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Trial record 69 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis

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: NCT00298272
Recruitment Status : Terminated (Sponsor decided to end long term extension phase for business reasons unrelated to safety.)
First Posted : March 2, 2006
Results First Posted : November 17, 2010
Last Update Posted : September 28, 2015
Sponsor:
Collaborators:
Hoffmann-La Roche
Genentech, Inc.
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: IDEC-C2B8 (rituximab)
Drug: Placebo
Drug: Methotrexate
Drug: Etanercept
Drug: Adalimumab
Drug: Methylprednisolone
Dietary Supplement: Folate
Enrollment 54
Recruitment Details Participants were enrolled at 17 sites in the United States.
Pre-assignment Details After 24 weeks, participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and “restart” the 56-week treatment/follow-up schedule prior to the 48-week SFU.
Arm/Group Title Double-blind/Open Label Rituximab Double-blind Placebo/Open Label Rituximab
Hide Arm/Group Description The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU. The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU.
Period Title: Double-blind Phase
Started 36 [1] 18
Safety Population 33 [2] 18
Completed to Week 24 31 [3] 18 [4]
Completed to Week 56 8 3
Completed 28 18
Not Completed 8 0
Reason Not Completed
Adverse Event             2             0
Failure to Return             2             0
Protocol Violation             2             0
Withdrawal by Subject             2             0
[1]
enrolled and randomized (2:1 scheme)
[2]
received treatment
[3]
received full course of rituximab therapy
[4]
received full course of placebo therapy
Period Title: Open Label Retreatment Phase
Started 22 16
Completed to Week 24 22 [1] 15 [1]
Completed to Week 56 13 12
Completed 13 12
Not Completed 9 4
Reason Not Completed
Adverse Event             1             2
Insufficient Therapeutic Response             2             1
Failure to Return             1             0
Protocol Violation             2             1
Withdrawal by Subject             1             0
Administrative/Other Reason             2             0
[1]
received full course of open-label rituximab therapy
Period Title: Safety Follow-up Phase
Started 22 17
Completed 18 13
Not Completed 4 4
Reason Not Completed
Failure to Return             1             1
Withdrawal by Subject             2             2
Administrative/Other Reason             1             1
Arm/Group Title Double-blind/Open Label Rituximab Double-blind Placebo/Open Label Rituximab Total
Hide Arm/Group Description The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU. The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU. Total of all reporting groups
Overall Number of Baseline Participants 33 18 51
Hide Baseline Analysis Population Description
Safety Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 18 participants 51 participants
49.7  (12.1) 50.4  (11.4) 50.0  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 18 participants 51 participants
Female
28
  84.8%
17
  94.4%
45
  88.2%
Male
5
  15.2%
1
   5.6%
6
  11.8%
Years since rheumatoid arthritis (RA) diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 18 participants 51 participants
10.3  (6.7) 10.7  (7.5) 10.5  (6.9)
Number of Prior Tumor Necrosis Factor (TNF) Inhibitors  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 18 participants 51 participants
1 32 18 50
2 1 0 1
C-Reactive Protein  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 33 participants 18 participants 51 participants
0.97
(0.0 to 6.3)
0.83
(0.1 to 3.3)
0.92
(0.0 to 6.3)
Swollen and Tender Joints   [1] 
Mean (Full Range)
Unit of measure:  Joint counts
Number Analyzed 33 participants 18 participants 51 participants
Swollen joints
16.9
(5 to 43)
14.2
(6 to 30)
16.0
(5 to 43)
Tender joints
25.6
(5 to 56)
22.8
(9 to 63)
24.6
(5 to 63)
[1]
Measure Description: Total number of swollen joints evaluated was 66 and total number of tender joints evaluated was 68.
1.Primary Outcome
Title Proportion of Participants With at Least One Serious Infection Through Week 24
Hide Description An infection was considered serious if it required intravenous (IV) antibiotics or met the regulatory definition of a serious adverse event (SAE). An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes.
Time Frame Through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
Overall Number of Participants Analyzed 33 18
Measure Type: Number
Unit of Measure: proportion of participants
0.03 0.00
2.Primary Outcome
Title Number of Participants With Any Infections or Any Grade 3/4 Infections Through Week 24
Hide Description Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of “infections and infestations” and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). Participants with multiple infections were calculated only once. The severity of all reported adverse events, including infections, was graded and reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events. This scale defines the severity of an adverse event as follows: Grade 1 = a mild adverse event, Grade 2 = a moderate adverse event, Grade 3 = a severe adverse event, and Grade 4 = a life-threatening or disabling adverse event.
Time Frame Through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.
