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)

This study has been completed.

Sponsor:

Collaborator:

Schering-Plough

Information provided by (Responsible Party):

Centocor, Inc.

ClinicalTrials.gov Identifier:

NCT00299546

First received: March 3, 2006

Last updated: September 12, 2012

Last verified: September 2012

History of Changes

Results First Received: May 21, 2009

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

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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
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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.

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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	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.

Serious Adverse Events

	Group I: Placebo	Group II: Golimumab 50 mg	Group III: Golimumab 100 mg
Total, serious adverse events
# participants affected	11	8	4
Blood and lymphatic system disorders
Anaemia ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Cardiac disorders
Angina pectoris ^{† 1}
# participants affected / at risk	0/155 (0.00%)	1/152 (0.66%)	0/152 (0.00%)
Myocardial infarction ^{† 1}
# participants affected / at risk	0/155 (0.00%)	0/152 (0.00%)	1/152 (0.66%)
Coronary artery disease ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Gastrointestinal disorders
Nausea ^{† 1}
# participants affected / at risk	0/155 (0.00%)	1/152 (0.66%)	0/152 (0.00%)
Vomiting ^{† 1}
# participants affected / at risk	0/155 (0.00%)	1/152 (0.66%)	0/152 (0.00%)
Hepatobiliary disorders
Hepatotoxicity ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Infections and infestations
Bronchitis ^{† 1}
# participants affected / at risk	0/155 (0.00%)	1/152 (0.66%)	0/152 (0.00%)
Pneumonia ^{† 1}
# participants affected / at risk	0/155 (0.00%)	1/152 (0.66%)	0/152 (0.00%)
Upper respiratory track infection ^{† 1}
# participants affected / at risk	0/155 (0.00%)	0/152 (0.00%)	1/152 (0.66%)
Urosepsis ^{† 1}
# participants affected / at risk	0/155 (0.00%)	1/152 (0.66%)	0/152 (0.00%)
Cellulitis ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Gastroenteritis ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Herpes zoster ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Pelvic inflammatory disease ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Injury, poisoning and procedural complications
Dislocation of joint prosthesis ^{† 1}
# participants affected / at risk	0/155 (0.00%)	0/152 (0.00%)	1/152 (0.66%)
Laceration ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Diabetic ketoacidosis ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Musculoskeletal and connective tissue disorders
Acquired claw toe ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Rheumatoid arthritis ^{† 1}
# participants affected / at risk	3/155 (1.94%)	0/152 (0.00%)	0/152 (0.00%)
Toe deformity ^{† 1}
# participants affected / at risk	1/155 (0.65%)	0/152 (0.00%)	0/152 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma ^{† 1}
# participants affected / at risk	0/155 (0.00%)	0/152 (0.00%)	1/152 (0.66%)
Nervous system disorders
Cerebrovascular accident ^{† 1}
# participants affected / at risk	0/155 (0.00%)	1/152 (0.66%)	0/152 (0.00%)
Paraesthesia ^{† 1}
# participants affected / at risk	0/155 (0.00%)	1/152 (0.66%)	0/152 (0.00%)
Renal and urinary disorders
Renal disorder ^{† 1}
# participants affected / at risk	0/155 (0.00%)	1/152 (0.66%)	0/152 (0.00%)
Vascular disorders
Aortic thrombosis ^{† 1}
# participants affected / at risk	0/155 (0.00%)	1/152 (0.66%)	0/152 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0

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

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