A clinical trial to study the effects and safety of two drugs, Baricitinib and Mycophenolate mofetil in patients with skin thickening

INTERVENTION: Intervention1: Tablet Baricitinib 4 mg once a day, oral for 6 months: To compare the efficacy & safety of Baricitinib with Mycophenolate mofetil in systemic sclerosis Control Intervention1: Tablet Mycophenolate mofetil 1.5g twice a day, oral for 6 months: To compare the efficacy & safety of baricitinib with mycophenolate mofetil ins systemic sclerosis CONDITION: Health Condition 1: L948‐ Other specified localized connective tissue disorders PRIMARY OUTCOME: 1.Change in modified Rodnan skin score (mRSS) at week 24Timepoint: 1.Change in modified Rodnan skin score (mRSS) at week 24 SECONDARY OUTCOME: 1. To compare the change in forced vital capacity (FVC) (â??FVC) (%) in subjects with SSc‐ILD at 24 weeks ; 2. To compare the change in Quality of Life (QoL) scores by SF‐36 & dyspnea scores by Mahler Dyspnea Inde Xat 24 & 48 weeks ; 3. Change in modified Rodnan score (mRSS) at 24 & 48 weeks ; 4. Proportion of patients with clinically significant improvement in mRSS at 24 & 48 weeks ; 5. Absolute change from baseline in SGRQ total score at 24 & 48 weeks ; 6. Change in 6‐minute walking distance (â?? 6MWD) at 24 & 48 weeks ; 7. Absolute change from baseline in FVC in mL at 24 & 48 weeks ; 8. Absolute change from baseline in Indian HAQ score at 24 & 48 weeks ; 9. Change in ACR‐CRISS score at 24 & 48 weeks ; 10. Change in physician & patient global VAS at 24 & 48 weeks ; 11. All‐cause mortality at 24 & 48 weeks ; 12. Treatment related mortality at 24 & 48 weeks ; 13. Incidence of adverse effects between the two groups ; 14. Change from baseline in levels of TGF‐β, TNF‐α & IL‐6 at 24 weeks ; Timepoint: 24 and 48 weeks INCLUSION CRITERIA: 1. Patients with SSc as diagnosed by ACR 2013 criteria & patients with other connective tissue diseases who, in parallel, meet the ACR criteria for SSc (overlap syndromes) 2. Duration of SSc for <=7 years, with onset defined as the appearance of the first non‐Raynaudâ??s symptom 3. Modified Rodnan Skin Score (mRSS) >=7 at baseline 4. Consenting for participating in study 5. Oral corticosteroids (<= 10 mg/day of prednisone or equivalent) are permitted if the patient is on a stable dose regimen for 2 weeks prior to baseline visit 6. Calcium‐channel blockers, proton‐pump inhibitors, oral vasodilators and/or hydroxychloroquine are permitted if the patient is on a stable dose for >=2 weeks prior to baseline visit