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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Rheumatoid Arthritis (RA) | Patients receiving etanercept from Baghdad teaching hospital registry(Rheumatology center) from 2012 till 2017. Patients were identified as receiving early versus delayed etanercept treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Patients who received etanercept for RA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 12 (from the data retrieved and observed during 1 month of this study) |
| 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. | Month 12 (from the data retrieved and observed during 1 month of this study) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Data will be collected from the Baghdad teaching hospital registry. The Rheumatology patient registry is a prospective longitudinal multicentre cohort initiated in 2012.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Baghdad | Iraq |
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis population included all eligible participants who met the inclusion criteria to use the data for analysis for retrospective observation.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis population included all eligible participants who met the inclusion criteria to use the data for analysis for retrospective observation. | Posted | Mean | Standard Deviation | Units on a scale | Month 12 (from the data retrieved and observed during 1 month of this study) |
Not applicable as adverse events not collected during the study
Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e. identifiable participant, identifiable reporter, a suspect product, and event) could not met, hence, safety data was not collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2019 | Aug 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Baseline, Month 12 (from the data retrieved and observed during 1 month of this study) |
| 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. | Baseline, Month 12 (from the data retrieved and observed during 1 month of this study) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Etanercept: Participants With Early Referral (1 to 9.9 Year) | 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. |
| OG001 | Etanercept: Participants With Delayed Referral (> 9.9 Years) | 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. |
|
|
|
| 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. | Analysis population included all eligible participants who met the inclusion criteria to use the data for analysis for retrospective observation. | Posted | Mean | Standard Deviation | Units on a scale | Month 12 (from the data retrieved and observed during 1 month of this study) |
|
|
|
|
| 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. | Analysis population included all eligible participants who met the inclusion criteria to use the data for analysis for retrospective observation. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 12 (from the data retrieved and observed during 1 month of this study) |
|
|
|
|
| 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. | Analysis population included all eligible participants who met the inclusion criteria to use the data for analysis for retrospective observation. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 12 (from the data retrieved and observed during 1 month of this study) |
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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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |