M05 M06
Conditions
Interventions
Group 1: PET-MRI and SPECT of the clinical dominant hand of patients with newly diagnosed, therapy naiv rheumatoid arthritis prior and after 6 month antirheumatic treatment.
Sponsors
Universitätsklinikum Düsseldorf
Institut für Diagnostische und Interventionelle Radiologie
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: New diagnosed rheumatoid arthritis according to the 2010 ACR/EULAR criteria, disease duration < 6 month, inflammatory involvement of at least one metacarpophalangeal joint or at least one proximal interphalangeal joint
Exclusion criteria
Exclusion criteria: 1) Present malignant disease or history of malignant disease in the last five years (not basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of the cervix). 2) History of any kind of severe cardiac disease (e.g. decompensated heart insufficency, history of myocardial infarction in the last 12 month, unstable angina pectoris or unregulated hypertension). 3) Severe pulmonary disorder. 4) History of immunodeficiency syndroms (HIV or other) or any rheumatic disease (if not RA) or any demyelinating CNS disease (e.g. MS) 5) History of live vaccination in the past 4 weeks prior to screening. 6) Intraarticular injections in in joints of the surveyed hand (< 4 weeks prior to screening). 7) Any kind of acute or chronic infection (e.g. Hepatitis A,B,C) or predisposition for an infection (e.g. ulcera, diabetes mellitus). 8) Renal disorders (Kreatinin 175 µmol/l, GFR < 30 mg/dl) 9) Zirrhosis or fibrosis of the liver or inadequate liver function. 10) Psychiatric disorders if limting the understanding of participatance in this study 11) Breast feading or Pregnancy. 12) General contradictions against MRI examinations (e.g. implanted cardiac pacemaker/ defibrillator, claustrophobia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extent of inflammatory joint changes in hybrid MR-PET and -SPECT on follow-up (6 month under antirheumatic treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of structural joint pathologies (synovitis, bone marrow edema and erosions) and metabolic joint pathologies seen in PET and SPECT. | — |
Countries
Germany
Contacts
Public ContactBenedikt Ostendorf
Universitätsklinikum Düsseldorf Klinik für Endokrinologie, Diabetologie und Rheumatologie
Outcome results
None listed