Psoriasis, Psoriatic Arthritis
Conditions
Keywords
non-therapeutic, interventional
Brief 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. A subset of subjects will then go on to visit 3 for imaging procedures (x-ray, MRI, and ultrasound).
Interventions
PROCEDURElab draws and imaging
1 set of lab draws, imaging consists of radiographic imaging or X-ray, ultrasound and MRI
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History | 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 and physical examination as the basis for the diagnosis. |
| Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA) | Week 0 through Week 8 | 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. |
Countries
Belgium, Canada, Denmark, France, Germany, Hungary, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants with psoriasis were observed for 8 weeks. | 1,013 |
| Total | 1,013 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Investigator's Request | 1 |
| Overall Study | Lost to Follow-up | 25 |
| Overall Study | Other | 5 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Sponsor's Decision | 2 |
| Overall Study | Withdrawal by Subject | 24 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age Continuous | 49.90 Years STANDARD_DEVIATION 13.82 |
| Sex: Female, Male Female | 404 Participants |
| Sex: Female, Male Male | 609 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 1,013 |
| serious Total, serious adverse events | 0 / 1,013 |
Outcome results
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.
Time frame: Week 0 through Week 8
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results | 30.0 Percentage of participants |
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.
Time frame: Week 0 through Week 8
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History | 29.6 Percentage of participants |
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.
Time frame: Week 0 through Week 8
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA) | Primary PsA diagnosis | 12.3 Percentage of participants |
| All Participants | Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA) | Secondary PsA diagnosis | 12.0 Percentage of participants |