DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Patients with RA must fulfill 1987 ARA (ACR) criteria and be seropositive for rheumatoid factor and/or anti-CCP antibody, be aged 18 or over with disease established for at least 6 months and who have active disease as defined by a DAS28 score of >4.0. Patients must have previously failed treatment with diease-modifying anti-rheumatic drugs. Patients with psoriatic arthritis must have psoriatic skin (with >1 current 2cm or more biopsiable lesion) and >3 swollen and tender peripheral joints, be aged 18 or over with disease duration of at least 6 months. All patients must be on methotrexate (at least 7.5mg/week) at the start of the study, and the dose of this should have remained stable in the four weeks prior to commencing. All subjects must have provided written, informed consent prior to admission to the study. The subject must be able to understand and comply with the protocol requirements, instructions and restrictions.
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

Principal exclusion criteria will be in accord with current practice for use of biologic therapy:
•Pregnant or breastfeeding
•Demyelinating disease
•Active infections. High risk include: chronic leg ulcers, untreated TB, septic arthritis of a native or prosthetic joint within the last 12 months (indefinitely if the prosthetic joint remains in situ), persistant or recurrent chest infections, indwelling urinary catheter.
•Malignancy or premalignancy states excluding basal cell carcinoma and malignancies diagnosed and treated more than 10 years previously (where the probability of total cure is very high)
•congestive cardiac failure NYHA grade 3 or 4.
In addition patients will also be excluded if, in the opinion of the investigator, they would have difficulty complying with the study requirements or have past or present disease that may affect the outcome of the study. Patients should not currently be receiving a biological therapy or received a dose of infliximab or adalimumab within 3 months of enrolling, or etanercept or anakinra within 1 month. Patients should not have received glucocorticoids (steroids) in the month prior to commencing treatment with anti-TNF.
Patients will also be excluded with the following laboratory results: haemoglobin <8.5 gm/dl, total white cell count <3.5 x 10[9]/litre, serum transaminase value more than twice the upper linmit of normal, and serum creatinine >150 micromoles/litre.

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

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