Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis (PsA) (STEREO)

Abbott

Status and phase

Completed

Phase 3

Conditions

Psoriatic Arthritis

Treatments

Drug: adalimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00235885

M04-724

EudraCT: 2005/001185-14

Details and patient eligibility

About

The purpose of the study is to assess the safety and clinical efficacy of adalimumab in active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard therapy including patients that have failed other TNF therapies

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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 .