Assessment of Predictive Factors for Persistence of Treatment After Substitution of Reference Adalimumab...
Crohn DiseaseUlcerative Colitis3 moreA prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
Multicentre ObservatioNal Initiative in Treat to Target Outcomes in Psoriatic Arthritis
Psoriatic ArthritisMONITOR is a cohort study recruiting patients with a new diagnosis of psoriatic arthritis (PsA) which will establish outcomes using a pragmatic feasible 'treat to target' approach in a real-life clinic population. It is the central cohort for a planned Trials Within Cohorts (TWiCs) design which will test alternative therapies and interventions in embedded clinical trials comparing outcomes to those receiving "standard care" in the cohort.
Identification of New Biomarkers to Promote Personalized Treatment of Patients With Inflammatory...
ArthritisRheumatoid4 moreIntroduction: The medical treatment of inflammatory rheumatic diseases has improved dramatically during the last decades primarily due to the introduction of biological disease modifying anti-rheumatic drugs (bDMARDs). However, bDMARD treatment failure occurs in 30-40% of patients due to lack of effectiveness or side effects. The tools to predict treatment outcomes in the individual patient are currently limited. The objective of the present study is to identify diagnostic, prognostic and predictive biomarkers, which can be used to 1) diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity, 2) improve prognostication or 3) predict treatment effectiveness and tolerability for the individual patient. Methods and analysis: Observational and translational open cohort study with prospective collection of clinical data and biological materials in patients with inflammatory rheumatic diseases treated in routine care. Patients contribute one cross-sectional blood sample (i.e. whole blood, serum, EDTA-plasma and -buffy coat, and blood in PAXgene RNA tubes) and/or are enrolled for longitudinal follow-up upon start of new DMARD (blood sampling after 0/3/6/12/24/36/48/60 months' treatment). Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected repeatedly during follow-up. Currently (June 2017) >5,000 samples from ≈3,000 patients have been collected. Data will be analysed using appropriate statistical analyses. Ethics and dissemination: The protocol is approved by the Danish Ethics Committee and The Danish Data Protection Agency. All participants give written informed consent. Biomarkers will be evaluated and published according to REMARK, STROBE and STARD guidelines. Results will be published in peer-reviewed medical journals and presented at international conferences.
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
PsoriasisPregnancy2 moreThe purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.
Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)...
Psoriasis VulgarisPsoriasis Arthropathica2 moreTo collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status of use.
PANLAR's Latin American Registry of Rheumatic Patients Treated With Jak Inhibitors
ArthritisRheumatoid3 moreThis prospective, non-interventional, research registry is designed to study the comparative safety and comparative effectiveness of approved Jak Inhibitors treatment for RA-PsA-SpA in a cohort of patients and theirs controls cared for by rheumatologists across Latin América (LA).
AsseSSing Impact in pSoriatic Treatment
Psoriatic ArthritisPsoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice. This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA. This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.
Psorcast Mobile Study
Psoriatic ArthritisPsoriasis7 moreThe purpose of this study is to understand variation in the symptoms of psoriasis and psoriatic arthritis using simple, scalable smartphone-based measurements. This study uses an iPhone app to record these symptoms through questionnaires and sensors.
Pregnancy and Medically Assisted Conception in Rare Diseases
Rheumatoid ArthritisSpondyloarthritis9 moreRare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. As a consequence, the management of these pregnancies is non-standardised in terms of treatment, monitoring (frequency of consultations, laboratory tests and ultrasound), and organisation of care. Moreover, although these women (all diseases combined) are frequently exposed to medications potentially incompatible with pregnancy, little is known about the frequency of these exposures and especially their consequences to mother and child. For these reasons, researchers and clinicians from different specialties created an interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve the management of these patients' pregnancies. Using a single computer server, the investigators plan to set up a large prospective study of pregnancies in patients with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome, scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse the complications of pregnancies in women with rare diseases and then to improve their management and their quality of life.
Korean College of Rheumatology Biologics and Targeted Therapy Registry
Rheumatoid ArthritisAnkylosing Spondylitis1 moreWe established a nationwide biologics and targeted synthetic DMARDs registry (in the form of an inception cohort) to study the safety profiles in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis patients receiving biologics or targeted synthetic DMARDs. As this registry is to observe the "real world" use of anti-rheumatic treatments under routine clinical practice, no hypothesis to prove is planned.