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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT00686595
Eligibility Criteria:
Inclusion Criteria:
* \>=18 to 75 years of age at Screening, either sex, and any race.
* Diagnosis of moderate-to-severe plaque psoriasis \>6 months prior to Screening.
* Resistant (after 12 weeks) or failed 24 weeks of etanercept treatment.
* Not reached PASI 75 at Screening Visit after 24 weeks of etanercept treatment or resistant to etanercept.
* Agree to avoid prolonged sun exposure or artificial ultraviolet light sources during study.
* Satisfy requirements of Screening and tuberculosis (TB) test as specified in protocol.
* Chest x-ray at Visit 1 or within 3 months prior to Visit 1 with no evidence of malignancy, infection, or fibrosis.
* Laboratory tests must be within protocol-specified parameters.
* Free of any clinically significant disease that would interfere with study evaluations.
* Willing to participate and adhere to study procedures by signing written informed consent.
* Women of childbearing potential and all men must be using adequate birth control measures and continue to do so until 6 months after receiving last dose of study medication.
* Females of childbearing potential must have negative serum pregnancy test at Visit 1 and negative urine pregnancy test at Visit 2.
Exclusion Criteria:
* Achieve PASI 75 or have BSA \<10% after 24 weeks of etanercept.
* Current drug-induced psoriasis.
* Females who are pregnant or nursing and both males and females who are planning pregnancy during study period or during 6 months after receiving last dose of study medication.
* Previously treated with infliximab.
* Currently taking or have taken protocol-specified prohibited drugs within specified time frame prior to Baseline.
* Congestive Heart Failure (CHF)
* Chronic or recurrent infectious disease.
* Have or have had serious infection, or been hospitalized or received IV antibiotics for this infection during the 2 months prior to Visit 1.
* Have or have had opportunistic infection within 6 months prior to Visit 1.
* Have or have had herpes zoster infection within 2 months prior to Visit 1.
* Human Immunodeficiency Virus (HIV), hepatitis B or C.
* History of any clinically significant adverse events (AEs) to murine or chimeric proteins or human/murine recombinant products.
* Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
* History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
* Current signs and symptoms or history of systemic lupus erythematosus.
* Transplanted organ (exception - corneal transplant \>3 months prior to Visit 1).
* History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location.
* Malignancy within previous 5 years (exception - basal cell carcinoma of skin that has been treated with no evidence of recurrence).
* Unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
* Have had substance abuse (drug or alcohol) problem within previous 3 years.
* History of any clinically significant adverse reactions (including allergic reactions) to paracetamol/acetaminophen or histamine H1 receptor antagonist.
* In a situation or have a condition that, in opinion of investigator, may interfere with optimal participation in study.
* Used investigational drugs within 4 weeks of Screening.
* Participating in any other clinical study.
* Staff personnel directly involved with this study.
* Family members of investigational study staff.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00686595
Study Brief:
Protocol Section:
NCT00686595