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A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

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: NCT01194570
Recruitment Status : Active, not recruiting
First Posted : September 3, 2010
Results First Posted : December 26, 2017
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Primary Progressive
Interventions Drug: Ocrelizumab
Other: Placebo
Enrollment 732
Recruitment Details  
Pre-assignment Details A total of 943 participants were screened and 732 were randomized into the study, of which 725 received at least one dose of placebo or ocrelizumab. A total of 549 participants were ongoing with double-blind treatment at the clinical cut-off date (CCOD).
Arm/Group Title Placebo Ocrelizumab 600 mg
Hide Arm/Group Description Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks. Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Period Title: Overall Study
Started 244 488
Completed 0 [1] 0
Not Completed 244 488
Reason Not Completed
Death             1             3
Ongoing at CCOD             162             387
Physician Decision             2             6
Reason not specified             13             20
Protocol Violation             0             2
Non-compliance with study drug             2             2
Adverse Event             12             18
Non-compliance             2             2
Lack of Efficacy             27             21
Withdrawal by Subject             21             22
Pregnancy             1             1
Lost to Follow-up             1             4
[1]
Reason for discontinuation were provided for "Core Treatment Completion".
Arm/Group Title Placebo Ocrelizumab 600 mg Total
Hide Arm/Group Description Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks. Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks. Total of all reporting groups
Overall Number of Baseline Participants 244 488 732
Hide Baseline Analysis Population Description
Analysis was performed on intent to treat (ITT) population which included all randomized participants in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants 488 participants 732 participants
44.4  (8.3) 44.7  (7.9) 44.6  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 488 participants 732 participants
Female
124
  50.8%
237
  48.6%
361
  49.3%
Male
120
  49.2%
251
  51.4%
371
  50.7%
1.Primary Outcome
Title Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period
Hide Description The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.
Time Frame Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Ocrelizumab 600 mg
Hide Arm/Group Description:
Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Overall Number of Participants Analyzed 244 487
Median (Full Range)
Unit of Measure: weeks
NA [1] 
(0 to NA)
NA [1] 
(0 to NA)
[1]
The median and upper limit of full range for time to onset of CDP has not been reached due to low number of participants with the event at the end of the study.
2.Secondary Outcome
Title Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period
Hide Description The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.
Time Frame Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this endpoint.
Arm/Group Title Placebo Ocrelizumab 600 mg
Hide Arm/Group Description:
Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Overall Number of Participants Analyzed 244 487
Median (Full Range)
Unit of Measure: weeks
NA [1] 
(0 to NA)
NA [1] 
(0 to NA)
[1]
The median and upper limit of full range for time to onset of CDP has not been reached due to low number of participants with the event at the end of the study.
3.Secondary Outcome
Title Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120
Hide Description [Not Specified]
Time Frame Baseline, Week 120
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Here, number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.
Arm/Group Title Placebo Ocrelizumab 600 mg
Hide Arm/Group Description:
Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Overall Number of Participants Analyzed 239 473
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
55.097
(39.855 to 71.999)
38.933
(29.222 to 49.374)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ocrelizumab 600 mg
Comments Estimates (back-transformed) based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-baseline(BL)/BL) = log(BL 25-FTW) + Geographical Region (US vs. ROW) + Age (<=45, > 45 years) + Week + Treatment + Treatment*Week (repeated values over Week) + log (BL 25-FTW)*Week. Relative reduction was calculated as -Relative change = -(OCR response-Placebo response)/Placebo response*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0404
Comments P-value from a ranked ANCOVA on Percent Change from BL adjusting for rank of BL 25-Foot Timed Walk (25-FTW), Geographical Region (US vs ROW) and Age (<=45, > 45 years); missing observations imputed with LOCF.
Method Ranked ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Reduction (%)
Estimated Value 29.337
Confidence Interval (2-Sided) 95%
-1.618 to 51.456
Estimation Comments Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.
