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| ID | Type | Description | Link |
|---|---|---|---|
| B1801032 |
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This is a phase 4, multicenter, randomized, non-therapeutic interventional trial in subjects with psoriasis looking for the prevalence of psoriatic arthritis. Subjects will be seen and evaluated by a dermatologist at visit 1 and by a rheumatologist at visit 2. A subset of subjects will then go on to visit 3 for imaging procedures (x-ray, MRI, and ultrasound).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| psoriatic arthritis (PsA) questionnaire | No Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lab draws and imaging | Procedure | 1 set of lab draws, imaging consists of radiographic imaging or X-ray, ultrasound and MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results | PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history, physical examination and laboratory results as the basis for the diagnosis. | Week 0 through Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History | PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history and physical examination as the basis for the diagnosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Modern Research Assoc. PLLC | Dallas | Texas | 75205 | United States | ||
| Rheumatology Practive of Scott Zashin, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23981683 | Derived | Mease PJ, Gladman DD, Papp KA, Khraishi MM, Thaci D, Behrens F, Northington R, Fuiman J, Bananis E, Boggs R, Alvarez D. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013 Nov;69(5):729-735. doi: 10.1016/j.jaad.2013.07.023. Epub 2013 Aug 24. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants with psoriasis were observed for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 0 through Week 8 |
| Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA) | PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Primary PsA diagnosis made by rheumatologist based on physical examination, medical history and laboratory test results. Secondary PsA diagnosis made by rheumatologist based on physical examination and medical history only. For both, numerator was number of participants with "No" answer to question concerning previous diagnosis of PsA at Visit 1 (dermatology visit) and were subsequently classified as positive by rheumatologist; denominator was total number of participants evaluated for PsA. | Week 0 through Week 8 |
| Dallas |
| Texas |
| 75231 |
| United States |
| Center for Clinical Studies Ltd LLP | Houston | Texas | 77030 | United States |
| Rheumatology Associates of Houston | Houston | Texas | 77054 | United States |
| Center for Clinical Studies LTD LLP | Webster | Texas | 77598 | United States |
| Dermatology Associates | Seattle | Washington | 98101 | United States |
| Universitair Ziekenhuis Gent | Ghent | Belgium | 9000 | Belgium |
| Algemeen Ziekenhuis St. Jan | Bruges | 8000 | Belgium |
| Kirk Barber Research | Calgary | Alberta | T2S 3B3 | Canada |
| Stratica Medical | Edmonton | Alberta | T5K 1X3 | Canada |
| Rheumatology Research Associates | Edmonton | Alberta | T5M 0H4 | Canada |
| The Skin Care Centre-Clinical Trials Unit | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Winnipeg Clinic | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Nexus Clinical Research | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Dermatrials Research | Hamilton | Ontario | L8N 1V6 | Canada |
| MAC Research Ind. | Hamilton | Ontario | L8N 2B6 | Canada |
| K-W Musculoskeletal Research Inc. | Kitchener | Ontario | N2M 5N6 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P 1A8 | Canada |
| The Toronto Western Hospital-Division of Rheumatology | Toronto | Ontario | M5T 2S8 | Canada |
| K.Papp Clinical Research Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| Windsor Clinical Research | Windsor | Ontario | N8W 5L7 | Canada |
| Medical Office | Windsor | Ontario | N8X 4T2 | Canada |
| Innovaderm Research Inc | Montreal | Quebec | H2K 4L5 | Canada |
| Institut de Rheumatologie de Montreal | Montreal | Quebec | H2L 1S6 | Canada |
| GRMO Inc. | Québec | Quebec | G1V 3M7 | Canada |
| Centre de Recherche Dermatologique du Quebec metropolitain | Québec | Quebec | G1V 4X7 | Canada |
| Diex Research Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Clinique Medicale Belvedere | Sherbrooke | Quebec | J1K 1K6 | Canada |
| Hudlaegerne | Arhus C | 8000 | Denmark |
| Bispebjerg University Hospital | Copenhagen NV | DK-2400 | Denmark |
| Gentofte Hospital | Hellerup | 2900 | Denmark |
| CHU de l Archet | Nice | 06202 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| Hôpital Larrey | Toulouse | 31059 | France |
| Klinik fuer Dermatologie, Allergologie und Venerologie | Berlin | 10117 | Germany |
| Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum | Erlangen | 91054 | Germany |
| Klinikum der Johann Wolfgang Goethe Universitaet | Frankfurt am Main | 60590 | Germany |
| Klinik und Poliklinik fuer Dermatologie und | München | 80802 | Germany |
| Praxis Dres. Bredlich, Rosenbach und Thiele | Osnabrück | 49078 | Germany |
| Klinik und Poliklinik fuer Dermatologie | Regensburg | 93042 | Germany |
| Synexus Magyarorszag Kft. | Budapest | 1036 | Hungary |
| Debreceni Egyetem Orvos-és Egészségtudományi Centrum | Debrecen | 4012 | Hungary |
| Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely | Miskolc | 3529 | Hungary |
| Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat | Miskolc | 3529 | Hungary |
| Borgyogyaszati es Allergologiai | Szolnok | 5000 | Hungary |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants with psoriasis were observed for 8 weeks. |
| 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 | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results | PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history, physical examination and laboratory results as the basis for the diagnosis. | Full analysis set (FAS) population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 0 through Week 8 |
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| Secondary | Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History | PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history and physical examination as the basis for the diagnosis. | FAS population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 0 through Week 8 |
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| Secondary | Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA) | PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Primary PsA diagnosis made by rheumatologist based on physical examination, medical history and laboratory test results. Secondary PsA diagnosis made by rheumatologist based on physical examination and medical history only. For both, numerator was number of participants with "No" answer to question concerning previous diagnosis of PsA at Visit 1 (dermatology visit) and were subsequently classified as positive by rheumatologist; denominator was total number of participants evaluated for PsA. | FAS population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 0 through Week 8 |
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Visit 2 (rheumatology visit), Visit 3 (imaging studies visit)
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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 | All Participants | Participants with psoriasis were observed for 8 weeks. | 0 | 1,013 | 7 | 1,013 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Claustrophobia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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