M05
Conditions
Interventions
Group 1: Prednihexal (Prednisolon), daily oral tablet,
60 mg during the first week, weekly tapering: 40 mg, 20mg, 15mg, 10mg, 7,5mg. 7,5mg continued for one more week. Finally 5 mg for four weeks.
Gro
Sponsors
Ruhr-Universität Bochum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Diagnosis of RA according to the ACR/EULAR 2010 criteria (Aletaha et al. 2010), • disease duration 4 plus = 3 swollen joints. • adequate compliance related to medication and paticipating in examinations in assessment of the physician • legal capacity • sufficient German language skills to fill in the questioning forms • written informed consent
Exclusion criteria
Exclusion criteria: - age 2 times upper limit of normal), - active hepatitis B or C viral infection, - renal disease (creatinine clearance < 30 ml/minute), - clinically relevant haematological disease due to the judgement of the rheumatologist, - uncontrolled diabetes mellitus, - uncontrolled arterial hypertension, - relevant immunodeficiency incl. HIV-infection, - clinically significant pulmonary fibrosis, - history of malignant melanoma, - complicated or refractory gastrointestinal ulcers, - uncontrolled increased intraocular pressure, - non-compliance,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of radiographic damage after one year as quantified by the van der Heijde modification of the Sharp score (SHS). Determined at basline and after one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients in remission as defined by DAS 28 < 2.6 (DAS 28 = Disease Activity Score 28) or in a state of low disease activity (DAS 28 = 2.6 and DAS 28 < 3.2) after 12 weeks, 24 weeks and after one year (the DAS 28 score is a compound score comprising the number of tender joints (out of 28), swollen joints (out of 28), the ESR in mm (after 1 hour), and patient´s assessment of disease activity. The range of the score is between 0 (no activity) and 10 (maximum of disease activity), a range between 3.2 and 5.1 is regarded as reflecting a moderate disease activity, 2. changes of functional capacity (FfbH) at week 12 and after one year compared to baseline, 3. difference in bone mineral density (DXA lumbar spine and hip) at month 6 in comparison to baseline, 4. number of GC injections and overall dose of Triamcinolons over one year , 5. direct costs of treatment/month over 1 year, 6. mean methotrexate dosage over one year, 7. patient global assessment of disease activity, 8. percentage of patients with switch to biological treatment in case of inefficacy of conventional DMARD therapy, 9. Progression of radiographic damage after one year as quantified by the Ratingen score. Determined at basline and after one year, 10. rate and SAE determined by structured questioning and laboratory test. | — |
Countries
Germany
Contacts
Public ContactDietmar Krause
Abteilung für medizinische Informatik, Biometrie und Epidemiologie
Outcome results
None listed