo and Group II:50 mg.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Test was performed because Group I: Placebo differs from Combined Groups II & III.

Statistical Analysis 3 for American College of Rheumatology 20 Response at Week 14.

Groups ^[1]	Group I: Placebo vs. Group III: Golimumab 100 mg
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group I: Placebo and Group III:100 mg.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Test was performed because Group I: Placebo was significantly different from Combined: Groups II & III.

2. Secondary:

American College of Rheumatology 50 Response at Week 14 [ Time Frame: Week 14 ]

Measure Type	Secondary
Measure Title	American College of Rheumatology 50 Response at Week 14
Measure Description	Number of patients who achieved an American College of Rheumatology (ACR) 50 response at Week (Wk) 14. ACR 50 response is an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)
Time Frame	Week 14
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent 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 were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.

Reporting Groups

	Description
Group I: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group II: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group III: Golimumab 100 mg	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combined: Groups II & III	Combined Group II (golimumab 50 mg) and Group III (golimumab 100 mg).

Measured Values

	Group I: Placebo	Group II: Golimumab 50 mg	Group III: Golimumab 100 mg	Combined: Groups II & III
Number of Participants Analyzed [units: participants]	155	153	153	306
American College of Rheumatology 50 Response at Week 14 [units: participants]	10	25	31	56

Statistical Analysis 1 for American College of Rheumatology 50 Response at Week 14

Groups ^[1]	Group I: Placebo vs. Combined: Groups II & III
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in ACR 50 response at Wk 14 between Group I: Placebo and Combined: Group II and III at 0.05 level of significance.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline Methotrexate (MTX).
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	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.

Statistical Analysis 2 for American College of Rheumatology 50 Response at Week 14

Groups ^[1]	Group I: Placebo vs. Group II: Golimumab 50 mg
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	0.006

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in ACR 50 response at Wk 14 between Group I: Placebo and Group II: 50 mg.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Test was performed because Group I: Placebo differs from Combined Groups II & III.

Statistical Analysis 3 for American College of Rheumatology 50 Response at Week 14

Groups ^[1]	Group I: Placebo vs. Group III: Golimumab 100 mg
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in ACR 50 response at Wk 14 between Group I: Placebo and Group III: 100 mg.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Test was performed because Group I: Placebo differs from Group III: 100 mg.

3. Secondary:

Disease Activity Index Score 28 (Using C-reactive Protein) Response at Week 14 [ Time Frame: Week 14 ]

Measure Type	Secondary
Measure Title	Disease Activity Index Score 28 (Using C-reactive Protein) Response at Week 14
Measure Description	Number of patients who achieved Disease Activity Index Score 28 (DAS28) (using C-reactive protein CRP) response at Week (Wk) 14. DAS has a low value of about 1; if the CRP is 10, indicating a very serious condition, all 28 joints are swollen and tender and the disease activity index is the maximum score of 100, DAS is about 8.4.
Time Frame	Week 14
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent 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 DAS28 components were imputed by Last Observation Carried Forward (LOCF) unless all DAS28 components are missing in which case considered non-responders.

Reporting Groups

	Description
Group I: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group II: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group III: Golimumab 100 mg	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combined: Groups II & III	Combined Group II (golimumab 50 mg) and Group III (golimumab 100 mg).

Measured Values

	Group I: Placebo	Group II: Golimumab 50 mg	Group III: Golimumab 100 mg	Combined: Groups II & III
Number of Participants Analyzed [units: participants]	155	153	153	306
Disease Activity Index Score 28 (Using C-reactive Protein) Response at Week 14 [units: participants]	47	86	91	177

Statistical Analysis 1 for Disease Activity Index Score 28 (Using C-reactive Protein) Response at Week 14

Groups ^[1]	Group I: Placebo vs. Combined: Groups II & III
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in DAS28 (using CRP) response at Wk 14 between Group I: Placebo and Combined: Groups II and III at 0.05 level of significance.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline Methorexate (MTX).
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	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.

Statistical Analysis 2 for Disease Activity Index Score 28 (Using C-reactive Protein) Response at Week 14

Groups ^[1]	Group I: Placebo vs. Group II: Golimumab 50 mg
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in DAS28 (using CRP) response at Wk 14 between Group I: Placebo and Group II: 50 mg.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Test was performed because Group I: Placebo differs from Group II: 50 mg.

Statistical Analysis 3 for Disease Activity Index Score 28 (Using C-reactive Protein) Response at Week 14

Groups ^[1]	Group I: Placebo vs. Group III: Golimumab 100 mg
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis:No difference in DAS28 (using CRP) response at Wk 14 between Group I: Placebo and Group III: 100 mg.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Test was preformed because Group I: Placebo was significantly different from Group III: 100 mg.

4. Secondary:

American College of Rheumatology 20 at Week 24 [ Time Frame: From Baseline to Week 24 ]

Measure Type	Secondary
Measure Title	American College of Rheumatology 20 at Week 24
Measure Description	Number of patients who achieved 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 visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)
Time Frame	From Baseline to Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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. Week 16 ACR response was used for patient with change in study treatment.

