Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00768053
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00768053
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : April 21, 2011
Last Update Posted : July 29, 2011
Sponsor:
Collaborators:
Lincoln Medical and Mental Health Center
Umanis
SODIA
depolabo
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: Etanercept
Enrollment 108
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Period Title: Overall Study
Started 108
Completed 97
Not Completed 11
Reason Not Completed
Adverse Event             10
Lost to Follow-up             1
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Baseline Participants 108
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants
53.6  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Female
81
  75.0%
Male
27
  25.0%
1.Primary Outcome
Title Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score
Hide Description EULAR-RAID score reliability assessed using an intraclass correlation coefficient (using a consistency definition where the between-measure variance is excluded from the denominator variance and its 95% confidence interval) and the standard error of measurement (SEM) and its 95% confidence interval (CI). A higher intraclass correlation coefficient (ICC) indicates greater score reliability (0.0 to 0.10=virtually none; 0.11 to 0.40=slight; 0.41 to 0.60=fair; 0.61 to 0.80=moderate; 0.81 to 1.00=substantial).
Time Frame Screening, baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population: received at least 1 dose of study treatment (same as Safety population).
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: intraclass correlation coefficient
0.85
(0.79 to 0.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Intraclass correlation coefficient (ICC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments F test for H0: ICC = 0
Method F test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Standardized response mean: standard error of measurement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter standard error of measurement
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.57 to 0.75
Estimation Comments [Not Specified]
2.Primary Outcome
Title Simplicity: Time for Completion of the EULAR-RAID Questionnaire
Hide Description EULAR-RAID is an assessment of patient reported outcomes for pain, functional disability, fatigue, sleep disturbance, coping, overall assessments of physical well-being and emotional well-being based on 7 numerical rating scales (NRS) questions. NRS individual questions with range of 0 (not affected, very good) to 10 (most affected) weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected).
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population. Data was not summarized; the time to complete the EULAR-RAID questionnaire was not analyzed separately from other components of the EULAR questionnaire (EULAR-RAID, questions on pain, Modified Health Assessment Questionnaire, sleep and coping)
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28)
Hide Description DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: correlation coefficient
Baseline
0.33
(0.15 to 0.49)
Week 4
0.64
(0.50 to 0.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test for the Pearson correlation
Comments [Not Specified]
4.Primary Outcome
Title Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12
Hide Description DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: correlation coefficient
0.55
(0.40 to 0.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test for the Pearson correlation
Comments [Not Specified]
5.Primary Outcome
Title Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average
Hide Description Time-normalized average is the area under the curve (AUC) / time between first and last observations. DAS28 calculated from number of swollen joints and painful joints using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID and DAS28 scores. A higher correlation coefficient indicates greater EULAR-RAID score validity.
Time Frame Baseline, Last observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; score profile from baseline to last observation post-baseline.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: correlation coefficient
0.59
(0.45 to 0.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Time-normalized average
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test for the Pearson correlation
Comments [Not Specified]
6.Primary Outcome
Title Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status
Hide Description PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the PGA. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: correlation coefficient
Baseline
0.77
(0.68 to 0.84)
Week 4
0.93
(0.90 to 0.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test for the Pearson correlation
Comments [Not Specified]
7.Primary Outcome
Title Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12
Hide Description PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: correlation coefficient
0.89
(0.84 to 0.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test for the Pearson correlation
Comments [Not Specified]
8.Primary Outcome
Title Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average
Hide Description Time-normalized average is the area under the curve (AUC) / time between first and last observations. PGA of health status is a single-item participant rated response to the question "in general, how would you rate your health over the last 2 to 3 weeks"; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).
Time Frame Baseline, Last observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; score profile from baseline to last observation post-baseline.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: correlation coefficient
0.92
(0.89 to 0.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Time-normalized average
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test for the Pearson correlation
Comments [Not Specified]
9.Primary Outcome
Title Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4
Hide Description Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: standardized response mean
EULAR-RAID score -1.01
Pain NRS value -1.06
Functional disability NRS value -1.02
Fatigue NRS value -0.86
Sleep NRS value -0.64
Physical well-being NRS value -0.90
Emotional well-being NRS value -0.68
Coping NRS value -0.60
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Pain NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Sleep NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.351
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Coping NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
10.Primary Outcome
Title Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12
Hide Description Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: standardized response mean
EULAR-RAID score -1.37
Pain NRS value -1.37
Functional disability NRS value -1.24
Fatigue NRS value -1.15
Sleep NRS value -0.92
Physical well-being NRS value -1.27
Emotional well-being NRS value -1.06
Coping NRS value -0.96
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Pain NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.895
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Sleep NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Etanercept (ETN)
Comments Comparison of change from baseline between EULAR-RAID score and Coping NRS value
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method paired t-test
Comments A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.
11.Secondary Outcome
Title Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12
Hide Description EULAR response rate is based on DAS28. For DAS28 ≤3.2 at observation (low disease activity), change from baseline of <-1.2=good response or ≥-1.2 to <-0.6=moderate response; DAS28 >3.2 to 5.1 at observation (moderate or high disease activity), change from baseline of <-1.2 or ≥-1.2 to <-0.6=moderate response; DAS28 >5.1 (high disease activity) at observation, change from baseline of <-1.2=moderate response. DAS28 calculated using the 28 joints count, ESR mm/hour, and PGA of disease activity (participant rated arthritis activity measured on 11-point rating scale: 0 [none] to 10 [extreme]).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; N=number of participants with evaluable data at observation.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 95
Measure Type: Number
Unit of Measure: percentage of participants
87.4
12.Secondary Outcome
Title Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12
Hide Description MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No Change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). The MCII score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of the response therapy at observation was Moderately or Slightly important improvement.
