Rheumatoid arthritis
Conditions
Interventions
Discontinuation of infliximab
Sponsors
Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 18 years or older 2) RA patients who fulfill 2010 ACR/EULAR Classification Criteria 3) Patients who have been treated with infliximab (Remicade) for 26 weeks or longer 4) DAS28 (CRP) < 3.2 at screening 5) Patients who give written informed consent after receiving sufficient information
Exclusion criteria
Exclusion criteria: 1) Receiving prednisolone > 10 mg/day 2) Receiving biological or molecular-target anti-rheumatic drug 3) Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior to screening visit 4) Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to screening visit 5) History of infusion reaction to infliximab 6) Current infection which requires treatment 7) Current or previous demyelinating disorder 8) Current congestive heart failure which requires treatment 9) Breast-feeding or pregnant/possibly pregnant woman, or woman who does not agree to prevent conception during and 6 months after study period 10) Patients whom investigator or co-investigator consider inappropriate for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in diagnostic value (AUC of ROC) to predict relapse between DAS28 and total PD score at baseline | — |
Countries
Japan
Contacts
Public ContactKei Ikeda
Chiba University Hospital Department of Allergy and Clinical Immunology
Outcome results
None listed