Effectiveness of mycophenolate mofetil vs azathioprin on progression of rheumatoid arthritis related interstitial lung disease in patients followed up at the rheumatology clinic, Teaching Hospital Karapitiya – a randomized controlled trial

Phase 4

Conditions: Rheumatoid arthritis related interstitial lung disease

Registration Number: SLCTR/2018/031

Lead Sponsor: Teaching Hospital Karapitiya

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete: follow up continuing

Sex: Not specified

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute change in FVC (expressed in mL) and DLCO from baseline (point of recruitment) [At baseline 14 months after initiating of therapy]<br>

Secondary Outcome Measures

Name	Time	Method
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]<br>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]<br>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]<br>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]<br>