Interstitial lung disease related to rheumatoid arthritis
Conditions
Interventions
In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to
Sponsors
Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria to be eligible for this study. 1. Fulfill the 2010 ACR/EULAR classification criteria for RA 2. Aged 20 years or older 3. Have newly developed or recurrent RA-related ILD, which is categorized as either UIP, NSIP or OP pattern based on HRCT findings. A patient who meets either of the following conditions. 1)A patient with newly developed RA-related ILD which is categorized as either UIP or NSIP pattern based on HRCT findings 2)A patient with recurrent ILD (a patient must fulfill both i. and ii.) i. A patient has a history of RA-related ILD which was categorized as either UIP or NSIP pattern based on previous image findings (HRCT is preferable) ii. A patient has exacerbation of ILD or ILD is considered to be active based on HRCT findings. 3)A patient with newly developed RA-related ILD which is categorized as an OP pattern based on HRCT findings. 4)A patient with recurrent RA-related ILD which is categorized as an OP pattern based on HRCT findings.
Exclusion criteria
Exclusion criteria: A patient who has any of the following conditions will be excluded from this study. 1. When a patient has acute exacerbation of interstitial lung disease (when a patient has acutely progressive bilateral lung infiltration and is considered to be inappropriate for the study entry by the attending physician) 2. When a patient has pulmonary hemorrhage 3. When a patient is considered to require positive pressure ventilation (positive pressure ventilation via endotracheal intubation or noninvasive positive pressure ventilation) 4. When a patient is diagnosed as having active respiratory infection or drug-induced pneumonia 5. In a case with ILD of UIP or NSIP pattern, when tacrolimus is contraindicated or a patient has ever treated with tacrolimus for ILD before 6. In a case with ILD of OP pattern, both MTX and tacrolimus are contraindicated or a patient has ever treated by either MTX or tacrolimus for ILD 7. When a patient is considered to require prednisolone with the dose of more than 0.5 mg/kg/day 8. When a patient has moderate or severe pulmonary hypertension or heart failure 9. When a patient has collagen vascular disease other than rheumatoid arthritis (Sjogren's syndrome is permissible) 10. When a patient has severe organ involvement other than interstitial lung disease 11. When a patient is considered as ineligible for this study for any reason by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For cases with UIP/NSIP pattern ILD, improvement in forced vital capacity (FVC), which is defined as 10% or 200ml increase in FVC at week 24 For cases with OP pattern ILD, improvement of HRCT findings which is defined as 1 or more score improvement of Kazerooni score in affected lobes at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms related to interstitial lung disease (Borg scale, MRC dyspnoea scale, UCSD shortness of breath questionnaire), improvement of HRCT findings (Kazerooni score), pulmonary function tests (change in FVC, diffusing capacity of the lung for CO), change in a serum marker (KL-6), a relapse rate of interstitial lung disease requiring increase in the dose of corticosteroid, activity of rheumatoid arthritis(SDAI, CDAI), adverse events, infectious events | — |
Countries
Japan
Contacts
Public ContactFumio Hirano
Tokyo Medical and Dental University Department of Lifetime Clinical Immunology
Outcome results
None listed