The TACERA Study: a longitudinal observational study of patients with early rheumatoid arthritis

King's College London (UK)0 个研究点目标入组 267 人开始时间: 2012年10月5日最近更新: 2020年8月17日

适应症

试验速览

•1. Patients should fulfill either 1987 ACR or 2010 ACR/EULAR classification criteria for diagnosis of early RA
•2. Positive for serum rheumatoid factor and anti-citrullinated protein autoantibodies (ACPA)
•3. Within 6 months of symptom onset
•4. Supervising rheumatologist considers that starting therapy with Disease-modifying antirheumatic drugs (DMARDs) is appropriate
•5. At least 18 years of age
•6. Able and willing to give informed consent to provide clinical data and blood samples at defined time points for the duration of the study

•1. Previous treatment with DMARDs or biologics
•2. Corticosteroid treatment for the current episode of inflammatory arthritis within the last 6 months (patients with a previous episode of inflammatory arthritis treated with corticosteroids more than 6 months before screening will be permitted providing this episode was not ongoing)
•3. Use of intramuscular steroid injections between the first clinic attendance (when the diagnosis of RA is made) and study entry
•4. Significant co-morbidities (e.g. severe congestive heart failure, renal, hepatic, malignant disease), as judged by the supervising physician
•5. Pregnant or wishing to conceive
•6. Participating in trials of investigational medicinal products or devices, or other interventions (e.g. exercise) which may have an impact on the patient?s treatment, immune status or disease activity

发起方

King's College London (UK)