Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT01139918
Eligibility Criteria:
Inclusion Criteria:
* Patient with plaque psoriasis and psoriatic arthritis with either:
* Moderate psoriatic arthritis and moderate psoriasis defined as: \[psoriatic arthritis with either 3-7 joints showing signs of synovitis OR a BASDAI of 2-4\] AND \[between 3 to less than 10% of the body surface area involved with psoriasis\] (COHORT A) OR
* Mild psoriatic arthritis and Moderate psoriasis defined as: \[psoriatic arthritis with either 1-2 joints showing signs of synovitis OR a BASDAI greater than 0 but less than 2\] AND \[between 3 to less than 10% of the body surface area involved with psoriasis\] (COHORT B) OR
* Moderate psoriatic arthritis and Mild psoriasis defined as: \[psoriatic arthritis with either 3-7 joints showing signs of synovitis OR a BASDAI of 2-4\] AND \[more than 0 but less than 3% of the body surface area involved with psoriasis\] (COHORT C)
* Patient is between 18 years and older.
* Patient is capable of reading and understanding French or English questionnaires.
* Patient is capable of giving informed consent.
Exclusion Criteria:
* Patient has presence of eythrodermic, pustular or guttate psoriasis.
* Patient has another non psoriatic arthropathy (such as osteoarthritis) that could have a significant impact of QoL related to psoriatic arthritis
* Patient has another non psoriatic dermatosis that could have a significant impact on QoL related to psoriasis
* Patient has any other co-morbidity with a severity that could have a significant impact on QoL
* Patient has had a significant flare-up of psoriasis or psoriatic arthritis within 90 days of Day 0
* Patient has received investigational drugs within four weeks prior to Day 0
* Patient has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy within the four weeks prior to Day 0. Methotrexate, sulphasalazine and leflunomide are allowed during the study as long as patient has been on a stable dose within 90 days of Day 0.
* Patient has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0
* Patient has used biologics (such etanercept, adalimumab, infliximab, abatacept, ustekinumab) within 180 days of Day 0
* Patient is currently pregnant or lactating.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01139918
Study Brief:
Protocol Section:
NCT01139918