Rheumatoid arthritis
Conditions
Interventions
Patients will be treated with adalimumab (Humira) subcutaneously every other
week, according to the manufacturers guidelines. Before and after 8 weeks of
treatment, they will undergo a mini-artrosco
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Disease Activity Score (DAS) 28 > 18 years of age and
Exclusion criteria
Exclusion criteria: A history of or acute inflammatory joint disease of different origin e.g. mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter*s syndrome, systemic lupus erythematosus or any arthritis with onset prior to age 16 years Acute major trauma 5)Therapy within the previous 60 days with: * any experimental drug * alkylating agents, e.g. cyclophosphamide, chlorambucil * antimetabolites * monoclonal antibodies * growth factors * other cytokines Therapy within the previous 28 days with: * parenteral or intraarticular corticoid injections * oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily * present use of DMARDs other than methotrexate Fever (orally measured > 38°C), chronic infections or infections requiring anti-microbial therapy Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus Manifest cardiac failure (stage III or IV according to NYHA classification) Impaired coagulation A congenital or acquired immunodeficiency, a history of cancer or lymphoproliferative disease or treatment with total lymphoid irradiation. * (The known HIV-positive status may be defined either by a positive blood test or clinical diagnosis.) Platelet count less than 100 x 109/l Inability to give informed consent Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of the changes in the cellular infiltrate and the expression of cytokines will be performed by immunohistochemical staining, analyzed by digital image analysis The following biomarkers will be assessed: * CD3 (T-cell marker) * CD4 * CD8 * CD22 (B-cell marker) * CD68 (macrophages) * CD163 (resident tissue macrophages) * MRP8 (S100A8, infiltrating macrophages) * MRP14 (S100A9, infiltrating macrophages) * CD38 (plasma cells) * CD55 (fibroblast like synoviocytes) * CD15 (neutrophils) * IL-1 * IL-6 * TNFalpha * Tweak/ Fn14 | — |
Secondary
| Measure | Time frame |
|---|---|
| The endpoint of clinical efficacy will be evaluated at week 8 and week 16 after start of adalimumab therapy. Clinical response will analysed by the change in DAS28 score and according to the EULAR response criteria. Immunohistochemistry and PCR analysis of the following cytokines in the peripheral blood and synovial tissue will be performed Tissue samples and peripheral blood will be stored for future microarray and PCR-analysis. Cellular reactions of the synovial cells measured by cytokine production in fresh synovial biopsies before and after treatment will be assessed. | — |
Countries
Netherlands
Outcome results
None listed