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A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02383589
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pemphigus Vulgaris
Interventions Drug: Mycophenolate Mofetil Placebo
Drug: Mycophenolate Mofetil
Drug: Rituximab
Drug: Rituximab Placebo
Enrollment 135
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
Period Title: Overall Study
Started 67 68
Completed [1] 66 58
Not Completed 1 10
Reason Not Completed
Adverse Event             1             3
Lost to Follow-up             0             1
Withdrawal by Subject             0             5
Non-compliance with study drug             0             1
[1]
Completed the 52-week treatment period and entered safety follow up (SFU)
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF) Total
Hide Arm/Group Description Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Total of all reporting groups
Overall Number of Baseline Participants 67 68 135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 68 participants 135 participants
50.66  (12.98) 46.34  (13.08) 48.48  (13.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 68 participants 135 participants
Female
35
  52.2%
38
  55.9%
73
  54.1%
Male
32
  47.8%
30
  44.1%
62
  45.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 68 participants 135 participants
Hispanic or Latino
13
  19.4%
21
  30.9%
34
  25.2%
Not Hispanic or Latino
45
  67.2%
41
  60.3%
86
  63.7%
Not Stated
8
  11.9%
5
   7.4%
13
   9.6%
Unknown
1
   1.5%
1
   1.5%
2
   1.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 68 participants 135 participants
American Indian or Alaska Native
0
   0.0%
1
   1.5%
1
   0.7%
Asian
3
   4.5%
1
   1.5%
4
   3.0%
Black or African American
1
   1.5%
2
   2.9%
3
   2.2%
White
49
  73.1%
51
  75.0%
100
  74.1%
Unknown
14
  20.9%
13
  19.1%
27
  20.0%
1.Primary Outcome
Title Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score
Hide Description [Not Specified]
Time Frame From Baseline up to 52 Weeks (up to clinical cut-off date (CCOD) of 28 November 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
Overall Number of Participants Analyzed 62 63
Measure Type: Number
Unit of Measure: Percentage of Participants
40.3 9.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab (RTX), Mycophenolate Mofetil (MMF)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The analysis was stratified by the stratification factors applied at randomization.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportion
Estimated Value 30.80
Confidence Interval (2-Sided) 95%
14.70 to 45.15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Cumulative Oral Corticosteroid Dose
Hide Description [Not Specified]
Time Frame From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
Overall Number of Participants Analyzed 62 63
Median (Inter-Quartile Range)
Unit of Measure: milligram (mg)
2775.00
(2146.88 to 3610.00)
4005.00
(2662.50 to 5815.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab (RTX), Mycophenolate Mofetil (MMF)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Total Number of Protocol Defined Disease Flares
Hide Description 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.
Time Frame From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
Overall Number of Participants Analyzed 62 63
Measure Type: Number
Unit of Measure: Number of Flares
6 44
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab (RTX), Mycophenolate Mofetil (MMF)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The model was adjusted for the following covariates in addition to log (each participant’s duration in study) as an offset: treatment, region, duration of illness, baseline PDAI activity score, and baseline prednisone dose.
Method Negative Binominal Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Rate Ratio
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.05 to 0.29
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Initial Sustained Complete Remission
Hide Description [Not Specified]
Time Frame From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
Overall Number of Participants Analyzed 62 63
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(32.1 to NA)
NA [1] 
(NA to NA)
[1]
The median is not estimable due to limited number of events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab (RTX), Mycophenolate Mofetil (MMF)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 4.83
Confidence Interval (2-Sided) 95%
1.97 to 11.81
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Protocol Defined Disease Flare
Hide Description 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.
Time Frame From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
Overall Number of Participants Analyzed 62 63
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(NA to NA)
NA [1] 
(36.9 to NA)
[1]
The median is not estimable due to limited number of events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab (RTX), Mycophenolate Mofetil (MMF)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
0.06 to 0.39
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score
Hide Description 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.
Time Frame From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes. Only participants for whom data were collected are included in the analysis.
