Effects of treatment with etanercept on fatigue, sleepiness, well being, sleep quality and selected immune parameters in patients with rheumatoid arthritis
- Conditions
- M06.99
- Registration Number
- DRKS00000150
- Lead Sponsor
- Charité - Universitätsmedizin BerlinMedizinische Klinik m.S. Rheumatologie / klinische Immunologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 36
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fatigue (Questionnaire), sleep quality (questionnaire), sleep efficiency (polysomnographically evaluated)
- Secondary Outcome Measures
Name Time Method ong 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