Golimumab in Rheumatoid Arthritis Patients 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: August 26, 2014
Last verified: August 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 & Placebo IV + MTX: Golimumab 50 mg SC + Methotrexate (MTX) + Placebo IV
Drug: Golimumab 2mg/kg IV & Placebo SC + MTX
Drug: Golimumab 50 mg SC + Methotrexate (MTX)
Drug: Open label Golimumab 50 mg SC + Methotrexate (MTX)

  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
OL Overall Group: Golimumab 50 mg SC + MTX OL Overall Group: Golimumab 50 mg SC + MTX: Golimumab 50mg SC + Methotrexate (MTX): All enrolled and dosed subjects. Golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 – 12. Where OL is used to abbreviate Open-Label.
OL Group 1: Golimumab Open Label 50 mg + MTX OL Group 1: Golimumab Open Label 50 mg + MTX: Open label Golimumab 50 mg SC + Methotrexate (MTX): Subjects who achieved DAS28 good response at Week 16. Golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 – 48.
DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX: Golimumab 50 mg SC + Methotrexate (MTX) + Placebo IV: Subjects who did not achieved good DAS28 response at Week 16. Randomized to receive Golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 – 48. Placebo IV at Weeks 16, 20, 28, 36, and 44. Where DB is used to abbreviate Double Blind.
DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX: Golimumab 2mg/kg + Methotrexate (MTX) + Placebo SC: Subjects who did not achieve DAS28 good response at Week 16. Randomized to receive Golimumab 2mg/kg IV at Weeks 16, 20, 28, 36 and 44 + MTX. Placebo SC every 4 weeks from Week 16 – 48.

Participant Flow for 2 periods

Period 1:   Open-Label Period (Weeks 1-16)
    OL Overall Group: Golimumab 50 mg SC + MTX     OL Group 1: Golimumab Open Label 50 mg + MTX     DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX     DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX  
STARTED     433     0     0     0  
COMPLETED     350     0     0     0  
NOT COMPLETED     83     0     0     0  
Adverse Event                 20                 0                 0                 0  
Protocol Violation                 29                 0                 0                 0  
Withdrawal by Subject                 17                 0                 0                 0  
Lack of Efficacy                 15                 0                 0                 0  
Lost to Follow-up                 2                 0                 0                 0  

Period 2:   OL/Double-Blind Period (Weeks 16-52)
    OL Overall Group: Golimumab 50 mg SC + MTX     OL Group 1: Golimumab Open Label 50 mg + MTX     DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX     DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX  
STARTED     0     75     91     184  
COMPLETED     0     65     54     126  
NOT COMPLETED     0     10     37     58  
Adverse Event                 0                 1                 5                 6  
Protocol Violation                 0                 3                 3                 4  
Withdrawal by Subject                 0                 1                 4                 7  
Death                 0                 0                 0                 1  
Lack of Efficacy                 0                 2                 24                 37  
Lost to Follow-up                 0                 3                 1                 3  



  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 OL Overall Group: Golimumab 50 mg SC + MTX: Golimumab 50mg SC + Methotrexate (MTX): All enrolled and dosed subjects. Golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 – 12. Where OL is used to abbreviate Open-Label.

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 Subjects Achieving (Erythrocyte Sedimentation Rate) ESR-based American College of Rheumatology [ACR] 20 at Week 14   [ Time Frame: Week 14 ]

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

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


  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
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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:
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: August 26, 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