RABBIT-SpA: Disease Register for Axial Spondyloarthritis and Psoriatic Arthritis

Overview
Related items

The RABBIT-SpA disease register, established in May 2017, aims to investigate the long-term effectiveness and safety of therapies used in spondyloarthritis. Data from rheumatologists and patients on disease progression, treatment, therapy outcomes, and therapy safety are collected to gain a better understanding of the different treatment approaches. Aspects related to quality of life, mental health, and work ability are also the focus of our analyses. The web-based documentation system was developed in a way that allows additional modules to be integrated. Rheumatologists from both outpatient and inpatient care across Germany participate in the register. We are involved in national and international research collaborations.

Programme: Programme Area 2 - Epidemiology and Health Services Research

SEEK ID: https://ldh.drfz.imise.uni-leipzig.de/projects/4

Public web page: https://rabbit-spa.de/for-researchers/

NFDI4Health PALs: No PALs for this Project

Project start date: 1st May 2017

Extended Metadata (Nfdi4Health MDS 3.3)

Expand All Collapse All

Resource classification(*)

Type of the resource : Registry

Title(s)/name(s) of the Project

Title/name : RABBIT-SpA
Language of the title/name : English

Acronym(s) of the Project

Acronym : RABBIT-SpA
Language of the acronym : English

Description(s) of the Project

Description : The RABBIT-SpA disease register, established in May 2017, aims to investigate the long-term effectiveness and safety of therapies used in spondyloarthritis. Data from rheumatologists and patients on disease progression, treatment, therapy outcomes, and therapy safety are collected to gain a better understanding of the different treatment approaches. Aspects related to quality of life, mental health, and work ability are also the focus of our analyses. The web-based documentation system was developed in a way that allows additional modules to be integrated. Rheumatologists from both outpatient and inpatient care across Germany participate in the register. We are involved in national and international research collaborations.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : spondyloarthritis

Keyword(*) : axial spondyloarthritis

Keyword(*) : psoriatic arthritis

Keyword(*) : longitudinal

Keyword(*) : cohort study

Keyword(*) : register

Language(s) of the project : German

Web page of the project : https://rabbit-spa.de/for-researchers/

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Anne
Family name(s)(*) : Regierer
Digital identifier(s)
Identifier(*) : 0000-0003-2456-4049
Scheme(*) : ORCID
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : Other
Identifier(*) : https://registersuche.bqs.de/detail.php?pid=RABBIT-SpA

Includes chronic diseases? : true

Characteristics of the Project

Is it an interventional or non-interventional Project? : Non-interventional
Specification of the type of the Project
Interventional Project type : []
Non-interventional Project type : Cohort, Longitudinal, Register studies
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : axial spondyloarthritis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M45. (all)
Primary health condition or disease name(*) : psoriatic arthritis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M07.0, M07.1, M07.2, M07.3, L40.5, M09.0
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the blood or blood-forming organs and certain disorders involving the immune mechanism (III), Diseases of the skin and subcutaneous tissue (XII), Diseases of the musculoskeletal system and connective tissue (XIII), Certain infectious or parasitic diseases (I), Neoplasms (II), Endocrine, nutritional and metabolic diseases (IV), Diseases of the circulatory system (IX), Diseases of the respiratory system (X), Mental and behavioural disorders (V), Diseases of the nervous system (VI), Diseases of the eye and adnexa (VII), Diseases of the ear or mastoid process (VIII), Diseases of the digestive system (XI), Diseases of the genitourinary system (XIV), Pregnancy, childbirth or the puerperium (XV), Certain conditions originating in the perinatal period (XVI), Congenital malformations, deformations and chromosomal abnormalities (XVII), Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified (XVIII), Other
On which diseases or conditions were the data collected? : []
Collects mortality data? : Yes, with cause of death
Administrative information about the Project
Status of the ethics committee approval : Not specified
Overall Project status : Not specified
Participants enrolled by invitation? : Not specified
Start date : Not specified
End date : Not specified
Mono- or multicentric? : Not specified
Number of centers : Not specified
One or more data providers? : One data provider
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : []
Inclusion criteria : informed consent; diagnosis of axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA); start of a new therapy with b/tsDMARD (treatment group) or start of conventional treatment (control group)
Exclusion criteria : Not specified
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : disease-modifying anti-rheumatic drugs (DMARDs)
Type of the exposure : Drug (including placebo)
Additional information about the exposure : Any approved drug for the treatment of axial spondyloarthritis or psoriatic arthritis
Name(s) of the group(s) associated with the given exposure : conventional-synthetic (cs) DMARD; biologic (b) DMARD; biosimilar (bs) DMARD, targeted-synthetic (ts) DMARD
Outcome measures in the Project
Name of the outcome measure(*) : Effectiveness
Description of the outcome measure : Effectiveness: measured by disease activity scores, inflammation, and patient reported outcomes
Type of the outcome measure : Primary
Time point(s) of assessment : regularly at 3, 6 and 12 month and then semiannually up to 10 years
Name of the outcome measure(*) : Safety
Description of the outcome measure : any adverse and serious adverse events following DMARD initiation including death
Type of the outcome measure : Primary
Time point(s) of assessment : regularly at 3, 6 and 12 month and then semiannually up to 10 years plus spontaneous reporting
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : Physical activity, Tobacco use, Body weight, Body height, Waist circumference, Body Mass Index, Sociodemographic information
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : 10 years after termination of the project
Criteria for data access : There is no standardized routine to access the data.
Additional information about data sharing : There have been numerous national and international collaborations in which data of the registry were utilized for the conduct of combined analysis. The scientific advisory board may be approached via the PIs to suggest research questions or collaborations.
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : 10
Unit of time(*) : Years
Number of follow-ups conducted : 21
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

Annotated Properties

Topic annotations

Pharmacovigilance

RABBIT-SpA: Disease Register for Axial Spondyloarthritis and Psoriatic Arthritis

Related items