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A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00264537
First received: December 11, 2005
Last updated: August 27, 2014
Last verified: August 2014
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: Rheumatoid Arthritis
Interventions: Drug: Placebo injections
Drug: Placebo capsules
Drug: Methotrexate capsules
Biological: Golimumab 50 mg injections
Biological: Golimumab 100 mg injections

  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
A total of 637 participants were enrolled at 90 centers: 25 sites in Asia, 34 sites in Europe/Australia/New Zealand, 10 sites in Latin America and 21 sites in North America.

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 1: Placebo + Methotrexate Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
Group 2: Golimumab 100 mg + Placebo Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
Group 3: Golimumab 50 mg + Methotrexate Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
Group 4: Golimumab 100 mg + Methotrexate Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.

Participant Flow:   Overall Study
    Group 1: Placebo + Methotrexate     Group 2: Golimumab 100 mg + Placebo     Group 3: Golimumab 50 mg + Methotrexate     Group 4: Golimumab 100 mg + Methotrexate  
STARTED     160     159     159     159  
COMPLETED     110     101     109     99  
NOT COMPLETED     50     58     50     60  
Death                 0                 3                 3                 2  
Lost to Follow-up                 3                 4                 7                 6  
Adverse Event                 21                 32                 24                 34  
Unsatisfactory therapeutic effect                 5                 6                 5                 7  
Not specified                 21                 11                 10                 11  
Not treated                 0                 2                 1                 0  



  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
Group 1: Placebo + Methotrexate Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
Group 2: Golimumab 100 mg + Placebo Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
Group 3: Golimumab 50 mg + Methotrexate Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
Group 4: Golimumab 100 mg + Methotrexate Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
Total Total of all reporting groups

Baseline Measures
    Group 1: Placebo + Methotrexate     Group 2: Golimumab 100 mg + Placebo     Group 3: Golimumab 50 mg + Methotrexate     Group 4: Golimumab 100 mg + Methotrexate     Total  
Number of Participants  
[units: participants]
  160     159     159     159     637  
Age  
[units: years]
Mean ± Standard Deviation
  48.6  ± 12.91     48.2  ± 12.85     50.9  ± 11.32     50.2  ± 11.87     49.5  ± 12.28  
Gender  
[units: participants]
         
Female     134     134     135     125     528  
Male     26     25     24     34     109  



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24   [ Time Frame: Week 24 ]

2.  Primary:   Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24   [ Time Frame: Week 24 ]

5.  Secondary:   Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline   [ Time Frame: Baseline and 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
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in less than or equal to 5% of patients. This information may vary from existing approved labeling and publications.


  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 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.


Results Point of Contact:  
Name/Title: 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:

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00264537     History of Changes
Other Study ID Numbers: CR006331, GO-BEFORE, C0524T05
Study First Received: December 11, 2005
Results First Received: May 21, 2009
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration