Rheumatoid arthritis and Psoriatic arthritis
Conditions
Interventions
Trade Name: Remicade
Product Name: Infliximab
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Infliximab
Conc
Sponsors
Greater Glasgow Health Board
Glasgow University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 150 micromoles/litre.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the effect of inhibiting the biological activity of TNF-alpha (using two agents; infliximab and etanercept) on the global transcriptional (microarray) and cytokine protein (multiplex analysis) profile of cells/serum isolated from both the peripheral blood and tissue of patients with rheumatoid arthritis and psoriatic arthritis. To be compared with similar data from a cohort of patients with inflammatory bowel disease in an ongoing study.; Secondary Objective: To compare and contrast the effect of inhibiting the biological activity of TNF-alpha (using two different agents; infliximab and etanercept) on clinical measures of disease activity and repair of damaged tissue in patients with rheumatoid arthritis and psoriatic arthritis. To explore the relationship between inhibiting the biological activity of TNF-alpha (using two agents; infliximab and etanercept) on key physiological (blood flow, angiogenesis and oxygen tension) measures in the rheumatoid arthritis cohort. To correlate the molecular and clinical outcomes in order to provide a potential explanation for the differences in the mechanism of action of infliximab and entanercept at different sites (skin, synovium and gut) and between diseases at the same site (rheumatoid versus psoriatic arthritis). ;Primary end point(s): Change in blood and tissue (synovium +/- skin) mRNA as determined by microarray after 1 month of treatment with either infliximab or etanercept. | — |
Countries
United Kingdom
Outcome results
None listed