Evaluation the efficacy of Rituximab (Zytux) in diffuse cutaneous Systemic sclerosis treatment

Phase 3

Recruiting

• Conditions: Systemic sclerosis (Scleroderma).; systemic sclerosis with lung involvementJ99.1*

• Registration Number: IRCT2016022126686N1
• Lead Sponsor: Aryogen pharmed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Inclusion Criteria: age more than 20 year old; patients with diffuse cutaneous Systemic sclerosis (SSc) with disease duration less than 7 years from the Raynaud's phenomen; modified Rodnan skin score (mRSS) more than 20; the presence of interstitial lung disease (ILD) in high resolution computed tomography (HRCT) or pulmonary function test (PFT) or both (if the ILD involvement is more than 20% it will be sufficient and in the other situation the ILD should be proved by HRCT and PFT); the mRSS should be remained unchanged after 6 months of the treatment with Endoxan or Cellcept as the previous therapy.

Exclusion Criteria

the previous history of Rituximab administration; the history of nervous system disorders like Multiple sclerosis; the history of viral hepatitis like Hepatitis B or C; the history of human immunodeficiency virus infection; the history of tuberculosis infection with PPD more than 5 millimeter; the history of malignancy; dyspnea at rest; the sign and symptoms of congestive heart failure at rest; the history of infectious diseases; the history of cardiac arhythmia on electrocardiogram; the history of prednisolone usage more than 10 mg per day; tricuspid regurgitation jet flow velocity more than 2.8; pulmonary arterial pressure more than 35 according to trans-thoracic ecocardiography; ejection fraction less than 40%; diffusion capacity of the lung for carbon monoxide less than 50%; forced vital capacity less than 50%; serum creatinine level more than 1.5; the history of scleroderma renal crisis; the history of co-morbid cardiac, pulmonary and renal diseases unrelated to SSc.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin stiffness (modified Rodnan skin score). Timepoint: Before and after 6 months of treatment. Method of measurement: The examination by fixed Rheumatologist.;Lung involvement according to ground glass opacities and lung fibrosis. Timepoint: Before and after 6 months of treatment. Method of measurement: Spirometery, diffusion capacity of the lungs for carbon monoxide, high resolution computed tomography.

Secondary Outcome Measures

Name	Time	Method
The side effects of the biosimilar drug, Zytux. Timepoint: Three and six months after treatment if any side effect will present. Method of measurement: Clinical and laboratory examination and diagnosis.