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CompletedNCT00883129SLSIIUpdated Feb 10, 2017Results posted

Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)

A Phase 2 interventional study of Mycophenolate mofetil and Cyclophosphamide in Scleroderma and Interstitial Lung Disease, sponsored by Michael Roth. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-10.

Sponsored by Michael Roth · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Scleroderma
  • Interstitial Lung Disease

Keywords

  • Systemic Sclerosis
  • Mycophenolate Mofetil
  • Cyclophosphamide
  • High Resolution Computerized Tomography
  • Pulmonary Function
  • Dyspnea
  • Health Related Quality of Life
03

In context

Scleroderma, Diffuse

310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.

This study's enrollment of 142 is above the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.

Browse Scleroderma, Diffuse studies →

Lead sponsor

Michael Roth is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
  • /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 ( count less than 150,000)
  • Clinically significant anemia (less than 10g/dl)
  • Baseline liver function test (LFTs) or more than 1.5 times the , 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 for > 5 years and who has not had a hysterectomy and/or oophorectomy), failure to employ two reliable means of (which may include surgical sterilization, barrier methods, spermicidals, intrauterine devices, and/or hormonal contraception).
  • Use of 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)
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
142 participants (actual)

Study arms

  • Experimental
    Mycophenolate Arm

    Participants will receive oral mycophenolate mofetil for 2 years.

    Drug: Mycophenolate mofetil

  • Experimental
    Cyclophosphamide Arm

    Participants will receive oral cyclophosphamide for 1 year, followed by placebo for 1 year.

    Drug: Cyclophosphamide · Drug: Placebo

Interventions

  • DrugMycophenolate mofetil

    24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated

    Also known as: CellCept

  • DrugCyclophosphamide

    12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated

    Also known as: Cytoxan

  • DrugPlacebo

    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.

    Also known as: Sugar Pill

06

What researchers measure

Primary outcomes

  1. Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value

    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.

    Time frame: Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24

Secondary outcomes

  1. Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value

    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.

    Time frame: Measured at study entry and Months 6, 12, 18, and 24

  2. Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value

    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.

    Time frame: Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24

  3. Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT)

    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.

    Time frame: Measured at baseline and Month 24

  4. Transitional Dyspnea Index Score

    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.

    Time frame: Measured at Months 6, 12, 18, and 24

  5. Health-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI)

    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.

    Time frame: Measured at study entry and Months 3, 6, 9, 12, 15, 18, 21, and 24

  6. Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS)

    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.

    Time frame: Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24

  7. Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death

    Time frame: Measured throughout the 2-year study

  8. Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure.

    The number of participants who remained in the study at the listed time points are reported

    Time frame: Continuous assessment from randomization to 24 months

07

Results

Posted Feb 10, 2017
Limitations and caveats
While the rate of premature withdrawal from taking study drug was significant, this was anticipated in the study design and addressed by the sample size and the use of the mixed model statistical analysis.

Participant flow

Recruitment was carried out between September 28, 2009, and January 14, 2013, at 14 University Medical Centers within the United States.

Participant flow — Overall Study
MilestoneMycophenolate ArmCyclophosphamide Arm
Started6973
Completed4937
Not completed2036
Withdrew: Adverse event715
Withdrew: Withdrawal by subject89
Withdrew: Non-compliance36
Withdrew: Lost to follow-up12
Withdrew: Death12
Withdrew: Defined treatment failure02

Outcome measures

PrimaryForced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value

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.

Time frame:
Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24
Reported as:
Mean · FVC %-pred
Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value
FVC %-predMycophenolate ArmCyclophosphamide Arm
Baseline66.52 (64.55 to 68.49)66.52 (64.22 to 68.82)
Month 366.22 (64.08 to 69.42)67.03 (64.64 to 69.42)
Month 668.02 (65.55 to 70.49)67.86 (65.27 to 70.45)
Month 968.11 (65.55 to 70.67)69.42 (66.34 to 72.50)
Month 1268.43 (65.48 to 71.38)69.86 (66.82 to 72.90)
Month 1569.84 (67.14 to 72.54)71.94 (68.40 to 75.48)
Month 1870.57 (67.57 to 73.57)72.57 (69.53 to 75.61)
Month 2170.87 (67.91 to 73.83)72.55 (69.18 to 75.92)
Month 2469.65 (66.53 to 72.77)70.15 (66.88 to 73.42)
Statistical analysis
  • Mycophenolate Arm vs Cyclophosphamide Arm · Mixed Models Analysis · p = 0.24 (The threshold for statistical significance was a P-Value of \</=0.05.)
  • Mycophenolate Arm vs Cyclophosphamide Arm · Mixed Models Analysis · p = <0.05 (The threshold for statistical significance was a P-Value of \</=0.05.)
  • Mycophenolate Arm vs Cyclophosphamide Arm · Fisher Exact · p = 0.55 (The threshold for statistical significance was a P-Value of \</=0.05.)
SecondaryTotal Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value

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.

