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This study is to evaluate local data in Iraqi patients with Spondyloarthropathies on Enbrel treatment with regards to efficacy and adherence using data from the Baghdad Teaching Hospital (Rheumatology Center)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with spondyloarthropathies | Patients with spondyloarthrosis that received Etanercept as treatment for disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Patients with spondyloarthrosis as provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 7 Years Adherence to Etanercept | In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported. | 7 years [from the data retrieved and observed in 1 month of this study] |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ [Q5 + Q6/2])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared absolute BASDAI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. |
Inclusion Criteria:
Exclusion Criteria:
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Patients data from the local Baghdad Teaching Hospital (Rheumatology Center) registry
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36178583 | Derived | Younis AA, Al-Hafidh AH, Adnan A, Yasiry D, Abdulateef N, Gorial FI, Llamado L, AlJabban A. Long-Term Adherence to Etanercept in Treatment Effectiveness of Patients with Spondyloarthritis: 7-Year Data from the Iraq National Registry. Rheumatol Ther. 2022 Dec;9(6):1605-1616. doi: 10.1007/s40744-022-00497-y. Epub 2022 Sep 30. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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's participants aged greater than or equal to (>=) 18 years, who received etanercept for at least 1 year, anytime from May 2012 through August 2019, for treatment of spondyloarthropathies (SpA) and met American College of Rheumatology/ European League Against Rheumatism (EULAR) 2019 criteria for SpA were included in the study. Data were collected from dermatology center of Baghdad teaching hospital. Available data were evaluated in 1 month of this retrospective, observational study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis population included all participants whose data were included in the study for retrospective observation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of 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 | Percentage of Participants With 7 Years Adherence to Etanercept | In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported. | Analysis population included all participants whose data were included in the study for retrospective observation. | Posted | Number | Percentage of participants | 7 years [from the data retrieved and observed in 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 meet, hence adverse events were 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 SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of 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 | Jul 28, 2021 | Sep 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal 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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| Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] |
| Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ [Q5 + Q6/2])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared change from baseline in BASDAI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] |
| Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared absolute BASFI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence, last visit was Year 7. | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] |
| Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared change from baseline in BASFI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Other Pre-specified | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ [Q5 + Q6/2])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared absolute BASDAI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. | Analysis population included all participants whose data were included in the study for retrospective observation. Here, "number analyzed" signifies the number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | Units on a scale | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] |
|
|
|
|
| Other Pre-specified | Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ [Q5 + Q6/2])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared change from baseline in BASDAI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. | Analysis population included all participants whose data were included in the study for retrospective observation. Here, "number analyzed" signifies the number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | Units on a scale | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] |
|
|
|
|
| Other Pre-specified | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared absolute BASFI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence, last visit was Year 7. | Analysis population included all participants whose data were included in the study for retrospective observation. Here, "number analyzed" signifies the number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | Units on a scale | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] |
|
|
|
|
| Other Pre-specified | Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared change from baseline in BASFI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. | Analysis population included all participants whose data were included in the study for retrospective observation. Here, "number analyzed" signifies the number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | Units on a scale | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] |
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| 0 |
| 0 |
| 0 |
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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.
| D001168 |
| Arthritis |
| D007592 | Joint 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 |
| Year 1 Adherence: Year 1 (Month 12) |
|
|
| Year 7 Adherence: Baseline |
|
|
| Year 7 Adherence: Year 7 |
|
|
| <0.05 |
| Other |
| Year 7 Adherence: Baseline | t-test, 2 sided | <0.05 | Other |
| Year 7 Adherence: Year 7 | t-test, 2 sided | 0.43 | Other |
| Year 7 Adherence: Change at Year 7 |
|
|
| 0.247 |
| Other |
| Year 1 Adherence: Year 1 (Month 12) |
|
|
| Year 7 Adherence: Baseline |
|
|
| Year 7 Adherence: Year 7 |
|
|
| <0.05 |
| Other |
| Year 7 Adherence: Baseline | t-test, 2 sided | 0.62 | Other |
| Year 7 Adherence: Year 7 | t-test, 2 sided | 0.18 | Other |
| Year 7 Adherence: Change at Year 7 |
|
|
| 0.003 |
| Other |