Health Condition 1: M349- Systemic sclerosis, unspecified
Conditions
Interventions
Intervention1: Prednisolone: Prednisolone at 0.25mg/kg body weight, orally at baseline, followed by decrease to 0.1 mg/kg body weight at 1 month from baseline and tapered and stopped over 3 months fro
Sponsors
Dr Anusha Jawahar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years 2. Early limited and diffuse systemic sclerosis defined as less than or equal to 5 years since the onset of skin thickening 3. Modified Rodnan skin scoring greater than or equal to 6 and lesser than or equal to 21 4. Currently on IS therapy (MMF , Methotrexate) or biological therapy which has been stable in the last 12 weeks
Exclusion criteria
Exclusion criteria: 1. Age below 18 years 2. Previous history of renal crisis or significant renal dysfunction (eGFR less than or equal to 40 ml per minute) 3. Current corticosteroid treatment or previous corticosteroid treatment in the last 6 months, except for inhaled or topical steroids 4. Major myositis defined as CPK more than 10 times upper limit of the normal or MMRC grade less than or equal to 3 in any muscle group or dysphagia 5. Severe ILD in respiratory failure , FVC less than or equal to minus 3 (Z score) 6. Uncontrolled hypertension more than or equal to 140/90mmHg on treatment 6. Pregnant or breastfeeding at the time of screening 7. Conditions as per physicians discretion where steroids may worsen the patients outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of low to moderate dose steroids in early systemic sclerosis by comparing the modified Rodnan Skin Scores between the intervention and control groups at the end of 3 monthsTimepoint: At the end of 3 months from first visit | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the Indian Cochin Hand function scale, Scleroderma HAQ and swollen , tender joint counts between the intervention and control group at the end of 3 monthsTimepoint: At the end of 3 months from baseline visit | — |
Countries
India
Contacts
Public ContactDr Vineeta Shobha
St Johns Medical College
Outcome results
None listed