Time frame:
Measured at study entry and Months 6, 12, 18, and 24
Reported as:
Mean · TLC %-pred
Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value
TLC %-predMycophenolate ArmCyclophosphamide Arm
Baseline66.16 (63.74 to 68.58)65.49 (62.72 to 68.26)
Month 667.84 (65.35 to 70.33)67.39 (64.30 to 70.48)
Month 1267.31 (64.45 to 70.17)68.25 (64.93 to 71.57)
Month 1868.50 (65.45 to 71.55)69.63 (65.65 to 73.61)
Month 2468.24 (64.99 to 71.49)66.97 (63.42 to 70.52)
Statistical analysis
  • Mycophenolate Arm vs Cyclophosphamide Arm · Mixed Models Analysis · p = >0.05 (The threshold for statistical significance was a P-Value of \</=0.05.)
SecondarySingle-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value

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.

Time frame:
Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24
Reported as:
Mean · DLCO %-pred
Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value
DLCO %-predMycophenolate ArmCyclophosphamide Arm
Baseline53.99 (51.35 to 56.63)54.05 (50.80 to 57.30)
Month 353.38 (50.48 to 56.28)51.92 (48.34 to 55.50)
Month 654.86 (51.27 to 58.45)50.87 (46.84 to 56.28)
Month 954.13 (50.50 to 57.76)51.55 (47.09 to 56.01)
Month 1255.32 (51.31 to 59.33)53.12 (48.38 to 57.86)
Month 1557.77 (54.20 to 61.34)53.62 (48.29 to 58.95)
Month 1856.62 (52.84 to 60.40)55.9 (50.82 to 60.98)
Month 2155.47 (51.39 to 59.55)54.26 (49.29 to 59.23)
Month 2455.31 (51.64 to 58.98)52.90 (48.71 to 57.09)
Statistical analysis
  • Mycophenolate Arm vs Cyclophosphamide Arm · Mixed Models Analysis · p = <0.001 (The threshold for statistical significance was a P-Value of \</=0.05.)
  • Mycophenolate Arm · Mixed Models Analysis · p = >0.05 (The threshold for statistical significance was a P-Value of \</=0.05.)
SecondaryFibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT)

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.

Time frame:
Measured at baseline and Month 24
Reported as:
Mean · % of lung exhibiting QLF
Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT)
% of lung exhibiting QLFMycophenolate ArmCyclophosphamide Arm
Baseline8.25 (6.58 to 9.92)8.91 (7.26 to 10.56)
Month 247.99 (6.14 to 9.84)8.48 (6.33 to 10.63)
Statistical analysis
  • Mycophenolate Arm · Mixed Models Analysis · p = >0.05 (The threshold for statistical significance was a P-Value of \</=0.05.)
SecondaryTransitional Dyspnea Index Score

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.

Time frame:
Measured at Months 6, 12, 18, and 24
Reported as:
Mean · Transitional Dyspnea Index Score
Transitional Dyspnea Index Score
Transitional Dyspnea Index ScoreMycophenolate ArmCyclophosphamide Arm
Month 60.74 (-0.07 to 1.55)0.31 (-0.43 to 1.05)
Month 121.17 (0.23 to 2.11)1.23 (0.14 to 2.32)
Month 180.91 (-0.01 to 1.83)1.78 (0.47 to 3.09)
Month 241.86 (0.62 to 3.10)2.09 (0.80 to 3.38)
Statistical analysis
  • Mycophenolate Arm · Mixed Models Analysis · p = >0.05 (The threshold for statistical significance was a P-Value of \</=0.05.)
  • Mycophenolate Arm vs Cyclophosphamide Arm · Mixed Models Analysis · p = <0.05 (The threshold for statistical significance was a P-Value of \</=0.05.)
SecondaryHealth-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI)

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.

Time frame:
Measured at study entry and Months 3, 6, 9, 12, 15, 18, 21, and 24
Reported as:
Mean · HAQ-DI Total Score
Health-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI)
HAQ-DI Total ScoreMycophenolate ArmCyclophosphamide Arm
Baseline0.71 ± 0.620.74 ± 0.73
Month 30.83 ± 0.720.64 ± 0.67
Month 60.75 ± 0.710.58 ± 0.65
Month 90.66 ± 0.660.65 ± 0.62
Month 120.64 ± 0.670.56 ± 0.60
Month 150.58 ± 0.620.62 ± 0.63
Month 180.55 ± 0.550.55 ± 0.66
Month 210.65 ± 0.650.48 ± 0.53
Month 240.62 ± 0.690.57 ± 0.68
SecondarySkin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS)

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.

