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A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus (EXPLORER)

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ClinicalTrials.gov Identifier: NCT00137969
Recruitment Status : Completed
First Posted : August 30, 2005
Results First Posted : December 10, 2010
Last Update Posted : May 19, 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 Erythematosus, Systemic
Interventions Drug: Rituximab
Drug: Placebo
Drug: Prednisone
Drug: Acetaminophen
Drug: Diphenhydramine
Enrollment 262

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone
Hide Arm/Group Description Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Period Title: Overall Study
Started 174 88
Received Study Drug 169 88
Completed 107 67
Not Completed 67 21
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone Total
Hide Arm/Group Description Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. Total of all reporting groups
Overall Number of Baseline Participants 169 88 257
Hide Baseline Analysis Population Description
Intent-to-treat population: All randomized participants who received any amount of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 169 participants 88 participants 257 participants
40.2  (11.4) 40.5  (12.8) 40.3  (11.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 169 participants 88 participants 257 participants
< 20 years 2 2 4
20 to 64 years 166 83 249
> 64 years 1 3 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 169 participants 88 participants 257 participants
Female
152
  89.9%
82
  93.2%
234
  91.1%
Male
17
  10.1%
6
   6.8%
23
   8.9%
1.Primary Outcome
Title Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period
Time Frame From baseline to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Overall Number of Participants Analyzed 169 88
Measure Type: Number
Unit of Measure: Participants
MCR (excluding PCR) 21 14
PCR 29 11
Nonclinical Response (NCR) 119 63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab 1000 mg + Prednisone, Placebo + Prednisone
Comments Stratified by randomization factors (race and initial prednisone dose)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4875
Comments One-sided p-value.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period
Hide Description

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks was calculated as:

  1. Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks.
  2. Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study.
  3. Minus the Time-Adjusted AUC by the baseline BILAG global score
Time Frame From baseline to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Overall Number of Participants Analyzed 169 88
Mean (Standard Deviation)
Unit of Measure: BILAG score unit
-5.8  (4.0) -5.9  (4.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab 1000 mg + Prednisone, Placebo + Prednisone
Comments Stratified by randomization factors (race and initial prednisone dose)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8230
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Achieved an MCR (Excluding PCR)
Hide Description The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.
Time Frame From baseline to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Overall Number of Participants Analyzed 169 88
Measure Type: Number
Unit of Measure: participants
21 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab 1000 mg + Prednisone, Placebo + Prednisone
Comments Stratified by randomization factors (race and initial prednisone dose)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4318
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Who Achieved a PCR (Including MCR)
Hide Description The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. MCR = participants who achieved BILAG C or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.
Time Frame From baseline to 52 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Overall Number of Participants Analyzed 169 88
Measure Type: Number
Unit of Measure: participants
50 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab 1000 mg + Prednisone, Placebo + Prednisone
Comments Stratified by randomization factors (race and initial prednisone dose)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9069
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Who Achieved a BILAG C or Better in All Domains
Hide Description The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Overall Number of Participants Analyzed 169 88
Measure Type: Number
Unit of Measure: participants
42 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab 1000 mg + Prednisone, Placebo + Prednisone
Comments Stratified by randomization factors (race and initial prednisone dose)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5602
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Time to First Moderate or Severe Flare
Hide Description The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. A severe flare = participants had BILAG A score(s) present in one or more domains or BILAG B scores present in three or more domains at the same visit following a visit of inactive disease state defined above. A moderate flare = participants had only BILAG B scores present in two domains at the same visit following a visit of inactive disease state.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants who ever reached C/D/E for all 8 BILAG domains before Day 364 visit. If a participant reached C/D/E at the last visit, then this participant was excluded from the analysis.
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Overall Number of Participants Analyzed 127 58
Median (95% Confidence Interval)
Unit of Measure: days
112.0
(84.00 to 146.00)
126.0
(56.00 to 225.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab 1000 mg + Prednisone, Placebo + Prednisone
Comments Stratified by randomization factors (race and initial prednisone dose)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8979
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Change in SLE Expanded Health Survey Physical Function Score From Baseline
Time Frame From baseline to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Overall Number of Participants Analyzed 169 88
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.2  (22.8) 4.1  (17.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab 1000 mg + Prednisone, Placebo + Prednisone
Comments Stratified by randomization factors (race and initial prednisone dose)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1277
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants Who Achieved an MCR in The ITT Population
Hide Description The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.