4.Secondary Outcome
Title Percent Change From Baseline in Total Volume of T2 Lesions at Week 120
Hide Description [Not Specified]
Time Frame From Baseline to Week 120
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Here, Number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.
Arm/Group Title Placebo Ocrelizumab 600 mg
Hide Arm/Group Description:
Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Overall Number of Participants Analyzed 234 464
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
7.426
(4.967 to 9.942)
-3.366
(-4.987 to -1.718)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ocrelizumab 600 mg
Comments Estimates (back-transformed) are based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-BL/BL) = log(BL T2 lesion volume) + Geographical Region (US vs. ROW) + Age (<=45, > 45 years) + Week + Treatment + Treatment*Week (repeated values over Week) + log (BL T2 lesion volume)*Week.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value is from ranked ANCOVA on Percent Change from BL adjusting for rank of BL T2 lesion volume, Geographical Region (US vs ROW) and Age (<=45, > 45 years); missing observations imputed with LOCF.
Method Ranked ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geometric Means
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.876 to 0.924
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change in Total Brain Volume From Week 24 to Week 120
Hide Description [Not Specified]
Time Frame From Week 24 to Week 120
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this endpoint. Here, least square mean is indicating adjusted mean.
Arm/Group Title Placebo Ocrelizumab 600 mg
Hide Arm/Group Description:
Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Overall Number of Participants Analyzed 203 407
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-1.093
(-1.236 to -0.951)
-0.902
(-1.004 to -0.799)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ocrelizumab 600 mg
Comments Estimates are from analysis based on MMRM using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Age (<=45, > 45 years) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week. Relative reduction was calculated as – Relative change = - (OCR response-Placebo response)/Placebo response*100%. The 95% CI for relative reduction was obtained using Bootstrap method.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0206
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Reduction (%)
Estimated Value 17.475
Confidence Interval (2-Sided) 95%
3.206 to 29.251
Estimation Comments Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.
6.Secondary Outcome
Title Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120
Hide Description The SF-36v2 is a 36-item, self- reported, generic measure of quality of life that has been widely used in multiple disease areas. It is composed of 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The PCS score was derived based on the SF-36 V2 User's Manual. Scoring for PCS involves (a) recoding item response values, (b) summing recoded response values for all items in a given scale to obtain the scale raw score, (c) transforming scale raw score to a 0−100 score. The PCS score was computed by (a) multiplying each health domain z score by a scale-specific physical factor score coefficient, (b) summing the resulting products, (c) converting the product total to T score. The total score ranges from 0-100, higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame From Baseline to Week 120
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants in the study. Here, Number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.
Arm/Group Title Placebo Ocrelizumab 600 mg
Hide Arm/Group Description:
Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Overall Number of Participants Analyzed 128 292
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.108
(-2.394 to 0.177)
-0.731
(-1.655 to 0.193)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ocrelizumab 600 mg
Comments Estimates are from analysis based on MMRM using unstructured covariance matrix: Change = Baseline PCS Score + Geographical Region (US vs. ROW) + Age (<=45, > 45 years) + Week + Treatment + Treatment*Week (repeated values over Week) + Baseline PCS Score*Week.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6034
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.377
Confidence Interval (2-Sided) 95%
-1.048 to 1.802
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.725
Estimation Comments Difference in adjusted mean was calculated as Ocrelizumab SF-36 Physical Component Summary Score - Placebo SF-36 Physical Component Summary Score.
7.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE)
Hide Description AEs included infusion related reactions (IRRs) and serious multiple sclerosis (MS) relapses, but excluded non-serious MS relapses.
Time Frame From the first infusion up to the study clinical cut-off date 24 July 2015 (up to 229 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants who received at least one dose of study drug.
