Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and females \> 18 years of age
Active PsA with \> 3 tender and \> 3 swollen joints despite standard therapy
Unsatisfactory response or intolerance to at least one prior or ongoing DMARD (study enrollment must be in accordance with current national guidelines for treatment of PsA with TNF inhibitors)
A negative serum pregnancy test (serum HCG) for women of childbearing potential prior to the start of treatment.
Use of a reliable method of contraception by all female patients of childbearing potential
Able and willing to self-administer sc injections or have a suitable person to administer sc injections
Able and willing to give written informed consent and comply with the protocol
You may not be if
Prior treatment with any investigational agent within 30 days or five half lives of the product, whichever is longer
Treatment within last 2 months with infliximab or within last 3 weeks with etanercept
Treatment within last 4 weeks with a combination of MTX and leflunomide
Treatment within last 4 weeks with a combination of cyclosporine with any other DMARD-Subject has received UVA phototherapy (including PUVA within 2 weeks prior to screening)
History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia
History of or current active acute inflammatory joint disease of origin other than PsA
Comorbidities (uncontrolled diabetes, unstable ischemic heart disease, CHF, active IBD, stroke within 3 months, chronic leg ulcer and other condition which would put subject at risk by participation in the protocol
Positive serology for hepatitis B or C
History of positive HIV status
Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment
Females who are pregnant or breast-feeding
History of clinically significant drug or alcohol abuse in the last year
Previous diagnosis or signs of central nervous system demyelinating diseases
History of tuberculosis, histoplasmosis or listeriosis
Subjects with latent TB or having other risk factors for activation of latent TB who have not initiated a TB prophylaxis prior to the first adalimumab treatment .
