Rheumatoid arthritis
Conditions
Interventions
Rheumatoid arthritis patients treated with adalimumab will be randomly assigned to a dose reduction strategy using disease activity scores or to a dose reduction strategy using serum drug concentratio
Sponsors
Reade Rheumatology Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: Rheumatoid arthritis patient, according to ACR 1987 or ACR/EULAR 2010 criteria; Starting adalimumab as the first biological therapy Who has agreed to participate (written informed consent); Age 18 years or older.
Exclusion criteria
Exclusion criteria: Scheduled surgery during the follow-up of the study or other pre-planned reasons for treatment discontinuation; Life expectancy shorter than follow-up period of the study; Other disease that might flare if adalimumab is tapered like psoriasis, inflammatory bowel disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective is to evaluate whether adalimumab dose reduction using adalimumab serum concentration will minimize medical costs, compared to disease activity guided dose reduction in rheumatoid arthritis patients | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to investigate the percentage of patients reaching minimal disease activity (DAS28-CRP<2.9) in both study arms; to study the difference in cumulative incidence of flares between the study arms; to evaluate the algorithm used to prolong the dosing interval based on adalimumab concentration; to study the difference in cumulative incidence of flares between both arm after discontinuation of treatment after 52 weeks and 80 weeks | — |
Contacts
Public ContactSadaf Atiqi
Reade
Outcome results
None listed