Date

2019-11-06

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

<br>Study setting will be outpatient rheumatology clinic, Teaching hospital, Karapitiya</br> <br>Participants will be subject to base line screening tests including pulmonary function test (Forced vital capacity (FVC) and carbon monoxide diffusion capacity (DLCO)) and high resolution computerized tomography chest (HRCT) to identify the radiological pattern and to assess the extent of lung fibrosis.</br> Following basic investigations, participants will be subject to stratified randomization based on gender, predominant HRCT pattern, and lung disease severity. Permuted block design will be applied to each stratum for 1:1 allocation of two groups. Route of drug administration will be oral Mycophenolate mofetil (MMF) treatment group will receive a MMF 250mg bd dosage initially and will be titrated up to 2g/daily or maximum tolerating dose over a period of eight weeks. Azathioprine treatment group will be given azathioprine 50mg daily at the beginning, increasing up to 2mg/kg or maximum tolerating dose over an eight weeks period. Both groups will be given prednisolone 0.5mg/kg up to a maximum dose of 25mg for the initial three months period which will be gradually tailed off over a three month period. This is an open label study. Therefore no one will be blinded.

Next Version

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 (FVC) and high-resolution computerized tomography chest (HRCT) to identify the radiological pattern and to assess the extent of lung fibrosis. (Encountered multiple episodes of machinery failure in performing DLCO. Investigators decided to continue the trial without DLCO parameter to maintain the quality of study.) Following basic investigations, participants will be subject to stratified randomization based on gender, predominant HRCT pattern, and lung disease severity. Permuted block design will be applied to each stratum for 1:1 allocation of two groups. Route of drug administration will be oral Mycophenolate mofetil (MMF) treatment group will receive a MMF 250mg bd dosage initially and will be titrated up to 2g/daily or maximum tolerating dose over a period of eight weeks. Azathioprine treatment group will be given azathioprine 50mg daily at the beginning, increasing up to 2mg/kg or maximum tolerating dose over an eight weeks period. Both groups will be given prednisolone 0.5mg/kg up to a maximum dose of 25mg for the initial three months period which will be gradually tailed off over a three-month period. This is an open label study. Therefore no one will be blinded.