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CAMEO: Canadian Methotrexate and Etanercept Outcome Study

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00654368
First received: April 3, 2008
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: February 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Biological: Etanercept
Drug: Methotrexate

  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
First patient was enrolled 28 June 2008 and last patient was enrolled 07 November 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 258 participants were enrolled, of whom 205 were randomized after 6 months and 53 were not randomized.

Reporting Groups
  Description
Non-randomized Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
Etanercept Alone After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
Etanercept + Methotrexate After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.

Participant Flow:   Overall Study
    Non-randomized   Etanercept Alone   Etanercept + Methotrexate
STARTED   53   98   107 
COMPLETED   0   50   75 
NOT COMPLETED   53   48   32 
Ineligibility determined                6                0                0 
Protocol deviation                3                2                1 
Non-compliance                2                1                2 
Withdrawal by Subject                5                2                2 
Disease progression                21                31                13 
Requirement for alternative therapy                1                1                1 
Physician Decision                0                0                2 
Death                1                0                0 
Pregnancy                0                0                2 
Other                0                2                3 
Adverse Event                14                9                6 



  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
Non-randomized Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
Etanercept Alone After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
Etanercept + Methotrexate After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
Total Total of all reporting groups

Baseline Measures
   Non-randomized   Etanercept Alone   Etanercept + Methotrexate   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   98   107   258 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.2  (13.4)   54.3  (11.9)   54.4  (12.7)   54.7  (12.5) 
Gender 
[Units: Participants]
       
Female   41   72   84   197 
Male   12   26   23   61 
Race/Ethnicity, Customized 
[Units: Participants]
       
White or Caucasian   47   96   103   246 
Black or African American   2   1   0   3 
Hispanic or Latino   0   0   1   1 
Asian   2   0   0   2 
Native Hawaiian or other Pacific Islander   0   0   3   3 
Aborigine   1   0   0   1 
Other   1   1   0   2 
Duration of rheumatoid arthritis 
[Units: Participants]
       
< 2 years   11   23   23   57 
>= 2 years   42   75   84   201 
Reimbursement type 
[Units: Participants]
       
Private   23   48   55   126 
Public   16   33   37   86 
Combination/Other   14   17   15   46 
Disease Activity Score (DAS28-ESR) [1] 
[Units: Participants]
       
<= 5.1   20   43   41   104 
> 5.1   33   55   66   154 
[1] The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity.


  Outcome Measures
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1.  Primary:   Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)   [ Time Frame: Month 6 (randomization) and Month 12 ]

2.  Secondary:   Disease Activity Score (DAS) 28 Response   [ Time Frame: Month 6, 12, 18 and 24 ]

3.  Secondary:   Change From Baseline in Disease Activity Score 28 (DAS28)   [ Time Frame: Baseline and Month 6, 12, 18 and 24 ]

4.  Secondary:   Drug Persistence   [ Time Frame: Month 6, 12, 18 and 24 ]

5.  Secondary:   Change From Baseline in Modified Total Sharp Score (mTSS)   [ Time Frame: Baseline, Month 12 and Month 24 ]

6.  Secondary:   Change From Baseline in Joint Erosion Score   [ Time Frame: Baseline, Month 12 and Month 24 ]

7.  Secondary:   Change From Baseline in Joint Space Narrowing   [ Time Frame: Baseline, Month 12 and Month 24 ]

8.  Secondary:   Change From Month 6 in Health Assessment Questionnaire Disability Index (HAQ DI)   [ Time Frame: Month 6, 12, 18 and 24 ]

9.  Secondary:   Change From Month 6 in Health Assessment Questionnaire Pain Visual Analog Scale (VAS)   [ Time Frame: Month 6, 12, 18 and 24 ]

10.  Secondary:   Change From Month 6 in Short Form 36 Health Survey (SF-36)   [ Time Frame: Month 6, 12, 18 and 24 ]

11.  Secondary:   Change From Month 6 in Work Productivity and Activity Impairment (WPAI)   [ Time Frame: Month 6, 12, 18 and 24 ]

12.  Secondary:   Change From Month 6 in Treatment Satisfaction Questionnaire for Medication (TSQM)   [ Time Frame: Month 6, 12, 18 and 24 ]

13.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: 25 months ]


  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