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

Phase 2

• Conditions: Health Condition 1: L948- Other specified localized connective tissue disorders

• Registration Number: CTRI/2023/04/051790
• Lead Sponsor: PGIMER pharmacy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Exclusion Criteria

1.Modified Rodnan Skin Score (mRSS) <7 at baseline visit

2.FVC <=60% or DLCO <=50%

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 ( <1000/mm3) or thrombocytopenia ( <100,000/mm3)

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 <=4 weeks prior to baseline visit

19.Life expectancy of <3 years for disease other than the underlying CTD in investigator assessment

20.Other serious co-morbidities which could compromise the patientâ??s ability to complete the study

21.Allergy/hypersensitivity to medication or its constituents

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in modified Rodnan skin score (mRSS) at week 24Timepoint: 1.Change in modified Rodnan skin score (mRSS) at week 24