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A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis (LUNAR)

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: NCT00282347
Recruitment Status : Completed
First Posted : January 26, 2006
Results First Posted : February 23, 2010
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lupus Nephritis
Interventions Drug: Rituximab
Drug: Placebo
Drug: Mycophenolate mofetil
Drug: Methylprednisolone
Drug: Diphenhydramine
Drug: Acetaminophen
Drug: Prednisone
Enrollment 144
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details. Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Period Title: Treatment Period
Started 72 72
Completed 67 63
Not Completed 5 9
Reason Not Completed
Death             2             0
Lost to Follow-up             2             5
Withdrawal by Subject             1             3
Physician Decision             0             1
Period Title: Safety Follow-up Period
Started 67 63
Completed 64 57
Not Completed 3 6
Reason Not Completed
Lost to Follow-up             0             2
Withdrawal by Subject             2             1
Physician Decision             1             1
Protocol Deviation             0             2
Period Title: B Cell Follow-up Period
Started 20 4
Completed 15 4
Not Completed 5 0
Reason Not Completed
Withdrawal by Subject             2             0
Physician Decision             1             0
Reason Not Specified             2             0
Arm/Group Title Rituximab Placebo Total
Hide Arm/Group Description Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details. Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details. Total of all reporting groups
Overall Number of Baseline Participants 72 72 144
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 72 participants 144 participants
< 18 years 2 1 3
18 to < 35 years 48 48 96
35 to < 50 years 18 19 37
≥ 50 years 4 4 8
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 72 participants 144 participants
31.8  (9.6) 29.4  (9.3) 30.6  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 72 participants 144 participants
Female
63
  87.5%
67
  93.1%
130
  90.3%
Male
9
  12.5%
5
   6.9%
14
   9.7%
1.Primary Outcome
Title Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52
Hide Description A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) < 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of < 1.0 or if the Baseline UP to CR was > 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: Percentage of participants
CRR 26.4 30.6
PRR 30.6 15.3
NRR 43.1 54.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5538
Comments [Not Specified]
Method Stratified Wilcoxon-Rank Sum Test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52
Hide Description A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.
Time Frame Week 24 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: Percentage of participants
1.4 6.9
3.Secondary Outcome
Title Percentage of Participants Who Achieved a Complete Renal Response at Week 52
Hide Description A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: Percentage of participants
26.4 30.6
4.Secondary Outcome
Title Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52
Hide Description [Not Specified]
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo). Only those participants with a Baseline urine protein to creatinine ratio of > 3.0 were included in the analysis.
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed 38 41
Measure Type: Number
Unit of Measure: Percentage of participants
47.4 53.7
5.Secondary Outcome
Title British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks
Hide Description The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-8.49  (5.79) -8.58  (5.14)
6.Secondary Outcome
Title Time to Achieve a Complete Renal Response
Hide Description [Not Specified]
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed 72 72
Median (95% Confidence Interval)
Unit of Measure: Weeks
11.99 [1] 
(8.31 to NA)
12.12
(9.26 to 13.47)
[1]
The upper limit of the confidence interval could not be estimated due to too few events.
7.Secondary Outcome
Title Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52
Hide Description The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.8  (10.4) 5.7  (9.4)
8.Secondary Outcome
Title Change From Baseline in Anti-double-stranded DNA at Week 52
Hide Description [Not Specified]
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: IU/mL
0.45  (0.35) 1.06  (2.19)
9.Secondary Outcome
Title Change From Baseline in C3 and C4 Complement Levels at Week 52
Hide Description [Not Specified]
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
Overall Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: mg/dL
C3 Complement 37.5  (28.7) 25.9  (32.5)
C4 Complement 9.9  (7.5) 6.6  (8.9)
Time Frame Baseline to the end of the study (up to 7 years)
Adverse Event Reporting Description

Safety analysis population: All randomized subjects who receive any amount of study drug (rituximab or placebo).

Adverse events reported for the B cell follow-up period only include adverse events that occurred in participants who were followed after the last participant reached study Week 78.

