IEI patient with arthritis with joint swelling
Conditions
Interventions
Protocol treatment will begin with Phase I, with activity assessed every 12 weeks, and if the goal (>=50% reduction in CDAI from baseline assessment) is not achieved, the patient will be moved to the
after 36 weeks, patients will continue on the DMARDs they were receiving at the primary endpoint, until a final evaluation at 52 weeks.
The primary endpoint will be CDAI at 36 weeks after initiation
after 36 weeks, patients will continue on the DMARDs they were receiving at the primary endpoint, with a final evaluation at 52 weeks.
Sponsors
Yasuda Shinsuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who meet the diagnostic criteria for each IEI disease *Refer to the diagnostic criteria for primary immunodeficiency syndrome (designated intractable disease 65) prepared by the Ministry of Health, Labour and Welfare, the "Guide to Primary Immunodeficiency Syndrome, Revised Second Edition" by the Japanese Society for Immunodeficiency and Autoinflammatory diseases (ed.), and other sources for diagnostic criteria. 2) Patients presenting with arthritis with one or more swollen joints who have an inadequate response to NSAIDs (symptoms and findings remain, and the improvement in patient pain VAS and physician general VAS with NSAIDs administration should be less than 70% (comparing before and after introduction of NSIADs) 3) Patients who are at least 18 years of age at the time consent is obtained. 4) Patients who have given their written consent to participate in this clinical study.
Exclusion criteria
Exclusion criteria: 1) Patients with serious complications 2) Patients with active infections requiring systemic treatment 3) Patients on corticosteroids at doses exceeding 7.5 mg prednisolone (PSL) equivalent per day 4) Patients who are carriers of hepatitis B virus (unless treatment with antiviral drugs has been initiated) 5) Patients with suspected latent tuberculosis infection (unless treatment with isoniazid or rifampicin has been started) 6) Pregnant women or patients who may be pregnant. 7) Other patients who are deemed inappropriate to participate in this study by the investigator(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CDAI(Clinical Disease Activity Index) | — |
Secondary
| Measure | Time frame |
|---|---|
| SDAI(Simplified Disease Activity Index) Percentage of adverse events | — |
Contacts
Public ContactHirokazu Sasaki
Institute of Science Tokyo Hospital
Outcome results
None listed