Time Frame Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injects subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: scores on a scale
Week 4 (n=102) -0.19
Week 12 (n=99) -1.29
13.Secondary Outcome
Title 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)
Hide Description MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 4 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.
Time Frame Week 4, Week 12, and Last observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Mod/Slightly Imp Improvement Week 4 (n=102) 78.4
Mod/Slightly Imp Improvement Week 12 (n=99) 87.9
Mod/Slightly Imp Improvement Last Obs (n=108) 87.0
14.Secondary Outcome
Title 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)
Hide Description MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 12 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.
Time Frame Week 4, Week 12, and Last observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Mod/Slightly Imp Improvement Week 4 (n=102) 61.8
Mod/Slightly Imp Improvement Week 12 (n=99) 78.8
Mod/Slightly Imp Improvement Last Obs (n=108) 76.9
15.Secondary Outcome
Title Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12
Hide Description PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be Acceptable or Unacceptable to you?). PASS score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of their symptom state at observation was Acceptable.
Time Frame Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population. Unacceptable value put to participants prematurely withdrawn or with missing data; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: scores on a scale
Week 4 (n=102) 4.15
Week 12 (=99) 3.27
16.Secondary Outcome
Title 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)
Hide Description PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 4 calculated on participants with Acceptable symptom state achieved at observation.
Time Frame Week 4, Week 12, and Last observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Acceptable Week 4 (n=102) 57.8
Acceptable Week 12 (n=99) 74.7
Acceptable Last Obs (n=108) 72.2
17.Secondary Outcome
Title 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)
Hide Description PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 12 calculated on participants with Acceptable symptom state achieved at observation.
Time Frame Week 4, Week 12, and Last observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Acceptable Week 4 (n=102) 49.0
Acceptable Week 12 (n=99) 64.6
Acceptable Last Obs (n=108) 62.0
18.Secondary Outcome
Title Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12
Hide Description DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (i.e., change in DAS28 < -1.2).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; N=number of participants with evaluable data at observation.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 95
Measure Type: Number
Unit of Measure: percentage of participants
77.9
19.Secondary Outcome
Title Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12
Hide Description DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scalescored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; N=number of participants with evaluable data at observation.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: percentage of participants
28.1
20.Secondary Outcome
Title Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12
Hide Description DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; N=number of participants with evaluable data at observation.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: percentage of participants
46.9
21.Secondary Outcome
Title Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12
Hide Description DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >0.6 DAS28 response defined as decrease in DAS28 > 0.6 (i.e. change in DAS28 < -0.6).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; N=number of participants with evaluable data at observation.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 95
Measure Type: Number
Unit of Measure: percentage of participants
91.6
22.Secondary Outcome
Title Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2
Hide Description Time to sustained LDAS measured as maintenance of low disease activity score beyond Week 12. DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; DAS28 assessed at Week 4 and Week 12; sustained LDAS could only have been observed beyond Week 12. Time to event analysis not possible within study duration.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12
Hide Description American College of Rheumatology 20% (ACR20) response: responder = ≥20% improvement in tender and swollen joint count and ≥20% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; N=number of participants with evaluable data at observation.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: percentage of participants
71.3
24.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12
Hide Description American College of Rheumatology 50% (ACR50) response: responder = ≥50% improvement in tender and swollen joint count and ≥50% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; N=number of participants with evaluable data at observation.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: percentage of participants
47.3
25.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12
Hide Description American College of Rheumatology 70% (ACR70) response: responder = ≥70% improvement in tender and swollen joint count and ≥70% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; N=number of participants with evaluable data at observation.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 98
Measure Type: Number
Unit of Measure: percentage of participants
16.3
26.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12
Hide Description American College of Rheumatology 90% (ACR90) response: responder = ≥90% improvement in tender and swollen joint count and ≥90% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All injected subjects population; N=number of participants with evaluable data at observation.
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description:
Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: percentage of participants
3.0
Time Frame Time the Informed Consent Form was signed up to Week 16 Follow-up visit
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Etanercept (ETN)
Hide Arm/Group Description Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
All-Cause Mortality
Etanercept (ETN)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Etanercept (ETN)
Affected / at Risk (%)
Total   5/108 (4.63%) 
Gastrointestinal disorders   
Abdominal pain  1  1/108 (0.93%) 
Infections and infestations   
Arthritis bacterial  1  2/108 (1.85%) 
Sepsis  1  1/108 (0.93%) 
Musculoskeletal and connective tissue disorders   
Rheumatoid arthritis  1  1/108 (0.93%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Etanercept (ETN)
Affected / at Risk (%)
Total   53/108 (49.07%) 
Gastrointestinal disorders   
Nausea  1  3/108 (2.78%) 
General disorders   
Asthenia  1  4/108 (3.70%) 
Fatigue  1  4/108 (3.70%) 
Injection site erythema  1  8/108 (7.41%) 
Injection site reaction  1  18/108 (16.67%) 
Infections and infestations   
Bronchitis  1  8/108 (7.41%) 
Influenza  1  3/108 (2.78%) 
Nasopharyngitis  1  3/108 (2.78%) 
Tonsillitis  1  3/108 (2.78%) 
Skin and subcutaneous tissue disorders   
Erythema  1  10/108 (9.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 12.0
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.
Wyeth has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00768053    
Other Study ID Numbers: 0881X1-4508
B1801019
First Submitted: October 3, 2008
First Posted: October 7, 2008
Results First Submitted: March 24, 2011
Results First Posted: April 21, 2011
Last Update Posted: July 29, 2011