Arthritis, Rheumatoid
Conditions
Brief summary
This study is to evaluate available local data in Iraqi patients with rheumatoid arthritis on Enbrel treatment with regards to the impact of Rheumatoid factor and Anti-cyclic citrullinated peptide using data from the Baghdad Teaching Hospital registry.
Interventions
DRUGEnbrel
As provided in real world practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed RA patients. -≥18 years of age * Did not receive previous another biological treatment
Exclusion criteria
* Had previous biological treatment * Use of etanercept for less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score 28 (DAS28) in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Month 12 visit during retrospective data collection period of approximately 7 years | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 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 equal to (\<=) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity. DAS28 score in participants with positive RF and ACCP were reported in this outcome measure. |
| Clinical Disease Activity Index (CDAI) Score in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Month 12 visit during retrospective data collection period of approximately 7 years | 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. CDAI score in participants with positive RF and ACCP were reported in this outcome measure. |
| Disease Activity Score 28 (DAS28) in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Month 12 visit during retrospective data collection period of approximately 7 years | DAS28 calculated from the SJC and PJC using the 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. DAS28 score in participants with negative RF and ACCP were reported in this outcome measure. |
| Clinical Disease Activity Index (CDAI) Score in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Month 12 visit during retrospective data collection period of approximately 7 years | 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. CDAI score in participants with negative RF and ACCP were reported in this outcome measure. |
Countries
Iraq
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants with RA and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month. | 1,493 |
| Total | 1,493 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Does not meet entrance criteria | 132 |
| Overall Study | Lost to Follow-up | 115 |
Baseline characteristics
| Characteristic | Etanercept | — |
|---|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 11.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1234 Participants | — |
| Sex: Female, Male Male | 259 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 in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (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. CDAI score in participants with negative RF and ACCP were reported in this outcome measure.
Time frame: Month 12 visit during retrospective data collection period of approximately 7 years
Population: Analysis was performed on all participants who were included in this study. Here overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Clinical Disease Activity Index (CDAI) Score in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Negative RF | 7.3 units on a scale | Standard Deviation 9 |
| Etanercept | Clinical Disease Activity Index (CDAI) Score in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Negative ACCP | 6.8 units on a scale | Standard Deviation 7.5 |
Primary
Clinical Disease Activity Index (CDAI) Score in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (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. CDAI score in participants with positive RF and ACCP were reported in this outcome measure.
Time frame: Month 12 visit during retrospective data collection period of approximately 7 years
Population: Analysis was performed on all participants who were included in this study. Here overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Clinical Disease Activity Index (CDAI) Score in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Positive RF | 8.0 units on a scale | Standard Deviation 10.4 |
| Etanercept | Clinical Disease Activity Index (CDAI) Score in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Positive ACCP | 8.2 units on a scale | Standard Deviation 10.9 |
Primary
Disease Activity Score 28 (DAS28) in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
DAS28 calculated from the SJC and PJC using the 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. DAS28 score in participants with negative RF and ACCP were reported in this outcome measure.
Time frame: Month 12 visit during retrospective data collection period of approximately 7 years
Population: Analysis was performed on all participants who were included in this study. Here overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Disease Activity Score 28 (DAS28) in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Negative RF | 3.10 units on a scale | Standard Deviation 1.59 |
| Etanercept | Disease Activity Score 28 (DAS28) in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Negative ACCP | 3.16 units on a scale | Standard Deviation 1.6 |
Primary
Disease Activity Score 28 (DAS28) in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 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 equal to (\<=) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity. DAS28 score in participants with positive RF and ACCP were reported in this outcome measure.
Time frame: Month 12 visit during retrospective data collection period of approximately 7 years
Population: Analysis was performed on all participants who were included in this study. Here overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for this outcome measure for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Disease Activity Score 28 (DAS28) in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Positive RF | 3.13 units on a scale | Standard Deviation 1.6 |
| Etanercept | Disease Activity Score 28 (DAS28) in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12) | Positive ACCP | 3.1 units on a scale | Standard Deviation 1.58 |