Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01578850
First received: April 12, 2012
Last updated: May 25, 2016
Last verified: May 2016
Results First Received: February 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Etanercept
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
The study consisted of Period 1 (an open-label, 24-week treat-to-target period), and Period 2 (a double-blind, randomized, 28-week period for participants who qualified for randomization).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was conducted in participants with rheumatoid arthritis (RA) who had moderate to severe disease activity despite methotrexate (MTX) therapy (≥10 mg/week) with or without other non-biologic disease modifying anti-rheumatic drugs (DMARDs) for at least 12 weeks prior to screening.

Reporting Groups
  Description
Open-Label Treatment Participants in open-label treatment received Etanercept (ETN) 50 milligram (mg) once a week (QW) with MTX (with or without other DMARDs).
Etanercept Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
Placebo Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).

Participant Flow for 2 periods

Period 1:   Period 1
    Open-Label Treatment     Etanercept     Placebo  
STARTED     489 [1]   0     0  
COMPLETED     452     0     0  
NOT COMPLETED     37     0     0  
Insufficient Clinical Response                 1                 0                 0  
Adverse Event                 11                 0                 0  
Death                 1                 0                 0  
Does Not Meet Entrance Criteria                 12                 0                 0  
Withdrawal by Subject                 9                 0                 0  
Study Terminated by Sponsor                 3                 0                 0  
[1] 491 participants were enrolled in open-label treatment but 2 did not receive study medication.

Period 2:   Period 2
    Open-Label Treatment     Etanercept     Placebo  
STARTED     0     167 [1]   176 [2]
COMPLETED     0     154     162  
NOT COMPLETED     0     13     14  
Insufficient Clinical Response                 0                 1                 0  
Adverse Event                 0                 3                 6  
Lost to Follow-up                 0                 1                 2  
Withdrawal by Subject                 0                 2                 2  
Study Terminated by Sponsor                 0                 5                 4  
Unspecified Reasons                 0                 1                 0  
[1] Two participants in ETN did not receive treatment.
[2] One participants in PBO did not receive treatment.



  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.
The Full Analysis Set for Period 2 (Double Blind FAS) included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or placebo) and have at least one valid efficacy (DAS28-ESR) evaluation after randomization.

Reporting Groups
  Description
Etanercept Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
Placebo Participants were randomized to receive PBO 50 mg QW with MTX (with or without other DMARDs).
Total Total of all reporting groups

Baseline Measures
    Etanercept     Placebo     Total  
Number of Participants  
[units: participants]
  167     176     343  
Age  
[units: Years]
Mean (Standard Deviation)
  46.2  (12.88)     47.0  (12.02)     46.6  (12.44)  
Gender  
[units: Participants]
     
Female     140     150     290  
Male     27     26     53  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.   [ Time Frame: Baseline and Week 52 ]

2.  Secondary:   Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

4.  Secondary:   Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

5.  Secondary:   Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

6.  Secondary:   Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

7.  Secondary:   Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

8.  Secondary:   Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

9.  Secondary:   Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria   [ Time Frame: Baseline and Week 52 ]

10.  Secondary:   Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1.   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

11.  Secondary:   Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2.   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

12.  Secondary:   Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1.   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

13.  Secondary:   Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2.   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

14.  Secondary:   Change of CDAI and SDAI at Each Visit During Period 1.   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

15.  Secondary:   Change of CDAI and SDAI at Each Visit During Period 2   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

16.  Secondary:   Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit.   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

17.  Secondary:   Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit.   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

18.  Secondary:   Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts).   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

19.  Secondary:   Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts).   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

20.  Secondary:   Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

21.  Secondary:   Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

22.  Secondary:   Change in the Subject Global Assessment of Arthritis in Period 1   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

23.  Secondary:   Change in the Subject Global Assessment of Arthritis in Period 2   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

24.  Secondary:   Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

25.  Secondary:   Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

26.  Secondary:   Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

27.  Secondary:   Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52 ]

28.  Secondary:   Change in CRP and ESR at Each Visit During Period 1   [ Time Frame: Baseline, Weeks 4, 8, 16 and 24 ]

29.  Secondary:   Change in CRP and ESR at Each Visit During Period 2   [ Time Frame: Baseline, Weeks 24, 28, 36, 44 and 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
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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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01578850     History of Changes
Other Study ID Numbers: B1801315
2011-005448-87 ( EudraCT Number )
B1801315 ( Other Identifier: Alias Study Number )
Study First Received: April 12, 2012
Results First Received: February 16, 2016
Last Updated: May 25, 2016
Health Authority: South Africa: Medicines Control Council