ong-Term Extension Study of BIIB023 in Subjects with Lupus Nephritis
- Conditions
- upus NephritisMedDRA version: 16.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-000594-69-BE
- Lead Sponsor
- Biogen Idec Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
To be eligible to participate in this study, candidates must meet the following eligibility criteria at Baseline (Day 1) or at the timepoint specified in the individual eligibility criterion listed:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
2. Subjects who completed Week 52 of Study 211LE201 and did not discontinue BIIB023 or placebo study treatment.
3. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 209
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
Candidates will be excluded from study entry if any of the following exclusion criteria exist at Baseline (Day 1) or at the timepoint specified in the individual criterion listed:
1. 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.
2. Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201.
3. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
4. Previous participation in Study 211LE202; subjects who were enrolled in Study 211LE202 and consequently withdrew for any reason are prohibited from re-entering the study.
5. 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.
6. Subjects who were prescribed MMF >3 g/day during Study 211LE201 and/or subjects for whom the Investigator is planning to prescribe MMF >3 g/day during this study.
7. Subjects having received disallowed concomitant medication during Study 211LE201 including the following:
a. Immunosuppressant used for therapy of LN (cyclophosphamide, nitrogen mustard, chlorambucil, vincristine, procarbazine, etoposide, mycophenolic acid, azathioprine, cyclosporine, methotrexate, atacicept, or any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], or anti-BLyS/B-cell activating factor [e.g., belimumab] therapy).
b. Treatment with Campath (alemtuzumab)
c. Anti-tumor necrosis factor (infliximab, adalimumab, etanercept, efalizumab or alefacept) treatment
d. Cyclophosphamide, calcineurin, or a calcineurin inhibitor (i.e., cyclosporine A or tacrolimus)
8. Subjects with the following laboratory test results at Week 48 of Study 211LE201:
a. Absolute neutrophil count <1.5 × 1000/µL
b. Platelet count <20,000/µL; subjects with platelet count >20,000/µL and <150,000/µL who are experiencing, or at high risk for developing, clinically significant bleeding or organ dysfunction requiring therapy (as determined by the Investigator)
c. Hemoglobin <8.5 g/dL
d. Aspartate aminotransferase/serum glutamate oxaloacetate transaminase or alanine aminotransferase/serum glutamate pyruvate transaminase >2 × upper limit of normal established by the central laboratory
9. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, makes the subject unsuitable for enrollment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in subjects with LN.;Secondary Objective: Secondary objectives of this study are as follows:<br>-To evaluate the long-term efficacy of BIIB023 in subjects with LN - To evaluate the long-term immunogenicity of BIIB023 in subjects with LN <br>-To evaluate the long-term pharmacokinetics (PK) of BIIB023 in subjects with LN;Primary end point(s): -Incidence of adverse events (AEs) and serious adverse events (SAEs) <br>-Discontinuation of study treatment or withdrawal from the study due to an AE;Timepoint(s) of evaluation of this end point: Week 108 and throughout the duration of study
- Secondary Outcome Measures
Name Time Method