Trial · NCT02370693
Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis
NCT02370693, Phase 2, Completed, Northwestern University; results first posted 2021-08-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis. Trials, record NCT02370693. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02370693
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis
- NCT number
- NCT02370693
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Lung Diseases, Interstitial, Systemic Sclerosis, Scleroderma
- Interventions
- Bortezomib, Placebo, Mycophenolate mofetil
- First posted
- 2015-02-25
- Last updated
- 2021-08-25
- Results first posted
- 2021-08-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events | First dosing day to last study visit day: Mean duration 8 months. | To assess the safety and tolerability of bortezomib with mycophenolate mofetil assessed by the incidence of serious adverse events. |
| Secondary | Change of Skin Fibrosis Measured by the Rodnan Skin Score Between Baseline and 24 Weeks | 24 weeks | The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness that sums individual scores of skin thickness (0 - No Thickening, 1 - Mild Thickening, 2 - Moderate Thickening, 3 - Severe Thickening) measured at 17 body sites to reach a total score (Range: 0 to 51, higher value representing thicker skin). The Score is used as a surrogate for disease activity and severity, and a worsening score over time is associated with worse outcomes. |
| Secondary | Change of Lung Function Measured by Forced Vital Capacity (FVC) Between Baseline and 24 Weeks | 24 weeks | Forced vital capacity, or FVC, is the amount in liters of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It measures the effect that lung disease has on a person's ability to inhale and exhale. Higher values are better, and decreases over time can indicate disease progression. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Serious Adverse Events | First dosing day to last study visit day: Mean duration 8 months. | All subjects who received at least one dose. | Number of Participants with Serious Adve | MEAN |
| SECONDARY | Change of Skin Fibrosis Measured by the Rodnan Skin Score Between Baseline and 24 Weeks | 24 weeks | All subjects who had comparable skin score data. | Score on a Scale | MEAN |
| SECONDARY | Change of Lung Function Measured by Forced Vital Capacity (FVC) Between Baseline and 24 Weeks | 24 weeks | All subjects who had comparable forced vital capacity data. | Percentage of change in FVC %predicted | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Serious Adverse Events | Bortezomib Plus Mycophenolate Mofetil | 0.33 | Standard Deviation .58 | Number of Participants with Serious Adve | |
| Number of Participants With Serious Adverse Events | Placebo Plus Mycophenolate Mofetil | 0.25 | Standard Deviation .50 | Number of Participants with Serious Adve | |
| Change of Skin Fibrosis Measured by the Rodnan Skin Score Between Baseline and 24 Weeks | Bortezomib Plus Mycophenolate Mofetil | -3.00 | Standard Deviation 2.65 | Score on a Scale | |
| Change of Skin Fibrosis Measured by the Rodnan Skin Score Between Baseline and 24 Weeks | Placebo Plus Mycophenolate Mofetil | -0.33 | Standard Deviation 0.58 | Score on a Scale | |
| Change of Lung Function Measured by Forced Vital Capacity (FVC) Between Baseline and 24 Weeks | Bortezomib Plus Mycophenolate Mofetil | 0.51 | Standard Deviation 0.55 | Percentage of change in FVC %predicted | |
| Change of Lung Function Measured by Forced Vital Capacity (FVC) Between Baseline and 24 Weeks | Placebo Plus Mycophenolate Mofetil | -0.69 | Standard Deviation 1.02 | Percentage of change in FVC %predicted |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bortezomib Plus Mycophenolate Mofetil | 3 | |
| Overall Study | STARTED | Placebo Plus Mycophenolate Mofetil | 4 | |
| Overall Study | COMPLETED | Bortezomib Plus Mycophenolate Mofetil | 2 | |
| Overall Study | COMPLETED | Placebo Plus Mycophenolate Mofetil | 3 | |
| Overall Study | NOT COMPLETED | Bortezomib Plus Mycophenolate Mofetil | 1 | |
| Overall Study | NOT COMPLETED | Placebo Plus Mycophenolate Mofetil | 1 |
Source ClinicalTrials.gov
Adverse events102
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 | Ache on forehead and eyelids | General disorders | Bortezomib Plus Mycophenolate Mofetil | 0 | 3 | 0 |
| other | Ache on forehead and eyelids | General disorders | Placebo Plus Mycophenolate Mofetil | 1 | 4 | 1 |
| other | Acid reflux | Gastrointestinal disorders | Bortezomib Plus Mycophenolate Mofetil | 0 | 3 | 0 |
| other | Acid reflux | Gastrointestinal disorders | Placebo Plus Mycophenolate Mofetil | 1 | 4 | 1 |
| other | Bach ache | Musculoskeletal and connective tissue disorders | Bortezomib Plus Mycophenolate Mofetil | 0 | 3 | 0 |
| other | Bach ache | Musculoskeletal and connective tissue disorders | Placebo Plus Mycophenolate Mofetil | 1 | 4 | 1 |
| other | Bloating | Gastrointestinal disorders | Bortezomib Plus Mycophenolate Mofetil | 0 | 3 | 0 |
| other | Bloating | Gastrointestinal disorders | Placebo Plus Mycophenolate Mofetil | 1 | 4 | 1 |
| other | Body aches | Musculoskeletal and connective tissue disorders | Bortezomib Plus Mycophenolate Mofetil | 0 | 3 | 0 |
| other | Body aches | Musculoskeletal and connective tissue disorders | Placebo Plus Mycophenolate Mofetil | 1 | 4 | 1 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bortezomib Plus Mycophenolate Mofetil | 0 | 3 |
| Total, all-cause mortality | Placebo Plus Mycophenolate Mofetil | 0 | 4 |
| Total, other adverse events | Bortezomib Plus Mycophenolate Mofetil | 3 | 3 |
| Total, other adverse events | Placebo Plus Mycophenolate Mofetil | 4 | 4 |
| Total, serious adverse events | Bortezomib Plus Mycophenolate Mofetil | 1 | 3 |
| Total, serious adverse events | Placebo Plus Mycophenolate Mofetil | 1 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| R34HL122558 | Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis | JAIN, MANU | NORTHWESTERN UNIVERSITY AT CHICAGO | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2015 to 2017 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bortezomib Plus Mycophenolate Mofetil vs Placebo Plus Mycophenolate Mofetil: deaths from any cause | Trial comparisons |
| Bortezomib Plus Mycophenolate Mofetil vs Placebo Plus Mycophenolate Mofetil: serious adverse events | 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.
GET https://conductscience.org/api/trials/v1/NCT02370693
GET https://conductscience.org/api/trials/v1/NCT02370693/events?page=2