Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease
- Conditions
- Interstitial lung disease related to rheumatoid arthritis
- Registration Number
- JPRN-UMIN000010126
- Lead Sponsor
- Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 34
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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