Etanercept in Psoriasis and Psoriatic Arthritis: a single center, open-label study in 15 patients.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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any study-related procedure not part of the patient’s normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care.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
Female patients must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either
being post-menopausal or surgically sterile, or
using an accepted form of contraception.
Confirmation that the patient is not pregnant must be established by a negative serum or urinary hCG test within 7 days prior to study day 1. A pregnancy test is not required if the patient is post-menopausal or surgically sterile.

Patients with PsA of > 3 months duration defined by the following criteria:
Peripheral arthritis alone or in combination with sacroiliitis
Active arthritis with >3 swollen joints and >3 tender joints considered capable of responding to drug therapy. At least one of the inflamed joints should be a knee joint.
An evaluable psoriatic skin lesion, diagnosed by a consultant rheumatologist or dermatologist.
Negative serum test for rheumatoid factor.

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

Exclusion Criteria

Patients who have received systemic treatment with biologics, including cytokines/anti-cytokines within three months prior to study day 1.
Patients who have participated in any other investigational study (and received active compound) or received an experimental therapeutic procedure considered by the investigator to interfere with the study within three months prior to study day 1.
Patient with inadequate bone marrow reserve, defined as:
·leukocytes = 3.5 x 109/L,
·thrombocytes = 100 x 109/L, and
·haemoglobin = 5.5 mmol/L (8.9 g/dL).
Patients treated with prednisone >10 mg/day or a treatment change in the prednisone regime during the 28 days prior to Study Day 1.
Positive antibodies against double stranded DNA.
Patients taking more than one NSAID or a treatment change in the NSAID regime during the 28 days prior to Study Day 1.
Patients previously treated with chlorambucil or cyclophosphamide.
Patients treated with DMARDS during the 28 days prior to Study Day 1 or cyclosporin within 8 weeks of Study Day 1 or leflunomide within 8 weeks of Study Day 1 (Patients taking leflunomide must undergo a cholestyramine washout consisting of Cholestyramine 8 Grams three times per day, or activated powdered charcoal four times a day, for eleven days followed by a two week waiting period prior to the screening visit, or complete an 8 week washout prior to the screening visit).
Patients with inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase = 1.5 times the upper limit of the normal values.
Inadequate renal function, defined by serum creatinine > 150 micromol/L.
Planned major surgery (eg. joint replacement) within the duration of the treatment period of the study.
History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and carcinoma in situ of the skin).
Have history of active Tuberculosis, or currently active Tuberculosis or currently undergoing treatment for Tuberculosis.
Active severe infection (or non-severe infections at the discretion of the Investigator).
Opportunistic infection in the preceding 3 months.
Clinically significant serious abnormalities on electrocardiography or chest X?ray.
Other serious concomitant disorders incompatible with the study (at the discretion of the Investigator).
Have history of drug (including narcotics) abuse, or current active problems with alcohol abuse.

For Articular Component:
Patients with seropositive, symmetric polyarthritis.
Patients treated with intra-articular injections with corticosteroids within 28 days prior to Study Day 1.
Patients with Arthritis Mutilans.
Patients who are wheelchair bound or bedridden.

For Cutaneous Component:
Patients with guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
Evidence of skin conditions other than psoriasis (e.g. eczema).
Topical therapies and oral retinoids within 14 days of study day 1.
Phototherapy within 28 days of study day 1.
Clinically significant psoriasis flare during screening or at the time of enrollment