rheumatoid arthritis & inflammatory arthritis
Conditions
Interventions
The intervention consists of pharmacological conditioning (variable treatment
dosage).
Sponsors
Universiteit Leiden
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult (minimum age of 18 years), recent-onset RA, fluent in Dutch, able to give informed consent, in clinical remission at month 5 after completing the protocolized pharmacological treatment.
Exclusion criteria
Exclusion criteria: - Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception. - Concomitant treatment with another experimental drug. - History or presence of malignancy within the last five years. - Bone marrow hypoplasia. - Elevated hepatic enzyme levels (ASAT, ALAT > 3 times normal value). - Serum creatinine levels > 150 umol/l or estimated creatinine clearance of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the percentage of patients who achieve a drug-free clinical remission (DAS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcome measures include the percentage of patients achieving a clinical remission, clinician- and patient-assessed clinical functioning (e.g., disease activity), laboratory assessments (e.g., cytokine levels), and self-report outcomes (e.g., side effects) following the experimental period (8 months), the tapering period (12 months), and during the end-of-study visit (16 months). Additionally, the possible influence of psychological and genetic predictors on the susceptibility to conditioning will be explored. Finally, a cost-effectiveness analysis will be performed to investigate the cost-effectiveness of the conditioning procedure compared to standard treatment. | — |
Countries
Netherlands
Outcome results
None listed