Trial · NCT00683930

A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)

NCT00683930, Phase 3, Completed, Hoffmann-La Roche; results first posted 2011-06-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV). Trials, record NCT00683930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00683930

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
NCT number: NCT00683930
Status: Completed
Phases: Phase 3
Enrollment: 96 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Pemphigus Vulgaris (PV)
Interventions: Mycophenolate Mofetil 2 g/Day, Mycophenolate Mofetil (MMF) 3 g/Day, Placebo
First posted: 2008-05-26
Last updated: 2011-06-22
Results first posted: 2011-06-22

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Patients Achieving Responder Status at Week 52	52 weeks	The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group
Secondary	Time to Initial Response	up to 52 weeks	Time to initial response defined as the time that the subject first demonstrated responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52)
Secondary	Time to Sustained Response	up to 52 weeks	Time to sustained response is defined as the week the subject first demonstrates both of the conditions of responder status provided the conditions are maintained through to study termination at Week 52. If a subject does not have a sustained response, time to sustained response is censored on the last day of the study.
Secondary	Duration of Prednisone Maintenance Dosing	52 weeks	The duration of prednisone maintenance dosing was defined as the number of days that subjects maintained a prednisone dose of not more than 10 mg/day in the absence of new persistent lesions.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Patients Achieving Responder Status at Week 52	52 weeks	Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day or 3 g/day = 58.	Percentage of Participants	NUMBER
SECONDARY	Time to Initial Response	up to 52 weeks	Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 7; MMF 2 g/day or 3 g/day = 58, subjects censored = 10.	Weeks	MEDIAN
SECONDARY	Time to Sustained Response	up to 52 weeks	Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 20; MMF 2 g/day or 3 g/day = 58, subjects censored = 23.	Weeks	MEDIAN
SECONDARY	Duration of Prednisone Maintenance Dosing	52 weeks	Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day = 21; MMF 3 g/day = 37; MMF Groups Combined (2 g/day or 3 g/day) = 58.	Days	MEDIAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Patients Achieving Responder Status at Week 52	Placebo	63.9		Percentage of Participants
Percentage of Patients Achieving Responder Status at Week 52	MMF 2 g/Day and MMF 3 g/Day Groups Combined	69.0		Percentage of Participants
Time to Initial Response	Placebo	31.3	Inter-Quartile Range 25.0 to 36.4	Weeks
Time to Initial Response	MMF 2 g/Day and MMF 3 g/Day Groups Combined	24.1	Inter-Quartile Range 20.3 to 32.4	Weeks
Time to Sustained Response	Placebo	46.0	Full Range 29.7 to NA	Weeks
Time to Sustained Response	MMF 2 g/Day and MMF 3 g/Day Groups Combined	32.1	Full Range 20.6 to NA	Weeks
Duration of Prednisone Maintenance Dosing	Placebo	136.5	Inter-Quartile Range 60.0 to 191.0	Days
Duration of Prednisone Maintenance Dosing	MMF 2 g/Day and MMF 3 g/Day Groups Combined	186.0	Inter-Quartile Range 79.0 to 244.0	Days
Duration of Prednisone Maintenance Dosing	Mycophenolate Mofetil 2 g/Day	185.0	Inter-Quartile Range 109.0 to 246.0	Days
Duration of Prednisone Maintenance Dosing	Mycophenolate Mofetil 3 g/Day	187.0	Inter-Quartile Range 75.0 to 225.0	Days

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	36
Overall Study	STARTED	MMF 2 g/Day	21
Overall Study	STARTED	MMF 3 g/Day	37
Overall Study	COMPLETED	Placebo	29
Overall Study	COMPLETED	MMF 2 g/Day	18
Overall Study	COMPLETED	MMF 3 g/Day	28
Overall Study	NOT COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	MMF 2 g/Day	3
Overall Study	NOT COMPLETED	MMF 3 g/Day	9

Source ClinicalTrials.gov

Adverse events651

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
other	Nasopharyngitis	Infections and infestations	Placebo	0	36
other	Nasopharyngitis	Infections and infestations	MMF 2 g/Day	4	21
other	Nasopharyngitis	Infections and infestations	MMF 3 g/Day	3	37
other	Upper Respiratory Tract Infection	Infections and infestations	Placebo	1	36
other	Upper Respiratory Tract Infection	Infections and infestations	MMF 2 g/Day	1	21
other	Upper Respiratory Tract Infection	Infections and infestations	MMF 3 g/Day	5	37
other	Rhinitis	Infections and infestations	Placebo	0	36
other	Rhinitis	Infections and infestations	MMF 2 g/Day	0	21
other	Rhinitis	Infections and infestations	MMF 3 g/Day	2	37
other	Laryngitis	Infections and infestations	Placebo	0	36

1 to 10 of 651Source ClinicalTrials.gov

See all 651 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	MMF 2 g/Day
Total, all-cause mortality	MMF 3 g/Day
Total, other adverse events	Placebo	31	36
Total, other adverse events	MMF 2 g/Day	20	21
Total, other adverse events	MMF 3 g/Day	32	37
Total, serious adverse events	Placebo	4	36
Total, serious adverse events	MMF 2 g/Day	1	21
Total, serious adverse events	MMF 3 g/Day	3	37

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20410913	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00683930

GET https://conductscience.org/api/trials/v1/NCT00683930/events?page=2

API reference For AI assistants