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
Overall Number of Participants Analyzed 62 63
Mean (Standard Error)
Unit of Measure: Scores on a Scale
Baseline Number Analyzed 57 participants 58 participants
10.14  (7.89) 11.09  (8.52)
Week 52 Number Analyzed 45 participants 27 participants
-8.874  (0.532) -6.002  (0.662)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab (RTX), Mycophenolate Mofetil (MMF)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments P-value is from Mixed Model Repeated Measures (MMRM) with unstructured covariance matrix, adjusting for treatment, region, duration of illness, baseline DLQI score, visit, and an interaction terms for visit × baseline DLQI score and visit × treatment
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Estimated Means
Estimated Value -2.872
Confidence Interval (2-Sided) 95%
-4.577 to -1.167
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events
Hide Description 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.
Time Frame Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
Overall Number of Participants Analyzed 67 68
Measure Type: Number
Unit of Measure: Percentage of Participants
Participants with AE 85.1 88.2
Participants with SAE 22.4 14.7
Participants with Corticosteroid (CS)-Related AE 34.3 38.2
Participants with CS-Related AE Grade 3 or higher 1.5 7.4
8.Secondary Outcome
Title Percentage of Participants With Anti-Drug Antibodies (ADA)
Hide Description 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.
Time Frame Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab (RTX)
Hide Arm/Group Description:
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: Percentage of Participants
31.7
9.Secondary Outcome
Title Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Hide Description [Not Specified]
Time Frame Baseline; Weeks 16, 24, 40 and 52; (end of treatment: up to Week 52) (up to CCOD of 28 November 2018)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
Overall Number of Participants Analyzed 67 68
Measure Type: Number
Unit of Measure: Percentage of Participants
Baseline (IgA) 0 0
Week 16 (IgA) 0 1.8
Week 24 (IgA) 1.7 2.2
Week 40 (IgA) 0 2.7
Week 52 (IgA) 0 3.6
Baseline (IgG) 6.1 6.0
Week 16 (IgG) 9.8 1.8
Week 24 (IgG) 3.4 2.2
Week 40 (IgG) 3.5 0
Week 52 (IgG) 4.3 0
Baseline (IgM) 7.6 11.9
Week 16 (IgM) 24.6 23.2
Week 24 (IgM) 27.1 28.3
Week 40 (IgM) 29.8 24.3
Week 52 (IgM) 29.8 28.6
Time Frame From Baseline up to Week 52 (up to CCOD of 28 November 2018)
Adverse Event Reporting Description 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. Participants who received the incorrect therapy from that assigned were summarized according to the therapy actually received. This population was used for the analyses of safety outcomes.
 
Arm/Group Title Rituximab (RTX) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
All-Cause Mortality
Rituximab (RTX) Mycophenolate Mofetil (MMF)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)      1/68 (1.47%)    
Hide Serious Adverse Events
Rituximab (RTX) Mycophenolate Mofetil (MMF)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/67 (22.39%)      10/68 (14.71%)    
Cardiac disorders     
MYOCARDIAL INFARCTION  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN  1  1/67 (1.49%)  2 0/68 (0.00%)  0
HAEMATEMESIS  1  0/67 (0.00%)  0 1/68 (1.47%)  1
ILEUS  1  1/67 (1.49%)  1 0/68 (0.00%)  0
INCARCERATED UMBILICAL HERNIA  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Infections and infestations     
