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Trial record 53 of 146 for:    lupus AND Lupus Nephritis

BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

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: NCT01930890
Recruitment Status : Terminated (Results from pre-specified criteria in study NCT01499355 (211LE201) did not demonstrate sufficient efficacy to warrant continuation of the study)
First Posted : August 29, 2013
Results First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Lupus Nephritis
Interventions Biological: BIIB023
Drug: mycophenolate mofetil
Drug: oral corticosteroids
Enrollment 87

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 14 33 13 27
Completed 0 0 0 0
Not Completed 14 33 13 27
Reason Not Completed
Study Termination             14             28             13             25
Death             0             0             0             1
Investigator Decision             0             1             0             0
Consent Withdrawn             0             3             0             1
Adverse Event             0             1             0             0
Arm/Group Title Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202) Total
Hide Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 14 33 13 27 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 33 participants 13 participants 27 participants 87 participants
31.3  (8.96) 32.6  (8.93) 31.5  (10.06) 32.2  (8.23) 32.1  (8.76)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 33 participants 13 participants 27 participants 87 participants
18 to 19 years 0 0 1 1 2
20 to 29 years 6 15 6 9 36
30 to 39 years 6 11 3 14 34
40 to 49 years 2 6 2 1 11
50 to 55 years 0 0 1 2 3
> 55 years 0 1 0 0 1
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 33 participants 13 participants 27 participants 87 participants
Female
11
  78.6%
29
  87.9%
10
  76.9%
25
  92.6%
75
  86.2%
Male
3
  21.4%
4
  12.1%
3
  23.1%
2
   7.4%
12
  13.8%
1.Primary Outcome
Title Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 14 33 13 27
Measure Type: Number
Unit of Measure: participants
Any event 4 23 7 19
Moderate or severe event 2 12 3 6
Severe event 0 4 1 3
Event related to dose-blinded treatment 1 5 1 4
Event related to MMF 2 8 2 9
Serious event 1 7 4 3
Serious event related to dose-blinded treatment 0 2 1 1
Serious event related to MMF 0 3 1 2
Fatal event 0 0 0 1
2.Primary Outcome
Title Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE
Hide Description 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.
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 14 33 13 27
Measure Type: Number
Unit of Measure: participants
Discontinued treatment due to an AE 0 0 0 0
Withdrew from study due to an AE 0 2 0 1
Time Frame Up to Week 108
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/14 (7.14%)   7/33 (21.21%)   4/13 (30.77%)   3/27 (11.11%) 
Blood and lymphatic system disorders         
Neutropenia  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Eye disorders         
Aphakia  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Cataract  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  0/14 (0.00%)  0/33 (0.00%)  0/13 (0.00%)  1/27 (3.70%) 
General disorders         
Multi-organ failure  1  0/14 (0.00%)  0/33 (0.00%)  0/13 (0.00%)  1/27 (3.70%) 
Hepatobiliary disorders         
Drug-induced liver injury  1  1/14 (7.14%)  0/33 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Infections and infestations         
Appendicitis  1  0/14 (0.00%)  1/33 (3.03%)  0/13 (0.00%)  0/27 (0.00%) 
Gastroenteritis  1  0/14 (0.00%)  0/33 (0.00%)  0/13 (0.00%)  1/27 (3.70%) 
Gastroenteritis norovirus  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Pneumonia  1  0/14 (0.00%)  1/33 (3.03%)  0/13 (0.00%)  0/27 (0.00%) 
Septic shock  1  0/14 (0.00%)  0/33 (0.00%)  0/13 (0.00%)  1/27 (3.70%) 
Tuberculosis  1  0/14 (0.00%)  1/33 (3.03%)  0/13 (0.00%)  0/27 (0.00%) 
Investigations         
Hepatic enzyme abnormal  1  0/14 (0.00%)  0/33 (0.00%)  0/13 (0.00%)  1/27 (3.70%) 
Metabolism and nutrition disorders         
Hyperkalaemia  1  0/14 (0.00%)  1/33 (3.03%)  0/13 (0.00%)  0/27 (0.00%) 
Nervous system disorders         
Tension headache  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Psychiatric disorders         
Psychotic disorder  1  0/14 (0.00%)  1/33 (3.03%)  0/13 (0.00%)  0/27 (0.00%) 
Renal and urinary disorders         
Lupus nephritis  1  0/14 (0.00%)  3/33 (9.09%)  0/13 (0.00%)  0/27 (0.00%) 
Skin and subcutaneous tissue disorders         
Stevens-Johnson syndrome  1  1/14 (7.14%)  0/33 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (211LE201) to BIIB023 3 mg/kg (211LE202) BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202) Placebo (211LE201) to BIIB023 20 mg/kg (211LE202) BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/14 (28.57%)   19/33 (57.58%)   7/13 (53.85%)   13/27 (48.15%) 
Ear and labyrinth disorders         
Vertigo  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  0/14 (0.00%)  1/33 (3.03%)  2/13 (15.38%)  1/27 (3.70%) 
