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Personalized Therapy in Rheumatoid Arthritis 2.0

Personalized Therapy in Rheumatoid Arthritis 2.0 - PETRA 2.0

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028144
Enrollment
440
Registered
2022-03-01
Start date
2022-03-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M05 M06

Interventions

Group 1: Intervention group: The intervention consists of a 9-month psychological group program with a total of 15 sessions (first 6 months in 2-week intervals, thereafter monthly) conducted by specia

Sponsors

BKK Landesverband Bayern
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Confirmed diagnosis of fibromyalgia (ICD10 M79.7)

Design outcomes

Primary

MeasureTime frame
Psychological well-being: Quality of life, self-efficacy and health literacy. 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

MeasureTime frame
Neuroimmunological 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).

Countries

Germany

Contacts

Public ContactClaudia Bentele

BKK Landesverband Bayern

bentele@bkk-lv-bayern.de0049 89 74579155

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026