Arm/Group Title Placebo Ocrelizumab 600 mg
Hide Arm/Group Description:
Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Overall Number of Participants Analyzed 239 486
Measure Type: Number
Unit of Measure: percentage of participants
90.0 95.1
Time Frame From the first infusion up to the study clinical cut-off date 24 July 2015 (up to 229 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Ocrelizumab 600 mg
Hide Arm/Group Description Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks. Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
All-Cause Mortality
Placebo Ocrelizumab 600 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Ocrelizumab 600 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   53/239 (22.18%)   99/486 (20.37%) 
Blood and lymphatic system disorders     
Anaemia  1  1/239 (0.42%)  1/486 (0.21%) 
Agranulocytosis  1  0/239 (0.00%)  1/486 (0.21%) 
Febrile neutropenia  1  0/239 (0.00%)  1/486 (0.21%) 
Microcytic anaemia  1  0/239 (0.00%)  1/486 (0.21%) 
Cardiac disorders     
Myocardial infarction  1  0/239 (0.00%)  2/486 (0.41%) 
Atrial fibrillation  1  1/239 (0.42%)  0/486 (0.00%) 
Sinus tachycardia  1  0/239 (0.00%)  1/486 (0.21%) 
Tachycardia  1  1/239 (0.42%)  0/486 (0.00%) 
Eye disorders     
Cataract  1  0/239 (0.00%)  1/486 (0.21%) 
Gastrointestinal disorders     
Ileus  1  2/239 (0.84%)  0/486 (0.00%) 
Pancreatitis acute  1  0/239 (0.00%)  2/486 (0.41%) 
Abdominal pain lower  1  0/239 (0.00%)  1/486 (0.21%) 
Colitis ischaemic  1  0/239 (0.00%)  1/486 (0.21%) 
Constipation  1  1/239 (0.42%)  0/486 (0.00%) 
Crohn's disease  1  0/239 (0.00%)  1/486 (0.21%) 
Diarrhoea  1  0/239 (0.00%)  1/486 (0.21%) 
Duodenal ulcer haemorrhage  1  0/239 (0.00%)  1/486 (0.21%) 
Faecaloma  1  0/239 (0.00%)  1/486 (0.21%) 
Gastric ulcer haemorrhage  1  0/239 (0.00%)  1/486 (0.21%) 
Gastrointestinal polyp haemorrhage  1  0/239 (0.00%)  1/486 (0.21%) 
Incarcerated umbilical hernia  1  0/239 (0.00%)  1/486 (0.21%) 
General disorders     
Gait disturbance  1  1/239 (0.42%)  2/486 (0.41%) 
Oedema peripheral  1  0/239 (0.00%)  2/486 (0.41%) 
Asthenia  1  1/239 (0.42%)  0/486 (0.00%) 
Drug intolerance  1  0/239 (0.00%)  1/486 (0.21%) 
Fatigue  1  1/239 (0.42%)  0/486 (0.00%) 
Non-cardiac chest pain  1  0/239 (0.00%)  1/486 (0.21%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/239 (0.42%)  1/486 (0.21%) 
Cholelithiasis  1  1/239 (0.42%)  1/486 (0.21%) 
Bile duct stenosis  1  0/239 (0.00%)  1/486 (0.21%) 
Cholecystitis chronic  1  0/239 (0.00%)  1/486 (0.21%) 
Drug-induced liver injury  1  1/239 (0.42%)  0/486 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  0/239 (0.00%)  1/486 (0.21%) 
Infections and infestations     
Bronchopneumonia  1  0/239 (0.00%)  1/486 (0.21%) 
Pneumonia  1  2/239 (0.84%)  6/486 (1.23%) 
