Trial Outcomes & Findings for Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice (NCT NCT01147874)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1013 participants

Primary outcome timeframe

Week 0 through Week 8

Results posted on

2012-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Participants with psoriasis were observed for 8 weeks.
Overall Study STARTED	1013
Overall Study COMPLETED	946
Overall Study NOT COMPLETED	67

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Participants with psoriasis were observed for 8 weeks.
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

Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=1013 Participants Participants with psoriasis were observed for 8 weeks.
Age Continuous	49.90 Years STANDARD_DEVIATION 13.82 • n=5 Participants
Sex: Female, Male Female	404 Participants n=5 Participants
Sex: Female, Male Male	609 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	All Participants n=949 Participants Participants with psoriasis were observed for 8 weeks.
Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results	30.0 Percentage of participants Interval 27.1 to 33.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	All Participants n=949 Participants Participants with psoriasis were observed for 8 weeks.
Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History	29.6 Percentage of participants Interval 26.7 to 32.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	All Participants n=949 Participants Participants with psoriasis were observed for 8 weeks.
Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA) Primary PsA diagnosis	12.3 Percentage of participants Interval 10.3 to 14.6
Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA) Secondary PsA diagnosis	12.0 Percentage of participants Interval 10.0 to 14.2

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=1013 participants at risk Participants with psoriasis were observed for 8 weeks.
Injury, poisoning and procedural complications Procedural dizziness	0.10% 1/1013 • Visit 2 (rheumatology visit), Visit 3 (imaging studies visit)
Nervous system disorders Dizziness	0.10% 1/1013 • Visit 2 (rheumatology visit), Visit 3 (imaging studies visit)
Psychiatric disorders Claustrophobia	0.49% 5/1013 • Visit 2 (rheumatology visit), Visit 3 (imaging studies visit)

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER