A Study to Evaluate Two Doses of Ocrelizumab in Patients... | NCT00539838

NCT00539838

ID	Type	Description	Link
WA20499

Status Module

Sponsor/Collaborators Module

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ocrelizumab 1000 mg	Experimental	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks	Drug: Prednisone Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate) Drug: Methylprednisolone Drug: Ocrelizumab
Ocrelizumab 400 mg	Experimental	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks	Drug: Prednisone Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate) Drug: Methylprednisolone Drug: Ocrelizumab
Placebo	Placebo Comparator	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks	Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate) Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Prednisone	Drug	Oral repeating dose	Ocrelizumab 1000 mg Ocrelizumab 400 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Major Clinical Response (MCR)		Week 48
Number of Participants With Partial Clinical Response (PCR)		Week 48
Number of Non-responders (NR)		Week 48

Measure	Description	Time Frame
Number of Participants Who Achieved a BILAG Score of C or Better at Week 24.		Week 24
Time Adjusted Mean SLEDAI-2K Score		Week 48
Annualized Flare Rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 16 years or above at the time of screening
Diagnosis of SLE
Active disease at screening

Exclusion Criteria:

Presence of active moderate to severe glomerulonephritis
Currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia
Lack of peripheral venous access
Pregnancy or breast feeding mothers
History of severe allergic or anaphylactic reactions to humanized, chimeric or murine monoclonal antibodies or i.v. immunoglobulin
Known severe chronic pulmonary disease
Evidence of significant or uncontrolled concomitant diseases in any organ system not related to SLE, which, in the investigator's opinion, would impair patient participation
Concomitant condition which has required treatment with systemic corticosteroid (excluding topical or inhaled) at any time in the 52 weeks prior to screening
Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection
Known active infection of any kind (but excluding fungal infection of nail beds or oral thrush which has resolved before Day 1) within 30 days prior to Day 1. In addition, any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives in the 30 days prior to Day 1 or oral anti-infectives in the 14 days prior to Day 1
History of serious recurrent or chronic infection
History of cancer (except basal cell carcinoma of the skin that has been excised and cured)
History of alcohol or drug abuse in the 52 weeks prior to screening
Major surgery in the 4 weeks prior to screening excluding diagnostic surgery
Previous treatment with CAMPATH-1H
Previous treatment with a BAFF directed treatment in the 12 months prior to screening
Previous treatment with a B-cell targeted therapy other than one directed at BAFF
Treatment with any investigational agent, other than those above, in the 28 days prior to screening or five half-lives of the investigational drug (whichever is longer)
Receipt of any live vaccine in the 6 weeks prior to Day 1
Intolerance or contraindication to oral or i.v. corticosteroids
Treatment with a second immunosuppressive or immunomodulatory drug in the 8 weeks prior to Day 1
Prednisone dose of ≥ 0.7 mg/kg/day (or equivalent) for > 7 of the previous 30 days prior to screening
Treatment with cyclophosphamide or a calcineurin inhibitor in the 12 weeks prior to screening
Positive hepatitis BsAg or hepatitis C serology. Patients who are HBsAg negative but HBcAb positive may be enrolled with a negative DNA test

Contacts/Locations Module

Name	Affiliation	Role
Jorn Drappa, M.D., Ph.D.	Genentech, Inc.	Study Director

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
FG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
BG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
BG002	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00010 BG00111 BG00212 BG00333

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00041.0± 13.82 BG00140.2± 8.80 BG00236.3± 11.31 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0009 BG00111 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0006 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0004 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Major Clinical Response (MCR)

Evaluation of the primary and some secondary endpoints was to occur at Week 48 with further analyses conducted at Week 96. However, following the early termination of the study, the analysis of the primary and secondary endpoints were not conducted.

Posted

Week 48

ID	Title	Description
OG000	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks

Units	Counts
Participants	OG0000 OG0010 OG0020

Primary

Number of Participants With Partial Clinical Response (PCR)

Posted

Week 48

ID	Title	Description
OG000	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks

Units	Counts
Participants

Primary

Number of Non-responders (NR)

Posted

Week 48

ID	Title	Description
OG000	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Number of Participants Who Achieved a BILAG Score of C or Better at Week 24.