Time Frame From Weeks 24 to 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Overall Number of Participants Analyzed 169 88
Measure Type: Number
Unit of Measure: participants
14 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab 1000 mg + Prednisone, Placebo + Prednisone
Comments Stratified by randomization factors (race and initial prednisone dose)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6202
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame From the beginning to the end of the study (Week 78 plus extended safety follow-up, with an average duration of 96 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab 1000 mg + Prednisone Placebo + Prednisone
Hide Arm/Group Description Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
All-Cause Mortality
Rituximab 1000 mg + Prednisone Placebo + Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab 1000 mg + Prednisone Placebo + Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   72/169 (42.60%)   32/88 (36.36%) 
Blood and lymphatic system disorders     
Neutropenia  1  6/169 (3.55%)  0/88 (0.00%) 
Pancytopenia  1  1/169 (0.59%)  1/88 (1.14%) 
Haemolytic Anaemia  1  1/169 (0.59%)  0/88 (0.00%) 
Lymphophenia  1  1/169 (0.59%)  0/88 (0.00%) 
Thrombocythaemia  1  2/169 (1.18%)  0/88 (0.00%) 
Thrombocytosis  1  1/169 (0.59%)  0/88 (0.00%) 
Cardiac disorders     
Coronary Artery Disease  1  1/169 (0.59%)  1/88 (1.14%) 
Diastolic Dysfunction  1  2/169 (1.18%)  0/88 (0.00%) 
Cardiomyopathy  1  1/169 (0.59%)  0/88 (0.00%) 
Cardiac Failure  1  1/169 (0.59%)  0/88 (0.00%) 
Angina Pectoris  1  1/169 (0.59%)  0/88 (0.00%) 
Myocarditis  1  0/169 (0.00%)  1/88 (1.14%) 
Pericarditis  1  1/169 (0.59%)  0/88 (0.00%) 
Pericardial Effusion  1  1/169 (0.59%)  0/88 (0.00%) 
Right Ventricular Failure  1  0/169 (0.00%)  1/88 (1.14%) 
Supraventricular Extrasystoles  1  0/169 (0.00%)  1/88 (1.14%) 
Cardiac Failure Congestive  1  1/169 (0.59%)  0/88 (0.00%) 
Cardiac Arrest  1  1/169 (0.59%)  0/88 (0.00%) 
Endocrine disorders     
Hypothyroidism  1  0/169 (0.00%)  1/88 (1.14%) 
Gastrointestinal disorders     
Gastrointestinal Haemorrhage  1  2/169 (1.18%)  2/88 (2.27%) 
Abdominal Pain  1  2/169 (1.18%)  1/88 (1.14%) 
Pancreatitis  1  1/169 (0.59%)  1/88 (1.14%) 
Pancreatitis Acute  1  1/169 (0.59%)  1/88 (1.14%) 
Gastric Ulcer  1  0/169 (0.00%)  1/88 (1.14%) 
Gastric Ulcer Perforation  1  0/169 (0.00%)  1/88 (1.14%) 
Diverticular Perforation  1  1/169 (0.59%)  1/88 (1.14%) 
Colitis  1  0/169 (0.00%)  1/88 (1.14%) 
Irritable Bowel Syndrome  1  1/169 (0.59%)  0/88 (0.00%) 
Intestinal Perforation  1  1/169 (0.59%)  0/88 (0.00%) 
Malabsorption  1  0/169 (0.00%)  1/88 (1.14%) 
Vomiting  1  1/169 (0.59%)  0/88 (0.00%) 
Peptic Ulcer  1  1/169 (0.59%)  0/88 (0.00%) 
General disorders     
Pyrexia  1  4/169 (2.37%)  1/88 (1.14%) 
Chest Pain  1  2/169 (1.18%)  3/88 (3.41%) 
Death  1  1/169 (0.59%)  0/88 (0.00%) 
Multi-Organ Failure  1  1/169 (0.59%)  0/88 (0.00%) 
Asthenia  1  1/169 (0.59%)  0/88 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/169 (0.00%)  1/88 (1.14%) 
Immune system disorders     
Serum Sickness  1  1/169 (0.59%)  0/88 (0.00%) 
Drug Hypersensitivity  1  1/169 (0.59%)  0/88 (0.00%) 
Infections and infestations     
Cellulitis  1  4/169 (2.37%)  3/88 (3.41%) 
Pneumonia Bacterial  1  1/169 (0.59%)  0/88 (0.00%) 
Pneumonia  1  5/169 (2.96%)  3/88 (3.41%) 
Bronchitis  1  0/169 (0.00%)  1/88 (1.14%) 
Lobar Pneumonia  1  1/169 (0.59%)  0/88 (0.00%) 
Pneumonia Primary Atypical  1  1/169 (0.59%)  0/88 (0.00%) 
Periorbital Cellulitis  1  0/169 (0.00%)  1/88 (1.14%) 
Diverticulitis  1  2/169 (1.18%)  1/88 (1.14%) 
Abdominal Abscess  1  0/169 (0.00%)  1/88 (1.14%) 
Abscess Intestinal  1  1/169 (0.59%)  0/88 (0.00%) 
Appendiceal Abscess  1  0/169 (0.00%)  1/88 (1.14%) 
Gastroenteritis  1  0/169 (0.00%)  1/88 (1.14%) 
Sepsis  1  1/169 (0.59%)  2/88 (2.27%) 
Urosepsis  1  2/169 (1.18%)  1/88 (1.14%) 
Pyelonephritis  1  2/169 (1.18%)  0/88 (0.00%) 
Urinary Tract Infection  1  0/169 (0.00%)  3/88 (3.41%) 
Herpes Zoster  1  2/169 (1.18%)  0/88 (0.00%) 
Herpes Virus Infection  1  1/169 (0.59%)  0/88 (0.00%) 
Infection  1  1/169 (0.59%)  1/88 (1.14%) 
Abscess  1  1/169 (0.59%)  0/88 (0.00%) 
Subcutaneous Abscess  1  1/169 (0.59%)  0/88 (0.00%) 
Acute Sinusitis  1  1/169 (0.59%)  0/88 (0.00%) 
Sinusitis  1  2/169 (1.18%)  0/88 (0.00%) 
Gastroentiritis Viral  1  1/169 (0.59%)  1/88 (1.14%) 
Cytomegalovirus Colitis  1  1/169 (0.59%)  0/88 (0.00%) 
Genital Infection Female  1  0/169 (0.00%)  1/88 (1.14%) 
Gastroentiritis Salmonella  1  0/169 (0.00%)  1/88 (1.14%) 
Staphylococcal Bacteremia  1  0/169 (0.00%)  1/88 (1.14%) 
Febrile Infection  1  0/169 (0.00%)  1/88 (1.14%) 
Disseminated Cytomegaloviral Infection  1  0/169 (0.00%)  1/88 (1.14%) 
Viral Oesaphagitis  1  1/169 (0.59%)  0/88 (0.00%) 
Injury, poisoning and procedural complications     
Procedural Complication  1  1/169 (0.59%)  1/88 (1.14%) 
Incision Hernia  1  1/169 (0.59%)  0/88 (0.00%) 
Procedural Pain  1  2/169 (1.18%)  0/88 (0.00%) 
Injury  1  0/169 (0.00%)  1/88 (1.14%) 
Road Traffic Accident  1  1/169 (0.59%)  0/88 (0.00%) 
Joint Injury  1  1/169 (0.59%)  0/88 (0.00%) 
Tendon Rupture  1  1/169 (0.59%)  0/88 (0.00%) 
Drug Toxicity  1  1/169 (0.59%)  0/88 (0.00%) 
Investigations     
International Normalised Ratio Abnormal  1  1/169 (0.59%)  0/88 (0.00%) 
International Normalised Ratio Increased  1  1/169 (0.59%)  0/88 (0.00%) 
Blood Pressure Increased  1  1/169 (0.59%)  0/88 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  0/169 (0.00%)  1/88 (1.14%) 
Hypokalaemia  1  0/169 (0.00%)  1/88 (1.14%) 
Diabetes Mellitus  1  0/169 (0.00%)  1/88 (1.14%) 
Hyperglycaemia  1  1/169 (0.59%)  0/88 (0.00%) 
Musculoskeletal and connective tissue disorders     
Systemic Lupus Erythematosus  1  3/169 (1.78%)  4/88 (4.55%) 
Intervertebral Disc Protrusion  1  2/169 (1.18%)  0/88 (0.00%) 
SLE Arthritis  1  1/169 (0.59%)  0/88 (0.00%) 
Osteonecrosis  1  0/169 (0.00%)  1/88 (1.14%) 
Costochondritis  1  1/169 (0.59%)  0/88 (0.00%) 
Myositis  1  1/169 (0.59%)  0/88 (0.00%) 
Rotator Cuff Syndrome  1  1/169 (0.59%)  0/88 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer  1  0/169 (0.00%)  1/88 (1.14%) 
Endometrial Cancer  1  1/169 (0.59%)  0/88 (0.00%) 
Nervous system disorders     
Cerebellar Haemorrhage  1  0/169 (0.00%)  1/88 (1.14%) 
