]>
IRCT2016022126686N1 IRCT 2016-08-12 Aryogen pharmed Evaluation the efficacy of Rituximab (Zytux) in diffuse cutaneous Systemic sclerosis treatment Evaluation the clinical trial of Rituximab (Zytux) efficacy in improving the skin stiffness and lung involvements of the patients with diffuse cutaneous Systemic sclerosis with diffuse skin involvement 2016-07-22 anticipated 20 Complete https://irct.ir/trial/22047 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This project is designed in clinical trial without randomization and blindness. It is a before and after clinical trial. 3 Systemic sclerosis (Scleroderma). The Zytux which is Rituximab biosimilar with the Iran insurance approval will be administered intravenously with the dosage of 1 gram on the beginning of the treatment, followed by an other 1 gram in two weeks in the hospital. Before the administration, 10 milliliter diphenhydramin and 100 milligram hydrocortisone will be administered to the patients. All of the administrating processes will be under the monitoring..
public Kourosh Sheikh Ahmadi
Number 6, Kargar avenue, Shariati hospital, Rheumatology research center
Tehran Iran (Islamic Republic of) +98 21 8822 0065 maadarya@yahoo.com Rheumatology research center scientific Farhad Gharibdoost
Number 6, Kargar avenue, Shariati hospital, Rheumatology research center
Tehran Iran (Islamic Republic of) +98 21 8822 0065 gharibdoost@sina.tums.ac.ir; f_gharibdoost@hotmail.com; h-kavosi@sina.tums.ac.ir Rheumatology research center Iran (Islamic Republic of) 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. no limit no limit Both M34.8 systemic sclerosis with lung involvementJ99.1* Treatment - Drugs The Zytux which is Rituximab biosimilar with the Iran insurance approval will be administered intravenously with the dosage of 1 gram on the beginning of the treatment, followed by an other 1 gram in two weeks in the hospital. Before the administration, 10 milliliter diphenhydramin and 100 milligram hydrocortisone will be administered to the patients. All of the administrating processes will be under the monitoring. 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. 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. Aryogen pharmed Approved 2015-12-21 Technology and research management center of Tehran University of Medical Sciences Number 6, Keshavarz boulevard, Ghods avenue, the central department of Tehran University of Medical Sciences Tehran Iran (Islamic Republic of)