Arm/Group Title Double-blind/Open Label Rituximab Double-blind Placebo/Open Label Rituximab
Hide Arm/Group Description:
The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU.
The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU.
Overall Number of Participants Analyzed 33 18
Measure Type: Number
Unit of Measure: participants
Any Infection 18 11
Any Grade 3/4 Infection 3 0
3.Primary Outcome
Title Maximum Duration of Infections Through Week 24
Hide Description Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of “infections and infestations” and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). For participants with multiple infections, only the infection with the longest duration was included in this analysis.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Population with at least 1 infection. The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.
Arm/Group Title Double-blind/Open Label Rituximab Double-blind Placebo/Open Label Rituximab
Hide Arm/Group Description:
The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU.
The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU.
Overall Number of Participants Analyzed 18 11
Mean (Standard Deviation)
Unit of Measure: days
12.6  (9.6) 14.5  (5.2)
4.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Week 24
Hide Description An AE was any sign (including an abnormal laboratory result that the investigator determined to be clinically significant), symptom, or diagnosis/disease that is unfavorable or unintended, that was new, or if pre-existing, worsened in a participant and that did not necessarily have a causal relationship with the treatment. An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes.
Time Frame Through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.
Arm/Group Title Double-blind/Open Label Rituximab Double-blind Placebo/Open Label Rituximab
Hide Arm/Group Description:
The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU.
The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU.
Overall Number of Participants Analyzed 33 18
Measure Type: Number
Unit of Measure: participants
Any AE 31 15
Any SAE 2 0
5.Primary Outcome
Title Number of Participants With Clinically Significant Immunological and Laboratory Assessment Findings
Hide Description The following immunological assessments were conducted: autoantibody concentrations for RF, anti-cyclic-citrullinated peptide (CCP) antibody concentrations, quantitative immunoglobulin levels, and lymphocyte assessments of T- and B-cell populations, determined using whole blood expanded fluorescent-activated cell sorter (FACS) analysis. The following laboratory assessments were performed: hemoglobin, hematocrit, red blood cells (RBC), white blood cells (WBC) with differential, and platelet counts; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total protein, albumin, total bilirubin, blood urea nitrogen (BUN), uric acid, creatinine, random glucose, potassium, sodium, chloride, calcium, and phosphorous; blood, protein, and glucose (microscopic examination, if abnormal and applicable).
Time Frame Through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.
Arm/Group Title Double-blind/Open Label Rituximab Double-blind Placebo/Open Label Rituximab
Hide Arm/Group Description:
The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU.
The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and "restart" the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU.
Overall Number of Participants Analyzed 33 18
Measure Type: Number
Unit of Measure: participants
0 0
6.Secondary Outcome
Title Proportion of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 24
Hide Description An ACR20 response is defined as a 20% reduction in the number of both swollen and tender joints, and a 20% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
Overall Number of Participants Analyzed 33 18
Measure Type: Number
Unit of Measure: proportion of participants
0.30 0.17
7.Secondary Outcome
Title Proportion of Participants Achieving an American College of Rheumatology 50 (ACR50) Response at Week 24
Hide Description An ACR50 response is defined as a 50% reduction in the number of both swollen and tender joints, and a 50% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
Overall Number of Participants Analyzed 33 18
Measure Type: Number
Unit of Measure: proportion of participants
0.12 0.06
8.Secondary Outcome
Title Proportion of Participants Achieving an American College of Rheumatology 70 (ACR70) Response at Week 24
Hide Description An ACR70 response is defined as a 70% reduction in the number of both swollen and tender joints, and a 70% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.
Arm/Group Title Rituximab Placebo
Hide Arm/Group Description:
The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
Overall Number of Participants Analyzed 33 18
Measure Type: Number
Unit of Measure: proportion of participants
0.00 0.00
Time Frame For Double-Blind Rituximab and Double-Blind Placebo reporting groups, nonserious AE data and SAE data are presented through the Week 24 treatment phase (primary endpoint completion). See Additional Description (below) for Cumulative Rituximab time frame.
Adverse Event Reporting Description For Cumulative Rituximab reporting group, nonserious AEs were captured only through Week 56. Serious adverse events (SAEs) were captured during treatment and post-treatment periods, through the safety follow-up (SFU) period (48 weeks) and the extended safety follow-up (ESFU; 1760 days).