Urinary tract infection  1  2/239 (0.84%)  5/486 (1.03%) 
Urosepsis  1  3/239 (1.26%)  2/486 (0.41%) 
Appendictis  1  0/239 (0.00%)  2/486 (0.41%) 
Bronchitis  1  0/239 (0.00%)  2/486 (0.41%) 
Cellulitis  1  0/239 (0.00%)  2/486 (0.41%) 
Infectious colitis  1  1/239 (0.42%)  1/486 (0.21%) 
Pyelonephritis  1  0/239 (0.00%)  2/486 (0.41%) 
Abscess limb  1  0/239 (0.00%)  1/486 (0.21%) 
Abscess of eyelid  1  1/239 (0.42%)  0/486 (0.00%) 
Appendicitis perforated  1  1/239 (0.42%)  0/486 (0.00%) 
Arthritis infective  1  1/239 (0.42%)  0/486 (0.00%) 
Bacterial pyelonephritis  1  0/239 (0.00%)  1/486 (0.21%) 
Bursitis infective  1  0/239 (0.00%)  1/486 (0.21%) 
Diverticulitis  1  0/239 (0.00%)  1/486 (0.21%) 
Erysipelas  1  0/239 (0.00%)  1/486 (0.21%) 
Gastroenteritis  1  0/239 (0.00%)  1/486 (0.21%) 
Gastrointestinal infection  1  0/239 (0.00%)  1/486 (0.21%) 
Hepatitis viral  1  1/239 (0.42%)  0/486 (0.00%) 
Impetigo  1  0/239 (0.00%)  1/486 (0.21%) 
Infected dermal cyst  1  0/239 (0.00%)  1/486 (0.21%) 
Mastitis  1  0/239 (0.00%)  1/486 (0.21%) 
Meningitis aseptic  1  1/239 (0.42%)  0/486 (0.00%) 
Neutropenic sepsis  1  0/239 (0.00%)  1/486 (0.21%) 
Pelvic inflammatory disease  1  1/239 (0.42%)  0/486 (0.00%) 
Peritonitis  1  0/239 (0.00%)  1/486 (0.21%) 
Post procedural cellulitis  1  0/239 (0.00%)  1/486 (0.21%) 
Pyelonephritis acute  1  0/239 (0.00%)  1/486 (0.21%) 
Septic shock  1  1/239 (0.42%)  0/486 (0.00%) 
Sinusitis  1  1/239 (0.42%)  0/486 (0.00%) 
Viral infection  1  0/239 (0.00%)  1/486 (0.21%) 
Viral pericarditis  1  0/239 (0.00%)  1/486 (0.21%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  0/239 (0.00%)  5/486 (1.03%) 
Femur fracture  1  2/239 (0.84%)  1/486 (0.21%) 
Ankle fracture  1  0/239 (0.00%)  2/486 (0.41%) 
Tendon rupture  1  0/239 (0.00%)  2/486 (0.41%) 
Upper limb fracture  1  1/239 (0.42%)  1/486 (0.21%) 
Femoral neck fracture  1  0/239 (0.00%)  1/486 (0.21%) 
Fibula fracture  1  0/239 (0.00%)  1/486 (0.21%) 
Hip fracture  1  1/239 (0.42%)  0/486 (0.00%) 
Joint dislocation  1  1/239 (0.42%)  0/486 (0.00%) 
Lumbar vertebral fracture  1  1/239 (0.42%)  0/486 (0.00%) 
Multiple fractures  1  0/239 (0.00%)  1/486 (0.21%) 
Overdose  1  1/239 (0.42%)  0/486 (0.00%) 
Post lumbar puncture syndrome  1  0/239 (0.00%)  1/486 (0.21%) 
Post procedural haematuria  1  1/239 (0.42%)  0/486 (0.00%) 
Postoperative fever  1  0/239 (0.00%)  1/486 (0.21%) 
Procedural intestinal perforation  1  1/239 (0.42%)  0/486 (0.00%) 
Radius fracture  1  0/239 (0.00%)  1/486 (0.21%) 
Road traffic accident  1  1/239 (0.42%)  0/486 (0.00%) 
Subdural haematoma  1  0/239 (0.00%)  1/486 (0.21%) 
Tibia fracture  1  0/239 (0.00%)  1/486 (0.21%) 
Toxicity to various agents  1  1/239 (0.42%)  0/486 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/239 (0.00%)  1/486 (0.21%) 