Posted

Week 24

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Time Adjusted Mean SLEDAI-2K Score

Posted

Week 48

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Annualized Flare Rate

Posted

Week 48 to Week 96

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Time to First Moderate to Severe Flare

Posted

Week 48 to Week 96

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Number of Participants Who Achieved A Major Or Partial Clinical Response At Week 48 (PCR Plus MCR Proportion), Who Did Not Experience A Flare Before Week 96

Posted

Week 48 to Week 96

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Number of Participants Who Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 72

Posted

Week 48 to Week 72

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Number of Participants Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 96

Posted

Week 48 to Week 96

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Change in SF-36 Subscale And Summary Scores From Baseline At Week 48

Posted

Baseline, Week 48

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Change In FACIT-Fatigue Assessment From Baseline To Week 48

Posted

Baseline, Week 48

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Change From Baseline In Pain Quality And Impact Of Pain On Daily Function Measured By The Brief Pain Inventory Short Form At Week 48

Posted

Baseline, Week 48

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

The EQ-5D Single Index Utility Score At Week 48

Posted

Baseline, Week 48

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Secondary

Number of Participants With Adverse Events

Posted

Up to 2.5 years

ID	Title	Description
OG000	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
OG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
OG002	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks	0	10	5	10
EG001	Ocrelizumab 400 mg	Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks	6	11	10	11
EG002	Ocrelizumab 1000 mg	Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks	3	12	8	12

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
CYTOMEGALOVIRUS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
CHORIORETINITIS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
PNEUMOCYSTIS JIROVECI	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
PNEUMONIA	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
NEPHROTIC SYNDROME	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
PERICARDITIS	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
SYSTEMIC LUPUS ERYTHEMATOSUS	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
SYNCOPE	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0002 events2 affected10 at risk EG0013 events3 affected11 at risk EG0022 events2 affected12 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 events1 affected10 at risk EG0013 events3 affected11 at risk EG0021 events1 affected12 at risk
SINUSITIS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected11 at risk EG0021 events1 affected12 at risk
BRONCHITIS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0023 events3 affected12 at risk
OTITIS MEDIA	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0022 events2 affected12 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
PNEUMONIA	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
CELLULITIS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
CONJUNCTIVITIS INFECTIVE	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
CYTOMEGALOVIRUS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
CHORIORETINITIS FUNGAL SKIN INFECTION	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
NAIL INFECTION	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
ONYCHOMYCOSIS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
ORAL HERPES	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
ORAL HERPES	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
PNEUMOCYSTIS JIROVECI	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
PNEUMONIA RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
TINEA CRURIS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
VAGINITIS BACTERIAL	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
VULVOVAGINAL CANDIDIASIS	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
VULVOVAGINAL MYCOTIC INFECTION	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0013 events3 affected11 at risk EG0021 events1 affected12 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 events1 affected10 at risk EG0012 events2 affected11 at risk EG0021 events1 affected12 at risk
VOMITING	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 events1 affected10 at risk EG0012 events2 affected11 at risk EG0020 events0 affected12 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
TONGUE DISORDER	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
HEADACHE	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 events1 affected10 at risk EG0012 events2 affected11 at risk EG0021 events1 affected12 at risk
DIZZINESS	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
HEMIANOPIA	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
MIGRAINE	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
POST HERPETIC NEURALGIA	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
SYNCOPE	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
INSOMNIA	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected11 at risk EG0022 events2 affected12 at risk
DEPRESSION	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
ANXIETY	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
MAJOR DEPRESSION	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
INFUSION RELATED REACTION	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected11 at risk EG0021 events1 affected12 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
PYREXIA	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
SWELLING	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0022 events2 affected12 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
MUSCLE TWITCHING	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
NODULE ON EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
PARANASAL SINUS HYPERSECRETION	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
SLEEP APNOEA SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
DYSURIA	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
NEPHROTIC SYNDROME	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
SKIN HYPERPIGMENTATION	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
SYSTEMIC LUPUS ERYTHEMATOSUS	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected11 at risk EG0020 events0 affected12 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected11 at risk EG0020 events0 affected12 at risk
PERICARDITIS	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
VITAMIN D DECREASED	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
WEIGHT DECREASED	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
HYPERTENSION	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0021 events1 affected12 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
CONJUNCTIVITIS	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
EYELID PTOSIS	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
PHOTOPHOBIA	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
VISION BLURRED	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
MENISCUS LESION	Injury, poisoning and procedural complications	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
AMENORRHOEA	Reproductive system and breast disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
VAGINAL DISCHARGE	Reproductive system and breast disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
ADRENAL INSUFFICIENCY	Endocrine disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected11 at risk EG0020 events0 affected12 at risk
SEASONAL ALLERGY	Immune system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected11 at risk EG0021 events1 affected12 at risk

The study was terminated before any patients reached the Week 48 visit. Therefore, the safety analysis included all safety data for the 33 randomized patients that were available up to the data cutoff date (22 March 2010)

Certain Agreements

ID	Term
D008180	Lupus Erythematosus, Systemic

ID	Term
D011241	Prednisone
D001379	Azathioprine
D009173	Mycophenolic Acid
D008727	Methotrexate
D008775	Methylprednisolone
C533411	ocrelizumab

Ancestor Terms

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013872	Thionucleosides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D015122	Mercaptopurine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D005227	Fatty Acids
D008055	Lipids
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D011239	Prednisolone
D011246	Pregnadienetriols

OG0000
OG0010
OG0020

OG0000
OG0010
OG0020

OG0000
OG0010
OG0020

OG0000
OG0010
OG0020

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases