Trial document





This trial has been registered retrospectively.
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  DRKS00000150

Trial Description

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Title

Effects of treatment with etanercept on fatigue, sleepiness, well being, sleep quality and selected immune parameters in patients with rheumatoid arthritis

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Trial Acronym

Schlafprojekt

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study, the influence of medical treatment (either Methotrexate or Etanercept) will be studied on fatigue, well-being and quality of sleep. Results might help in coping with the signs and symptoms of Rheumatoid Arthritis.
Patients have to come in for four visits (screening, baseline, week 8 and week 16) after having slept for 2 consecutive nights
prior to baseline, week 8 and week 16 visit

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Brief Summary in Scientific Language

Rheumatoid arthritis is characterized by articular as well as extraarticular manifestation. Extraarticular Symptoms include fatigue and sleep disturbances. In situations of high disease activity these symptoms become more prominent and reduce overall quality of life. TNF alpha is one of the most well known proinflammatory cytokines. TNF alpha blockade has been shown to be effective in treating articular symptoms of RA thus improving quality of life measurements. There are hardly any studies on fatigue and sleep quality available yet. The prevalence of fatigue in RA patients has been evaluated to be up to 80 %.

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Organizational Data

  •   DRKS00000150
  •   2009/06/19
  •   [---]*
  •   yes
  •   Approved
  •   EA1/098/06, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1111-2826 
  •   0881A1-102134  (Prüfplancode (Wyeth))
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Health Condition or Problem studied

  •   M06.99 -  [generalization M06.9: Rheumatoid arthritis, unspecified]
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Interventions/Observational Groups

  •   new introduction of methotrexate
  •   New introduction of Etanercept 25 mg biweekly s.c.
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   IV
  •   [---]*
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Primary Outcome

Fatigue (Questionnaire), sleep quality (questionnaire), sleep efficiency (polysomnographically evaluated)

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2007/01/24
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional 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

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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

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Addresses

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    • Charité - Universitätsmedizin Berlin Medizinische Klinik m.S. Rheumatologie / klinische Immunologie
    • Mr.  Prof. Dr. med.  Frank  Buttgereit 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin Medizinische Klinik m.S. Rheumatologie / klinische Immunologie
    • Mr.  Prof. Dr. med.  Frank  Buttgereit 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin Medizinische Klinik m.S. Rheumatologie / klinische Immunologie
    • Mr.  Dr. med.  René  Dziurla 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Wyeth Pharma GmbH
    • Mr.  Dr. med.  Thomas  Meng 
    • Wienburgstr. 207
    • 48159  Münster
    • Germany
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    • Charité-Universitätsmedizin Berlin Medizinische Klinik m.S. Rheumatologie / klinische Immunologie
    • Mr.  Prof. Dr. med.  Frank  Buttgereit 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2009/07/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.