Time frame:
Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24
Reported as:
Mean · mRSS score
Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS)
mRSS scoreMycophenolate ArmCyclophosphamide Arm
Baseline15.32 (12.85 to 17.79)14.04 (11.58 to 16.50)
Month 316.03 (13.44 to 18.62)12.85 (10.17 to 15.53)
Month 614.37 (11.75 to 16.99)11.95 (9.27 to 14.63)
Month 914.33 (11.62 to 17.04)10.61 (8.27 to 12.95)
Month 1212.45 (10.05 to 14.85)9.47 (7.35 to 11.59)
Month 1512.43 (10.08 to 14.78)9.80 (7.66 to 11.94)
Month 1811.98 (9.48 to 14.48)9.87 (7.60 to 12.14)
Month 2111.22 (8.74 to 13.70)8.50 (6.19 to 10.81)
Month 2411.40 (8.91 to 13.89)7.87 (5.85 to 9.89)
Statistical analysis
  • Mycophenolate Arm vs Cyclophosphamide Arm · Mixed Models Analysis · p = >0.05 (The threshold for statistical significance was a P-Value of \</=0.05.)
  • Mycophenolate Arm vs Cyclophosphamide Arm · Mixed Models Analysis · p = <0.05 (The threshold for statistical significance was a P-Value of \</=0.05.)
  • Mycophenolate Arm vs Cyclophosphamide Arm · Fisher Exact · p = >0.05 (The threshold for statistical significance was a P-Value of \</=0.05.)
SecondaryToxicity, as Measured by Adverse Events, Serious Adverse Events, and Death
Time frame:
Measured throughout the 2-year study
Reported as:
Count of participants · Participants
Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death
ParticipantsMycophenolate ArmCyclophosphamide Arm
Leukopenia (<2.5x10^3 WBC/microliter)430
Neutropenia (<1.0x10^3 neutrophils/microliter)37
Anemia (Hgb <10 g/dl)813
Thrombocytopenia (<100x10^3 platelets/microliter)04
Hematuria (>10 RBC/high power field)32
Pneumonia54
SAE-Total2722
SAE-related to treatment37
Deaths511
Statistical analysis
  • Mycophenolate Arm vs Cyclophosphamide Arm · Fisher Exact · p = <0.05 (The threshold for statistical significance was a P-Value of \</=0.05.)The threshold for statistical significance was met only for the frequency of leukopenia and thrombocytopenia, but not for total SAE or death.
SecondaryTolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure.

The number of participants who remained in the study at the listed time points are reported

Time frame:
Continuous assessment from randomization to 24 months
Reported as:
Count of participants · Participants
Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure.
ParticipantsMycophenolate ArmCyclophosphamide Arm
Baseline6973
Month 36664
Month 65856
Month 95551
Month 125246
Month 155244
Month 184942
Month 214939
Month 244938
Statistical analysis
  • Mycophenolate Arm vs Cyclophosphamide Arm · Log Rank · p = 0.019 (The threshold for statistical significance was a P-Value of \</=0.05.)

Adverse events

Collected over Randomization to withdrawal from taking study drug or completion of the 24 month treatment protocol.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mycophenolate Arm—27/69 (39.1%)68/69 (98.6%)
Cyclophosphamide Arm—22/73 (30.1%)71/73 (97.3%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventMycophenolate ArmCyclophosphamide Arm
CardiacCardiac disorders8/698/73
Respiratory EventsRespiratory, thoracic and mediastinal disorders7/695/73
Respiratory InfectionInfections and infestations2/697/73
MusculoskeletalMusculoskeletal and connective tissue disorders4/693/73
GastrointestinalGastrointestinal disorders2/694/73
CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/691/73
Syncope and SeizureNervous system disorders2/690/73
Elective SurgerySurgical and medical procedures2/690/73
HematologicBlood and lymphatic system disorders1/692/73
Renal and BladderRenal and urinary disorders1/691/73
Most frequent other events
Showing 10 of 20
Most frequent other events
EventMycophenolate ArmCyclophosphamide Arm
Infections and InfestationsInfections and infestations52/6957/73
GastrointestinalGastrointestinal disorders47/6940/73
Respiratory and ThoracicRespiratory, thoracic and mediastinal disorders46/6945/73
Blood and LymphaticBlood and lymphatic system disorders20/6947/73
Skin and Subcutaneous TissueSkin and subcutaneous tissue disorders35/6943/73
Musculoskeletal and Connective TissueMusculoskeletal and connective tissue disorders34/6934/73
GeneralGeneral disorders31/6933/73
Renal and UrinaryRenal and urinary disorders26/6927/73
Metabolism and NutritionMetabolism and nutrition disorders11/6922/73
VascularVascular disorders19/6922/73

