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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01004432
First received: October 29, 2009
Last updated: October 20, 2014
Last verified: October 2014
Results First Received: March 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  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
No text entered.

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
Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
OL Group 1: Golimumab 50 mg SC + MTX 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.
Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX 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.
DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX 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.
OL Study Extension Group: Golimumab 50 mg SC + MTX 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.

Participant Flow for 3 periods

Period 1:   Open-label (OL) Period (Week 0 – 16)
    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  
STARTED     433     0     0     0     0  
COMPLETED     350 [1]   0     0     0     0  
NOT COMPLETED     83     0     0     0     0  
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 2:   OL/Double-Blind (DB) Period (Week 16-52)
    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  
STARTED     0     75     91     184     0  
COMPLETED     0     65     54     126     0  
NOT COMPLETED     0     10     37     58     0  
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 3:   OL Study Extension (Week 52 - 76)
    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  
STARTED     0     0     0     0     212  
COMPLETED     0     0     0     0     194  
NOT COMPLETED     0     0     0     0     18  
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  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
OL Overall Group: Golimumab 50 mg SC + MTX All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.

Baseline Measures
    OL Overall Group: Golimumab 50 mg SC + MTX  
Number of Participants  
[units: participants]
  433  
Age  
[units: years]
Mean ± Standard Deviation
  55.7  ± 11.52  
Gender  
[units: participants]
 
Female     358  
Male     75  
Region of Enrollment  
[units: participants]
 
Austria     1  
Belgium     9  
Canada     37  
Germany     7  
Greece     8  
Italy     12  
Sweden     1  
United Kingdom     9  
United States     349  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14   [ Time Frame: Week 14 ]

2.  Secondary:   Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2   [ Time Frame: Within 2 weeks of initiating therapy ]

3.  Secondary:   Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52   [ Time Frame: Week 52 ]

4.  Secondary:   Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16   [ Time Frame: Week 52 ]

5.  Secondary:   Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16   [ Time Frame: Week 76 ]

6.  Secondary:   Change in ESR-based DAS28 Score at Week 76 Relative to Week 52   [ Time Frame: Week 52, 76 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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.


  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Director
Organization: Janssen Scientific Affairs, LLC
phone: 215-325-4209
e-mail: rdehorat@its.jnj.com


No publications provided


Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01004432     History of Changes
Other Study ID Numbers: CR016663, CNTO148ART3002, 2009-010582-23, GO SAVE
Study First Received: October 29, 2009
Results First Received: March 13, 2014
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Canadian Institutes of Health Research
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: Department of Health
Greece: Ministry of Health and Welfare
Sweden: Medical Products Agency
United States: Federal Government
Austria: Federal Ministry for Health and Women
Great Britain: Research Ethics Committee