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A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-Naive
This study is ongoing, but not recruiting participants.
Study NCT00264537   Information provided by Centocor, Inc.
First Received: December 11, 2005   Last Updated: May 21, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition: Rheumatoid Arthritis
Interventions: Biological: golimumab
Drug: placebo; methotrexate
Drug: golimumab; methotrexate
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
This was a multicenter, randomized, double-blind, placebo-controlled, 4-arm, parallel-group study with the first patient consented on 12Dec2005. The Week 24 database lock was 01 Oct. 2007. 637 subjects were randomized 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 I: Placebo + Methotrexate (MTX) Placebo SC injections every 4 wks from Wk 0 to Wk 48 (unless early escape at Wk 28); MTX - 10 to 20 mg from Wk 0 for up to 5 years; golimumab - If early escape, 50 mg SC injection every 4 wks from Wk 28 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Group II: Golimumab 100 mg + Placebo Golimumab 100 mg SC injection every 4 wks from Wk 0 for up to 5 yrs, placebo capsule MTX weekly from Wk 0 to unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked) unless early escape at Wk 28; MTX - If early escape start 10 mg weekly during blinded period; MTX - Dr's discretion, adjust weekly dose after unblinding.
Group III: Golimumab 50 mg + Methotrexate (MTX) Golimumab 50 mg SC injections every 4 wks from Wk 0-48 (Wk 28 if early escape); MTX - 10 to 20 mg from Wk 0 for up to 5 years; golimumab - If early escape, 100 mg beginning at Wk 28 for up to 5 yrs; golimumab - Dr's discretion after unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Group IV: Golimumab 100 mg + Methotrexate (MTX) Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; MTX - 10 to 20 mg from Wk 0 for up to 5 years.

Participant Flow:   Overall Study
  Group I: Placebo + Methotrexate (MTX) Group II: Golimumab 100 mg + Placebo Group III: Golimumab 50 mg + Methotrexate (MTX) Group IV: Golimumab 100 mg + Methotrexate (MTX)
STARTED   160     159     159     159  
COMPLETED   150[1]   150[2]   151[3]   149[4]
NOT COMPLETED   10     9     8     10  
      Adverse Event               1                 1                 5                 6  
      Unsatisfactory theapeutic effect               1                 3                 0                 0  
      Lost to Follow-up               3                 0                 1                 1  
      Death               0                 0                 1                 1  
      Patient relocated               1                 0                 0                 0  
      Not specified               4                 5                 1                 2  
[1] Indicates number of patients that are continuing subcutaneous study agent at Week 24
[2] Indicates number of patients that are continuing subcutaneous study agent at Week 24
[3] Indicates number of patients that are continuing subcutaneous study agent at Week 24
[4] Indicates number of patients that are continuing subcutaneous study agent at Week 24



  Baseline Characteristics
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Reporting Groups
  Description
Group I: Placebo + Methotrexate (MTX) Placebo SC injections every 4 wks from Wk 0 to Wk 48 (unless early escape at Wk 28); MTX - 10 to 20 mg from Wk 0 for up to 5 years; golimumab - If early escape, 50 mg SC injection every 4 wks from Wk 28 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Group II: Golimumab 100 mg + Placebo Golimumab 100 mg SC injection every 4 wks from Wk 0 for up to 5 yrs, placebo capsule MTX weekly from Wk 0 to unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked) unless early escape at Wk 28; MTX - If early escape start 10 mg weekly during blinded period; MTX - Dr's discretion, adjust weekly dose after unblinding.
Group III: Golimumab 50 mg + Methotrexate (MTX) Golimumab 50 mg SC injections every 4 wks from Wk 0-48 (Wk 28 if early escape); MTX - 10 to 20 mg from Wk 0 for up to 5 years; golimumab - If early escape, 100 mg beginning at Wk 28 for up to 5 yrs; golimumab - Dr's discretion after unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Group IV: Golimumab 100 mg + Methotrexate (MTX) Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; MTX - 10 to 20 mg from Wk 0 for up to 5 years.

Baseline Measures
  Group I: Placebo + Methotrexate (MTX) Group II: Golimumab 100 mg + Placebo Group III: Golimumab 50 mg + Methotrexate (MTX) Group IV: Golimumab 100 mg + Methotrexate (MTX) 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:   American College of Rheumatology 50 Response at Week 24   [ Week 24 ]
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2.  Secondary:   American College of Rheumatology 20 Response at Week 24   [ Week 24 ]
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3.  Secondary:   American College of Rheumatology 50 Response at Week 24 in Patients With Abnormal C-reactive Protein at Baseline   [ Week 24 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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