Personalized Therapy in Rheumatoid Arthritis 2.0
Phase 2
- Conditions
- M05M06Seropositive rheumatoid arthritisOther rheumatoid arthritis
- Registration Number
- DRKS00028144
- Lead Sponsor
- BKK Landesverband Bayern
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 440
Inclusion Criteria
Adults are eligible to participate,
a. with a confirmed ICD 10 code M05. and M06. diagnosis
b. who are insured by the AOK Bayern or a participating BKK
c. who have submitted a declaration of participation in the PETRA 2.0 model project and
d. a valid data release for innovation fund projects for the PETRA 2.0 model project.
model project in accordance with § 75 SGB X (approval for the use of
routine data), and
e. who present themselves in a rheumatologists office participating in the study and
f. have sufficient knowledge of German to participate in the survey by means of questionnaires
Exclusion Criteria
Confirmed diagnosis of fibromyalgia (ICD10 M79.7)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Psychological well-being: Quality of life, self-efficacy and health literacy.<br>The main outcome variable will be assessed at 9 time points during the intervention (9 months) and follow-up (9 months) phase of the study through clinical examinations with participating rheumatologists, laboratory measurements, and questionnaires.
- Secondary Outcome Measures
Name Time Method euroimmunological parameters (TNFa, IL-1b, IL-2, IL-6, IL-10, IL-12, IL-13, IL-2 receptor, cortisol), disease activity and symptoms (CRP/BSG, DAS28, SDAI, CDAI) and the treatment expenditure with routine data of the health insurance companies (number and type of physician visits and prescribed remedies, number and duration of hospital stays, sick days and drug costs as well as the resulting inpatient, outpatient and total SHI expenditures).