PsoriasisPhase 4PREPARENCT01147874
Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice
A Phase 4 study testing lab draws and imaging in people with Psoriasis and Psoriatic Arthritis, run by Pfizer at 45 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis
- What is being tested?
- lab draws and imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,013 participants
- Where
- 45 sitesin 7 countries
- Study dates
- Aug 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
45 sites in 7 countries.
45 sites in 7 countries
Canada20 sites
Kirk Barber Research
Calgary, Alberta, T2S 3B3
Stratica Medical
Edmonton, Alberta, T5K 1X3
Rheumatology Research Associates
Edmonton, Alberta, T5M 0H4
Dermatrials Research
Hamilton, Ontario, L8N 1V6
MAC Research Ind.
Hamilton, Ontario, L8N 2B6
K-W Musculoskeletal Research Inc.
Kitchener, Ontario, N2M 5N6
Lynderm Research Inc
Markham, Ontario, L3P 1A8
Innovaderm Research Inc
Montreal, Quebec, H2K 4L5
Institut de Rheumatologie de Montreal
Montreal, Quebec, H2L 1S6
GRMO Inc.
Québec, Quebec, G1V 3M7
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, Quebec, G1V 4X7
Diex Research Inc.
Sherbrooke, Quebec, J1H 1Z1
Clinique Medicale Belvedere
Sherbrooke, Quebec, J1K 1K6
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8
The Toronto Western Hospital-Division of Rheumatology
Toronto, Ontario, M5T 2S8
The Skin Care Centre-Clinical Trials Unit
Vancouver, British Columbia, V5Z 4E8
K.Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4
Windsor Clinical Research
Windsor, Ontario, N8W 5L7
Medical Office
Windsor, Ontario, N8X 4T2
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
United States6 sites
Modern Research Assoc. PLLC
Dallas, Texas, 75205
Rheumatology Practive of Scott Zashin, MD
Dallas, Texas, 75231
Center for Clinical Studies Ltd LLP
Houston, Texas, 77030
Rheumatology Associates of Houston
Houston, Texas, 77054
Dermatology Associates
Seattle, Washington, 98101
Center for Clinical Studies LTD LLP
Webster, Texas, 77598
Germany6 sites
Klinik fuer Dermatologie, Allergologie und Venerologie
Berlin, 10117
Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
Erlangen, 91054
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt am Main, 60590
Klinik und Poliklinik fuer Dermatologie und
München, 80802
Praxis Dres. Bredlich, Rosenbach und Thiele
Osnabrück, 49078
Klinik und Poliklinik fuer Dermatologie
Regensburg, 93042
Hungary5 sites
Synexus Magyarorszag Kft.
Budapest, 1036
Debreceni Egyetem Orvos-és Egészségtudományi Centrum
Debrecen, 4012
Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely
Miskolc, 3529
Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat
Miskolc, 3529
Borgyogyaszati es Allergologiai
Szolnok, 5000
Denmark3 sites
Hudlaegerne
Arhus C, 8000
Bispebjerg University Hospital
Copenhagen NV, DK-2400
Gentofte Hospital
Hellerup, 2900
France3 sites
CHU de l Archet
Nice, 06202
Hopital Saint Louis
Paris, 75475
Hôpital Larrey
Toulouse, 31059
Belgium2 sites
Algemeen Ziekenhuis St. Jan
Bruges, 8000
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
About this study
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).
- Conditions
- Psoriasis, Psoriatic Arthritis
- Being tested
- lab draws and imaging
- Keywords
- non-therapeutic, interventional
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lab draws and imagingProcedure or surgery
1 set of lab draws, imaging consists of radiographic imaging or X-ray, ultrasound and MRI
| Study group | Role | What they receive |
|---|---|---|
| psoriatic arthritis (PsA) questionnaire | No intervention | Not described Receives: Procedure: lab draws and imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 through Week 8
Secondary outcomes (2)
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.
Measured: 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.
Measured: Week 0 through Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147874
- Sponsor's protocol ID
- 0881A6-4728
- Other IDs
- B1801032
- Acronym
- PREPARE
- Status last verified
- Apr 2012
- First submitted
- 17 Jun 2010
- Last updated
- 21 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23981683
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice
- ClinicalTrials.gov ID
- NCT01147874
- Acronym / sponsor ID
- PREPARE / 0881A6-4728
- Conditions
- Psoriasis, Psoriatic Arthritis
- Keywords
- non-therapeutic, interventional
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 21 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| psoriatic arthritis (PsA) questionnaire | No intervention | Procedure: lab draws and imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lab draws and imaging1 set of lab draws, imaging consists of radiographic imaging or X-ray, ultrasound and MRI | Procedure or surgery | psoriatic arthritis (PsA) questionnaire |
Primary outcome
Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results
Time frame: Week 0 through Week 8
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.
2 secondary outcomes
Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History
Time frame: Week 0 through Week 8
Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA)
Time frame: Week 0 through Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23981683Mease 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
45 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lab draws and imaging in people with Psoriasis and Psoriatic Arthritis, run by Pfizer at 45 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Canada, United States, Germany, Hungary, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results (time frame: Week 0 through Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01147874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.