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This study is to evaluate available data in Iraqi patients with ankylosing spondylitis on Enbrel treatment with regards to the impact of early treatment using data from the Baghdad Teaching Hospital registry
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ankylosing spondylitis | Iraqi patients diagnosed with ankylosing spondylitis that received Etanercept as treatment for disease |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Patients with ankylosing spondylitis as provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | BASFI is a set of 10 questions to determine degree of functional limitation in participants with AS. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI total score was calculated as mean of scores from 10 questions. BASFI total score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in less than or equal to (<=) 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and greater than (>) 10 years after diagnosis with AS. | Baseline, Month 12 [from the data retrieved and observed in 2 months of this study] |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | BASDAI is a set of 6 questions to determine disease activity in participant with AS. 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. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in <= 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and >10 years after diagnosis with AS. | Baseline, Month 12 [from the data retrieved and observed in 2 months of this study] |
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Inclusion Criteria:
Diagnosed AS patients.
Did not receive previous biological treatment for any reason
Exclusion Criteria:
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Patients data from local registry at the Baghdad Teaching Hospital
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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 |
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| 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 August 2012 through March 2020 for treatment of ankylosing spondylitis (AS) and met American College of Rheumatology/ European League Against Rheumatism (EULAR) 2019 criteria for AS were included in the study. Data were collected from dermatology center of Baghdad teaching hospital. Available data were evaluated in 2 months of this retrospective, observational study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants received etanercept to treat AS for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept [Enbrel] is 25 milligrams [mg] administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).Data of these participants were studied for 2 months in this retrospective, observational study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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 received etanercept to treat AS for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).Data of these participants were studied for 2 months in this retrospective, observational study. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | BASFI is a set of 10 questions to determine degree of functional limitation in participants with AS. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI total score was calculated as mean of scores from 10 questions. BASFI total score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in less than or equal to (<=) 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and greater than (>) 10 years after diagnosis with AS. | Analysis population included all participants whose data were included in the study for retrospective observation. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 12 [from the data retrieved and observed in 2 months of this study] |
Not applicable as adverse events were not collected for 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 received etanercept to treat AS for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).Data of these participants were studied for 2 months 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 29, 2021 | Sep 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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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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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Education Level | In this baseline measure, number of participants were classified according to their education level. | Count of Participants | Participants |
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| Smoking Status | In this baseline measure, number of participants were classified according to their smoking status as "Yes" or "No". | Count of Participants | Participants |
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| Disease Duration | Mean | Standard Deviation | Years |
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| Current Steroid Therapy | In this baseline measure, number of participants who were on steroid therapy were reported. | Count of Participants | Participants |
|
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | BASDAI is a set of 6 questions to determine disease activity in participant with AS. 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. | Mean | Standard Deviation | Units on a scale |
|
| Bath Ankylosing Spondylitis Functional Index (BASFI) | BASFI is a set of 10 questions to determine degree of functional limitation in participants with AS. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI total score was calculated as mean of scores from 10 questions. BASFI total score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. | Mean | Standard Deviation | Units on a scale |
|
| Human Leukocyte Antigen B27 (HLA-B27) | In this baseline measure, number of participants were classified according to presence of human leukocyte antigen B27 (HLA-B27) type as positive, negative and not done (if test not performed). | Count of Participants | Participants |
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| Primary | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | BASDAI is a set of 6 questions to determine disease activity in participant with AS. 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. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in <= 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and >10 years after diagnosis with AS. | Analysis population included all participants whose data were included in the study for retrospective observation. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 12 [from the data retrieved and observed in 2 months 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.
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| 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 |
| Change from baseline at month 12 |
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