Rheumatoid Arthritis - Observation of Biologic Therapies

First published 01/02/2024

Last updated 09/03/2026

Data source

Human

Disease registry

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The data source contains the following information

Disease information Does the data source collect information with a focus on a specific disease? This might be a patient registry or other similar initiatives.: Yes

Disease details: Rheumatoid arthritis

Disease details, other: Disease information for rheumatoid arthritis: Disease activity measured by the DAS28 score (DAS28-ESR and DAS28-CRP) and CDAI (clinical disease activity index) and SDAI (simplified disease activity index). Functional status measured by the FFbH (Funktionsfragebogen Hannover) which can be transformed into HAQ values. Joint counts, joint surgeries, sleep disturbancies, level of fatigue, patient global).

Rare diseases Are rare diseases captured? In the European Union a rare disease is one that affects no more than 5 people in 10,000.: Yes

Pregnancy and/or neonates Does the data source collect information on pregnant women and/or neonatal subpopulation (under 28 days of age)?: Yes

Hospital admission and/or discharge: Yes

ICU admission Is information on intensive care unit admission available?: Yes

Cause of death: Captured

Cause of death vocabulary: MedDRA

Prescriptions of medicines: Captured

Dispensing of medicines: Not Captured

Advanced therapy medicinal products (ATMP) Is information on advanced therapy medicinal products included? A medicinal product for human use that is either a gene therapy medicinal product, a somatic cell therapy product or a tissue engineered products as defined in Regulation (EC) No 1394/2007 [Reg (EC) No 1394/2007 Art 1(1)].: No

Contraception Is information on the use of any type of contraception (oral, injectable, devices etc.) available?: No

Indication for use Does the data source capture information on the therapeutic indication for the use of medicinal products?: Captured

Indication vocabulary: MedDRA

Medical devices Is information on medicinal devices (e.g., pens, syringes, inhalers) available?: No

Administration of vaccines: Yes

Procedures Does the data source capture information on procedures (e.g., diagnostic tests, therapeutic, surgical interventions)?: Captured

Procedures vocabulary: ICD-10

MedDRA

Clinical measurements Is information on clinical measurements (e.g., BMI, blood pressure, height) available?: Yes

Healthcare provider Is information on the person providing healthcare (e.g., physician, pharmacist, specialist) available? The healthcare provider refers to individual health professionals or a health facility organisation licensed to provide health care diagnosis and treatment services including medication, surgery and medical devices.: Yes

Genetic data Are data related to genotyping, genome sequencing available?: Not Captured

Biomarker data Does the data source capture biomarker information? The term “biomarker” refers to a broad subcategory of medical signs ( objective indications of medical state observed from outside the patient), which can be measured accurately and reproducibly. For example, haematological assays, infectious disease markers or metabolomic biomarkers.: Captured

Biomarker data vocabulary: Other

Biomarker vocabulary, other: lab values, free text.

Patient-reported outcomes Is information on patient-reported outcomes (e.g., quality of life) available?: Yes

Patient-generated data Is patient-generated information (e.g., from wearable devices) available?: Yes

Units of healthcare utilisation Are units of healthcare utilisation (e.g., number of visits to GP per year, number of hospital days) available or can they be derived? Units of healthcare utilisation refer to the quantification of the use of services for the purpose of preventing or curing health problems.: No

Unique identifier for persons Are patients uniquely identified in the data source?: Yes

Diagnostic codes: Captured

Diagnosis / medical event vocabulary: ICD-10

MedDRA

SNOMED

Medicinal product information: Captured

Medicinal product information collected: Brand name

Dosage regime

Dose

Route of administration

Medicinal product vocabulary: Not coded (Free text)

Quality of life measurements: Captured

Quality of life measurements vocabulary: SF-36

Lifestyle factors: Captured

Lifestyle factors collected: Alcohol use

Tobacco use

Sociodemographic information: Captured

Sociodemographic information collected: Age

Education level

Gender

Living in rural area

Other