Health Condition 1: D862- Sarcoidosis of lung with sarcoidosis of lymph nodes
Conditions
Interventions
Intervention1: methotrexate with prednisolone: Methotrexate with prednisolone arm:
Methotrexate 15mg weekly once for 6 months with Folic acid 5mg weekly once for 6 months with
Prednisolone at 20mg/da
Sponsors
Investigator initiated academic clinical trial
Eligibility
Inclusion criteria
Inclusion criteria: a) Participants aged 18 to 80 years b) Diagnosed cases of sarcoidosis based on cytology or histopathology c) Cases eligible for treatment (determined by the treating physician and according to existing guidelines) d) Participants can be steroid na ve or not For those who are not steroid na ve, the participant has received steroids for less than 2 months (cumulative) and should not be on steroids for at least 6 months at the time of inclusion in the study.
Exclusion criteria
Exclusion criteria: Participants at baseline, with other concomitant progressive pulmonary diseases like ILD, lung cancer etc. Participants on other immunosuppressive medications for any other reasons Pregnant and lactating females Contraindications for methotrexate therapy including liver failure, history of severe hypersensitivity reaction to methotrexate use, preexisting severe blood dyscrasias including severe anemia, leucopenia or thrombocytopenia High risk of steroid related adverse effects like Uncontrolled diabetes and unwilling to be on medications, severe osteoporosis, glaucoma, active HBV infection, recently diagnosed case of active peptic ulcer disease with history of upper gastrointestinal bleed, severe psychiatric disturbances at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Difference in the change in FVC % predicted between the two groups 2) The proportion of patients with relapseTimepoint: At 6 months and 12 months from enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Patient reported levels of response to treatment in terms of change in health status & fatigue 2)Difference in quality of life between the 2 groups 3)Time to disease relapse 4)Proportion of patients with relapse 5)Drug related adverse effects Timepoint: At the end of 6 months, 12 months & 18 months | — |
Countries
India
Contacts
Public ContactDr Karan Madan
AIIMS, New Delhi
Outcome results
None listed