rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patients with the diagnosis rheumatoid arthritis according to the American Rheumatism Association (ARA) 1987 criteria and in ACR 1991 functional classes I, II, and III (see appendix) 2) The patient is naive for anti-TNF-alpha therapy or has failed other prior TNF-alpha blockers 3) DAS 28 > or 18 and
Exclusion criteria
Exclusion criteria: 1) Pregnancy 2) Breastfeeding 3) A history of or current 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 4) Acute major trauma 5) Therapy within the previous 60 days with: * any experimental drug * alkylating agents, e.g. cyclophosphamide, chlorambucil * antimetabolites * monoclonal antibodies (including infliximab and adalimumab) * growth factors * other cytokines 6) 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 7) Receipt of any live (attenuated) vaccines within 4 weeks prior to baseline 8) Fever (orally measured > 38 °C), chronic infections or infections requiring anti- microbial therapy 9) Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus 10) Manifest cardiac failure (stage III or IV according to NYHA classification) 11) Progressive fatal disease/terminal illness 12) a history of lymphoproliferative disease or treatment with total lymphoid irradiation. 13) A white cell count less than 3.5 x 10^9/l 14) Platelet count less than 100 x 10^9/l 15) Haemoglobin of less than 5.3 mmol/l 16) Body weight of less than 45 kg 17) History of drug or alcohol abuse 18) Any concomitant medical condition which would in the investigator*s opinion compromise the patient*s ability to tolerate, absorb, metabolize or excrete the study medication. 19) Inability to give informed consent 20) 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 |
|---|---|
| The primary outcomes are: 1) factors distinguishing responding patients from non responding patients on etanercept treatment Differences in cytokine profiles or other serological markers, RA activity driven by other mediators than TNF-alpha) 2)percentage of patients (TNF-alpha blockade naïve versus failures on prior anti-TNF-alpha treatment) respond after 16 weeks of etanercept treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The secundary outcomes are: 1) the clinical efficacy of etanercept after 1 year treatment (Eular response criteria (DAS 28), ACR response, RADAI, SF 36, HAQ, and radiological progession) 2) genetic markers, e.g. genetic polymorphisms in the TNF-alpha genes, that may predict diagnosis, efficacy and side-effects of treatment in the individual patient 3) periferal blood (mRNA) micro-array analysis identifying new markers that distinguish responders from non-responders to etanercept treatment | — |
Countries
Netherlands
Outcome results
None listed