BURSITIS INFECTIVE  1  1/67 (1.49%)  1 0/68 (0.00%)  0
CELLULITIS  1  1/67 (1.49%)  1 1/68 (1.47%)  1
HERPES ZOSTER  1  0/67 (0.00%)  0 1/68 (1.47%)  1
INFLUENZA  1  0/67 (0.00%)  0 1/68 (1.47%)  1
PNEUMONIA  1  1/67 (1.49%)  1 1/68 (1.47%)  1
PNEUMONIA VIRAL  1  1/67 (1.49%)  1 0/68 (0.00%)  0
PYELONEPHRITIS  1  1/67 (1.49%)  1 1/68 (1.47%)  1
PYELONEPHRITIS ACUTE  1  1/67 (1.49%)  1 0/68 (0.00%)  0
SEPSIS  1  0/67 (0.00%)  0 1/68 (1.47%)  1
SKIN INFECTION  1  1/67 (1.49%)  1 0/68 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Injury, poisoning and procedural complications     
INFUSION RELATED REACTION  1  3/67 (4.48%)  3 1/68 (1.47%)  1
LUMBAR VERTEBRAL FRACTURE  1  1/67 (1.49%)  1 0/68 (0.00%)  0
PELVIC FRACTURE  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
SMALL CELL LUNG CANCER  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Nervous system disorders     
PARAESTHESIA  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Renal and urinary disorders     
URINARY RETENTION  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Respiratory, thoracic and mediastinal disorders     
ACUTE PULMONARY OEDEMA  1  0/67 (0.00%)  0 1/68 (1.47%)  1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/67 (0.00%)  0 1/68 (1.47%)  1
DYSPNOEA  1  0/67 (0.00%)  0 1/68 (1.47%)  1
PULMONARY EMBOLISM  1  1/67 (1.49%)  1 2/68 (2.94%)  2
Skin and subcutaneous tissue disorders     
SKIN ULCER  1  0/67 (0.00%)  0 1/68 (1.47%)  1
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab (RTX) Mycophenolate Mofetil (MMF)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/67 (62.69%)      41/68 (60.29%)    
Blood and lymphatic system disorders     
LYMPHOPENIA  1  8/67 (11.94%)  14 1/68 (1.47%)  1
Gastrointestinal disorders     
DIARRHOEA  1  3/67 (4.48%)  5 10/68 (14.71%)  11
NAUSEA  1  2/67 (2.99%)  4 4/68 (5.88%)  4
General disorders     
ASTHENIA  1  4/67 (5.97%)  5 4/68 (5.88%)  4
FATIGUE  1  5/67 (7.46%)  8 3/68 (4.41%)  3
OEDEMA PERIPHERAL  1  2/67 (2.99%)  2 6/68 (8.82%)  8
Infections and infestations     
NASOPHARYNGITIS  1  6/67 (8.96%)  8 8/68 (11.76%)  12
ORAL CANDIDIASIS  1  6/67 (8.96%)  8 6/68 (8.82%)  6
UPPER RESPIRATORY TRACT INFECTION  1  6/67 (8.96%)  9 5/68 (7.35%)  6
URINARY TRACT INFECTION  1  5/67 (7.46%)  6 2/68 (2.94%)  2
Injury, poisoning and procedural complications     
INFUSION RELATED REACTION  1  12/67 (17.91%)  19 5/68 (7.35%)  6
Metabolism and nutrition disorders     
HYPOPHOSPHATAEMIA  1  5/67 (7.46%)  5 0/68 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  6/67 (8.96%)  6 2/68 (2.94%)  2
BACK PAIN  1  6/67 (8.96%)  6 1/68 (1.47%)  1
Nervous system disorders     
DIZZINESS  1  4/67 (5.97%)  4 2/68 (2.94%)  2
HEADACHE  1  10/67 (14.93%)  17 6/68 (8.82%)  7
Psychiatric disorders     
INSOMNIA  1  1/67 (1.49%)  1 6/68 (8.82%)  6
Respiratory, thoracic and mediastinal disorders     
COUGH  1  6/67 (8.96%)  6 2/68 (2.94%)  2
OROPHARYNGEAL PAIN  1  4/67 (5.97%)  4 3/68 (4.41%)  3
Skin and subcutaneous tissue disorders     
ALOPECIA  1  2/67 (2.99%)  2 5/68 (7.35%)  5
Vascular disorders     
HYPERTENSION  1  2/67 (2.99%)  2 4/68 (5.88%)  4
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02383589    
Other Study ID Numbers: WA29330
2014-000382-41 ( EudraCT Number )
First Submitted: March 4, 2015
First Posted: March 9, 2015
Results First Submitted: November 19, 2019
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020