Rheumatoid arthritis related interstitial lung disease
Conditions
Interventions
Study setting will be outpatient rheumatology clinic, Teaching hospital, Karapitiya
Participants will be subject to base line screening tests including pulmonary function test (Forced vital capacity
Sponsors
Teaching Hospital Karapitiya
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients above 18 years of age 2. Both male and female 3. Patients who full fill the American College of Rheumatology (ACR) /European League Against Rheumatism Collaborative initiative (ACR /EULAR) criteria for the diagnosis of rheumatoid arthritis. 4. Patients with interstitial lung disease, which are diagnosed either based on surgical lung biopsy or radiologically with use of HRCT. 5. Patients with abnormal diffusing capacity for carbon monoxide (DLCO) and Forced vital capacity (FVC) <85% predicted. 6. Low disease activity or remission of arthritis, based on disease activity score calculated by using Disease Activity (DAS 28), without treatment of methotrexate or leflunomide three months prior to the screening
Exclusion criteria
Exclusion criteria: 1. Prior use of oral MMF for more than 4 weeks. 2. Patients with clinical evidence of interstitial lung disease, having other connective tissue disorders other than rheumatoid arthritis 3. Patients with significant pulmonary pathology on CXR or HRCT, other than interstitial lung disease (eg. lung mass or evidence of active or chronic pulmonary infection). 4. Patients with pulmonary hypertension requiring specific treatment 5. patients with evidence of acute infection either in lung or anywhere of the body, whose management would be compromised by either azathioprine or MMF 6. Patients who are having contraindications or allergic reactions to MMF or azathioprine on previous exposure. 7. History of persistent leukopenia (white blood cell count < 4000/mm3) or thrombocytopenia (platelet count<100) 8. Pregnancy (documented by urine pregnancy test) and breast feeding 9. Smoking of cigars, pipes or cigarettes during the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in FVC (expressed in mL) and DLCO from baseline (point of recruitment) [At baseline 14 months after initiating of therapy] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in diffusing capacity for carbon monoxide (DLCO) at 6 and12 months of treatment initiation. [At baseline and then at 6 months and 12 months after initiating the treatment] Change from baseline in Forced Vital Capacity (FVC) at 6 and 12 months of treatment initiation. [ At baseline and then at 6 months and 12 months after initiating the treatment] Change in 6-minute walk distance after 6 and 12 months of treatment initiation. [ At baseline and then at 6 months and 12 months after initiating the treatment] Assessment of improvement in quality of life by using SF-36 [ At baseline and then at 6 months and 12 months after initiating the treatment] | — |
Countries
Sri Lanka
Contacts
Public ContactDr Kalum Deshapriya
Consultant Rheumatologist
Outcome results
None listed