Open labelled, Randomized control trial comparing upfront Rituximab and Mycophenolate Mofetil use with Mycophenolate mofetil alone in patients with Systemic sclerosis related interstitial lung disease

Rituximab and mycophenolate mofetil combination vs mycophenolate mofetil alone in patients with systemic sclerosis-ild: open label, randomized, controlled trial - RIMSI

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097773

Enrollment

Registered

2025-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M340- Progressive systemic sclerosis

Interventions

Intervention1: Rituximab plus mycophenolate mofetil combination versus mycophenolate alone: Rituximab plus MMF arm: Rituximab 2 induction doses of 1g each at day 0 and day 14 Mycophenolate mofetil fro

Eligibility

Inclusion criteria

Inclusion criteria: Age 18-60 years Diagnosed as diffuse cutaneous Systemic sclerosis (ACR classification criteria) Disease duration less than equal to 5 years Presence of ILD by HRCT criteria & PFT (predicted FVC below 80%) 5. Baseline Dyspnoea Level MMRC I & II

Exclusion criteria

Exclusion criteria: Received Rituximab or MMF before Pregnancy or breastfeeding Active systemic infections Hepatitis B or C or HIV or Active TB Autoimmune Overlap syndromes MMRC III or IV dyspnoea Moderate to severe pulmonary hypertension (mPAP by echocardiogram more than 40 mmHg) FVC of less than 45% predicted, ratio of FEV1/FVC of less than 65%, clinical evidence of substantial airflow obstruction Clinically significant abnormalities on HRCT not attributable to SSc Smoking within the past 6 months Persistent unexplained haematuria (more than 5 red blood cells per high power field); Serum creatinine more than 1.3 mg/dl or presence of scleroderma renal crisis Uncontrolled congestive heart failure Limited SSc with Anti centromere antibodies

Design outcomes

Secondary

Measure	Time frame
Progression free survival (PFS)Timepoint: 24 weeks;Cumulative doses of glucocorticoidsTimepoint: 24 weeks;Changes from baseline to 24 weeks in visual analogic scales (VAS 0-10 cm) for dyspnea and coughTimepoint: 24 weeks;Absolute change in FVC in mlTimepoint: 24 weeks;Skin score (mRSS)Timepoint: 24 weeks;6-minute walk distanceTimepoint: 24 weeks;ACR CRISS and revised CRISS responsesTimepoint: 24 weeks;Serious Adverse Events (SAE) including any infectionTimepoint: 24 weeks	—

Measure

Time frame

Progression free survival (PFS)Timepoint: 24 weeks;Cumulative doses of glucocorticoidsTimepoint: 24 weeks;Changes from baseline to 24 weeks in visual analogic scales (VAS 0-10 cm) for dyspnea and coughTimepoint: 24 weeks;Absolute change in FVC in mlTimepoint: 24 weeks;Skin score (mRSS)Timepoint: 24 weeks;6-minute walk distanceTimepoint: 24 weeks;ACR CRISS and revised CRISS responsesTimepoint: 24 weeks;Serious Adverse Events (SAE) including any infectionTimepoint: 24 weeks

—

Primary

Measure	Time frame
Difference in change in FVC%Timepoint: 24 weeks	—

Countries

India

Contacts

Public ContactMukul Preetam

Institute Of Post Graduate Medical Education And Research Kolkata

geet4in@yahoo.co.in9433514259

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026