Arthritis Rheumatoid
Conditions
Brief summary
This study is to investigate the effect of etanercept in early versus delayed referral for management of rheumatoid arthritis patients assessing real-world patient data entered in the Iraq National Center of Rheumatology database between May 2012 and May 2017.
Interventions
DRUGEtanercept
Patients who received etanercept for RA
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed RA patients. * 18 years old and above. * Did not receive pervious biological treatment.
Exclusion criteria
* Had previous biological treatment * Use etanercept for less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score 28 (DAS28) at Month 12 | Month 12 (from the data retrieved and observed during 1 month of this study) | 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. |
| Clinical Disease Activity Index (CDAI) Score at Month 12 | Month 12 (from the data retrieved and observed during 1 month of this study) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in DAS28 at Month 12 | Baseline, Month 12 (from the data retrieved and observed during 1 month of this study) | 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. |
| Mean Change From Baseline in CDAI Score at Month 12 | Baseline, Month 12 (from the data retrieved and observed during 1 month of this study) | 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. |
Countries
Iraq
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 979 |
| Total | 979 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 115 |
| Overall Study | Participants did not meet inclusion criteria | 132 |
Baseline characteristics
| Characteristic | Etanercept | — |
|---|---|---|
| Age, Continuous | 48.06 Years STANDARD_DEVIATION 12.08 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 813 Participants | — |
| Sex: Female, Male Male | 166 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Clinical Disease Activity Index (CDAI) Score at Month 12
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Participants With Early Referral (1 to 9.9 Year) | Clinical Disease Activity Index (CDAI) Score at Month 12 | 19 Units on a scale | Standard Deviation 10 |
| Etanercept: Participants With Delayed Referral (> 9.9 Years) | Clinical Disease Activity Index (CDAI) Score at Month 12 | 22 Units on a scale | Standard Deviation 11.2 |
p-value: <0.05t-test, 2 sided
Primary
Disease Activity Score 28 (DAS28) at Month 12
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Participants With Early Referral (1 to 9.9 Year) | Disease Activity Score 28 (DAS28) at Month 12 | 4.56 Units on a scale | Standard Deviation 1.12 |
| Etanercept: Participants With Delayed Referral (> 9.9 Years) | Disease Activity Score 28 (DAS28) at Month 12 | 4.9 Units on a scale | Standard Deviation 1.23 |
p-value: <0.05t-test, 2 sided
Other Pre-specified
Mean Change From Baseline in CDAI Score at Month 12
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Participants With Early Referral (1 to 9.9 Year) | Mean Change From Baseline in CDAI Score at Month 12 | Baseline | 27.03 Units on a scale | Standard Deviation 11.79 |
| Etanercept: Participants With Early Referral (1 to 9.9 Year) | Mean Change From Baseline in CDAI Score at Month 12 | Change at Month 12 | 7.9 Units on a scale | Standard Deviation 6.7 |
| Etanercept: Participants With Delayed Referral (> 9.9 Years) | Mean Change From Baseline in CDAI Score at Month 12 | Baseline | 28.55 Units on a scale | Standard Deviation 11.35 |
| Etanercept: Participants With Delayed Referral (> 9.9 Years) | Mean Change From Baseline in CDAI Score at Month 12 | Change at Month 12 | 6.5 Units on a scale | Standard Deviation 7.1 |
p-value: <0.05t-test, 2 sided
Other Pre-specified
Mean Change From Baseline in DAS28 at Month 12
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Participants With Early Referral (1 to 9.9 Year) | Mean Change From Baseline in DAS28 at Month 12 | Baseline | 5.61 Units on a scale | Standard Deviation 1.24 |
| Etanercept: Participants With Early Referral (1 to 9.9 Year) | Mean Change From Baseline in DAS28 at Month 12 | Change at Month 12 | 1.0 Units on a scale | Standard Deviation 1.1 |
| Etanercept: Participants With Delayed Referral (> 9.9 Years) | Mean Change From Baseline in DAS28 at Month 12 | Baseline | 5.79 Units on a scale | Standard Deviation 1.17 |
| Etanercept: Participants With Delayed Referral (> 9.9 Years) | Mean Change From Baseline in DAS28 at Month 12 | Change at Month 12 | 0.9 Units on a scale | Standard Deviation 1.09 |
p-value: <0.05t-test, 2 sided