Hyperglycaemia  1  1/239 (0.42%)  0/486 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/239 (0.42%)  4/486 (0.82%) 
Rotator cuff syndrome  1  1/239 (0.42%)  1/486 (0.21%) 
Mobility decreased  1  1/239 (0.42%)  0/486 (0.00%) 
Muscular weakness  1  0/239 (0.00%)  1/486 (0.21%) 
Osteoarthritis  1  1/239 (0.42%)  0/486 (0.00%) 
Pain in extremity  1  0/239 (0.00%)  1/486 (0.21%) 
Polyarthritis  1  1/239 (0.42%)  0/486 (0.00%) 
Rhabdomyolysis  1  1/239 (0.42%)  0/486 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Invasive ductal breast carcinoma  1  0/239 (0.00%)  2/486 (0.41%) 
Adenocarcinoma of the cervix  1  1/239 (0.42%)  0/486 (0.00%) 
Anaplastic large-cell lymphoma  1  0/239 (0.00%)  1/486 (0.21%) 
Basal cell carcinoma  1  1/239 (0.42%)  0/486 (0.00%) 
Benign vaginal neoplasm  1  1/239 (0.42%)  0/486 (0.00%) 
Breast cancer  1  0/239 (0.00%)  1/486 (0.21%) 
Chondroma  1  1/239 (0.42%)  0/486 (0.00%) 
Endometrial cancer  1  0/239 (0.00%)  1/486 (0.21%) 
Invasive breast carcinoma  1  0/239 (0.00%)  1/486 (0.21%) 
Lung neoplasm  1  1/239 (0.42%)  0/486 (0.00%) 
Malignant fibrous histiocytoma  1  0/239 (0.00%)  1/486 (0.21%) 
Pancreatic carcinoma metastatic  1  0/239 (0.00%)  1/486 (0.21%) 
Parathyroid tumour benign  1  1/239 (0.42%)  0/486 (0.00%) 
Rosai-Dorfman syndrome  1  1/239 (0.42%)  0/486 (0.00%) 
Uterine leiomyoma  1  1/239 (0.42%)  0/486 (0.00%) 
Nervous system disorders     
Multiple sclerosis relapse  1  2/239 (0.84%)  5/486 (1.03%) 
Seizure  1  2/239 (0.84%)  1/486 (0.21%) 
Syncope  1  0/239 (0.00%)  2/486 (0.41%) 
Trigeminal neuralgia  1  0/239 (0.00%)  2/486 (0.41%) 
Dizziness  1  1/239 (0.42%)  0/486 (0.00%) 
Epilepsy  1  1/239 (0.42%)  0/486 (0.00%) 
Haemorrhage intracranial  1  0/239 (0.00%)  1/486 (0.21%) 
Headache  1  1/239 (0.42%)  0/486 (0.00%) 
Intracranial pressure increased  1  0/239 (0.00%)  1/486 (0.21%) 
Migraine  1  0/239 (0.00%)  1/486 (0.21%) 
Multiple sclerosis  1  0/239 (0.00%)  1/486 (0.21%) 
Muscle spasticity  1  1/239 (0.42%)  0/486 (0.00%) 
Optic neuritis  1  0/239 (0.00%)  1/486 (0.21%) 
Partial seizures with secondary generalisation  1  0/239 (0.00%)  1/486 (0.21%) 
Primary progressive multiple sclerosis  1  0/239 (0.00%)  1/486 (0.21%) 
Sciatica  1  0/239 (0.00%)  1/486 (0.21%) 
Uhthoff's phenomenon  1  1/239 (0.42%)  0/486 (0.00%) 
Paralysis  1  1/239 (0.42%)  0/486 (0.00%) 
Psychiatric disorders     
Suicide attempt  1  0/239 (0.00%)  2/486 (0.41%) 
Depression suicidal  1  0/239 (0.00%)  1/486 (0.21%) 
Suicidal ideation  1  0/239 (0.00%)  1/486 (0.21%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/239 (0.42%)  2/486 (0.41%) 
Urinary retention  1  2/239 (0.84%)  1/486 (0.21%) 
Proteinuria  1  0/239 (0.00%)  1/486 (0.21%) 
