RABBIT (Rheumatoid Arthritis - Observation of Biologic Therapies)

Overview
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RABBIT is the German register for the long-term observation of therapy with biologics, biosimilars and Janus kinase (JAK) inhibitors in adult patients with rheumatoid arthritis. The project was initiated in 2001 by the German Rheumatology Research Center (DRFZ) in coordination with the German Society for Rheumatology, the Professional Association of German Rheumatologists and the Competence Network Rheumatology. RABBIT is involved in international research and co-operates with other European registers. The RABBIT register is supported by a scientific advisory board and a research partner in the Rheumaliga. The RABBIT register is supported by long-term shared funding from various manufacturers of innovative drugs. The DRFZ has full academic freedom in conducting the register and publishing the results.

Programme: Programme Area 2 - Epidemiology and Health Services Research

SEEK ID: https://ldh.drfz.imise.uni-leipzig.de/projects/2

Public web page: https://biologika-register.de/en/

NFDI4Health PALs: No PALs for this Project

Project start date: 1st May 2001

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource : Study

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

Title/name : Rheumatoid Arthritis - Observation of Biologic Therapies
Language of the title/name : English

Acronym(s) of the Project

Acronym : RABBIT
Language of the acronym : German

Description(s) of the Project

Description : RABBIT is the German register for the long-term observation of therapy with biologics, biosimilars and Janus kinase (JAK) inhibitors in adult patients with rheumatoid arthritis. The project was initiated in 2001 by the German Rheumatology Research Center (DRFZ) in coordination with the German Society for Rheumatology, the Professional Association of German Rheumatologists and the Competence Network Rheumatology. RABBIT is involved in international research and co-operates with other European registers.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Rheumatoid arthritis

Keyword(*) : longitudinal

Keyword(*) : cohort study

Keyword(*) : disease-modifying anti-rheumatic drugs (DMARDs)

Keyword(*) : effectiveness

Keyword(*) : safety

Language(s) of the project : German

Web page of the project : https://biologika-register.de

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(*) : Anja
Family name(s)(*) : Strangfeld
Digital identifier(s)
Identifier(*) : 0000-0002-6233-022X
Scheme(*) : ORCID
Email address : strangfeld@drfz.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : German Rheumatology Research Center
Address : Charitéplatz 1, 10117 Berlin
Web page : https://www.drfz.de/forschung/programmbereich-2/
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : DRKS
Identifier(*) : DRKS00031523

Type of the registry(*) : Not specified
Identifier(*) : Not specified

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, Trend, Longitudinal
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Rheumatoid arthritis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M05
Primary health condition or disease name(*) : Rheumatoid arthritis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M06
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Certain infectious or parasitic diseases (I), Neoplasms (II), Diseases of the blood or blood-forming organs and certain disorders involving the immune mechanism (III), Endocrine, nutritional and metabolic diseases (IV), Mental and behavioural disorders (V), Diseases of the nervous system (VI)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Yes, vital status only (cause of death missing)
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (II): Recruitment and data collection ongoing
Participants enrolled by invitation? : Not applicable
Start date : 1 May 2001
End date : Not specified
Mono- or multicentric? : Multicentric
Number of centers : 400
One or more data providers? : Not specified
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 : Male, Female, Diverse
Inclusion criteria : At least one DMARD failure; start of new DMARD; age at onset of disease >= 16 years; specification of the no. of ACR criteria 1987
Exclusion criteria : Change of diagnosis
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 rheumatoid 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, 12, and then every 6 months 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, 12, and then every 6 months up to 10 years after DMARD initiation and by additional spontaneous reporting
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : Physical activity, Tobacco use, Body weight, Body height, 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? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
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 : Prospective
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 : None retained
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

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Pharmacovigilance

RABBIT (Rheumatoid Arthritis - Observation of Biologic Therapies)

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