Reporting Groups

	Description
Group I: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group II: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group III: Golimumab 100 mg	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combined: Groups II & III	Combined Group II (golimumab 50 mg) and Group III (golimumab 100 mg).

Measured Values

	Group I: Placebo	Group II: Golimumab 50 mg	Group III: Golimumab 100 mg	Combined: Groups II & III
Number of Participants Analyzed [units: participants]	155	153	153	306
American College of Rheumatology 20 at Week 24 [units: participants]	26	52	67	119

Statistical Analysis 1 for American College of Rheumatology 20 at Week 24

Groups ^[1]	Group I: Placebo vs. Combined: Groups II & III
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in ACR 20 response at Wk 24 between Group I: Placebo and Combined: Groups II and III at 0.05 level of significance.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline Methotrexate (MTX).
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	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.

Statistical Analysis 2 for American College of Rheumatology 20 at Week 24

Groups ^[1]	Group I: Placebo vs. Group II: Golimumab 50 mg
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in ACR 20 response at Wk 24 between Group I: Placebo and Group II: 50 mg.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Test was performed because Group I: Placebo differs from Group II: 50 mg.

Statistical Analysis 3 for American College of Rheumatology 20 at Week 24

Groups ^[1]	Group I: Placebo vs. Group III: Golimumab 100 mg
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in ACR 20 response at Wk 24 between Group I: Placebo and Group III: 100 mg.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Test was performed because Group I: Placebo differs from Group III: 100 mg.

5. Secondary:

Health Assessment Questionnaire Score at Week 24 [ Time Frame: From Baseline to Week 24 ]

Measure Type	Secondary
Measure Title	Health Assessment Questionnaire Score at Week 24
Measure Description	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; HAQ ranges from 0 to 3.
Time Frame	From Baseline to Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT). Missing scores were imputed by Last Observation Carried Forward (LOCF). Week 16 scores were used for subjects with change in study treatment.

Reporting Groups

	Description
Group I: Placebo	Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group II: Golimumab 50 mg	Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Group III: Golimumab 100 mg	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combined: Groups II & III	Combined Group II (golimumab 50 mg) and Group III (golimumab 100 mg).

Measured Values

	Group I: Placebo	Group II: Golimumab 50 mg	Group III: Golimumab 100 mg	Combined: Groups II & III
Number of Participants Analyzed [units: participants]	155	153	153	306
Health Assessment Questionnaire Score at Week 24 [units: scores on a scale] Median ( Inter-Quartile Range )	0.0000 ( -0.2500 to 0.2500 )	0.2500 ( 0.0000 to 0.5000 )	0.2500 ( 0.0000 to 0.5000 )	0.2500 ( 0.0000 to 0.5000 )

Statistical Analysis 1 for Health Assessment Questionnaire Score at Week 24

Groups ^[1]	Group I: Placebo vs. Combined: Groups II & III
Method ^[2]	ANOVA on van der Waerden normal scores.
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in improvement of HAQ score from baseline at Wk 24 between Group I: Placebo and Combined: Groups II and III at 0.05 level of significance.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline Methotrexate (MTX).
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	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.

Statistical Analysis 2 for Health Assessment Questionnaire Score at Week 24

Groups ^[1]	Group I: Placebo vs. Group II: Golimumab 50 mg
Method ^[2]	ANOVA on van der Waerden normal scores.
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in improvement from baseline in HAQ score at Wk 24 between Group I: Placebo and Group II: 50 mg.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Test was preformed because Group I: Placebo was significantly different from Group II: 50 mg.

Statistical Analysis 3 for Health Assessment Questionnaire Score at Week 24

Groups ^[1]	Group I: Placebo vs. Group III: Golimumab 100 mg
Method ^[2]	ANOVA on van der Waerden normal scores.
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: No difference in improvement from baseline in HAQ score at Wk 24 between Group I: Placebo and Group III: 100 mg.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Stratified by baseline MTX.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Test was preformed because Group I: Placebo was significantly different from Group III: 100 mg.

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Associate Director Clinical Research
Organization: Centocor Research & Development, Inc.
phone: 1-800-457-6399

No publications provided by Centocor, Inc.

Publications automatically indexed to this study:

Smolen JS, Kay J, Doyle MK, Landewé R, Matteson EL, Wollenhaupt J, Gaylis N, Murphy FT, Neal JS, Zhou Y, Visvanathan S, Hsia EC, Rahman MU; GO-AFTER study investigators. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009 Jul 18;374(9685):210-21. Epub 2009 Jun 26.

Responsible Party:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00299546 History of Changes
Other Study ID Numbers:	CR006334, C0524T11
Study First Received:	March 3, 2006
Results First Received:	May 21, 2009
Last Updated:	September 12, 2012
Health Authority:	United States: Food and Drug Administration