 
Arm/Group Title Double-Blind Rituximab Double-Blind Placebo Cumulative Rituximab
Hide Arm/Group Description The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly. The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly. The cumulative rituximab treatment group included all participants who received rituximab at any time during the study, including participants who received rituximab in the double-blind period and did not participate in the OL period, those who received placebo in the double-blind period and rituximab in the OL, and those who received rituximab in the double-blind and OL periods. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
All-Cause Mortality
Double-Blind Rituximab Double-Blind Placebo Cumulative Rituximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Double-Blind Rituximab Double-Blind Placebo Cumulative Rituximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/33 (6.06%)   0/18 (0.00%)   8/49 (16.33%) 
Blood and lymphatic system disorders       
Neutropenia  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Cardiac disorders       
Coronary Artery Occlusion  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Gastrointestinal disorders       
Impaired Gastric Emptying  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Nausea  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
General disorders       
Asthenia  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Infections and infestations       
Pneumonia  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Arthritis Infective  1  0/33 (0.00%)  0/18 (0.00%)  4/49 (8.16%) 
Cellulitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Osteomyelitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Musculoskeletal and connective tissue disorders       
Systemic Lupus Erythematosus  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Nervous system disorders       
Dizziness  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Headache  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders       
Interstitial Lung Disease  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Double-Blind Rituximab Double-Blind Placebo Cumulative Rituximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/33 (93.94%)   15/18 (83.33%)   48/49 (97.96%) 
Blood and lymphatic system disorders       
Neutropenia  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Iron Deficiency Anaemia  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Cardiac disorders       
Tachycardia  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Coronary Artery Atherosclerosis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Congenital, familial and genetic disorders       
Dermoid Cyst  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Ear and labyrinth disorders       
Ear Discomfort  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Ear Pruritus  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Tinnitus  1  0/33 (0.00%)  1/18 (5.56%)  1/49 (2.04%) 
Endocrine disorders       
Hypothyroidism  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Eye disorders       
Eyelid Oedema  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Conjunctivitis  1  0/33 (0.00%)  0/18 (0.00%)  3/49 (6.12%) 
Dry Eye  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Gastrointestinal disorders       
Diarrhea  1  3/33 (9.09%)  1/18 (5.56%)  5/49 (10.20%) 
Mouth ulceration  1  2/33 (6.06%)  0/18 (0.00%)  2/49 (4.08%) 
Nausea  1  5/33 (15.15%)  2/18 (11.11%)  7/49 (14.29%) 
Vomiting  1  3/33 (9.09%)  0/18 (0.00%)  5/49 (10.20%) 
Abdominal Adhesions  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Abdominal Pain  1  0/33 (0.00%)  1/18 (5.56%)  1/49 (2.04%) 
Abdominal Pain Upper  1  1/33 (3.03%)  0/18 (0.00%)  2/49 (4.08%) 
Diverticulum  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Dry Mouth  1  0/33 (0.00%)  1/18 (5.56%)  1/49 (2.04%) 
Dyspepsia  1  0/33 (0.00%)  1/18 (5.56%)  2/49 (4.08%) 
Dysphagia  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Gastrooesophageal Reflux Disease  1  1/33 (3.03%)  0/18 (0.00%)  3/49 (6.12%) 
Rectocele  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Tooth Fracture  1  0/33 (0.00%)  1/18 (5.56%)  1/49 (2.04%) 
Colonic Polyp  1  0/33 (0.00%)  0/18 (0.00%)  2/49 (4.08%) 
Colitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Constipation  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Gastric Disorder  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Gastric Ulcer  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Gastroduodenitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Impaired Gastric Emptying  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Irritable Bowel Syndrome  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Oesophageal Polyp  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Reflux Oesophagitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Salivary Gland Calculus  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Swollen Tongue  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
General disorders       
Edema peripheral  1  3/33 (9.09%)  2/18 (11.11%)  5/49 (10.20%) 
Asthenia  1  2/33 (6.06%)  1/18 (5.56%)  2/49 (4.08%) 
Infusion-related reaction  1  2/33 (6.06%)  1/18 (5.56%)  5/49 (10.20%) 
Fatigue  1  4/33 (12.12%)  0/18 (0.00%)  5/49 (10.20%) 
Pyrexia  1  1/33 (3.03%)  1/18 (5.56%)  1/49 (2.04%) 
Chest Pain  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Oedema  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Venipuncture Site Inflammation  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Localised Oedema  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Non-Cardiac Chest Pain  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Immune system disorders       
Seasonal Allergy  1  1/33 (3.03%)  0/18 (0.00%)  2/49 (4.08%) 
