Psoriasis Clinical Trial
— PREPAREOfficial title:
Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice
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).
| Status | Completed |
| Enrollment | 1013 |
| Est. completion date | July 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subject is >18 years of age at the time of consent. - Subject has a confirmed diagnosis of plaque psoriasis by clinical judgment. - Subject is able to read and complete questionnaires. - Subjects planning to undergo radiographic evaluation, should not have any contraindications to MRI. Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Algemeen Ziekenhuis St. Jan | Brugge | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Canada | Kirk Barber Research | Calgary | Alberta |
| Canada | Rheumatology Research Associates | Edmonton | Alberta |
| Canada | Stratica Medical | Edmonton | Alberta |
| Canada | Dermatrials Research | Hamilton | Ontario |
| Canada | MAC Research Ind. | Hamilton | Ontario |
| Canada | K-W Musculoskeletal Research Inc. | Kitchener | Ontario |
| Canada | Lynderm Research Inc | Markham | Ontario |
| Canada | Innovaderm Research Inc | Montreal | Quebec |
| Canada | Institut de Rheumatologie de Montreal | Montreal | Quebec |
| Canada | Centre de Recherche Dermatologique du Quebec metropolitain | Quebec | |
| Canada | GRMO Inc. | Quebec | |
| Canada | Nexus Clinical Research | Saint John's | Newfoundland and Labrador |
| Canada | Clinique Medicale Belvedere | Sherbrooke | Quebec |
| Canada | Diex Research Inc. | Sherbrooke | Quebec |
| Canada | The Toronto Western Hospital-Division of Rheumatology | Toronto | Ontario |
| Canada | The Skin Care Centre-Clinical Trials Unit | Vancouver | British Columbia |
| Canada | K.Papp Clinical Research Inc. | Waterloo | Ontario |
| Canada | Medical Office | Windsor | Ontario |
| Canada | Windsor Clinical Research | Windsor | Ontario |
| Canada | Winnipeg Clinic | Winnipeg | Manitoba |
| Denmark | Hudlaegerne | Arhus C | |
| Denmark | Bispebjerg University Hospital | Copenhagen NV | |
| Denmark | Gentofte Hospital | Hellerup | |
| France | CHU de l Archet | Nice Cedex 03 | |
| France | Hopital Saint Louis | Paris Cedex 10 | |
| France | Hôpital Larrey | Toulouse | |
| Germany | Klinik fuer Dermatologie, Allergologie und Venerologie | Berlin | |
| Germany | Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum | Erlangen | |
| Germany | Klinikum der Johann Wolfgang Goethe Universitaet | Frankfurt/Main | |
| Germany | Klinik und Poliklinik fuer Dermatologie und | Muenchen | |
| Germany | Praxis Dres. Bredlich, Rosenbach und Thiele | Osnabrueck | |
| Germany | Klinik und Poliklinik fuer Dermatologie | Regensburg | |
| Hungary | Synexus Magyarorszag Kft. | Budapest | |
| Hungary | Debreceni Egyetem Orvos-és Egészségtudományi Centrum | Debrecen | |
| Hungary | Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely | Miskolc | |
| Hungary | Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat | Miskolc | |
| Hungary | Borgyogyaszati es Allergologiai | Szolnok | |
| United States | Modern Research Assoc. PLLC | Dallas | Texas |
| United States | Rheumatology Practive of Scott Zashin, MD | Dallas | Texas |
| United States | Center for Clinical Studies Ltd LLP | Houston | Texas |
| United States | Rheumatology Associates of Houston | Houston | Texas |
| United States | Dermatology Associates | Seattle | Washington |
| United States | Center for Clinical Studies LTD LLP | Webster | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Belgium, Canada, Denmark, France, Germany, Hungary,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | Week 0 through Week 8 | No |
| 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. | Week 0 through Week 8 | No |
| 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. | Week 0 through Week 8 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03236870 -
A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
|
||
| Completed |
NCT00078819 -
Etanercept (Enbrel®) in Psoriasis - Pediatrics
|
Phase 3 | |
| Completed |
NCT04841187 -
Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
|
||
| Active, not recruiting |
NCT03927352 -
The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis
|
Phase 3 | |
| Completed |
NCT03284879 -
Post-Marketing Surveillance Study of OTEZLA
|
||
| Recruiting |
NCT06027034 -
Effectiveness of a Digital Health Application for Psoriasis
|
N/A | |
| Not yet recruiting |
NCT06050330 -
CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study
|
N/A | |
| Recruiting |
NCT05744466 -
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
|
||
| Completed |
NCT04149587 -
A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
|
||
| Completed |
NCT01384630 -
Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis
|
Phase 2 | |
| Completed |
NCT03998683 -
A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
|
Phase 3 | |
| Terminated |
NCT03556202 -
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
|
Phase 3 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Recruiting |
NCT06077331 -
A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
|
Phase 2 | |
| Completed |
NCT04316585 -
A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants
|
Phase 1 | |
| Completed |
NCT04894890 -
A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
|
||
| Completed |
NCT00358384 -
Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034
|
Phase 1 | |
| Completed |
NCT03757013 -
A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
|
||
| Completed |
NCT03265613 -
Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis
|
Phase 1/Phase 2 | |
| Completed |
NCT05003531 -
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
|
Phase 2 |