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Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients (Rainbow)

This study has been completed.
Sponsor:
Collaborators:
Lincoln
Umanis
SODIA
depolabo
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00768053
First received: October 3, 2008
Last updated: July 28, 2011
Last verified: July 2011
History of Changes
Results First Received: March 24, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Intervention: Drug: Etanercept

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study duration includes a screening period of up to 6 weeks, a 12 week open-label treatment period, and a 4 week follow-up period (telephone contact for the assessment of adverse events).

Reporting Groups
  Description
Etanercept (ETN) Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.

Participant Flow:   Overall Study
    Etanercept (ETN)  
STARTED     108  
COMPLETED     97  
NOT COMPLETED     11  
Adverse Event                 10  
Lost to Follow-up                 1  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score   [ Time Frame: Screening, baseline ]
  Show Outcome Measure 1

2.  Primary:   Simplicity: Time for Completion of the EULAR-RAID Questionnaire   [ Time Frame: Baseline up to Week 12 ]
  Show Outcome Measure 2

3.  Primary:   Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28)   [ Time Frame: Baseline, Week 4 ]
  Show Outcome Measure 3

4.  Primary:   Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 4

5.  Primary:   Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average   [ Time Frame: Baseline, Last observation up to Week 12 ]
  Show Outcome Measure 5

6.  Primary:   Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status   [ Time Frame: Baseline, Week 4 ]
  Show Outcome Measure 6

7.  Primary:   Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 7

8.  Primary:   Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average   [ Time Frame: Baseline, Last observation up to Week 12 ]
  Show Outcome Measure 8

9.  Primary:   Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4   [ Time Frame: Baseline, Week 4 ]
  Show Outcome Measure 9

10.  Primary:   Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12   [ Time Frame: Baseline, Week 12 ]
  Show Outcome Measure 10

11.  Secondary:   Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 11

12.  Secondary:   Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12   [ Time Frame: Week 4, Week 12 ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII) Score at Week 4 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)   [ Time Frame: Week 4, Week 12, and Last observation up to Week 12 ]
  Show Outcome Measure 13

14.  Secondary:   Percentage of Participants Achieving a Minimal Clinically Important Improvement Score at Week 12 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)   [ Time Frame: Week 4, Week 12, and Last observation up to Week 12 ]
  Show Outcome Measure 14

15.  Secondary:   Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12   [ Time Frame: Week 4, Week 12 ]
  Show Outcome Measure 15

16.  Secondary:   Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 4 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)   [ Time Frame: Week 4, Week 12, and Last observation up to Week 12 ]
  Show Outcome Measure 16

17.  Secondary:   Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 12 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)   [ Time Frame: Week 4, Week 12, and Last observation up to Week 12 ]
  Show Outcome Measure 17

18.  Secondary:   Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 18

19.  Secondary:   Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 19

20.  Secondary:   Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 20

21.  Secondary:   Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 21

22.  Secondary:   Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2   [ Time Frame: Baseline up to Week 12 ]
  Show Outcome Measure 22

23.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 23

24.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 24

25.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 25

26.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 26


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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.  


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 Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00768053     History of Changes
Other Study ID Numbers: 0881X1-4508, B1801019
Study First Received: October 3, 2008
Results First Received: March 24, 2011
Last Updated: July 28, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)