Cerebral Ischaemia  1  1/169 (0.59%)  0/88 (0.00%) 
Loss of Consciousness  1  1/169 (0.59%)  0/88 (0.00%) 
Reversible Posterior Leukoencephalopathy Syndrome  1  0/169 (0.00%)  1/88 (1.14%) 
Migraine  1  1/169 (0.59%)  0/88 (0.00%) 
Paraesthesia  1  1/169 (0.59%)  0/88 (0.00%) 
Convulsion  1  0/169 (0.00%)  1/88 (1.14%) 
Spinal Cord Herniation  1  1/169 (0.59%)  0/88 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Premature Labor  1  1/169 (0.59%)  0/88 (0.00%) 
Stillbirth  1  1/169 (0.59%)  0/88 (0.00%) 
Oligohydramnios  1  1/169 (0.59%)  0/88 (0.00%) 
Psychiatric disorders     
Psychotic Disorder  1  1/169 (0.59%)  0/88 (0.00%) 
Anxiety Disorder  1  1/169 (0.59%)  0/88 (0.00%) 
Mania  1  0/169 (0.00%)  1/88 (1.14%) 
Mental Status Change  1  1/169 (0.59%)  0/88 (0.00%) 
Substance-induced Psychotic Disorder  1  1/169 (0.59%)  0/88 (0.00%) 
Renal and urinary disorders     
Lupus Nephritis  1  3/169 (1.78%)  3/88 (3.41%) 
Nephrolithiasis  1  0/169 (0.00%)  1/88 (1.14%) 
Proteinuria  1  1/169 (0.59%)  0/88 (0.00%) 
Reproductive system and breast disorders     
Vaginal Haemorrhage  1  1/169 (0.59%)  0/88 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism  1  2/169 (1.18%)  1/88 (1.14%) 
Asthma  1  1/169 (0.59%)  0/88 (0.00%) 
Chronic Obstructive Pulmonary Disease  1  0/169 (0.00%)  1/88 (1.14%) 
Pulmonary Alveolar Haemorrhage  1  1/169 (0.59%)  1/88 (1.14%) 
Pneumonia Aspiration  1  0/169 (0.00%)  1/88 (1.14%) 
Pleuritic Pain  1  1/169 (0.59%)  0/88 (0.00%) 
Pleurisy  1  1/169 (0.59%)  0/88 (0.00%) 
Pneumothorax  1  1/169 (0.59%)  0/88 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  2/169 (1.18%)  0/88 (0.00%) 
Rash  1  1/169 (0.59%)  0/88 (0.00%) 
Skin Ulcer  1  1/169 (0.59%)  0/88 (0.00%) 
Hidradentis  1  1/169 (0.59%)  0/88 (0.00%) 
Surgical and medical procedures     
Abortion Induced  1  1/169 (0.59%)  2/88 (2.27%) 
Vascular disorders     
Hypertension  1  2/169 (1.18%)  1/88 (1.14%) 
Lupus Vasculitis  1  1/169 (0.59%)  0/88 (0.00%) 
Vasculitis  1  1/169 (0.59%)  0/88 (0.00%) 
Deep Vein Thrombosis  1  0/169 (0.00%)  1/88 (1.14%) 
Venous Insufficiency  1  1/169 (0.59%)  0/88 (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 1000 mg + Prednisone Placebo + Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   164/169 (97.04%)   85/88 (96.59%) 
Blood and lymphatic system disorders     
Anaemia  1  6/169 (3.55%)  7/88 (7.95%) 
Cardiac disorders     
Tachycardia  1  10/169 (5.92%)  3/88 (3.41%) 
Palpitations  1  9/169 (5.33%)  3/88 (3.41%) 
Endocrine disorders     
Cushingoid  1  7/169 (4.14%)  6/88 (6.82%) 
Eye disorders     
Vision Blurred  1  3/169 (1.78%)  5/88 (5.68%) 
Conjunctivitis  1  4/169 (2.37%)  6/88 (6.82%) 
Dry Eye  1  6/169 (3.55%)  5/88 (5.68%) 
Gastrointestinal disorders     
Nausea  1  44/169 (26.04%)  24/88 (27.27%) 
Vomiting  1  24/169 (14.20%)  11/88 (12.50%) 
Diarrhoea  1  30/169 (17.75%)  12/88 (13.64%) 
Abdominal Pain  1  12/169 (7.10%)  7/88 (7.95%) 
Abdominal Pain Upper  1  12/169 (7.10%)  5/88 (5.68%) 
Constipation  1  15/169 (8.88%)  8/88 (9.09%) 
Gastrooesophageal Reflux Disease  1  13/169 (7.69%)  7/88 (7.95%) 
Abdominal Discomfort  1  10/169 (5.92%)  5/88 (5.68%) 
Dyspepsia  1  8/169 (4.73%)  7/88 (7.95%) 
