Trial Outcomes & Findings for Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients (NCT NCT00768053)

NCT ID: NCT00768053

Last Updated: 2011-07-29

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 108 participants
• Primary outcome timeframe: Screening, baseline
• Results posted on: 2011-07-29

Participant Flow

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).

Participant milestones

Measure	Etanercept (ETN) Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Study STARTED	108
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Etanercept (ETN) Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Overall Study Adverse Event	10
Overall Study Lost to Follow-up	1

Baseline Characteristics

Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients

Baseline characteristics by cohort

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Age Continuous	53.6 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening, baseline

Population: All injected subjects population: received at least 1 dose of study treatment (same as Safety population).

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).

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score	0.85 intraclass correlation coefficient Interval 0.79 to 0.9

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: 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)

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).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: All injected subjects population

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28) Baseline	0.33 correlation coefficient Interval 0.15 to 0.49
Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28) Week 4	0.64 correlation coefficient Interval 0.5 to 0.74

PRIMARY outcome

Timeframe: Week 12

Population: All injected subjects population

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12	0.55 correlation coefficient Interval 0.4 to 0.68

PRIMARY outcome

Timeframe: Baseline, Last observation up to Week 12

Population: All injected subjects population; score profile from baseline to last observation post-baseline.

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average	0.59 correlation coefficient Interval 0.45 to 0.7

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: All injected subjects population

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).

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status Baseline	0.77 correlation coefficient Interval 0.68 to 0.84
Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status Week 4	0.93 correlation coefficient Interval 0.9 to 0.95

PRIMARY outcome

Timeframe: Week 12

Population: All injected subjects population

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).

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12	0.89 correlation coefficient Interval 0.84 to 0.93

PRIMARY outcome

Timeframe: Baseline, Last observation up to Week 12

Population: All injected subjects population; score profile from baseline to last observation post-baseline.

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).

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average	0.92 correlation coefficient Interval 0.89 to 0.95

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: All injected subjects population

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 EULAR-RAID score	-1.01 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 Pain NRS value	-1.06 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 Functional disability NRS value	-1.02 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 Fatigue NRS value	-0.86 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 Sleep NRS value	-0.64 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 Physical well-being NRS value	-0.90 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 Emotional well-being NRS value	-0.68 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4 Coping NRS value	-0.60 standardized response mean

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: All injected subjects population

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 EULAR-RAID score	-1.37 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 Pain NRS value	-1.37 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 Functional disability NRS value	-1.24 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 Fatigue NRS value	-1.15 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 Sleep NRS value	-0.92 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 Physical well-being NRS value	-1.27 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 Emotional well-being NRS value	-1.06 standardized response mean
Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12 Coping NRS value	-0.96 standardized response mean

SECONDARY outcome

Timeframe: Week 12

Population: All injected subjects population; N=number of participants with evaluable data at observation.

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]).

Outcome measures

Measure	Etanercept (ETN) n=95 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12	87.4 percentage of participants

SECONDARY outcome

Timeframe: Week 4, Week 12

Population: All injects subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12 Week 4 (n=102)	-0.19 scores on a scale
Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12 Week 12 (n=99)	-1.29 scores on a scale

SECONDARY outcome

Timeframe: Week 4, Week 12, and Last observation up to Week 12

Population: All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
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) Mod/Slightly Imp Improvement Week 4 (n=102)	78.4 percentage of participants
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) Mod/Slightly Imp Improvement Week 12 (n=99)	87.9 percentage of participants
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) Mod/Slightly Imp Improvement Last Obs (n=108)	87.0 percentage of participants

SECONDARY outcome

Timeframe: Week 4, Week 12, and Last observation up to Week 12

Population: All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
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) Mod/Slightly Imp Improvement Week 4 (n=102)	61.8 percentage of participants
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) Mod/Slightly Imp Improvement Week 12 (n=99)	78.8 percentage of participants
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) Mod/Slightly Imp Improvement Last Obs (n=108)	76.9 percentage of participants

SECONDARY outcome

Timeframe: Week 4, Week 12

Population: 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).

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12 Week 12 (=99)	3.27 scores on a scale
Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12 Week 4 (n=102)	4.15 scores on a scale

SECONDARY outcome

Timeframe: Week 4, Week 12, and Last observation up to Week 12

Population: All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
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) Acceptable Week 4 (n=102)	57.8 percentage of participants
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) Acceptable Week 12 (n=99)	74.7 percentage of participants
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) Acceptable Last Obs (n=108)	72.2 percentage of participants

SECONDARY outcome

Timeframe: Week 4, Week 12, and Last observation up to Week 12

Population: All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).

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.

Outcome measures

Measure	Etanercept (ETN) n=108 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
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) Acceptable Week 4 (n=102)	49.0 percentage of participants
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) Acceptable Week 12 (n=99)	64.6 percentage of participants
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) Acceptable Last Obs (n=108)	62.0 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All injected subjects population; N=number of participants with evaluable data at observation.

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).

Outcome measures

Measure	Etanercept (ETN) n=95 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12	77.9 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All injected subjects population; N=number of participants with evaluable data at observation.

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.

Outcome measures

Measure	Etanercept (ETN) n=96 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12	28.1 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All injected subjects population; N=number of participants with evaluable data at observation.

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.

Outcome measures

Measure	Etanercept (ETN) n=96 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12	46.9 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All injected subjects population; N=number of participants with evaluable data at observation.

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).

Outcome measures

Measure	Etanercept (ETN) n=95 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12	91.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12

Population: All injected subjects population; N=number of participants with evaluable data at observation.

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.

Outcome measures

Measure	Etanercept (ETN) n=94 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12	71.3 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All injected subjects population; N=number of participants with evaluable data at observation.

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.

Outcome measures

Measure	Etanercept (ETN) n=93 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12	47.3 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All injected subjects population; N=number of participants with evaluable data at observation.

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.

Outcome measures

Measure	Etanercept (ETN) n=98 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12	16.3 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All injected subjects population; N=number of participants with evaluable data at observation.

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.

Outcome measures

Measure	Etanercept (ETN) n=99 Participants Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12	3.0 percentage of participants

Adverse Events

Etanercept (ETN)

Serious events: 5 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etanercept (ETN) n=108 participants at risk Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Gastrointestinal disorders Abdominal pain	0.93% 1/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
Infections and infestations Arthritis bacterial	1.9% 2/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
Infections and infestations Sepsis	0.93% 1/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.93% 1/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.

Other adverse events

Measure	Etanercept (ETN) n=108 participants at risk Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
Gastrointestinal disorders Nausea	2.8% 3/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
General disorders Asthenia	3.7% 4/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
General disorders Fatigue	3.7% 4/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
General disorders Injection site erythema	7.4% 8/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
General disorders Injection site reaction	16.7% 18/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
Infections and infestations Bronchitis	7.4% 8/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
Infections and infestations Influenza	2.8% 3/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
Infections and infestations Nasopharyngitis	2.8% 3/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
Infections and infestations Tonsillitis	2.8% 3/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.
Skin and subcutaneous tissue disorders Erythema	9.3% 10/108 • Time the Informed Consent Form was signed up to Week 16 Follow-up visit 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER