Trial Outcomes & Findings for This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients. (NCT NCT04267614)
NCT ID: NCT04267614
Last Updated: 2023-07-07
Results Overview
DAS28 was calculated from the number of swollen joints (SJC) and painful joints (PJC) using 28 joints count, the erythrocyte sedimentation rate (ESR) (in millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity. Participants were grouped based on early and delayed referral to management of RA with etanercept treatment. Early referral was considered when participants were referred to management of RA from 1 to 9.9 years and delayed referral was considered when participants were referred to management of RA for \>9.9 years after diagnosis with RA.
COMPLETED
1226 participants
Month 12 (from the data retrieved and observed during 1 month of this study)
2023-07-07
Participant Flow
Data of Iraq participants aged greater than or equal to (\>=) 18 years, who received etanercept for at least 1 year anytime from 2012 until 2018 for treatment of rheumatoid arthritis (RA) and met American College of Rheumatology/ European League Against Rheumatism (EULAR) 2012 criteria for RA, were included in the study. Data were collected from Baghdad teaching hospital registry. Available data were evaluated in 1 month of this retrospective, observational study.
Participant milestones
| Measure |
Etanercept
Participants with RA received etanercept for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this study. Data for these participants were studied for 1 month in this retrospective observational study.
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|---|---|
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Overall Study
STARTED
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1226
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Overall Study
Included in Analysis
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979
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Overall Study
COMPLETED
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979
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Overall Study
NOT COMPLETED
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247
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Reasons for withdrawal
| Measure |
Etanercept
Participants with RA received etanercept for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this study. Data for these participants were studied for 1 month in this retrospective observational study.
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|---|---|
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Overall Study
Participants did not meet inclusion criteria
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132
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Overall Study
Lost to Follow-up
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115
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Etanercept
n=979 Participants
Participants with RA received etanercept for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this study. Data for these participants were studied for 1 month in this retrospective observational study.
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|---|---|
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Age, Continuous
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48.06 Years
STANDARD_DEVIATION 12.08 • n=979 Participants
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Sex: Female, Male
Female
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813 Participants
n=979 Participants
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Sex: Female, Male
Male
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166 Participants
n=979 Participants
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PRIMARY outcome
Timeframe: Month 12 (from the data retrieved and observed during 1 month of this study)Population: Analysis population included all eligible participants who met the inclusion criteria to use the data for analysis for retrospective observation.
DAS28 was calculated from the number of swollen joints (SJC) and painful joints (PJC) using 28 joints count, the erythrocyte sedimentation rate (ESR) (in millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity. Participants were grouped based on early and delayed referral to management of RA with etanercept treatment. Early referral was considered when participants were referred to management of RA from 1 to 9.9 years and delayed referral was considered when participants were referred to management of RA for \>9.9 years after diagnosis with RA.
Outcome measures
| Measure |
Etanercept: Participants With Early Referral (1 to 9.9 Year)
n=579 Participants
Participants who received early etanercept treatment for RA (1 to 9.9 year after diagnosis with RA) for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this arm. Data for these participants were studied for 1 month in this retrospective observational study.
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Etanercept: Participants With Delayed Referral (> 9.9 Years)
n=400 Participants
Participants who received delayed etanercept treatment for RA (\>9.9 year after diagnosis with RA) for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this arm. Data for these participants were studied for 1 month in this retrospective observational study.
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|---|---|---|
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Disease Activity Score 28 (DAS28) at Month 12
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4.56 Units on a scale
Standard Deviation 1.12
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4.9 Units on a scale
Standard Deviation 1.23
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PRIMARY outcome
Timeframe: Month 12 (from the data retrieved and observed during 1 month of this study)Population: Analysis population included all eligible participants who met the inclusion criteria to use the data for analysis for retrospective observation.
The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and SJC based on a 28-joint assessment, PGA and physician global assessment (PhGA) assessed on 0 to 10 centimeter (cm) visual analog scale (VAS); higher scores = high disease activity. CDAI total score = 0 to 76. CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \> 10 to 22 = moderate disease activity and \> 22 = high disease activity. Participants were grouped based on early and delayed referral to management of RA with etanercept treatment. Early referral was considered when participants were referred to management of RA from 1 to 9.9 years and delayed referral was considered when participants were referred to management of RA for \>9.9 years after diagnosis with RA.
Outcome measures
| Measure |
Etanercept: Participants With Early Referral (1 to 9.9 Year)
n=579 Participants
Participants who received early etanercept treatment for RA (1 to 9.9 year after diagnosis with RA) for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this arm. Data for these participants were studied for 1 month in this retrospective observational study.
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Etanercept: Participants With Delayed Referral (> 9.9 Years)
n=400 Participants
Participants who received delayed etanercept treatment for RA (\>9.9 year after diagnosis with RA) for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this arm. Data for these participants were studied for 1 month in this retrospective observational study.
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Clinical Disease Activity Index (CDAI) Score at Month 12
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19 Units on a scale
Standard Deviation 10
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22 Units on a scale
Standard Deviation 11.2
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 12 (from the data retrieved and observed during 1 month of this study)Population: Analysis population included all eligible participants who met the inclusion criteria to use the data for analysis for retrospective observation.
DAS28 was calculated from the SJC and PJC using 28 joints count, the ESR (in mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants were grouped based on early and delayed referral to management of RA with etanercept treatment. Early referral was considered when participants were referred to management of RA from 1 to 9.9 years and delayed referral was considered when participants were referred to management of RA for \>9.9 years after diagnosis with RA. Baseline was defined as Day 0 before receiving etanercept.
Outcome measures
| Measure |
Etanercept: Participants With Early Referral (1 to 9.9 Year)
n=579 Participants
Participants who received early etanercept treatment for RA (1 to 9.9 year after diagnosis with RA) for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this arm. Data for these participants were studied for 1 month in this retrospective observational study.
|
Etanercept: Participants With Delayed Referral (> 9.9 Years)
n=400 Participants
Participants who received delayed etanercept treatment for RA (\>9.9 year after diagnosis with RA) for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this arm. Data for these participants were studied for 1 month in this retrospective observational study.
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|---|---|---|
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Mean Change From Baseline in DAS28 at Month 12
Baseline
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5.61 Units on a scale
Standard Deviation 1.24
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5.79 Units on a scale
Standard Deviation 1.17
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Mean Change From Baseline in DAS28 at Month 12
Change at Month 12
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1.0 Units on a scale
Standard Deviation 1.1
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0.9 Units on a scale
Standard Deviation 1.09
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 12 (from the data retrieved and observed during 1 month of this study)Population: Analysis population included all eligible participants who met the inclusion criteria to use the data for analysis for retrospective observation.
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and PhGA assessed on 0 to 10 cm VAS; higher scores = high disease activity. CDAI total score = 0 to 76. CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \> 10 to 22 = moderate disease activity and \> 22 = high disease activity. Participants were grouped based on early and delayed referral to management of RA with etanercept treatment. Early referral was considered when participants were referred to management of RA from 1 to 9.9 years and delayed referral was considered when participants were referred to management of RA for \>9.9 years after diagnosis with RA. Baseline was defined as Day 0 before receiving etanercept.
Outcome measures
| Measure |
Etanercept: Participants With Early Referral (1 to 9.9 Year)
n=579 Participants
Participants who received early etanercept treatment for RA (1 to 9.9 year after diagnosis with RA) for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this arm. Data for these participants were studied for 1 month in this retrospective observational study.
|
Etanercept: Participants With Delayed Referral (> 9.9 Years)
n=400 Participants
Participants who received delayed etanercept treatment for RA (\>9.9 year after diagnosis with RA) for at least 1 year (anytime from 2012 until 2018) under standard real world clinical practice, were included in this arm. Data for these participants were studied for 1 month in this retrospective observational study.
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|---|---|---|
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Mean Change From Baseline in CDAI Score at Month 12
Baseline
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27.03 Units on a scale
Standard Deviation 11.79
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28.55 Units on a scale
Standard Deviation 11.35
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Mean Change From Baseline in CDAI Score at Month 12
Change at Month 12
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7.9 Units on a scale
Standard Deviation 6.7
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6.5 Units on a scale
Standard Deviation 7.1
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Adverse Events
Etanercept
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer 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