Biomonitoring of inflammation, therapy response and regeneration in patients with rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis during therapy with Certolizumab Pegol
- Conditions
- M07.00M45.00M06.99
- Registration Number
- DRKS00012509
- Lead Sponsor
- Charité Campus Charité Mitte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 137
The enrollment ensued according to the prescribing information of the medication CTZ. Every patient has to fulfill the following inclusion criteria:
•diagnosis in RA (ACR classification criteria), SpA (ASAS criteria) and PsoA (CASPAR)
•Is capable of understanding and signing an informed consent form
•An active RA and PsoA DAS28 = 3,2; active spondyloarthritis with BASDAI = 4 and spinal pain =4 (NRS)
•Fulfilling the DGRh cirteria for the indicated therapy
•With contraception in woman of child-bearing age during the time of treatment and at least up to 5 months after the last application
If there will be one of the following exclusion criteria applicable, the patient can´t enroll in the study
•Heart failure (NYHA III/IV)
•Pregnancy
•Active tuberculosis
•Contraindication for the treatment with CTZ or a hypersensitivity against the contents
•Recent therapy with Anakinra or Abatacet, or in combination with CTZ is planed
•Is female and capable of bearing children and use any reasonable contraception
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Several biomarkers (concentration of proteins, RNA levels, auto-antibody titers) will be determined at baseline, week 6, 12, 24 and 52 and compared to DAS28 (Disease Activity Score 28) for rheumatoid arthritis, to ASDAS (Ankylosig Spondylitis Activity Score) for axiale spondyloarthritis and to PsARC (Psoriatic Arthritis Response Criteria) for psoriatic arthritis.
- Secondary Outcome Measures
Name Time Method