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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01930890




Registration number
NCT01930890
Ethics application status
Date submitted
26/08/2013
Date registered
29/08/2013
Date last updated
18/01/2017

Titles & IDs
Public title
BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis
Scientific title
A Dose-Blinded, 2-Dose Level, Parallel-Group, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Efficacy, and Immunogenicity of BIIB023 in Subjects With Lupus Nephritis
Secondary ID [1] 0 0
2013-000594-69
Secondary ID [2] 0 0
211LE202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - mycophenolate mofetil
Treatment: Drugs - oral corticosteroids

Experimental: BIIB023 3 mg/kg - 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).

Experimental: BIIB023 20 mg/kg - 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.


Treatment: Drugs: mycophenolate mofetil
titrated to a target daily dose of 2 g (1 g twice daily)

Treatment: Drugs: oral corticosteroids
oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to Week 108
Primary outcome [2] 0 0
Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE
Timepoint [2] 0 0
Up to Week 108

Eligibility
Key inclusion criteria
Key

* Subjects who completed Week 52 of Study 211LE201 (NCT01499355) and did not discontinue BIIB023 or placebo study treatment.
* Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment.

Key
Minimum age
19 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any significant change in medical history in subjects from Study 211LE201, including laboratory tests or current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects' participation. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment under this protocol.
* Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201.
* Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
* Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
* Other unspecified reasons that, in the opinion of the Investigator or Biogen, makes the subject unsuitable for enrollment.

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria May Apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Argentina
State/province [5] 0 0
Tucuman
Country [6] 0 0
Argentina
State/province [6] 0 0
Ciudad Autonoma Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
San Juan
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Liège
Country [10] 0 0
Brazil
State/province [10] 0 0
Mato Grosso
Country [11] 0 0
Colombia
State/province [11] 0 0
Barranquilla
Country [12] 0 0
Colombia
State/province [12] 0 0
Bogota
Country [13] 0 0
Colombia
State/province [13] 0 0
Medellín
Country [14] 0 0
France
State/province [14] 0 0
Gironde
Country [15] 0 0
France
State/province [15] 0 0
Paris cedex 13
Country [16] 0 0
Hong Kong
State/province [16] 0 0
Shatin
Country [17] 0 0
Hungary
State/province [17] 0 0
Debrecen
Country [18] 0 0
Italy
State/province [18] 0 0
Pisa
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Gyeonggi-do
Country [20] 0 0
Malaysia
State/province [20] 0 0
Sarawak
Country [21] 0 0
Malaysia
State/province [21] 0 0
Kuala Lumpur
Country [22] 0 0
Malaysia
State/province [22] 0 0
Selangor
Country [23] 0 0
Mexico
State/province [23] 0 0
Distrito Federal
Country [24] 0 0
Peru
State/province [24] 0 0
Lima
Country [25] 0 0
Philippines
State/province [25] 0 0
Manila
Country [26] 0 0
Philippines
State/province [26] 0 0
Quezon City
Country [27] 0 0
Poland
State/province [27] 0 0
Lodz
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Moscow
Country [29] 0 0
Spain
State/province [29] 0 0
Valencia
Country [30] 0 0
Thailand
State/province [30] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01930890