rheumatism rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
CaRE Arthritis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 18 years of age or older; • RA according to the 2010 Rheumatoid Arthritis Classification Criteria; • Joint symptoms for >= 3 months prior to screening; • DAS44 > 2.4; • About to start DMARD therapy (methotrexate, salazopyrin, hydroxychloroquine, chloroquine, leflunomide) or - increased dose of methotrexate by >=10 mg weekly to a maximum dose of 25mg weekly (if already receiving >15mg will require add-on DMARD/anti-TNF or switch to alternative DMARD), - add-on of alternative DMARD, - switch to alternative DMARD, - start of first anti-TNFa agent (adalimumab, etanercept, infliximab, certolizumab pegol, golimumab); • If already on DMARD therapy this has been stable for the 3 months prior to the baseline visit; • If already on systemic steroid, dose must be stable (prednisone
Exclusion criteria
Exclusion criteria: • Intra-articular steroid injection within 4 weeks prior to the baseline visit; • Prior treatment with anti-TNFa or other biological agent (rituximab, abatacept, tocilizumab); • Malignancy within past 5 years (other than basal cell carcinoma that has been adequately treated or excised, squamous cell cancer of the skin, and cervical carcinoma in situ); • A serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >= 3 times the upper limit of normal; • A serum creatinine level >150 µmoles/liter or an estimated creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic joint progression according to the modified Sharp/Van der Heijde score (SHS) (range of 0-448) assessed on radiographs of the hands and feet obtained at baseline and after 6 months of follow up on standard DMARD therapy or combination DMARD/anti-TNF therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radiographic progression according to the SHS after 1 year of follow up on standard DMARD or combination DMARD/anti-TNF therapy. 2. Radiographic progression according to the SHS after 2 years of follow up on standard DMARD or combination DMARD/anti-TNF therapy. 3. Radiographic progression as assessed by only the SHS erosion score (range 0-280). 4. 3-month change in biomarker level from baseline following the introduction of standard DMARD therapy. 5. 3-month change in biomarker level from baseline following the introduction of methotrexate monotherapy. 6. 3-month change in biomarker level from the start of a change in standard DMARD therapy. 7. 3-month change in biomarker level from the start of treatment with combination DMARD/anti-TNFa therapy. 8. 6-month change in biomarker level from baseline following the introduction of standard DMARD therapy. 9. 6-month change in biomarker level from the start of a change in standard DMARD therapy. 10. 6-month change in biomarker level from the start of treatment with combination DMARD/anti-TNFa therapy. 11. Corresponding changes in DAS44, swollen joint count, tender joint count, patient pain NRS, patient global NRS, physician global NRS, HAQ, ESR, CRP, Hb, Platelet count, IgM-RF etc. | — |
Countries
Netherlands
Outcome results
None listed