Abatacept in Psoriasis and Psoriatic Arthritis: a single centre, placebo-controlled, crossover study in 15 patients.

Phase 1

• Conditions: Psoriatic Arthritis

• Registration Number: EUCTR2009-017525-19-IE
• Lead Sponsor: St. Vincents University Hospital, Department of Rheumatology.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-18
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

­Patients must give written informed consent,
given prior to any study-related procedure not part of the patient’s normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care.­
Patients between the ages 18 and 80 years, with a joint disease onset after 16 years old­­
Patients with active PsA (CASPAR criteria) of > 3 months duration defined by the following criteria:Active arthritis with >3 swollen joints and >3 tender joints considered capable of responding to drug therapy. Should present a clinical synovitis of a knee and have accepted to undergo synovial biopsies ? At least one of the inflamed joints should be a knee joint.§An evaluable psoriatic skin lesion, diagnosed by a consultant rheumatologist or a dermatologist is not a pre-requisite but where possible such patients will be recruited .
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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

·WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to14 weeks after the last dose of tre·atmentFemale patients who are pregnant or breast-feeding. ·Subjects who meet diagnostic criteria for any other rheumatic disease
Subjects who are impaired, incapacitated, or incapable of completing study related assessments (including prisoners and patients detained for treatment of psychiatric illness)·Evidence of skin conditions other than psoriasis .·History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and carcinoma in situ of the skin).·Subjects with current clinical or laboratory evidence of active tuberculosis .·Latent TB which was not successfully treated.·Active severe infection ·Have history of drug (including narcotics) abuse, or current active problems with drug or alcohol abuse·Subjects who have received a previous systemic treatment with biologic DMARDs, including cytokines/anti-cytokines

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified