Health Condition 1: L948- Other specified localized connective tissue disorders
Conditions
Interventions
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 My
Sponsors
PGIMER pharmacy
Eligibility
Inclusion criteria
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 3. Modified Rodnan Skin Score (mRSS) >=7 at baseline 4. Consenting for participating in study 5. Oral corticosteroids ( 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
Exclusion criteria
Exclusion criteria: 1. Modified Rodnan Skin Score (mRSS) 2. FVC 3. Severe pulmonary arterial hypertension (mPAP >55mmHg) requiring drug therapy 4. Active infection 5. Pregnant or breast feeding females 6. Prednisone > 10 mg/day 7. Treatment with methotrexate, azathioprine, mycophenolate mofetil in last 30 days 8. Treatment with cyclophosphamide or rituximab in last 6 months 9. Major surgery (including joint surgery) within 8 weeks prior to baseline visit 10. Major surgical procedures planned to occur during trial period 11. Neutropenia ( 12. Serum creatinine >2 ULN 13. Serum ALT or AST >2 ULN 14. Positive for hepatitis B surface antigen prior to the baseline visit 15. Positive for hepatitis C antigen prior to the baseline visit 16. Patient with a history of cardiovascular disease (stroke, myocardial infarction, peripheral vascular disease) 17. Patient with a history of venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) 18. Immunization with a live/attenuated vaccine within 19. Life expectancy of 20. Other serious co-morbidities which could compromise the patientâ??s ability to complete the study 21. Allergy/hypersensitivity to medication or its constituents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in modified Rodnan skin score (mRSS) at week 24Timepoint: 1.Change in modified Rodnan skin score (mRSS) at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Index at 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 | — |
Countries
India
Contacts
Public ContactDr Joban Preet Singh Deol
PGIMER, Chandigarh
Outcome results
None listed