Rheumatoid arthritis
Conditions
Interventions
Rheumatoid arthritis patients using adalimumab for at least 28 weeks and trough serum concentration of >5mg/L will be randomly assigned to dose reduction aiming a drug level of respectively 2 mg/L or
Sponsors
Reade Rheumatology Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: Rheumatoid arthritis patient, according to ACR 1987 ACR/EULAR 2010 criteria Treated for at least 28 weeks with adalimumab Adalimumab trough concentration >5mg/L 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; No other disease that might flare if adalimumab is tapered like psoriasis, inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the disease activity after dose reduction, aiming adalimumab concentration of 2 mg/L or 5 mg/L | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to evaluate whether reducing adalimumab dose aiming a concentration of 2 mg/L is superior in costs savings compared to dose tapering aiming adalimumab concentration of 5 mg/L, to evaluate the algorithm used to achieve target concentration of 2 mg/L or 5 mg/L and to study the difference in cumulative incidence of flares between the two study groups | — |
Contacts
Public ContactSadaf Atiqi
Reade
Outcome results
None listed