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:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01490450
Eligibility Criteria:
Inclusion Criteria:
* Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed
* Inadequate response to NSAID and/or non-biologic DMARD
* Minimum of 3 swollen and 3 tender joints
* Active psoriatic skin lesions over minimum 3% body surface area
* high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL
Exclusion Criteria:
* Previously received or currently receiving concomitant biologic therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01490450
Study Brief:
Protocol Section:
NCT01490450