Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis, unspecified
Conditions
Interventions
The study is observational, meaning that we are just looking at how arthritis responds to standard therapy in patients, rather than testing the effects of new treatments. Patients who have been diagno
Sponsors
King's College London (UK)
Guy's & St Thomas' Foundation NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 10/06/2015: Disease remission at 6 months will be the primary outcome and this will be measured using either the long established DAS28 criterion (DAS28 score <2.6) or the Simplified Disease Activity Index (SDAI) = 3.3, or the new ACR/EULAR 2010 remission criteria: 1. Swollen joint count =1 2. Tender joint count = 1 3. CRP = 1 (mg/dl) 4. Patient global = 1 (on a 1 to 10 scale) Previous primary outcome measures: Disease remission at 6 months will be the primary outcome and this will be measured using both the long established DAS28 criterion (DAS28 score <2.6) and the new ACR/EULAR remission criteria: 1. Swollen joint count =1 2. Tender joint count = 1 3. CRP = 1 (mg/dl) 4. Patient global = 1 (on a 1 to 10 scale) 5. Simplified Disease Activity Index (SDAI) = 3.3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Extended (66/68) Joint Count DAS28 2. Simple Disease Activity Score (SDAI) 3. Clinical Disease Activity Score (CDAI) 4. Health Assessment Questionnaire (HAQ) scores 5. EQ5D scores 6. SF-36 7. Radiographic progression of hands and feet X-rays scored by Larsen?s or van der Heijde Sharpe Modified Scores 8. Disease remission (as defined in primary outcome measure) at 12 and 18 months 9. Immune signatures derived from the analysis of biological samples | — |
Countries
United Kingdom
Outcome results
None listed