Baseline characteristics

Age, Continuous
Age, Continuous(years)Mycophenolate ArmCyclophosphamide ArmTotal
Mean52.6 ± 9.752.0 ± 9.852.3 ± 9.7
Sex: Female, Male
Sex: Female, Male(Participants)Mycophenolate ArmCyclophosphamide ArmTotal
Female4857105
Male211637
Duration of scleroderma
Duration of scleroderma(years)Mycophenolate ArmCyclophosphamide ArmTotal
Mean2.6 ± 1.72.5 ± 1.82.6 ± 1.8
Limited cutaneous scleroderma
Limited cutaneous scleroderma(Participants)Mycophenolate ArmCyclophosphamide ArmTotal
Count of participants263359
Diffuse cutaneous scleroderma
Diffuse cutaneous scleroderma(Participants)Mycophenolate ArmCyclophosphamide ArmTotal
Count of participants434083
modified-Rodnan Skin Score
modified-Rodnan Skin Score(Score)Mycophenolate ArmCyclophosphamide ArmTotal
Mean15.3 ± 10.414.0 ± 10.614.7 ± 10.5
FVC %-predicted
FVC %-predicted(Percent of predicted normal value)Mycophenolate ArmCyclophosphamide ArmTotal
Mean66.5 ± 9.166.5 ± 8.366.5 ± 9.9
FEV1/FVC %-predicted
FEV1/FVC %-predicted(Percent of predicted normal value)Mycophenolate ArmCyclophosphamide ArmTotal
Mean81.0 ± 5.583.3 ± 5.682.6 ± 5.6

14 further baseline measures are reported on the registry.

08

Study locations

14 sites
  • David Geffen School of Medicine at UCLA
    Los Angeles, California 90095, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • National Jewish Health
    Denver, Colorado 80206, United States
  • Georgetown University School of Medicine
    Washington, District of Columbia 20057, United States
  • Feinberg School of Medicine, Northwestern University
    Chicago, Illinois 60611, United States
  • University of Illinois at Chicago, College of Medicine
    Chicago, Illinois 60612, United States
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21205, United States
  • Boston University School of Medicine
    Boston, Massachusetts 02118, United States
  • University of Michigan Medical School
    Ann Arbor, Michigan 48109, United States
  • University of Minnesota
    Minneapolis, Minnesota 55454, United States
  • University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School
    New Brunswick, New Jersey 08854, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • University of Texas Medical School at Houston
    Houston, Texas 77225, United States
  • University of Utah
    Salt Lake City, Utah 84132, United States
09

References and documents

Publications

  • 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. PubMed 18620121 ↗
  • 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. PubMed 17124698 ↗
  • 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. PubMed 18162112 ↗
  • 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. PubMed 19197956 ↗
  • 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. PubMed 19286849 ↗
  • 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. PubMed 21050542 ↗
  • 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. PubMed 21531236 ↗
  • 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. PubMed 21547897 ↗
  • 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. PubMed 21618205 ↗
  • 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. PubMed 21927793 ↗
  • 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. PubMed 22156609 ↗
  • 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. PubMed 16790698 ↗
  • 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. PubMed 15692967 ↗
  • 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. PubMed 17469162 ↗
  • 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. PubMed 17485423 ↗
  • 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. PubMed 17717203 ↗
  • 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. PubMed 17901414 ↗
  • 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. PubMed 18641099 ↗
  • 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. PubMed 19776222 ↗
  • 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. PubMed 19892673 ↗
  • 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. PubMed 20740615 ↗
  • 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. PubMed 33350170 ↗
  • 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. PubMed 31430058 ↗
  • 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. PubMed 30651141 ↗
  • 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. PubMed 29099620 ↗
  • 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. PubMed 28544580 ↗
  • 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. PubMed 28038680 ↗
  • 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. PubMed 28012804 ↗
  • 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. PubMed 27469583 ↗
  • 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. PubMed 25452309 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00883129
Lead sponsor
Michael Roth
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Hoffmann-La Roche
Responsible party
Michael Roth (Professor, Division of Pulmonary & Critical Care; Vice Chairman for Research Compliance, University of California, Los Angeles) — Sponsor-investigator
First posted
Apr 17, 2009
Start date
Sep 2009
Primary completion
Jan 2015
Completion
Nov 2015
Results posted
Feb 10, 2017
Last update
Feb 10, 2017

Study contacts

Donald P. Tashkin, MD
principal investigator · University of California, Los Angeles
Robert M. Elashoff, PhD
principal investigator · UCLA School of Public Health
Michael D. Roth, MD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Mycophenolic Acid · Cyclophosphamide

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