Constipation  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Diarrhoea  1  0/14 (0.00%)  1/33 (3.03%)  1/13 (7.69%)  0/27 (0.00%) 
Gastritis  1  0/14 (0.00%)  2/33 (6.06%)  0/13 (0.00%)  1/27 (3.70%) 
Mouth ulceration  1  0/14 (0.00%)  2/33 (6.06%)  1/13 (7.69%)  0/27 (0.00%) 
Nausea  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
General disorders         
Face oedema  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Oedema  1  1/14 (7.14%)  1/33 (3.03%)  0/13 (0.00%)  0/27 (0.00%) 
Oedema peripheral  1  0/14 (0.00%)  2/33 (6.06%)  0/13 (0.00%)  0/27 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Granulomatous liver disease  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Hypertransaminasaemia  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Infections and infestations         
Bronchitis  1  1/14 (7.14%)  5/33 (15.15%)  0/13 (0.00%)  5/27 (18.52%) 
Gastroenteritis norovirus  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Herpes zoster  1  1/14 (7.14%)  1/33 (3.03%)  0/13 (0.00%)  0/27 (0.00%) 
Influenza  1  0/14 (0.00%)  2/33 (6.06%)  1/13 (7.69%)  1/27 (3.70%) 
Nasopharyngitis  1  1/14 (7.14%)  1/33 (3.03%)  0/13 (0.00%)  2/27 (7.41%) 
Onychomycosis  1  0/14 (0.00%)  2/33 (6.06%)  0/13 (0.00%)  0/27 (0.00%) 
Oral herpes  1  0/14 (0.00%)  2/33 (6.06%)  0/13 (0.00%)  0/27 (0.00%) 
Pharyngitis  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Upper respiratory tract infection  1  1/14 (7.14%)  5/33 (15.15%)  0/13 (0.00%)  1/27 (3.70%) 
Urinary tract infection  1  0/14 (0.00%)  2/33 (6.06%)  4/13 (30.77%)  0/27 (0.00%) 
Viral upper respiratory tract infection  1  0/14 (0.00%)  2/33 (6.06%)  0/13 (0.00%)  1/27 (3.70%) 
Injury, poisoning and procedural complications         
Contusion  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  1/27 (3.70%) 
Foot fracture  1  1/14 (7.14%)  1/33 (3.03%)  0/13 (0.00%)  0/27 (0.00%) 
Road traffic accident  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Investigations         
Blood alkaline phosphatase increased  1  0/14 (0.00%)  0/33 (0.00%)  0/13 (0.00%)  2/27 (7.41%) 
Gamma-glutamyltransferase increased  1  0/14 (0.00%)  1/33 (3.03%)  0/13 (0.00%)  2/27 (7.41%) 
Haemoglobin decreased  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Hepatic enzyme increased  1  0/14 (0.00%)  3/33 (9.09%)  0/13 (0.00%)  1/27 (3.70%) 
Red blood cell count decreased  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Spleen palpable  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Transaminases increased  1  0/14 (0.00%)  0/33 (0.00%)  0/13 (0.00%)  2/27 (7.41%) 
Metabolism and nutrition disorders         
Hyperkalaemia  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Hyperlipidaemia  1  1/14 (7.14%)  0/33 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/14 (0.00%)  3/33 (9.09%)  0/13 (0.00%)  1/27 (3.70%) 
Arthritis  1  0/14 (0.00%)  1/33 (3.03%)  1/13 (7.69%)  0/27 (0.00%) 
Back pain  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  1/27 (3.70%) 
Muscle spasms  1  0/14 (0.00%)  0/33 (0.00%)  2/13 (15.38%)  0/27 (0.00%) 
Osteoporosis  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Pain in extremity  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  2/27 (7.41%) 
Nervous system disorders         
Dysgeusia  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Headache  1  0/14 (0.00%)  1/33 (3.03%)  4/13 (30.77%)  1/27 (3.70%) 
Post herpetic neuralgia  1  1/14 (7.14%)  0/33 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Tension headache  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Renal and urinary disorders         
Acute kidney injury  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Dysuria  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  2/27 (7.41%) 
Renal impairment  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Reproductive system and breast disorders         
Menopausal symptoms  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/14 (7.14%)  1/33 (3.03%)  0/13 (0.00%)  0/27 (0.00%) 
Rhinorrhoea  1  0/14 (0.00%)  3/33 (9.09%)  0/13 (0.00%)  0/27 (0.00%) 
Skin and subcutaneous tissue disorders         
Butterfly rash  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Dermatitis  1  1/14 (7.14%)  0/33 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Livedo reticularis  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Rash  1  0/14 (0.00%)  1/33 (3.03%)  1/13 (7.69%)  0/27 (0.00%) 
Rash pruritic  1  0/14 (0.00%)  0/33 (0.00%)  1/13 (7.69%)  0/27 (0.00%) 
Systemic lupus erythematosus rash  1  1/14 (7.14%)  0/33 (0.00%)  0/13 (0.00%)  0/27 (0.00%) 
Vascular disorders         
Hypertension  1  1/14 (7.14%)  2/33 (6.06%)  0/13 (0.00%)  0/27 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Name/Title: Biogen Study Medical Director
Organization: Biogen
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01930890     History of Changes
Other Study ID Numbers: 211LE202
2013-000594-69 ( EudraCT Number )
First Submitted: August 26, 2013
First Posted: August 29, 2013
Results First Submitted: November 22, 2016
Results First Posted: January 18, 2017
Last Update Posted: January 18, 2017