Psoriasis Psoriatic arthritisRheumatoid arthritisAnkylosing SpondylitisHealthy controls
Conditions
Interventions
Group 1: This is a randomised, open, singel center, prospective interventional study with a cross-over design. The study population consists of six groups (group 1: healthy subjects, group 2: rheumato
group 4: psoriatic arthritis, group 5: psoriasis, group 6: ankylosing spondylitis (AS)) with a group size of 30 subjects each. Each of the groups will be consecutively recruited individually and rando
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General criteria (valid for all participants) - Adults, male or female, capable of giving consent. - Age 18 - 80 years - Present informed consent to participate in the study (Group 1) Healthy subjects o Clinical and medical history: no arthritis, no psoriasis o Serological: ACPA negative, RF negative o Exclusion: diagnosis of a chronic inflammatory disease o Exclusion: use of immunosuppressive therapy (csDMARD, bDMARD, tsDMARD) Disease-specific inclusion criteria: - (Group 2) Rheumatoid arthritis o Classification according to the ACR/EULAR 2010 classification criteria o Duration of disease: no restriction o Therapy: no restriction of immunosuppressive therapy o Disease activity: no restriction - (Group 3) Rheumatoid arthritis at risk o No classification according to ACR/EULAR 2010 classification criteria o Detection of ACPA-AK for screening purposes o Disease activity: no arthritis/synovitis in the 66/68 joint count at screening and baseline - (Group 4) Psoriasis vulgaris and/or palmo-plantaris o Diagnosis confirmed histologically or by a specialist (dermatology/rheumatology) - (Group 5) Psoriatic arthritis o Classification according to CASPAR classification criteria o Duration of disease: no restriction o Therapy: no limitation of immunosuppressive therapy o Disease activity: no restriction - (Group 6) Ankylosing spondylitis o Classification according to ASAS classification criteria o Duration of disease: no restriction o Therapy: no restriction of immunosuppressive therapy o Disease activity: no restriction
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of regulatory T cells (Tregs) (% CD4+, CD25+, FoxP3+) to total T cells (Tg, CD4+). Number of subjects with a 50% improvement in the Tregs/Tg quotient in peripheral blood after 28 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cellular: - Number of subjects in each subgroup with a 50% improvement in the Tregs/Tg quotient. - Differences in Tregs/Tg quotient between treated and non-treated subjects. Cytokines: - Change in levels of pro- and anti-inflammatory cytokines (TNFa, IL-10, IL-2, INF?, TGFß, IL-4, IL-1ß, IL-17a) in serum (pg/ml) time point weeks 0, 4, 8 and 16. Microbiome analysis: - Change in Firmicutes-Bacteroidetes ratio in stool microbiome via sequencing analysis (next generation sequencing) weeks 0, 4, 8 and 16. Clinical parameters: - Change at week 4 or 8 and 16 compared to baseline: o All subjects: - weight (kg) - Dietary habit (habitual intake of dietary fibre by subjects assessed using a modified version of the Food Frequency Questionnaire (FFQ) developed for the 2008-2011 Adult Health Survey (DEGS)). - Joint status (78/76 TJC/SJC) - Patient reported outcome: HAQ-DI, VAS patient, VAS physician - Quality of life: WHO-5 well-being o Disease-specific: - Rheumatoid arthritis (DAS28, CDAI/SDAI). - RA-at risk: DAS28, CDAI/SDAI; - Psoriasis: BSA/PASI; DLQI, SPARCC -PsoA: PASI/BSA, DLQI, SPARCC - AS: BASMI; BASDAI SPARCC - Safety: o Documentation of AEs | — |
Countries
Germany
Contacts
Public ContactArnd Kleyer
Medizinische Klinik 3, Rheumatologie und ImmunologieUniversitätsklinikum Erlangen
Outcome results
None listed