Safety and Efficacy of Adalimumab in Patients with Psoriatic Arthritis (PsA)- An Open-Label, Multinational Study to Evaluate the Response to Every-Other Week Adalimumab When Added to Insufficient Standard Therapy Including Patients who Failed Prior Treatment With Other TNF-Inhibitors (STEREO) - STEREO
- Conditions
- Psoriatic Arthritis
- Registration Number
- EUCTR2005-001185-14-GB
- Lead Sponsor
- Abbott GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
Males and females of 18yrs of age or more, with active psoriatic arthritis with 3 or more tender and swollen joints despite standard PsA therapy, who have had an unsatisfactory response or intolerance to at least 1 prior or ongoing DMARD. Females of childbearing capacity who have a negative pregnancy test at the start of treatment, and are on reliable contraception and females of non-childbearing capacity who are post-menopausal for atleast 1 year, or surgically sterile. Subjects who are able to self-administer the sc injections or who have suitable persons available to administer the injections for them, and subjects who are able and willing to give written informed consent and comply with the requirements of the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects on prior treatment with any investigational agent within 30 days, or 5 half lives of the product, whichever is longer; those who have had treatment within the last 2 months with infliximab, or within the last 3 weeks with etanercept; treatment within the last 4 weeks with a combination of MTX and leflunomide or with a combination of cyclosporin with any other DMARD.Subjects who have received UVA phototherapy, including PUVA within 2 weeks prior to screening,subjects with a history of cancer or lymphoproliferative disease- except successfully and completely treated squamous cell or basal cell Ca. of skin or cervical dysplasia, with no recurrence within the last 2 years, history of or current acute inflammatory joint disease of origin other than PsA, uncontrolled diabetes, unstable ischaemic heart disease, congestive heart failure, active inflammatory bowel disease, recent stroke (within 3 months), chronic leg ulcer and any other comorbidities, latent TB.Subjects with positive serology for Hep B, history of positive HIV status,persistent or recurrent infections or severe infections requiring hospitalisation or treatment with antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment, subjects with a history of drug or alcohol abuse.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method