Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis (PRESERVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00565409
First received: November 28, 2007
Last updated: August 4, 2015
Last verified: August 2015
Results First Received: May 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: Etanercept
Drug: Methotrexate
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
Etanercept 50 mg Plus MTX -Period 2 Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
Etanercept 25 mg Plus MTX-Period 2 Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
Placebo Plus MTX-Period 2 Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.

Participant Flow for 3 periods

Period 1:   Period 1 Open Label
    Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1     Etanercept 50 mg Plus MTX -Period 2     Etanercept 25 mg Plus MTX-Period 2     Placebo Plus MTX-Period 2  
STARTED     834     0     0     0  
COMPLETED     756     0     0     0  
NOT COMPLETED     78     0     0     0  
Adverse Event                 17                 0                 0                 0  
Death                 2                 0                 0                 0  
Lost to Follow-up                 1                 0                 0                 0  
unspecified                 21                 0                 0                 0  
Protocol Violation                 14                 0                 0                 0  
Unsatisfactory Response-Efficacy                 22                 0                 0                 0  
no conclusion of participation record                 1                 0                 0                 0  

Period 2:   After Period 1, Prior to Period 2
    Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1     Etanercept 50 mg Plus MTX -Period 2     Etanercept 25 mg Plus MTX-Period 2     Placebo Plus MTX-Period 2  
STARTED     756     0     0     0  
COMPLETED     604     0     0     0  
NOT COMPLETED     152     0     0     0  
did not meet criteria                 152                 0                 0                 0  

Period 3:   Period 2 Double-Blind
    Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1     Etanercept 50 mg Plus MTX -Period 2     Etanercept 25 mg Plus MTX-Period 2     Placebo Plus MTX-Period 2  
STARTED     0     202     202     200  
COMPLETED     0     181     175     141  
NOT COMPLETED     0     21     27     59  
Adverse Event                 0                 7                 4                 5  
Death                 0                 2                 0                 0  
Protocol Violation                 0                 4                 6                 2  
Lost to Follow-up                 0                 0                 1                 0  
unspecified                 0                 4                 5                 9  
Unsatisfactory Response-Efficacy                 0                 4                 11                 43  



  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.
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Reporting Groups
  Description
Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.

Baseline Measures
    Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1  
Number of Participants  
[units: participants]
  834  
Age  
[units: years]
Mean (Standard Deviation)
  48.36  (11.94)  
Gender  
[units: participants]
 
Female     694  
Male     140  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88   [ Time Frame: Week 88 ]

2.  Secondary:   Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28, 36 ]

3.  Secondary:   Percentage of Participants Achieving DAS28 Low Disease Activity or Remission   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ]

4.  Secondary:   Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ]

5.  Secondary:   Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ]

6.  Secondary:   Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28   [ Time Frame: Week 36 up to Week 88 ]

7.  Secondary:   Time to Loss of Low Disease Activity DAS28   [ Time Frame: Week 36 up to Week 88 ]

8.  Secondary:   Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88   [ Time Frame: Week 36 up to Week 88 ]

9.  Secondary:   Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ]

10.  Secondary:   Prorated Swollen Joint Count at Week 36   [ Time Frame: Week 36 ]

11.  Secondary:   Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88   [ Time Frame: Week 36, Weeks 40, 48, 56, 64, 72, 80 and 88 ]

12.  Secondary:   Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ]

13.  Secondary:   Painful Joint Count at Week 36   [ Time Frame: Week 36 ]

14.  Secondary:   Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88   [ Time Frame: Weeks 36 40, 48, 56, 64, 72, 80 and 88 ]

15.  Secondary:   Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ]

16.  Secondary:   PGA Score at Week 36   [ Time Frame: Week 36 ]

17.  Secondary:   Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ]

18.  Secondary:   Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ]

19.  Secondary:   PtGA of Arthritis Pain at Week 36   [ Time Frame: Week 36 ]

20.  Secondary:   Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80, 88 ]

21.  Secondary:   Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ]

22.  Secondary:   Duration of Morning Stiffness at Week 36   [ Time Frame: Week 36 ]

23.  Secondary:   Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80, 88 ]

24.  Secondary:   Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ]

25.  Secondary:   General Health at Week 36   [ Time Frame: Week 36 ]

26.  Secondary:   Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80, 88 ]

27.  Secondary:   Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ]

28.  Secondary:   Pain at Week 36   [ Time Frame: Week 36 ]

29.  Secondary:   Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ]

30.  Secondary:   Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36   [ Time Frame: Baseline, Week 36 ]

31.  Secondary:   Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88   [ Time Frame: Weeks 36, 64 and 88 ]

32.  Secondary:   Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Weeks 4, 8, 12, 20, 28 and 36 ]

33.  Secondary:   Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88   [ Time Frame: Week 36, 40, 48, 56, 64, 72, 80 and 88 ]

34.  Secondary:   Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Weeks 4, 8, 12, 20, 28 and 36 ]

35.  Secondary:   Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ]

36.  Secondary:   Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Weeks 4, 8, 12, 20, 28 and 36 ]

37.  Secondary:   Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ]

38.  Secondary:   Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Weeks 4, 8, 12, 20, 28 and 36 ]

39.  Secondary:   Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ]

40.  Secondary:   Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36   [ Time Frame: Weeks 4, 8, 12, 20, 28 and 36 ]

41.  Secondary:   Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88   [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ]

42.  Secondary:   DAS28 at Week 36   [ Time Frame: Week 36 ]


  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 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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00565409     History of Changes
Other Study ID Numbers: 0881A1-4423, B1801003
Study First Received: November 28, 2007
Results First Received: May 7, 2012
Last Updated: August 4, 2015
Health Authority: Australia: Human Research Ethics Committee
France: Institutional Ethical Committee
Hungary: Nation