Trial · NCT02383589
A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)
NCT02383589, Phase 3, Completed, Hoffmann-La Roche; results first posted 2020-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV). Trials, record NCT02383589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02383589
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)
- NCT number
- NCT02383589
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 135 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Pemphigus Vulgaris
- Interventions
- Mycophenolate Mofetil Placebo, Mycophenolate Mofetil, Rituximab, Rituximab Placebo
- First posted
- 2015-03-09
- Last updated
- 2020-11-10
- Other registries' IDs
- eudract:2014-000382-41
- Results first posted
- 2020-01-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score | From Baseline up to 52 Weeks (up to clinical cut-off date (CCOD) of 28 November 2018) | |
| Secondary | Cumulative Oral Corticosteroid Dose | From Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | |
| Secondary | Total Number of Protocol Defined Disease Flares | From Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | Disease flare is defined as appearance of three or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who has achieved disease control. |
| Secondary | Time to Initial Sustained Complete Remission | From Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | |
| Secondary | Time to Protocol Defined Disease Flare | From Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | Disease flare is defined as the appearance of three or more new lesions a month that do not heal spontaneously within 1 week or by the extension of established lesions in a participant who has achieved disease control. |
| Secondary | Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score | From Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | Total DLQI scores range from 0 to 30 with higher DLQI scores reflecting greater impairment in a participant's health-related quality of life. The DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The measure type mean is the estimated mean from adjusted MMRM. |
| Secondary | Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events | Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | An adverse event is any untoward medical occurrence in a participant to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment. A serious adverse event is an adverse event that results in death or is life-threatening or requires/prolongs hospitalization or results in persistent/significant disability/incapacity or congenital abnormality/birth defect. Adverse events of Grade 3 of higher are severe and life-threatening adverse events CS-related adverse events - causality as determined by the investigator. |
| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADA) | Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | Participants with treatment-induced and treatment-enhanced anti-drug antibodies. The clinical relevance of anti-rituximab antibody formation in RITUXAN treated pemphigus vulgaris (PV) participants is unclear. |
| Secondary | Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN) | Baseline; Weeks 16, 24, 40 and 52; (end of treatment: up to Week 52) (up to CCOD of 28 November 2018) |
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 | Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score | From Baseline up to 52 Weeks (up to clinical cut-off date (CCOD) of 28 November 2018) | The modified intent-to-treat (mITT) population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes. | Percentage of Participants | NUMBER |
| SECONDARY | Cumulative Oral Corticosteroid Dose | From Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes. | milligram (mg) | MEDIAN |
| SECONDARY | Total Number of Protocol Defined Disease Flares | From Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes. | Number of Flares | NUMBER |
| SECONDARY | Time to Initial Sustained Complete Remission | From Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes. | Weeks | MEDIAN |
| SECONDARY | Time to Protocol Defined Disease Flare | From Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes. | Weeks | MEDIAN |
| SECONDARY | Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score | From Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes. Only participants for whom data were collected are included in the analysis. | Scores on a Scale | MEAN |
| SECONDARY | Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events | Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Anti-Drug Antibodies (ADA) | Baseline up to 52 Weeks (up to CCOD of 28 November 2018) | The safety population (all participants who were randomized and received any part of an infusion of study drug), only participants for whom data were collected are included in the analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN) | Baseline; Weeks 16, 24, 40 and 52; (end of treatment: up to Week 52) (up to CCOD of 28 November 2018) | The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group53
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score | Rituximab (RTX) | 40.3 | Percentage of Participants | ||
| Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score | Mycophenolate Mofetil (MMF) | 9.5 | Percentage of Participants | ||
| Cumulative Oral Corticosteroid Dose | Rituximab (RTX) | 2775.00 | Inter-Quartile Range 2146.88 to 3610.00 | milligram (mg) | |
| Cumulative Oral Corticosteroid Dose | Mycophenolate Mofetil (MMF) | 4005.00 | Inter-Quartile Range 2662.50 to 5815.00 | milligram (mg) | |
| Total Number of Protocol Defined Disease Flares | Rituximab (RTX) | 6 | Number of Flares | ||
| Total Number of Protocol Defined Disease Flares | Mycophenolate Mofetil (MMF) | 44 | Number of Flares | ||
| Time to Initial Sustained Complete Remission | Rituximab (RTX) | NA | 95% Confidence Interval 32.1 to NA | Weeks | |
| Time to Initial Sustained Complete Remission | Mycophenolate Mofetil (MMF) | NA | 95% Confidence Interval NA to NA | Weeks | |
| Time to Protocol Defined Disease Flare | Rituximab (RTX) | NA | 95% Confidence Interval NA to NA | Weeks | |
| Time to Protocol Defined Disease Flare | Mycophenolate Mofetil (MMF) | NA | 95% Confidence Interval 36.9 to NA | Weeks |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Rituximab (RTX) | 67 | |
| Treatment Period | STARTED | Mycophenolate Mofetil (MMF) | 68 | |
| Treatment Period | COMPLETED | Rituximab (RTX) | 66 | |
| Treatment Period | COMPLETED | Mycophenolate Mofetil (MMF) | 58 | |
| Treatment Period | NOT COMPLETED | Rituximab (RTX) | 1 | |
| Treatment Period | NOT COMPLETED | Mycophenolate Mofetil (MMF) | 10 | |
| Safety Follow-up (SFU) | STARTED | Rituximab (RTX) | 66 | |
| Safety Follow-up (SFU) | STARTED | Mycophenolate Mofetil (MMF) | 58 | |
| Safety Follow-up (SFU) | COMPLETED | Rituximab (RTX) | 59 | |
| Safety Follow-up (SFU) | COMPLETED | Mycophenolate Mofetil (MMF) | 53 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events216
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 | LYMPHOPENIA | Blood and lymphatic system disorders | Rituximab (RTX) | 8 | 67 | 14 |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Mycophenolate Mofetil (MMF) | 1 | 68 | 1 |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | RTX Safety Follow-up | 0 | 66 | 0 |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | MMF Safety Follow-up | 0 | 58 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | Rituximab (RTX) | 3 | 67 | 5 |
| other | DIARRHOEA | Gastrointestinal disorders | Mycophenolate Mofetil (MMF) | 10 | 68 | 11 |
| other | DIARRHOEA | Gastrointestinal disorders | RTX Safety Follow-up | 0 | 66 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | MMF Safety Follow-up | 0 | 58 | 0 |
| other | NAUSEA | Gastrointestinal disorders | Rituximab (RTX) | 2 | 67 | 4 |
| other | NAUSEA | Gastrointestinal disorders | Mycophenolate Mofetil (MMF) | 4 | 68 | 4 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab (RTX) | 0 | 67 |
| Total, all-cause mortality | Mycophenolate Mofetil (MMF) | 1 | 68 |
| Total, all-cause mortality | RTX Safety Follow-up | 0 | 66 |
| Total, all-cause mortality | MMF Safety Follow-up | 0 | 58 |
| Total, other adverse events | Rituximab (RTX) | 42 | 67 |
| Total, other adverse events | Mycophenolate Mofetil (MMF) | 41 | 68 |
| Total, other adverse events | RTX Safety Follow-up | 2 | 66 |
| Total, other adverse events | MMF Safety Follow-up | 3 | 58 |
| Total, serious adverse events | Rituximab (RTX) | 15 | 67 |
| Total, serious adverse events | Mycophenolate Mofetil (MMF) | 10 | 68 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34097368 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02383589
GET https://conductscience.org/api/trials/v1/NCT02383589/results?page=2