Urethral stenosis  1  0/239 (0.00%)  1/486 (0.21%) 
Reproductive system and breast disorders     
Cervical polyp  1  0/239 (0.00%)  1/486 (0.21%) 
Metrorrhagia  1  0/239 (0.00%)  1/486 (0.21%) 
Ovarian cyst  1  1/239 (0.42%)  0/486 (0.00%) 
Uterine prolapse  1  1/239 (0.42%)  0/486 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/239 (0.42%)  1/486 (0.21%) 
Bronchitis chronic  1  1/239 (0.42%)  0/486 (0.00%) 
Pneumonia aspiration  1  0/239 (0.00%)  1/486 (0.21%) 
Pulmonary embolism  1  0/239 (0.00%)  1/486 (0.21%) 
Skin and subcutaneous tissue disorders     
Actinic keratosis  1  1/239 (0.42%)  0/486 (0.00%) 
Pruritus allergic  1  0/239 (0.00%)  1/486 (0.21%) 
Vascular disorders     
Deep vein thrombosis  1  1/239 (0.42%)  0/486 (0.00%) 
Dry gangrene  1  0/239 (0.00%)  1/486 (0.21%) 
Peripheral arterial occlusive disease  1  0/239 (0.00%)  1/486 (0.21%) 
Varicose vein  1  1/239 (0.42%)  0/486 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Ocrelizumab 600 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   179/239 (74.90%)   400/486 (82.30%) 
Gastrointestinal disorders     
Constipation  1  12/239 (5.02%)  23/486 (4.73%) 
Nausea  1  16/239 (6.69%)  19/486 (3.91%) 
Diarrhoea  1  12/239 (5.02%)  22/486 (4.53%) 
General disorders     
Fatigue  1  23/239 (9.62%)  27/486 (5.56%) 
Oedema peripheral  1  12/239 (5.02%)  24/486 (4.94%) 
Infections and infestations     
Nasopharyngitis  1  65/239 (27.20%)  110/486 (22.63%) 
Urinary tract infection  1  53/239 (22.18%)  96/486 (19.75%) 
Influenza  1  21/239 (8.79%)  56/486 (11.52%) 
Upper respiratory tract infection  1  14/239 (5.86%)  53/486 (10.91%) 
Bronchitis  1  12/239 (5.02%)  29/486 (5.97%) 
Gastroenteritis  1  12/239 (5.02%)  20/486 (4.12%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  61/239 (25.52%)  191/486 (39.30%) 
Contusion  1  19/239 (7.95%)  14/486 (2.88%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  36/239 (15.06%)  55/486 (11.32%) 
Arthralgia  1  21/239 (8.79%)  38/486 (7.82%) 
Pain in extremity  1  25/239 (10.46%)  32/486 (6.58%) 
Musculoskeletal pain  1  12/239 (5.02%)  19/486 (3.91%) 
Nervous system disorders     
Headache  1  32/239 (13.39%)  65/486 (13.37%) 
Dizziness  1  10/239 (4.18%)  25/486 (5.14%) 
Psychiatric disorders     
Depression  1  30/239 (12.55%)  37/486 (7.61%) 
Insomnia  1  12/239 (5.02%)  27/486 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/239 (3.35%)  29/486 (5.97%) 
Vascular disorders     
Hypertension  1  9/239 (3.77%)  25/486 (5.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01194570    
Other Study ID Numbers: WA25046
2010-020338-25 ( EudraCT Number )
First Submitted: August 28, 2010
First Posted: September 3, 2010
Results First Submitted: March 30, 2017
Results First Posted: December 26, 2017
Last Update Posted: March 24, 2020