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This study is to evaluate the local data in Iraqi patients with psoriatic arthritis on Enbrel treatment with positive Anti-Cyclic Citrullinated Peptide using data from the Rheumatologist in Baghdad Teaching Hospital registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with psoriatic arthritis | Iraqi patients diagnosed with psoriatic arthritis that receive Enbrel as treatment for disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enbrel | Drug | As provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1 | DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants. | Baseline, Month 1 |
| Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12 | DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants. | Baseline, Month 12 |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12 | DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour [mm/hour]) and participant'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). DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (<=) 3.2 = low disease activity, DAS28 ESR greater than (>) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants. |
Inclusion Criteria:
Exclusion Criteria:
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Patients data from the local Rheumatology Center of Baghdad Teaching Hospital 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 |
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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, 1) who aged greater than or equal to (>=) 18 years, 2) who met American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria for psoriatic arthritis (PsA), and 3) who received etanercept for at least for 1 year from May 2012 until August 2019 in the Baghdad teaching hospital (rheumatology center) were collected. Data collected were assessed in approximately 1.8 months of this retrospective observational study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was performed on all participants who were included in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months. |
| 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 | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1 | DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants. | Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants. | Posted | Baseline, Month 1 |
|
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) was not met, 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 PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months. |
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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 27, 2021 | Aug 17, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal 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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| Month 1, 6 and 12 |
| 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 |
|
Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had positive ACCP status. |
| OG001 | Etanercept: ACCP Negative | Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had negative ACCP status. |
|
| Primary | Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12 | DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants. | Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants. | Posted | Baseline, Month 12 |
|
|
| Other Pre-specified | Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12 | DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour [mm/hour]) and participant'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). DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (<=) 3.2 = low disease activity, DAS28 ESR greater than (>) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants. | Analysis was performed on all participants who were included in this study. | Posted | Mean | Standard Deviation | units on a scale | Month 1, 6 and 12 |
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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.
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue 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 |
| Month 12 |
|
At Month 6: P-value <0.05 was considered statistically significant, without multiplicity adjustment. |
| Student's t-test |
| 0.007 |
| Equivalence |
Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept. |
| At Month 12: P-value <0.05 was considered statistically significant, without multiplicity adjustment. | Student's t-test | 0.004 | Equivalence | Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept. |