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

TerminadoFase 2ClinicalTrials.gov

ID: NCT01930890Tipo: INTERVENTIONALInicio: 1 de nov de 2013Fin estimado: 1 de ene de 2016

Traducción no disponible, mostrando original

Resumen

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).

Descripción detallada

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.

Elegibilidad

Edad mínima: 19 YearsEdad máxima: 76 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

biological

BIIB023

drug

mycophenolate mofetil

titrated to a target daily dose of 2 g (1 g twice daily)

drug

oral corticosteroids

oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day

Ubicaciones

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

Patrocinadores

PrincipalBiogen

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