 
Arm/Group Title Rituximab - Treatment and Safety Follow-up Periods Placebo - Treatment and Safety Follow-up Periods Rituximab - B Cell Follow-up Period Placebo - B Cell Follow-up Period
Hide Arm/Group Description Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details. Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details. Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details. Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
All-Cause Mortality
Rituximab - Treatment and Safety Follow-up Periods Placebo - Treatment and Safety Follow-up Periods Rituximab - B Cell Follow-up Period Placebo - B Cell Follow-up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab - Treatment and Safety Follow-up Periods Placebo - Treatment and Safety Follow-up Periods Rituximab - B Cell Follow-up Period Placebo - B Cell Follow-up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/73 (32.88%)   29/71 (40.85%)   3/20 (15.00%)   0/4 (0.00%) 
Blood and lymphatic system disorders         
Anaemia  1  3/73 (4.11%)  3/71 (4.23%)  0/20 (0.00%)  0/4 (0.00%) 
Leukopenia  1  2/73 (2.74%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Neutropenia  1  2/73 (2.74%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Coagulopathy  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Disseminated Intravascular Coagulation  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Febrile Neutropenia  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Haemolytic Anaemia  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Nephrogenic anemia  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Cardiac disorders         
Atrial Fibrillation  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Myocardial Infarction  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Pericardial Effusion  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Pericarditis  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Endocrine disorders         
Thyroiditis  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Nausea  1  1/73 (1.37%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Abdominal Pain  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Ascites  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Diarrhoea  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Gastrointestinal Haemorrhage  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Haemorrhoids  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Lower Gastrointestinal Haemorrhage  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
General disorders         
Chest Pain  1  0/73 (0.00%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
Drug Intolerance  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Generalized Oedema  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Oedema  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Immune system disorders         
Antiphospholipid Syndrome  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Pneumonia  1  2/73 (2.74%)  3/71 (4.23%)  0/20 (0.00%)  0/4 (0.00%) 
Cellulitis  1  2/73 (2.74%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Herpes Zoster  1  1/73 (1.37%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
Bronchopneumonia  1  1/73 (1.37%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Gastroenteritis  1  0/73 (0.00%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
Urinary Tract Infection  1  1/73 (1.37%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Bacteraemia  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Bacterial Infection  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Bronchitis  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Catheter Related Infection  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Cytomegalovirus Colitis  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Fungal Sepsis  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Gastroenteritis Viral  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Genital Herpes  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Histoplasmosis  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Impetigo  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Lobar Pneumonia  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Pneumonia Cryptococcal  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Pneumonia Cytomegaloviral  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Sepsis  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Sinusitis  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Soft Tissue Infection  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Subcutaneous Abscess  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Upper Respiratory Tract Infection  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Wound Infection  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Investigations         
International Normalized Ratio Decreased  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders         
