Rheumatoid Arthritis
Conditions
Interventions
Observational
Sponsors
Leiden University Medical Center, Department of Rheumatology
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in the recall study, a subject must meet all of the following criteria: 1. Participant must be included in either the BeSt or IMPROVED study. 2. Participants must be capable of giving signed informed consent.
Exclusion criteria
Exclusion criteria: There are no criteria that exclude a potential subject from participation in this recall study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoints are measures of long-term outcome in RA and UA defined as: Radiological joint damage (measured by modified Sharp/van der Heijde score). Functional ability (measured by Health Assessment Questionnaire). Mortality in the separate study cohorts as compared to the general Dutch population by calculating a Standardized Mortality Ratio (SMR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints comprise of: Clinical outcome measures: including the percentage of patients that achieve LDA, remission, SDFR, and the percentage of patients who experience a disease flare after a period of clinical remission. Self-reported outcomes of functional ability and health related quality of life. Bone mineral density by DEXA of lumbar spine and hips and Vertebral Fracture Assessment (VFA) by radiologic assessment of total spine. Presence of joint prosthesis extra-articular rheumatoid manifestations as determined by physical examination and radiology. Comorbidities and toxicity as determined by medical history, laboratory tests and additional tests by indication. | — |
Contacts
Public ContactC.F. Allaart
Leiden University Medical Center (LUMC), Department of Rheumatology, C1-39, P.O. Box 9600
Outcome results
None listed