Clinical Trials Logo

Clinical Trial Summary

Scleroderma is a rare, long-term autoimmune disease in which normal tissue is replaced with dense, thick fibrous tissue. Normally, the immune system helps defend the body against disease and infection. In people with scleroderma, the immune system triggers fibroblast cells to produce too much of the protein collagen. The extra collagen becomes deposited in the skin and organs, causing hardening and thickening that is similar to the scarring process. Although scleroderma most often affects the skin, it also can affect other parts of the body, including the lungs, and in its most severe forms scleroderma can be life-threatening. Scleroderma-related interstitial lung disease is one example of a life-threatening scleroderma condition. In people with symptomatic scleroderma-related interstitial lung disease, scarring occurs in the delicate lung tissue, compromising lung function. The purpose of this study is to determine whether people with symptomatic scleroderma-related interstitial lung disease experience more respiratory benefits from treatment with a 2-year course of mycophenolate mofetil or treatment with a 1-year course of oral cyclophosphamide.


Clinical Trial Description

Interstitial lung disease describes a condition in which the lung tissue has become scarred or inflamed. Interstitial lung disease caused by scleroderma, specifically seen as progressive pulmonary fibrosis, occurs in approximately 40 percent of patients with scleroderma and has emerged as the leading overall cause of death.

In a previous study, the Scleroderma Lung Study I (SLS I), investigators evaluated a 1-year cyclophosphamide (CYC) treatment for people with scleroderma-related interstitial lung disease. The study results demonstrated statistically significant improvements in forced vital capacity, total lung capacity, dyspnea, Rodnan skin scores, and several measures of quality of life. However, when patients were followed for another year after completing their CYC therapy, the beneficial effects of CYC waned and were no longer significant by the 24-month follow-up. Preliminary information suggests that an alternative immunosuppressive medication, mycophenolate mofetil (MMF), may be effective in treating this disease, be given for longer periods, and result in fewer side effects.

This study, the Scleroderma Lung Study II (SLS II), will compare the safety and efficacy of a 2-year treatment with MMF versus a 1-year treatment with CYC. Specifically, investigators will determine whether MMF produces similar or better improvements in lung capacity and fewer side effects throughout the entire 2-year period.

Participation will include about 21 study visits over a 2-year period. Eligible participants will be randomly assigned to receive either MMF twice daily for 2 years or CYC once daily for 1 year, followed by placebo for 1 year. Blood and urine samples will be collected every 2 weeks for the first 2 months and then once a month for the remainder of the study. Every 3 months, participants will attend study visits that will include pulmonary function tests, blood and urine sampling, a physical exam, and questionnaires about current health and medications. At the final study visit, participants will also undergo a high resolution computerized tomography (HRCT) scan and possibly a punch biopsy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00883129
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase Phase 2
Start date September 2009
Completion date November 2015

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04905693 - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis Phase 3
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Recruiting NCT05417776 - Collagen-targeted PET Imaging for Early Interstitial Lung Disease Phase 2
Not yet recruiting NCT04089826 - Long Term Oxygen Therapy in Patients With Interstitial Lung Disease
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT00362739 - Blood Collection From Individuals With Lung Disease for Genetic Studies N/A
Recruiting NCT06133998 - Effects of Incentive Spirometry With and Without Aerobic Exercises in Interstitial Lung Disease N/A
Active, not recruiting NCT03485378 - Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease N/A
Recruiting NCT04098094 - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Recruiting NCT03400839 - Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases
Terminated NCT02633293 - An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE Phase 2/Phase 3
Enrolling by invitation NCT05001009 - Goals of Care Conversations Study N/A
Active, not recruiting NCT05068869 - Digital Outpatient Services N/A
Active, not recruiting NCT03727568 - Study Comparing Two Different Methods of Cryobiopsy in the Interstitial Lung Diseases N/A
Recruiting NCT06046547 - Integrating Palliative Care Education in Pulmonary Rehabilitation N/A
Completed NCT04946708 - Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients N/A
Recruiting NCT04139356 - The Effect of Spontaneous Respiration on Pulse-oximetry Measurements N/A
Recruiting NCT03726398 - CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH Phase 2/Phase 3
Active, not recruiting NCT03295279 - WTC Chest CT Imaging Archive
Completed NCT04435327 - Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)