Psoriasis and Psoriatic Arthritis
Conditions
Interventions
Trade Name: Enbrel (etanercept)
A centralised product with Marketing Authorisation in 25 EU Member States
EU MA granted 3 February 2000
Product Name: Enbrel (etanercept)
Product Code: 0881
Pharmaceuti
rhuTNFR:Fc
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Sponsors
St Vincents University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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any study-related procedure not part of the patient’s normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care.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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The proposed study is a single center, open label study of 15 patients with PsA and cutaneous Ps treated with a 3-month course of Etanercept (Enbrel). The aims of this study are to assess the effect of TNF inhibition with Etanercept on: The clinical features of PsA disease activity The clinical features of Ps disease activity Synovial immunohistologic changes Cutaneous immunohistologic changes Change of MRI features from baseline of the affected knee joint ;Secondary Objective: ;Primary end point(s): The primary response endpoint is the detection of an efficacy signal expressed as a change from baseline. Responses will be established on the basis of the clinical, immunohistologic and MRI changes at week 12 from baseline. For the articular component a clinical response will be evaluated using: Physician’s global assessment of disease activity (improvement: decrease by at least 1 unit; worsening increase by at least 1 unit) Patient’s global self-assessment of disease activity (improvement: decrease by at least 1 unit; worsening: increase by at least 1 unit) Tender joints score (improvement; decrease by at least 30%; worsening: increase by at least 30%) Swollen joints score (improvement: decrease by at least 30%; worsening: increase by at least 30%) ACR 20, 50 and 70 response criteria will be applied and the evolution of individual PsARC/ACR parameters will be followed over the duration of the study. The response to treatment of the cutaneous components of disease will be based on the change of the Psoriatic Area and Severity Index (PASI) at Week 12 from baseline. To have a PASI response, patients must improve at least by 75% in their PASI score between baseline and the end of treatment (Week 12). The evolution of individual PASI parameters will be followed over the duration of the study. Finally, a target lesion will be photographed at baseline and compared with findings at 12 weeks. With the exception of target lesion photography | — |
Countries
Ireland
Outcome results
None listed