Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01313208
First received: March 10, 2011
Last updated: May 7, 2014
Last verified: May 2014
Results First Received: May 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: etanercept
Drug: Placebo
Drug: DMARD Therapy

  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 enrolled on 31 March 2011; Last patient enrolled 29 November 2012

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
Placebo Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
Etanercept

Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.

All participants continued their DMARD treatment throughout the 24-week study period.


Participant Flow for 2 periods

Period 1:   Double-blind Phase (Weeks 1 - 12)
    Placebo     Etanercept  
STARTED     104     106  
COMPLETED     98     101  
NOT COMPLETED     6     5  
Withdrawal by Subject                 3                 2  
Adverse Event                 1                 2  
Ineligibility determined                 0                 1  
Lost to Follow-up                 1                 0  
Noncompliance                 1                 0  

Period 2:   Open-label Phase (Weeks 13 - 24)
    Placebo     Etanercept  
STARTED     98     101  
COMPLETED     92     98  
NOT COMPLETED     6     3  
Withdrawal by Subject                 3                 1  
Noncompliance                 0                 2  
Adverse Event                 1                 0  
Other                 2                 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
Placebo Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
Etanercept

Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.

All participants continued their DMARD treatment throughout the 24-week study period.

Total Total of all reporting groups

Baseline Measures
    Placebo     Etanercept     Total  
Number of Participants  
[units: participants]
  104     106     210  
Age  
[units: years]
Mean ± Standard Deviation
  55.5  ± 12.8     56.5  ± 12.1     56.0  ± 12.4  
Gender  
[units: participants]
     
Female     86     75     161  
Male     18     31     49  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     3     2     5  
Black or African American     8     9     17  
Mixed race     1     0     1  
White     90     91     181  
Other     1     4     5  
Duration of Rheumatoid Arthritis  
[units: years]
Mean ± Standard Deviation
  7.41  ± 8.11     8.26  ± 11.16     7.84  ± 9.76  
Baseline methotrexate use  
[units: participants]
     
Yes     93     94     187  
No     11     12     23  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Percentage of Participants Achieving DAS28 Remission at Week 12   [ Time Frame: Week 12 ]

3.  Secondary:   Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints   [ Time Frame: Baseline and Weeks 2, 4, 8, 16, 20 and 24 ]

4.  Secondary:   Percentage of Participants Achieving DAS28 Remission at All Other Timepoints   [ Time Frame: Baseline and Weeks 2, 4, 8, 16, 20 and 24 ]

5.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

6.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

7.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

8.  Secondary:   Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

9.  Secondary:   Percentage of Participants Achieving Count Remission at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

10.  Secondary:   Percentage of Participants Achieving CDAI Remission at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

11.  Secondary:   Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

12.  Secondary:   Clinical Disease Activity Index (CDAI) Score at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

13.  Secondary:   Percentage of Participants Achieving SDAI Remission at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

14.  Secondary:   Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

15.  Secondary:   Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

16.  Secondary:   Tender 28-Joint Count (TJC28) at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

17.  Secondary:   Swollen 28-Joint Count (SJC28) at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

18.  Secondary:   Patient Global Assessment of Joint Pain at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

19.  Secondary:   Patient's Global Assessment of Disease Activity at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

20.  Secondary:   Physician Global Assessment of Disease Activity at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

21.  Secondary:   Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

22.  Secondary:   C-reactive Protein Levels at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

23.  Secondary:   Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

24.  Secondary:   Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

25.  Secondary:   Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

26.  Secondary:   Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

27.  Secondary:   Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

28.  Secondary:   Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

29.  Secondary:   Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

30.  Secondary:   Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

31.  Secondary:   Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

32.  Secondary:   Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

33.  Secondary:   Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

34.  Secondary:   Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

35.  Secondary:   Participant Assessment of Fatigue at Each Time Point   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 ]

36.  Secondary:   Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

37.  Secondary:   Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

38.  Secondary:   Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

39.  Secondary:   Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

40.  Secondary:   Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

41.  Secondary:   Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]

42.  Secondary:   Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point   [ Time Frame: Baseline and Weeks 4, 12 and 24 ]


  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
No text entered.


  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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


No publications provided


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01313208     History of Changes
Other Study ID Numbers: 20070561
Study First Received: March 10, 2011
Results First Received: May 7, 2014
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada