- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00883129
Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II) (SLSII)
Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- David Geffen School of Medicine at UCLA
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Colorado
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Denver, Colorado, United States, 80206
- National Jewish Health
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District of Columbia
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Washington, District of Columbia, United States, 20057
- Georgetown University School of Medicine
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Illinois
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Chicago, Illinois, United States, 60611
- Feinberg School of Medicine, Northwestern University
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago, College of Medicine
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston University School of Medicine
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Medical School
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Minnesota
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Minneapolis, Minnesota, United States, 55454
- University of Minnesota
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New Jersey
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New Brunswick, New Jersey, United States, 08854
- University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Texas
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Houston, Texas, United States, 77225
- University of Texas Medical School at Houston
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The presence of either limited (cutaneous thickening distal but not proximal to elbows and knees, with or without facial involvement) or diffuse (cutaneous thickening proximal to elbows and knees, often involving the chest or abdomen) scleroderma, as determined by American College of Rheumatology criteria
- Dyspnea on exertion (grade 2 on the Magnitude of Task component of the Mahler Modified Dyspnea Index)
- FVC less than or equal to 80 percent of predicted value at screening and less than or equal to 85 percent predicted at baseline
- Onset of the first non-Raynaud manifestation of SSc within the prior 84 months
- Presence of any ground glass opacification on thoracic high resolution computerized tomography (HRCT)
- Repeat FVC at the baseline visit (Visit 2) within 10 percent of the FVC measured at screening and less than or equal to 85 percent predicted.
Exclusion Criteria:
- FVC less than 45 percent of predicted value at either screening or baseline
- Carbon monoxide diffusing capacity (DLCO) (HBg-corrected) less than 30 percent of predicted value and less than 40 percent of predicted when documentation of pulmonary artery pressures by echocardiogram, right heart catheterization or magnetic resonance imaging identifies clinically significant pulmonary hypertension. All participants with a DLCO less than 40 percent predicted must have documentation of pulmonary artery pressures in order to be considered for inclusion.
- FEV1/FVC ratio less than 65 percent at either screening or baseline
- Clinically significant abnormalities on HRCT not attributable to scleroderma
- Diagnosis of clinically significant resting pulmonary hypertension requiring treatment, as ascertained before study evaluation or as part of a standard of care clinical assessment performed outside of the study protocol
- Persistent unexplained hematuria (more than 10 red blood cells per high-power field [RBCs/hpf])
- History of persistent leukopenia (white blood cell count less than 4000) or thrombocytopenia (platelet count less than 150,000)
- Clinically significant anemia (less than 10g/dl)
- Baseline liver function test (LFTs) or bilirubin more than 1.5 times the upper limit of normal, other than that due to Gilbert's disease
- Concomitant and present use of captopril
- Serum creatinine more than 2.0mg/dL
- Uncontrolled congestive heart failure
- Pregnancy (documented by urine pregnancy test) and/or breast feeding
- Prior use of oral CYC or MMF for more than 8 weeks or the receipt of more than two intravenous doses of CYC in the past
- Use of CYC and/or MMF in the 30 days before random assignment
- Active infection (lung or elsewhere) whose management would be compromised by CYC or MMF
- Other serious concomitant medical illness (e.g., cancer), chronic debilitating illness (other than scleroderma), or unreliability or drug abuse that might compromise the patient's participation in the study
- Current use, or use within the 30 days prior to random assignment, of prednisone (or equivalent) in doses of more than 10 mg/day
- If of child bearing potential (a female participant <55 years of age who has not been postmenopausal for > 5 years and who has not had a hysterectomy and/or oophorectomy), failure to employ two reliable means of contraception (which may include surgical sterilization, barrier methods, spermicidals, intrauterine devices, and/or hormonal contraception).
- Use of contraindicated medications; more information on this criterion can be found in the study protocol
- Smoking of cigars, pipes, or cigarettes in the 6 months before study entry
- Use of medications with putative disease-modifying properties within the past month (e.g., D-penicillamine, azathioprine, methotrexate, Potaba)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Mycophenolate Arm
Participants will receive oral mycophenolate mofetil for 2 years.