Toothache  1  7/169 (4.14%)  5/88 (5.68%) 
General disorders     
Oedema Peripheral  1  25/169 (14.79%)  13/88 (14.77%) 
Chest Pain  1  10/169 (5.92%)  9/88 (10.23%) 
Pain  1  13/169 (7.69%)  5/88 (5.68%) 
Fatigue  1  21/169 (12.43%)  15/88 (17.05%) 
Pyrexia  1  17/169 (10.06%)  6/88 (6.82%) 
Infections and infestations     
Upper Respiratory Tract Infection  1  54/169 (31.95%)  32/88 (36.36%) 
Sinusitis  1  28/169 (16.57%)  15/88 (17.05%) 
Nasopharyngitis  1  17/169 (10.06%)  5/88 (5.68%) 
Urinary Tract Infection  1  48/169 (28.40%)  26/88 (29.55%) 
Candidiasis  1  12/169 (7.10%)  14/88 (15.91%) 
Oral Candidiasis  1  16/169 (9.47%)  9/88 (10.23%) 
Bronchitis  1  28/169 (16.57%)  12/88 (13.64%) 
Pneumonia  1  3/169 (1.78%)  5/88 (5.68%) 
Herpes Zoster  1  16/169 (9.47%)  4/88 (4.55%) 
Gastroenteritis Viral  1  9/169 (5.33%)  7/88 (7.95%) 
Vulvovaginal Mycotic Infection  1  12/169 (7.10%)  4/88 (4.55%) 
Gastroenteritis  1  15/169 (8.88%)  2/88 (2.27%) 
Influenza  1  9/169 (5.33%)  6/88 (6.82%) 
Ear Infection  1  2/169 (1.18%)  5/88 (5.68%) 
Injury, poisoning and procedural complications     
Contusion  1  10/169 (5.92%)  6/88 (6.82%) 
Investigations     
Weight Increased  1  4/169 (2.37%)  5/88 (5.68%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  7/169 (4.14%)  7/88 (7.95%) 
Decreased appetite  1  12/169 (7.10%)  2/88 (2.27%) 
Musculoskeletal and connective tissue disorders     
Pain in Extremity  1  22/169 (13.02%)  15/88 (17.05%) 
Back Pain  1  18/169 (10.65%)  13/88 (14.77%) 
Musculoskeletal Pain  1  11/169 (6.51%)  7/88 (7.95%) 
Neck Pain  1  9/169 (5.33%)  7/88 (7.95%) 
Joint Swelling  1  7/169 (4.14%)  6/88 (6.82%) 
Muscle Spasms  1  17/169 (10.06%)  13/88 (14.77%) 
Myalgia  1  8/169 (4.73%)  6/88 (6.82%) 
Systemic Lupus Erythematosus  1  11/169 (6.51%)  3/88 (3.41%) 
Arthritis  1  5/169 (2.96%)  5/88 (5.68%) 
Arthralgia  1  38/169 (22.49%)  19/88 (21.59%) 
Nervous system disorders     
Headache  1  38/169 (22.49%)  23/88 (26.14%) 
Dizziness  1  26/169 (15.38%)  15/88 (17.05%) 
Migraine  1  18/169 (10.65%)  11/88 (12.50%) 
Hypoaesthesia  1  8/169 (4.73%)  5/88 (5.68%) 
Paraesthesia  1  9/169 (5.33%)  8/88 (9.09%) 
Psychiatric disorders     
Insomnia  1  19/169 (11.24%)  8/88 (9.09%) 
Anxiety  1  15/169 (8.88%)  8/88 (9.09%) 
Depression  1  14/169 (8.28%)  4/88 (4.55%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  19/169 (11.24%)  12/88 (13.64%) 
Oropharyngeal Pain  1  14/169 (8.28%)  12/88 (13.64%) 
Sinus Congestion  1  9/169 (5.33%)  1/88 (1.14%) 
Skin and subcutaneous tissue disorders     
Rash  1  18/169 (10.65%)  4/88 (4.55%) 
Pruritus  1  19/169 (11.24%)  4/88 (4.55%) 
Erythema  1  10/169 (5.92%)  3/88 (3.41%) 
Alopecia  1  7/169 (4.14%)  5/88 (5.68%) 
Vascular disorders     
Hypertension  1  14/169 (8.28%)  8/88 (9.09%) 
Flushing  1  7/169 (4.14%)  6/88 (6.82%) 
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
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00137969     History of Changes
Other Study ID Numbers: U2971g
First Submitted: August 26, 2005
First Posted: August 30, 2005
Results First Submitted: June 5, 2009
Results First Posted: December 10, 2010
Last Update Posted: May 19, 2015