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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000594-69 | EudraCT Number |
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Results from pre-specified criteria in study NCT01499355 (211LE201) did not demonstrate sufficient efficacy to warrant continuation of the study
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The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).
This is an extension study for all participants who completed study 211LE201 (NCT01499355) through Week 52 and did not discontinue BIIB023 or placebo. Eligible participants from Study 211LE201 will be followed for up to 108 weeks.
Participants who received BIIB023 low dose or high dose in 211LE201 will continue to receive the same dosing in this study (211LE202; NCT01930890) in addition to background therapy. Participants who received placebo in 211LE201 are randomized to receive either BIIB023 low dose or high dose in addition to background therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB023 3 mg/kg | Experimental | Participants will receive BIIB023 3 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and mycophenolate mofetil (MMF). |
|
| BIIB023 20 mg/kg | Experimental | Participants will receive BIIB023 20 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and MMF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB023 | Biological |
| ||
| mycophenolate mofetil |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. | Up to Week 108 |
| Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE | AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. | Up to Week 108 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria May Apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Lake Success | New York | 11020 | United States | ||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | Participants who received placebo every 4 weeks (Q4W) plus mycophenolate mofetil (MMF) and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg intavenously (IV) Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
titrated to a target daily dose of 2 g (1 g twice daily) |
|
|
| oral corticosteroids | Drug | oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day |
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| Research Site | Memphis | Tennessee | 38119 | United States |
| Research Site | El Paso | Texas | 79905 | United States |
| Research Site | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires | Argentina |
| Research Site | San Juan | San Juan Province | Argentina |
| Research Site | San Miguel de Tucumán | Tucumán Province | Argentina |
| Research Site | Melbourne | Victoria | 3052 | Australia |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Cuiabá | Mato Grosso | 78040-360 | Brazil |
| Research Site | Barranquilla | Colombia |
| Research Site | Bogotá | Colombia |
| Research Site | MedellÃn | Colombia |
| Research Site | Pessac | Gironde | 33604 | France |
| Research Site | Paris | Paris Cedex 13 | 75651 | France |
| Research Site | Shatin | Hong Kong |
| Research Site | Debrecen | 4032 | Hungary |
| Research Site | Pisa | Pisa | 56126 | Italy |
| Research Site | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
| Research Site | Kuching | Sarawak | 93586 | Malaysia |
| Research Site | Kuala Selangor | 41200 | Malaysia |
| Research Site | Kuala Selangor | 43000 | Malaysia |
| Research Site | Cuauhtémoc | Mexico City | 06090 | Mexico |
| Research Site | Lima | Peru |
| Research Site | Manila | 1008 | Philippines |
| Research Site | Quezon City | 1102 | Philippines |
| Research Site | Lodz | 90-153 | Poland |
| Research Site | Moscow | 123182 | Russia |
| Research Site | Suwon | Gyeonggi-do | 443-380 | South Korea |
| Research Site | Sagunto | Valencia | 46520 | Spain |
| Research Site | Bangkoknoi | Bangkok | 10700 | Thailand |
| Research Site | Pathumwan | Bangkok | 10330 | Thailand |
| BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) |
Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. |
| FG002 | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. |
| FG003 | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. |
| BG001 | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. |
| BG002 | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. |
| BG003 | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Gender | Count of Participants | Participants |
|
| 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 Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. | The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202). | Posted | Number | participants | Up to Week 108 |
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|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE | AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. | The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202). | Posted | Number | participants | Up to Week 108 |
|
Up to Week 108
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) | Participants who received placebo Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. | 1 | 14 | 4 | 14 | ||
| EG001 | BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) | Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. | 7 | 33 | 19 | 33 | ||
| EG002 | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | Participants who received placebo every Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. | 4 | 13 | 7 | 13 | ||
| EG003 | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. | 3 | 27 | 13 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Aphakia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Granulomatous liver disease | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Onychomycosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Spleen palpable | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Butterfly rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
Study was terminated based on the pre-specified, blinded futility analysis of Study 211LE201 (NCT01499355), which did not demonstrate sufficient efficacy to warrant continuation of the studies. Study was not terminated based on safety considerations.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | clinicaltrials@biogen.com |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C586995 | BIIB023 |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| 20 to 29 years |
|
| 30 to 39 years |
|
| 40 to 49 years |
|
| 50 to 55 years |
|
| > 55 years |
|
| Male |
|
| Moderate or severe event |
|
| Severe event |
|
| Event related to dose-blinded treatment |
|
| Event related to MMF |
|
| Serious event |
|
| Serious event related to dose-blinded treatment |
|
| Serious event related to MMF |
|
| Fatal event |
|
| OG002 | Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) | Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. |
| OG003 | BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) | Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202. |
|
|