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24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated
Other Names:
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Experimental: Cyclophosphamide Arm
Participants will receive oral cyclophosphamide for 1 year, followed by placebo for 1 year.
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12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated
Other Names:
12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value
Time Frame: Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24
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The primary outcome is the course over time from baseline to 24 months for the FVC %-predicted.
The FVC %-predicted represents the adjusted volume of air (adjusted as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity) that can be forcibly exhaled from the lungs after taking the deepest breath possible.
The FVC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of lung involvement and disease severity.
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Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value
Time Frame: Measured at study entry and Months 6, 12, 18, and 24
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The TLC represents the total volume of air within the lung after taking the deepest breath possible and the TLC %-predicted represents the TLC expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity.
The TLC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.
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Measured at study entry and Months 6, 12, 18, and 24
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Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value
Time Frame: Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24
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The DLCO is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLCO %-predicted represents the DLCO expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity.
The DLCO %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.
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Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24
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Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT)
Time Frame: Measured at baseline and Month 24
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Imaging of the whole lung (WL) is performed using a volumetric high resolution computerized tomography (HRCT) scan, which is then analyzed using a computer algorithm to determine the percentage of overall pixels exhibiting features characteristic for quantitative lung fibrosis (QLF).
Higher percentages for QLF-WL therefore represent greater involvement by lung fibrosis.
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Measured at baseline and Month 24
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Transitional Dyspnea Index Score
Time Frame: Measured at Months 6, 12, 18, and 24
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Change in breathlessness was assessed using the Transitional Dyspnea Index, which compares current symptoms to those at baseline.
Total score ranges from - 9 to + 9.
The lower the score, the more deterioration in severity of dyspnea.
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Measured at Months 6, 12, 18, and 24
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Health-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: Measured at study entry and Months 3, 6, 9, 12, 15, 18, 21, and 24
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The HAQ-DI asks questions related to 8 activity domains (dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities) with the patient's capacity to carry out each activity scored from 0 to 3. Scores across all domains are averaged and a higher score represents greater disability.
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Measured at study entry and Months 3, 6, 9, 12, 15, 18, 21, and 24
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Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS)
Time Frame: Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24
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Skin thickness is quantified using the modified Rodnan measurement method (mRSS), with a scale that ranges from 0 (no skin involvement) to a maximum of 51.
The reported skin score is determined by a clinical assessment of skin thickness, which is performed by a trained reader, and represents the sum of individual assessments that are made in each of 17 body areas.
Each area is given a score in the range of 0-3 (0 = normal; 1= mild thickness; 2 = moderate; 3 = severe thickness).
A higher score represents more severe skin involvement.
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Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24
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Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death
Time Frame: Measured throughout the 2-year study
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Measured throughout the 2-year study
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Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure.
Time Frame: Continuous assessment from randomization to 24 months
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The number of participants who remained in the study at the listed time points are reported
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Continuous assessment from randomization to 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Donald P. Tashkin, MD, University of California, Los Angeles
- Principal Investigator: Robert M. Elashoff, PhD, UCLA School of Public Health
- Principal Investigator: Michael D. Roth, MD, University of California, Los Angeles
Publications and helpful links
General Publications
- Elashoff RM, Li G, Li N. A joint model for longitudinal measurements and survival data in the presence of multiple failure types. Biometrics. 2008 Sep;64(3):762-771. doi: 10.1111/j.1541-0420.2007.00952.x. Epub 2007 Dec 20.
- Tashkin DP, Elashoff R, Clements PJ, Goldin J, Roth MD, Furst DE, Arriola E, Silver R, Strange C, Bolster M, Seibold JR, Riley DJ, Hsu VM, Varga J, Schraufnagel DE, Theodore A, Simms R, Wise R, Wigley F, White B, Steen V, Read C, Mayes M, Parsley E, Mubarak K, Connolly MK, Golden J, Olman M, Fessler B, Rothfield N, Metersky M; Scleroderma Lung Study Research Group. Cyclophosphamide versus placebo in scleroderma lung disease. N Engl J Med. 2006 Jun 22;354(25):2655-66. doi: 10.1056/NEJMoa055120.
- Khanna D, Clements PJ, Volkmann ER, Wilhalme H, Tseng CH, Furst DE, Roth MD, Distler O, Tashkin DP. Minimal Clinically Important Differences for the Modified Rodnan Skin Score: Results from the Scleroderma Lung Studies (SLS-I and SLS-II). Arthritis Res Ther. 2019 Jan 16;21(1):23. doi: 10.1186/s13075-019-1809-y.
- Kafaja S, Clements PJ, Wilhalme H, Tseng CH, Furst DE, Kim GH, Goldin J, Volkmann ER, Roth MD, Tashkin DP, Khanna D. Reliability and minimal clinically important differences of forced vital capacity: Results from the Scleroderma Lung Studies (SLS-I and SLS-II). Am J Respir Crit Care Med. 2018 Mar 1;197(5):644-652. doi: 10.1164/rccm.201709-1845OC. Epub 2017 Nov 3.
- Namas R, Tashkin DP, Furst DE, Wilhalme H, Tseng CH, Roth MD, Kafaja S, Volkmann E, Clements PJ, Khanna D; Participants in the Scleroderma Lung Study I and members of the Scleroderma Lung Study II Research Group. Efficacy of Mycophenolate Mofetil and Oral Cyclophosphamide on Skin Thickness: Post Hoc Analyses From Two Randomized Placebo-Controlled Trials. Arthritis Care Res (Hoboken). 2018 Mar;70(3):439-444. doi: 10.1002/acr.23282. Epub 2018 Feb 9.
- Tashkin DP, Volkmann ER, Tseng CH, Kim HJ, Goldin J, Clements P, Furst D, Khanna D, Kleerup E, Roth MD, Elashoff R. Relationship between quantitative radiographic assessments of interstitial lung disease and physiological and clinical features of systemic sclerosis. Ann Rheum Dis. 2016 Feb;75(2):374-81. doi: 10.1136/annrheumdis-2014-206076. Epub 2014 Dec 1.
- Kim HJ, Li G, Gjertson D, Elashoff R, Shah SK, Ochs R, Vasunilashorn F, Abtin F, Brown MS, Goldin JG. Classification of parenchymal abnormality in scleroderma lung using a novel approach to denoise images collected via a multicenter study. Acad Radiol. 2008 Aug;15(8):1004-16. doi: 10.1016/j.acra.2008.03.011.
- Elashoff RM, Li G, Li N. An approach to joint analysis of longitudinal measurements and competing risks failure time data. Stat Med. 2007 Jun 30;26(14):2813-35. doi: 10.1002/sim.2749.
- Li N, Elashoff RM, Li G. Robust joint modeling of longitudinal measurements and competing risks failure time data. Biom J. 2009 Feb;51(1):19-30. doi: 10.1002/bimj.200810491.
- Hant FN, Ludwicka-Bradley A, Wang HJ, Li N, Elashoff R, Tashkin DP, Silver RM; Scleroderma Lung Study Research Group. Surfactant protein D and KL-6 as serum biomarkers of interstitial lung disease in patients with scleroderma. J Rheumatol. 2009 Apr;36(4):773-80. doi: 10.3899/jrheum.080633. Epub 2009 Mar 13.
- Kim HG, Tashkin DP, Clements PJ, Li G, Brown MS, Elashoff R, Gjertson DW, Abtin F, Lynch DA, Strollo DC, Goldin JG. A computer-aided diagnosis system for quantitative scoring of extent of lung fibrosis in scleroderma patients. Clin Exp Rheumatol. 2010 Sep-Oct;28(5 Suppl 62):S26-35. Epub 2010 Nov 3.
- Furst DE, Tseng CH, Clements PJ, Strange C, Tashkin DP, Roth MD, Khanna D, Li N, Elashoff R, Schraufnagel DE; Scleroderma Lung Study. Adverse events during the Scleroderma Lung Study. Am J Med. 2011 May;124(5):459-67. doi: 10.1016/j.amjmed.2010.12.009.
