Trial · NCT00883129
Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)
NCT00883129, Phase 2, Completed, Michael Roth; results first posted 2017-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II). Trials, record NCT00883129. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00883129
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)
- NCT number
- NCT00883129
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- Michael Roth
- Conditions
- Scleroderma, Interstitial Lung Disease
- Interventions
- Mycophenolate mofetil, Cyclophosphamide, Placebo
- First posted
- 2009-04-17
- Last updated
- 2017-02-10
- Results first posted
- 2017-02-10
- 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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24 | 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. |
| Secondary | Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Measured at study entry and Months 6, 12, 18, and 24 | 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. |
| Secondary | Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24 | 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. |
| Secondary | Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT) | Measured at baseline and Month 24 | 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. |
| Secondary | Transitional Dyspnea Index Score | Measured at Months 6, 12, 18, and 24 | 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. |
| Secondary | Health-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI) | Measured at study entry and Months 3, 6, 9, 12, 15, 18, 21, and 24 | 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. |
| Secondary | Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS) | Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24 | 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. |
| Secondary | Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death | Measured throughout the 2-year study | |
| Secondary | Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure. | Continuous assessment from randomization to 24 months | The number of participants who remained in the study at the listed time points are reported |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24 | Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure | FVC %-pred | MEAN |
| SECONDARY | Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Measured at study entry and Months 6, 12, 18, and 24 | Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure | TLC %-pred | MEAN |
| SECONDARY | Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24 | Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure | DLCO %-pred | MEAN |
| SECONDARY | Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT) | Measured at baseline and Month 24 | Analysis was carried out in the subset of subjects that had measurable HRCT scans at both study entry and 24 months | % of lung exhibiting QLF | MEAN |
| SECONDARY | Transitional Dyspnea Index Score | Measured at Months 6, 12, 18, and 24 | Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure | Transitional Dyspnea Index Score | MEAN |
| SECONDARY | Health-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI) | Measured at study entry and Months 3, 6, 9, 12, 15, 18, 21, and 24 | The analysis population contains all of those with data available at the defined time point. | HAQ-DI Total Score | MEAN |
| SECONDARY | Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS) | Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24 | Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure | mRSS score | MEAN |
| SECONDARY | Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death | Measured throughout the 2-year study | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure. | Continuous assessment from randomization to 24 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Mycophenolate Arm | Baseline | 66.52 | 95% Confidence Interval 64.55 to 68.49 | FVC %-pred |
| Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Cyclophosphamide Arm | Baseline | 66.52 | 95% Confidence Interval 64.22 to 68.82 | FVC %-pred |
| Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Mycophenolate Arm | Month 3 | 66.22 | 95% Confidence Interval 64.08 to 69.42 | FVC %-pred |
| Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Cyclophosphamide Arm | Month 3 | 67.03 | 95% Confidence Interval 64.64 to 69.42 | FVC %-pred |
| Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Mycophenolate Arm | Month 6 | 68.02 | 95% Confidence Interval 65.55 to 70.49 | FVC %-pred |
| Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Cyclophosphamide Arm | Month 6 | 67.86 | 95% Confidence Interval 65.27 to 70.45 | FVC %-pred |
| Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Mycophenolate Arm | Month 9 | 68.11 | 95% Confidence Interval 65.55 to 70.67 | FVC %-pred |
| Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Cyclophosphamide Arm | Month 9 | 69.42 | 95% Confidence Interval 66.34 to 72.50 | FVC %-pred |
| Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Mycophenolate Arm | Month 12 | 68.43 | 95% Confidence Interval 65.48 to 71.38 | FVC %-pred |
| Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value | Cyclophosphamide Arm | Month 12 | 69.86 | 95% Confidence Interval 66.82 to 72.90 | FVC %-pred |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mycophenolate Arm | 69 | |
| Overall Study | STARTED | Cyclophosphamide Arm | 73 | |
| Overall Study | COMPLETED | Mycophenolate Arm | 49 | |
| Overall Study | COMPLETED | Cyclophosphamide Arm | 37 | |
| Overall Study | NOT COMPLETED | Mycophenolate Arm | 20 | |
| Overall Study | NOT COMPLETED | Cyclophosphamide Arm | 36 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Mycophenolate Arm | 4 | 69 | |
| other | Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Cyclophosphamide Arm | 2 | 73 | |
| other | Immune disorder | Immune system disorders | Mycophenolate Arm | 2 | 69 | |
| other | Immune disorder | Immune system disorders | Cyclophosphamide Arm | 4 | 73 | |
| other | Vision and hearing | Ear and labyrinth disorders | Mycophenolate Arm | 2 | 69 | |
| other | Vision and hearing | Ear and labyrinth disorders | Cyclophosphamide Arm | 6 | 73 | |
| other | Hepatobiliary | Hepatobiliary disorders | Mycophenolate Arm | 6 | 69 | |
| other | Hepatobiliary | Hepatobiliary disorders | Cyclophosphamide Arm | 4 | 73 | |
| other | Procedures | Surgical and medical procedures | Mycophenolate Arm | 6 | 69 | |
| other | Procedures | Surgical and medical procedures | Cyclophosphamide Arm | 5 | 73 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mycophenolate Arm | ||
| Total, all-cause mortality | Cyclophosphamide Arm | ||
| Total, other adverse events | Mycophenolate Arm | 68 | 69 |
| Total, other adverse events | Cyclophosphamide Arm | 71 | 73 |
| Total, serious adverse events | Mycophenolate Arm | 27 | 69 |
| Total, serious adverse events | Cyclophosphamide Arm | 22 | 73 |
Source ClinicalTrials.gov
Papers31
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01HL089758 | MOCSLID-CCC | TASHKIN, DONALD P | UNIVERSITY OF CALIFORNIA LOS ANGELES | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2008 to 2012 | NIH RePORTER |
| R01HL089901 | MOCSLID-DCC | ELASHOFF, ROBERT M | UNIVERSITY OF CALIFORNIA LOS ANGELES | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2008 to 2012 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Mycophenolate Arm vs Cyclophosphamide Arm: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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