|- candidate number||18025|
|- NTR Number||NTR4626|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jun-2014|
|- Secondary IDs||13-696/M METC UMC Utrecht|
|- Public Title||From Psoriasis to Arthritis|
|- Scientific Title||A systems biology approach to identify novel biomarkers and causative pathways in patients with psoriatic arthritis |
|- hypothesis||Een "systeem biologische aanpak" kan nieuwe diagnostische markers en oorzakelijke immuunprocessen identificeren bij patiŽnten met artritis psoriatica. |
|- Healt Condition(s) or Problem(s) studied||Psoriatic arthritis, Arthritis, Psoriasis, Psoriatic arthritis, Spondyloarthritis|
|- Inclusion criteria||- The patient is age 18 - 75 years of age. |
- For Population 1: a diagnosis of psoriasis made by a dermatologist
- For Population 2: a diagnosis of PsA according to CASPAR criteria and not yet treated with DMARDs or Biologicals
- For Population 3: a diagnosis of PsA according to CASPAR criteria and treated with DMARDs and/or Biologicals
- For Population 4: a diagnosis of SpA made by a rheumatologist, where the SpA is caused by an alternative disease than PsA, namely: ankylosing spondylitis (AS), inflammatory bowel disease associated arthritis, reactive arthritis, or undifferentiated spondyloarthritis.
|- Exclusion criteria||- The patient is age 17 years or younger|
- The patient is age 76 years or older
- The patient has an alternative inflammatory rheumatological diagnosis (e.g. RA, gout, pseudo-gout).
- For Population 2: past or current treatment with DMARDs or Biologicals.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-jul-2014|
|- planned closingdate||1-jul-2024|
|- Target number of participants||900|
|- Primary outcome||- diagnose (artritis psoriatica versus psoriasis)
|- Secondary outcome||- ziekteactiviteit|
|- Timepoints||1-3x per jaar|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. E.F.A. Leijten|
|- CONTACT for SCIENTIFIC QUERIES||Drs. E.F.A. Leijten|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU), Pfizer|
|- Brief summary||Objective: The primary objective is to identify molecular signatures that can serve as diagnostic and/or severity-of-disease markers for PsA and markers that can predict treatment response in patients with PsA. The secondary objective is to elucidate the underlying pathways in the development of PsA with the aim of discovering novel therapeutic targets.|
Study design: Longitudinal observational study, where blood samples and clinical parameters will be prospectively collected for a maximum duration of five years per patient, and the data will be analysed using the systems biology approach.
Study population: Patients aged 18 - 75 years old with psoriasis (n=300), PsA (n=300), and a group of non-PsA spondyloarthritis (n=300, including ankylosing spondylitis, inflammatory bowel disease associated arthritis, reactive arthritis, or undifferentiated spondyloarthritis) in the out-patient clinics of the dermatology and rheumatology department.
Intervention: not applicable
Main study parameters/endpoints: Diagnosis, disease activity, and treatment response.
|- Main changes (audit trail)|
|- RECORD||3-jun-2014 - 10-jul-2014|