- Roth MD, Tseng CH, Clements PJ, Furst DE, Tashkin DP, Goldin JG, Khanna D, Kleerup EC, Li N, Elashoff D, Elashoff RM; Scleroderma Lung Study Research Group. Predicting treatment outcomes and responder subsets in scleroderma-related interstitial lung disease. Arthritis Rheum. 2011 Sep;63(9):2797-808. doi: 10.1002/art.30438.
- Khanna D, Tseng CH, Farmani N, Steen V, Furst DE, Clements PJ, Roth MD, Goldin J, Elashoff R, Seibold JR, Saggar R, Tashkin DP. Clinical course of lung physiology in patients with scleroderma and interstitial lung disease: analysis of the Scleroderma Lung Study Placebo Group. Arthritis Rheum. 2011 Oct;63(10):3078-85. doi: 10.1002/art.30467.
- Kim HJ, Brown MS, Elashoff R, Li G, Gjertson DW, Lynch DA, Strollo DC, Kleerup E, Chong D, Shah SK, Ahmad S, Abtin F, Tashkin DP, Goldin JG. Quantitative texture-based assessment of one-year changes in fibrotic reticular patterns on HRCT in scleroderma lung disease treated with oral cyclophosphamide. Eur Radiol. 2011 Dec;21(12):2455-65. doi: 10.1007/s00330-011-2223-2. Epub 2011 Sep 17.
- Theodore AC, Tseng CH, Li N, Elashoff RM, Tashkin DP. Correlation of cough with disease activity and treatment with cyclophosphamide in scleroderma interstitial lung disease: findings from the Scleroderma Lung Study. Chest. 2012 Sep;142(3):614-621. doi: 10.1378/chest.11-0801.
- Khanna D, Clements PJ, Furst DE, Chon Y, Elashoff R, Roth MD, Sterz MG, Chung J, FitzGerald JD, Seibold JR, Varga J, Theodore A, Wigley FM, Silver RM, Steen VD, Mayes MD, Connolly MK, Fessler BJ, Rothfield NF, Mubarak K, Molitor J, Tashkin DP; Scleroderma Lung Study Group. Correlation of the degree of dyspnea with health-related quality of life, functional abilities, and diffusing capacity for carbon monoxide in patients with systemic sclerosis and active alveolitis: results from the Scleroderma Lung Study. Arthritis Rheum. 2005 Feb;52(2):592-600. doi: 10.1002/art.20787.
- Khanna D, Yan X, Tashkin DP, Furst DE, Elashoff R, Roth MD, Silver R, Strange C, Bolster M, Seibold JR, Riley DJ, Hsu VM, Varga J, Schraufnagel DE, Theodore A, Simms R, Wise R, Wigley F, White B, Steen V, Read C, Mayes M, Parsley E, Mubarak K, Connolly MK, Golden J, Olman M, Fessler B, Rothfield N, Metersky M, Clements PJ; Scleroderma Lung Study Group. Impact of oral cyclophosphamide on health-related quality of life in patients with active scleroderma lung disease: results from the scleroderma lung study. Arthritis Rheum. 2007 May;56(5):1676-84. doi: 10.1002/art.22580.
- Clements PJ, Roth MD, Elashoff R, Tashkin DP, Goldin J, Silver RM, Sterz M, Seibold JR, Schraufnagel D, Simms RW, Bolster M, Wise RA, Steen V, Mayes MD, Connelly K, Metersky M, Furst DE; Scleroderma Lung Study Group. Scleroderma lung study (SLS): differences in the presentation and course of patients with limited versus diffuse systemic sclerosis. Ann Rheum Dis. 2007 Dec;66(12):1641-7. doi: 10.1136/ard.2007.069518. Epub 2007 May 7.