Infections and infestations       
Upper respiratory tract infection  1  6/33 (18.18%)  5/18 (27.78%)  15/49 (30.61%) 
Nasopharyngitis  1  2/33 (6.06%)  1/18 (5.56%)  4/49 (8.16%) 
Vaginal mycosis  1  2/33 (6.06%)  1/18 (5.56%)  4/49 (8.16%) 
Urinary tract infection  1  2/33 (6.06%)  1/18 (5.56%)  6/49 (12.24%) 
Sinusitis  1  3/33 (9.09%)  3/18 (16.67%)  14/49 (28.57%) 
Bronchitis  1  1/33 (3.03%)  1/18 (5.56%)  5/49 (10.20%) 
Gastroenteritis  1  1/33 (3.03%)  1/18 (5.56%)  2/49 (4.08%) 
Herpes Simplex  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Infected Insect Bite  1  0/33 (0.00%)  1/18 (5.56%)  1/49 (2.04%) 
Influenza  1  1/33 (3.03%)  0/18 (0.00%)  2/49 (4.08%) 
Postoperative Infection  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Tooth Abscess  1  1/33 (3.03%)  0/18 (0.00%)  3/49 (6.12%) 
Tooth Infection  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Cellulitis  1  0/33 (0.00%)  0/18 (0.00%)  3/49 (6.12%) 
Gastroenteritis Viral  1  0/33 (0.00%)  0/18 (0.00%)  3/49 (6.12%) 
Acute Sinusitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Arthritis Infective  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Bronchitis Acute  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Dental Caries  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Dermatophytosis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Diverticulitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Dry Socket  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Ear Infection  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Eye Infection  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Laryngitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Oral Candidiasis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Oral Fungal Infection  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Osteomyelitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Otitis Media  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Parotitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Pharyngitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Pneumonia  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Respiratory Tract Infection  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Tinea Infection  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Tinea Pedis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Viral Infection  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Viral Upper Respiratory Tract Infection  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Injury, poisoning and procedural complications       
Arthropod Bite  1  1/33 (3.03%)  0/18 (0.00%)  2/49 (4.08%) 
Contusion  1  1/33 (3.03%)  0/18 (0.00%)  2/49 (4.08%) 
Excoriation  1  1/33 (3.03%)  0/18 (0.00%)  3/49 (6.12%) 
Foot Fracture  1  0/33 (0.00%)  1/18 (5.56%)  1/49 (2.04%) 
Skin Injury  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Stress Fracture  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Thermal Burn  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Incision Site Complication  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Joint Sprain  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Ligament Injury  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Muscle Strain  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Tendon Rupture  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Wrist Fracture  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Investigations       
Blood glucose increased  1  2/33 (6.06%)  0/18 (0.00%)  2/49 (4.08%) 
Bacteria Sputum Identified  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Blood Calcium Increased  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Blood Phosphorus Decreased  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Heart Rate Increased  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Lymphocyte Count Increased  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Monocyte Count Increased  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Aspartate Aminotransferase Increased  1  0/33 (0.00%)  0/18 (0.00%)  2/49 (4.08%) 
Alanine Aminotransferase Increased  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Blood Pressure Increased  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Hepatic Enzyme Increased  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Mean Cell Volume Increased  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Platelet Count Increased  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Weight Increased  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Metabolism and nutrition disorders       
Hyperglycaemia  1  1/33 (3.03%)  1/18 (5.56%)  3/49 (6.12%) 
Hyperlipidaemia  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Hypokalaemia  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Glucose Tolerance Impaired  1  0/33 (0.00%)  0/18 (0.00%)  2/49 (4.08%) 
Diabetes Mellitus  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Diabetes Mellitus Non-Insulin-Dependent  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Hypercholesterolaemia  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  2/33 (6.06%)  1/18 (5.56%)  3/49 (6.12%) 
Bursitis  1  1/33 (3.03%)  1/18 (5.56%)  5/49 (10.20%) 
Rheumatoid arthritis  1  3/33 (9.09%)  3/18 (16.67%)  14/49 (28.57%) 
Neck pain  1  2/33 (6.06%)  1/18 (5.56%)  3/49 (6.12%) 
Arthralgia  1  3/33 (9.09%)  2/18 (11.11%)  6/49 (12.24%) 
Muscle Spasms  1  1/33 (3.03%)  2/18 (11.11%)  4/49 (8.16%) 
Joint Swelling  1  1/33 (3.03%)  1/18 (5.56%)  2/49 (4.08%) 
Fibromyalgia  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Muscular Weakness  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Plantar Fasciitis  1  1/33 (3.03%)  0/18 (0.00%)  2/49 (4.08%) 