Diabetes Mellitus  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Hypoalbuminaemia  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Systemic Lupus Erythematosus  1  0/73 (0.00%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
Arthralgia  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Pain in Extremity  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal Cell Carcinoma  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Breast cancer  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Nervous system disorders         
Convulsion  1  0/73 (0.00%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
Vasculitis Cerebral  1  1/73 (1.37%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Cerebral Ischaemia  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Hypersensitive Encephalopathy  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Ruptured Cerebral Aneurysm  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Syncope  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Abortion Spontaneous  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Psychiatric disorders         
Depression  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Psychotic Disorder  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders         
Renal Failure Acute  1  1/73 (1.37%)  3/71 (4.23%)  0/20 (0.00%)  0/4 (0.00%) 
Azotaemia  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Renal Failure  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Pyelonephritis  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonitis  1  2/73 (2.74%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Pleural Effusion  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Pleurisy  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Pulmonary Embolism  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Respiratory Failure  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash Vesicular  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Urticaria  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Surgical and medical procedures         
Renal transplant  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Vascular disorders         
Hypertension  1  0/73 (0.00%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
Deep Vein Thrombosis  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Hypotension  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Malignant Hypertension  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Thrombosis  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Vasculitis  1  0/73 (0.00%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Vena Cava Thrombosis  1  1/73 (1.37%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab - Treatment and Safety Follow-up Periods Placebo - Treatment and Safety Follow-up Periods Rituximab - B Cell Follow-up Period Placebo - B Cell Follow-up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   69/73 (94.52%)   66/71 (92.96%)   8/20 (40.00%)   0/4 (0.00%) 
Blood and lymphatic system disorders         
Anaemia  1  10/73 (13.70%)  9/71 (12.68%)  0/20 (0.00%)  0/4 (0.00%) 
Leukopenia  1  7/73 (9.59%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
Cardiac disorders         
Tachycardia  1  6/73 (8.22%)  5/71 (7.04%)  0/20 (0.00%)  0/4 (0.00%) 
Palpitations  1  2/73 (2.74%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Ear and labyrinth disorders         
Ear infection  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Endocrine disorders         
Cushingoid  1  4/73 (5.48%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
Amenorrhoea  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Eye disorders         
Conjunctivitis  1  3/73 (4.11%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Vision Blurred  1  3/73 (4.11%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Diarrhoea  1  28/73 (38.36%)  28/71 (39.44%)  0/20 (0.00%)  0/4 (0.00%) 
Nausea  1  20/73 (27.40%)  21/71 (29.58%)  0/20 (0.00%)  0/4 (0.00%) 
Vomiting  1  19/73 (26.03%)  14/71 (19.72%)  0/20 (0.00%)  0/4 (0.00%) 
Dyspepsia  1  5/73 (6.85%)  9/71 (12.68%)  0/20 (0.00%)  0/4 (0.00%) 
Gastroesophageal Reflux Disease  1  2/73 (2.74%)  7/71 (9.86%)  0/20 (0.00%)  0/4 (0.00%) 
Abdominal Distension  1  4/73 (5.48%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Abdominal Pain Upper  1  4/73 (5.48%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Abdominal Pain  1  3/73 (4.11%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Abdominal Discomfort  1  4/73 (5.48%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
Dental Caries  1  4/73 (5.48%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
Haemorrhoids  1  4/73 (5.48%)  2/71 (2.82%)  0/20 (0.00%)  0/4 (0.00%) 
General disorders         
Oedema Peripheral  1  6/73 (8.22%)  11/71 (15.49%)  0/20 (0.00%)  0/4 (0.00%) 
Oedema  1  8/73 (10.96%)  7/71 (9.86%)  0/20 (0.00%)  0/4 (0.00%) 