- Tashkin DP, Elashoff R, Clements PJ, Roth MD, Furst DE, Silver RM, Goldin J, Arriola E, Strange C, Bolster MB, Seibold JR, Riley DJ, Hsu VM, Varga J, Schraufnagel D, Theodore A, Simms R, Wise R, Wigley F, White B, Steen V, Read C, Mayes M, Parsley E, Mubarak K, Connolly MK, Golden J, Olman M, Fessler B, Rothfield N, Metersky M, Khanna D, Li N, Li G; Scleroderma Lung Study Research Group. Effects of 1-year treatment with cyclophosphamide on outcomes at 2 years in scleroderma lung disease. Am J Respir Crit Care Med. 2007 Nov 15;176(10):1026-34. doi: 10.1164/rccm.200702-326OC. Epub 2007 Aug 23.
- Strange C, Bolster MB, Roth MD, Silver RM, Theodore A, Goldin J, Clements P, Chung J, Elashoff RM, Suh R, Smith EA, Furst DE, Tashkin DP; Scleroderma Lung Study Research Group. Bronchoalveolar lavage and response to cyclophosphamide in scleroderma interstitial lung disease. Am J Respir Crit Care Med. 2008 Jan 1;177(1):91-8. doi: 10.1164/rccm.200705-655OC. Epub 2007 Sep 27.
- Goldin JG, Lynch DA, Strollo DC, Suh RD, Schraufnagel DE, Clements PJ, Elashoff RM, Furst DE, Vasunilashorn S, McNitt-Gray MF, Brown MS, Roth MD, Tashkin DP; Scleroderma Lung Study Research Group. High-resolution CT scan findings in patients with symptomatic scleroderma-related interstitial lung disease. Chest. 2008 Aug;134(2):358-367. doi: 10.1378/chest.07-2444. Epub 2008 Jul 18.
- Khanna D, Tseng CH, Furst DE, Clements PJ, Elashoff R, Roth M, Elashoff D, Tashkin DP; for Scleroderma Lung Study Investigators. Minimally important differences in the Mahler's Transition Dyspnoea Index in a large randomized controlled trial--results from the Scleroderma Lung Study. Rheumatology (Oxford). 2009 Dec;48(12):1537-40. doi: 10.1093/rheumatology/kep284. Epub 2009 Sep 23.
- Goldin J, Elashoff R, Kim HJ, Yan X, Lynch D, Strollo D, Roth MD, Clements P, Furst DE, Khanna D, Vasunilashorn S, Li G, Tashkin DP. Treatment of scleroderma-interstitial lung disease with cyclophosphamide is associated with less progressive fibrosis on serial thoracic high-resolution CT scan than placebo: findings from the scleroderma lung study. Chest. 2009 Nov;136(5):1333-1340. doi: 10.1378/chest.09-0108.
- Au K, Mayes MD, Maranian P, Clements PJ, Khanna D, Steen VD, Tashkin D, Roth MD, Elashoff R, Furst DE. Course of dermal ulcers and musculoskeletal involvement in systemic sclerosis patients in the scleroderma lung study. Arthritis Care Res (Hoboken). 2010 Dec;62(12):1772-8. doi: 10.1002/acr.20320.
- Assassi S, Li N, Volkmann ER, Mayes MD, Runger D, Ying J, Roth MD, Hinchcliff M, Khanna D, Frech T, Clements PJ, Furst DE, Goldin J, Bernstein EJ, Castelino FV, Domsic RT, Gordon JK, Hant FN, Shah AA, Shanmugam VK, Steen VD, Elashoff RM, Tashkin DP. Predictive Significance of Serum Interferon-Inducible Protein Score for Response to Treatment in Systemic Sclerosis-Related Interstitial Lung Disease. Arthritis Rheumatol. 2021 Jun;73(6):1005-1013. doi: 10.1002/art.41627. Epub 2021 Apr 20.
- Kim GHJ, Tashkin DP, Lo P, Brown MS, Volkmann ER, Gjertson DW, Khanna D, Elashoff RM, Tseng CH, Roth MD, Goldin JG. Using Transitional Changes on High-Resolution Computed Tomography to Monitor the Impact of Cyclophosphamide or Mycophenolate Mofetil on Systemic Sclerosis-Related Interstitial Lung Disease. Arthritis Rheumatol. 2020 Feb;72(2):316-325. doi: 10.1002/art.41085. Epub 2019 Dec 26.
