rheumatoid arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Trade Name: etanercept
Product Name: Etanercept
Pharmaceutical Form: Injection*
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Current Sponsor code: ETN-cohortRA2009
Other descriptive name: met
Sponsors
None listed
Eligibility
Sex/Gender
All
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 naïve for anti-TNF-alpha therapy or has failed other prior TNF-alpha blockers 3) DAS 28 higher and/or equal to 3.2 4) Failure on two previously used DMARDs 5) Age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
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 etanercept) ? 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 109/l 14) Platelet count less than 100 x 109/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 |
|---|---|
| Main Objective: To evaluate the response to etanercept treatment in TNF-alpha blockade naïve patients and patients who failed prior other anti-TNF-alpha treatment and to understand the mechanisms underlying the clinical response to TNF-alpha blockade. ;Secondary Objective: 1) What factors distinguish 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) What percentage of patients (TNF-alpha blockade naïve versus failures on prior anti-TNF-alpha treatment) respond after 16 weeks of etanercept treatment? 3) What is the clinical efficacy of etanercept after 1 year treatment? (Eular response criteria (DAS 28), ACR response, RADAI, SF 36, HAQ, and radiological progession) 4) Can we find 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? 5) Can periferal blood (mRNA) micro-array analysis identify new markers that distinguish responders from non-responders to etanercept treatment? ;Primary end point(s): The primary endpoint of the study is the percentage of patients with a moderate to good response to etanercept treatment at 16 weeks according to the Eular response criteria which is also applied in routine rheumatological practice. | — |
Countries
Netherlands
Outcome results
None listed