M06.99
Conditions
Interventions
Group 1: new introduction of methotrexate
Group 2: New introduction of Etanercept 25 mg biweekly s.c.
Sponsors
Charité - Universitätsmedizin Berlin
Medizinische Klinik m.S. Rheumatologie / klinische Immunologie
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Rheumatoid Arthritis according to ACR 1987 criteria; age 18 - 70; DAS28 geater or euqal to 3.2; morning stiffness greater or equal to 30 minutes; patients in etanercept group must fulfill DGRh criteria for initiation of biologic therapy; patients may not have received prior biologic therapy; NSAID, glucocorticoids must be at stable dosing 14 d prior to screening (gc dosing at a max of 10 mg/d prednisolon or equivalent); able and willing to understand and sign informed consent; able and willing to perform s.c injections themselves or having someone to do so; females with reproductive potential must use adequate form of contraception
Exclusion criteria
Exclusion criteria: Patients with history of severe disease including malignancies treated within 5 years of screening (except basal cell carcinoma of skin and squamous skin cell carcinoma and in situ carcinoma of the neck); Patients with uncompensated heart insufficiency, myocardial infarction within 12 months of screening, instable angina pectoris,uncontrolled arterial hypertension, severe lung disease, history of HIV-infection, immunodeficiency syndromes, other rheumatologic disorders than RA, demyelinating CNS disease, multiple sklerosis or psychiatric disorders; patients with other reasons for sleeping disorders (COLD, sleep apnea, allergic rhinitis etc.; patients who received live vaccination within 4 weeks of screening; patients receiving intraarticular injections with glucocorticoids within 4 weeks of screening Patients receiving intramuscular or i.v. injections of glucocorticoids of euqual to or more of 10 mg/d prednisolone equivalent within 4 weeks of screening; oral doses of more than 10 mg prednisolone equivalent ; history of blood dyscrasias; Patients with active infections or predisposing conditions for infection (e.g. leg ulcerations, untreated diabetes mellitus); Patients with active Hepatitis A,B,C, Tuberculosis, chronic or latent TB, latent TB must have been adequately treated with Isoniazid 300 mg/d for 10 month starting at least 4 weeks prior to first etanercept application. Renal disease or known cirrhosis or fibrosis of the liver, Liver function parameters at more than 2 times of upper limit of normal range; sleep associated respiratory disorder, ideopatic insomnia AHI >10/h, PMLI > 5/h; alcohol abuse; pregnancy; brest feeding; Patients incapable of giving informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue (Questionnaire), sleep quality (questionnaire), sleep efficiency (polysomnographically evaluated) | — |
Secondary
| Measure | Time frame |
|---|---|
| Long term effect of MTX vs. Etanercept on fatigue and sleep quality || DAS 28 at baseline, week 8 and week 16 || Evaluation of partial remission at week 8 and 16 || Determination of core set variables for clinical trials according to WHO/ILAR || Determination of ACR 20,50 and 70 at baseline, week 8 and 16 || Change in ACR 20, 50, 70 between week 1 and 8 / 16 , analysis of immunological parameters | — |
Countries
Germany
Contacts
Public ContactRené Dziurla
Charité Universitätsmedizin Berlin Medizinische Klinik m.S. Rheumatologie / klinische Immunologie
Outcome results
None listed