Chest Pain  1  4/73 (5.48%)  10/71 (14.08%)  0/20 (0.00%)  0/4 (0.00%) 
Pyrexia  1  9/73 (12.33%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Chills  1  2/73 (2.74%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Pain  1  2/73 (2.74%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Fatigue  1  12/73 (16.44%)  9/71 (12.68%)  0/20 (0.00%)  0/4 (0.00%) 
Immune system disorders         
Seasonal Allergy  1  5/73 (6.85%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Upper Respiratory Tract Infection  1  21/73 (28.77%)  23/71 (32.39%)  1/20 (5.00%)  0/4 (0.00%) 
Urinary Tract Infection  1  17/73 (23.29%)  20/71 (28.17%)  3/20 (15.00%)  0/4 (0.00%) 
Herpes Zoster  1  11/73 (15.07%)  8/71 (11.27%)  0/20 (0.00%)  0/4 (0.00%) 
Gastroenteritis  1  8/73 (10.96%)  7/71 (9.86%)  0/20 (0.00%)  0/4 (0.00%) 
Nasopharyngitis  1  8/73 (10.96%)  5/71 (7.04%)  1/20 (5.00%)  0/4 (0.00%) 
Sinusitis  1  9/73 (12.33%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Bronchitis  1  6/73 (8.22%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Oral Candidiasis  1  6/73 (8.22%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Candidiasis  1  4/73 (5.48%)  3/71 (4.23%)  0/20 (0.00%)  0/4 (0.00%) 
Cellulitis  1  3/73 (4.11%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Influenza  1  3/73 (4.11%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Gastroenteritis Viral  1  1/73 (1.37%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Peritonitis bacterial  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Fungal skin infection  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  1  5/73 (6.85%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Investigations         
Blood Potassium Decreased  1  1/73 (1.37%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Glomerular filtration rate decreased  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Blood creatinine increased  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders         
Hypokalaemia  1  10/73 (13.70%)  10/71 (14.08%)  0/20 (0.00%)  0/4 (0.00%) 
Hypercholesterolaemia  1  8/73 (10.96%)  3/71 (4.23%)  0/20 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle Spasms  1  17/73 (23.29%)  18/71 (25.35%)  0/20 (0.00%)  0/4 (0.00%) 
Arthralgia  1  16/73 (21.92%)  16/71 (22.54%)  0/20 (0.00%)  0/4 (0.00%) 
Pain in Extremity  1  9/73 (12.33%)  9/71 (12.68%)  0/20 (0.00%)  0/4 (0.00%) 
Back Pain  1  6/73 (8.22%)  11/71 (15.49%)  0/20 (0.00%)  0/4 (0.00%) 
Neck Pain  1  6/73 (8.22%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Myalgia  1  3/73 (4.11%)  6/71 (8.45%)  0/20 (0.00%)  0/4 (0.00%) 
Musculoskeletal Chest Pain  1  2/73 (2.74%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Nervous system disorders         
Headache  1  26/73 (35.62%)  19/71 (26.76%)  0/20 (0.00%)  0/4 (0.00%) 
Dizziness  1  9/73 (12.33%)  5/71 (7.04%)  0/20 (0.00%)  0/4 (0.00%) 
Tremor  1  3/73 (4.11%)  5/71 (7.04%)  0/20 (0.00%)  0/4 (0.00%) 
Dysgeusia  1  2/73 (2.74%)  5/71 (7.04%)  0/20 (0.00%)  0/4 (0.00%) 
Hypoaesthesia  1  1/73 (1.37%)  5/71 (7.04%)  0/20 (0.00%)  0/4 (0.00%) 
Psychiatric disorders         
Insomnia  1  10/73 (13.70%)  14/71 (19.72%)  0/20 (0.00%)  0/4 (0.00%) 
Anxiety  1  5/73 (6.85%)  8/71 (11.27%)  0/20 (0.00%)  0/4 (0.00%) 
Depression  1  5/73 (6.85%)  6/71 (8.45%)  0/20 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders         
Pyelonephritis  1  0/73 (0.00%)  0/71 (0.00%)  1/20 (5.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  16/73 (21.92%)  13/71 (18.31%)  0/20 (0.00%)  0/4 (0.00%) 
Dyspnoea  1  5/73 (6.85%)  7/71 (9.86%)  0/20 (0.00%)  0/4 (0.00%) 
Epistaxis  1  2/73 (2.74%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Oropharyngeal Pain  1  2/73 (2.74%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Pleuritic Pain  1  1/73 (1.37%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Rhinorrhoea  1  0/73 (0.00%)  4/71 (5.63%)  0/20 (0.00%)  0/4 (0.00%) 
Throat Irritation  1  4/73 (5.48%)  0/71 (0.00%)  0/20 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  10/73 (13.70%)  6/71 (8.45%)  0/20 (0.00%)  0/4 (0.00%) 
Rash  1  7/73 (9.59%)  8/71 (11.27%)  0/20 (0.00%)  0/4 (0.00%) 
Acne  1  3/73 (4.11%)  8/71 (11.27%)  0/20 (0.00%)  0/4 (0.00%) 
Swelling Face  1  4/73 (5.48%)  1/71 (1.41%)  0/20 (0.00%)  0/4 (0.00%) 
Vascular disorders         
Hypertension  1  7/73 (9.59%)  7/71 (9.86%)  0/20 (0.00%)  0/4 (0.00%) 
Hypotension  1  8/73 (10.96%)  3/71 (4.23%)  0/20 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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: Genentech, Inc.
Phone: 800-821-8590
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00282347     History of Changes
Other Study ID Numbers: U2970g
First Submitted: January 24, 2006
First Posted: January 26, 2006
Results First Submitted: February 1, 2010
Results First Posted: February 23, 2010
Last Update Posted: January 15, 2015