M06.99 M07.00 M45.00
Conditions
Interventions
Group 1: CTZ Standard therapy in patients with RA. Evaluation from diverse Biomarker and DAS28 at Baseline, week 6, 12, 24 and 52.
Group 2: CTZ Standard therapy in patients with PsoA. Evaluation from
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • Biomarkers/auto-reactivity will be correlated with clinical response, expressed as DAS28, ASDAS, BASDAI, BASMI and PsARC. Improvement from baseline to week 6, 12, 24, 52 or in case of aborting treatment with Certolizumab Pegol prematurely. • Biomarkers/auto-reactivity will be correlated with radiological data of imaging from centers of rheumatology that use thee daily methods in daily practice at baseline and week 6, 12, 24, 52 or in case of aborting treatment with Certolizumab Pegol prematurely. • To monitor DAS28 partial remission (DAS28 <2,6) and “remission/inactive disease” to the musculoskeletal manifestations for axiale spondyloarthritis (ASDAS and BASDAI) and psoriatic arthritis (PsARC and DAS28) from baseline to week 6, 12, 24, 52 or in case of aborting treatment with Certolizumab Pegol prematurely. • To evaluate the variables: DAS28, ASDAS, BASDAI, BASFI, BASMI, PsARC with Psoriasis Area and Severity Index, Leeds Enthesitis Index, Leeds Dactylitis Index and Modified Nail Psoriasis Severity Index, HAQ, EQ-5D, from baseline to week 6, 12, 24, 52 or in case of aborting treatment with Certolizumab Pegol prematurely. • Analysis of different immune parameters ( RF IgM, RF IgA, Anti-CCP, CRP) from baseline to week 6, 12, 24, 52 or in case of aborting treatment with Certolizumab Pegol prematurely. | — |
Countries
Germany
Contacts
Public ContactStudiengruppe INSIDER
Charité - Universitätsmedizin BerlinKlinik mS Rheumatologie und Klinische Immunologie
Outcome results
None listed