Rotator Cuff Syndrome  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Bone Pain  1  0/33 (0.00%)  0/18 (0.00%)  2/49 (4.08%) 
Osteoarthritis  1  0/33 (0.00%)  0/18 (0.00%)  2/49 (4.08%) 
Rheumatoid Nodule  1  0/33 (0.00%)  0/18 (0.00%)  2/49 (4.08%) 
Ganglion  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Intervertebral Disc Protrusion  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Musculoskeletal Discomfort  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Myalgia  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Pain In Extremity  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Shoulder Pain  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Spinal Osteoarthritis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Systemic Lupus Erythematosus  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Tendonitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Benign Neoplasm Of Skin  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Haemangioma  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Nervous system disorders       
Headache  1  3/33 (9.09%)  2/18 (11.11%)  8/49 (16.33%) 
Dizziness  1  3/33 (9.09%)  1/18 (5.56%)  4/49 (8.16%) 
Dysgeusia  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Lethargy  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Paraesthesia  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Restless Legs Syndrome  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Migraine  1  0/33 (0.00%)  0/18 (0.00%)  3/49 (6.12%) 
Hypoaesthesia  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Lumbar Radiculopathy  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Neuropathy  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Somnolence  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Tremor  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Psychiatric disorders       
Insomnia  1  3/33 (9.09%)  0/18 (0.00%)  4/49 (8.16%) 
Anxiety  1  3/33 (9.09%)  0/18 (0.00%)  4/49 (8.16%) 
Irritability  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Stress  1  0/33 (0.00%)  1/18 (5.56%)  1/49 (2.04%) 
Depression  1  0/33 (0.00%)  0/18 (0.00%)  2/49 (4.08%) 
Renal and urinary disorders       
Cystocele  1  1/33 (3.03%)  0/18 (0.00%)  2/49 (4.08%) 
Proteinuria  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Haematuria  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Reproductive system and breast disorders       
Genital Pruritus Female  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Menstruation Irregular  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Ovarian Cyst  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Menometrorrhagia  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Uterine Polyp  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders       
Sinus Congestion  1  1/33 (3.03%)  1/18 (5.56%)  4/49 (8.16%) 
Cough  1  0/33 (0.00%)  1/18 (5.56%)  2/49 (4.08%) 
Dyspnoea  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Pharyngolaryngeal Pain  1  0/33 (0.00%)  1/18 (5.56%)  2/49 (4.08%) 
Postnasal Drip  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Rhinitis Allergic  1  0/33 (0.00%)  1/18 (5.56%)  1/49 (2.04%) 
Emphysema  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Respiratory Tract Congestion  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  4/33 (12.12%)  0/18 (0.00%)  4/49 (8.16%) 
Urticaria  1  2/33 (6.06%)  0/18 (0.00%)  3/49 (6.12%) 
Rash erythematous  1  2/33 (6.06%)  1/18 (5.56%)  4/49 (8.16%) 
Alopecia  1  1/33 (3.03%)  1/18 (5.56%)  2/49 (4.08%) 
Dermatitis Contact  1  1/33 (3.03%)  0/18 (0.00%)  3/49 (6.12%) 
Rash  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Rash Pruritic  1  1/33 (3.03%)  0/18 (0.00%)  3/49 (6.12%) 
Skin Lesion  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Rash Macular  1  0/33 (0.00%)  0/18 (0.00%)  2/49 (4.08%) 
Rosacea  1  0/33 (0.00%)  0/18 (0.00%)  2/49 (4.08%) 
Blister  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Ecchymosis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Eczema  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Erythema  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Heat Rash  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Idiopathic Urticaria  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Pruritus Generalised  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Rash Vesicular  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Sebaceous Hyperplasia  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Skin Ulcer  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Telangiectasia  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Vascular disorders       
Flushing  1  2/33 (6.06%)  0/18 (0.00%)  2/49 (4.08%) 
Hypertension  1  1/33 (3.03%)  1/18 (5.56%)  1/49 (2.04%) 
Hypotension  1  1/33 (3.03%)  0/18 (0.00%)  1/49 (2.04%) 
Raynaud's Phenomenon  1  0/33 (0.00%)  1/18 (5.56%)  0/49 (0.00%) 
Lymphoedema  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Phlebitis  1  0/33 (0.00%)  0/18 (0.00%)  1/49 (2.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
Sponsor made a business decision to terminate study on 28 July 2011, after completion of the primary endpoint and during the long-term extension phase. One participant was still in extended safety follow-up and was referred for appropriate care.
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.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Name/Title: Biogen Idec Study Medical Director
Organization: Biogen Idec
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00298272     History of Changes
Other Study ID Numbers: 102-RA-201
First Submitted: March 1, 2006
First Posted: March 2, 2006
Results First Submitted: April 20, 2010
Results First Posted: November 17, 2010
Last Update Posted: September 28, 2015