- Volkmann ER, Tashkin DP, Roth MD, Clements PJ, Khanna D, Furst DE, Mayes M, Charles J, Tseng CH, Elashoff RM, Assassi S. Changes in plasma CXCL4 levels are associated with improvements in lung function in patients receiving immunosuppressive therapy for systemic sclerosis-related interstitial lung disease. Arthritis Res Ther. 2016 Dec 30;18(1):305. doi: 10.1186/s13075-016-1203-y.
- Tashkin DP, Volkmann ER, Tseng CH, Roth MD, Khanna D, Furst DE, Clements PJ, Theodore A, Kafaja S, Kim GH, Goldin J, Ariolla E, Elashoff RM. Improved Cough and Cough-Specific Quality of Life in Patients Treated for Scleroderma-Related Interstitial Lung Disease: Results of Scleroderma Lung Study II. Chest. 2017 Apr;151(4):813-820. doi: 10.1016/j.chest.2016.11.052. Epub 2016 Dec 22.
- Tashkin DP, Roth MD, Clements PJ, Furst DE, Khanna D, Kleerup EC, Goldin J, Arriola E, Volkmann ER, Kafaja S, Silver R, Steen V, Strange C, Wise R, Wigley F, Mayes M, Riley DJ, Hussain S, Assassi S, Hsu VM, Patel B, Phillips K, Martinez F, Golden J, Connolly MK, Varga J, Dematte J, Hinchcliff ME, Fischer A, Swigris J, Meehan R, Theodore A, Simms R, Volkov S, Schraufnagel DE, Scholand MB, Frech T, Molitor JA, Highland K, Read CA, Fritzler MJ, Kim GHJ, Tseng CH, Elashoff RM; Sclerodema Lung Study II Investigators. Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related interstitial lung disease (SLS II): a randomised controlled, double-blind, parallel group trial. Lancet Respir Med. 2016 Sep;4(9):708-719. doi: 10.1016/S2213-2600(16)30152-7. Epub 2016 Jul 25.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Respiratory Tract Diseases
- Connective Tissue Diseases
- Lung Diseases
- Scleroderma, Systemic
- Scleroderma, Diffuse
- Lung Diseases, Interstitial
- Scleroderma, Localized
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cyclophosphamide
- Mycophenolic Acid
Other Study ID Numbers
- 632
- R01HL089901 (U.S. NIH Grant/Contract)
- R01HL089758 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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University of AarhusAarhus University HospitalNot yet recruitingProgressive Fibrosing Interstitial Lung DiseaseDenmark
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West Virginia UniversityNot yet recruitingProgressive Fibrosing Interstitial Lung DiseaseUnited States
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Saglik Bilimleri UniversitesiRecruitingTelerehabilitation | Fibrosing Interstitial Lung DiseaseTurkey
Clinical Trials on Mycophenolate mofetil
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University of GiessenNovartis; Hoffmann-La Roche; Astellas Pharma Inc; Heidelberg UniversityCompletedPolyomavirus InfectionsGermany
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Novartis PharmaceuticalsCompletedRenal TransplantationUnited States
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Nanjing University School of MedicineCompletedNephritis | Henoch-Schoenlein PurpuraChina
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Children's Hospital of Fudan UniversityShanghai Children's Hospital; Shanghai Children's Medical Center; Xinhua Hospital...WithdrawnSteroid-Dependent Nephrotic Syndrome | Frequently Relapsing Nephrotic SyndromeChina
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Nanjing University School of MedicineCompletedVasculitis | Anti-Neutrophil Cytoplasmic AntibodyChina
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Teva Branded Pharmaceutical Products R&D, Inc.ParexelTerminatedStable Renal Transplant Recipients
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Panacea Biotec LtdCompletedHealthy VolunteersIndia
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Panacea Biotec LtdCompletedHealthy VolunteersIndia
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Fred Hutchinson Cancer CenterUniversity of WashingtonCompleted
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Samsung Medical CenterUnknown