Research

    

• Prospective observational cohort study in moderate-to-severe SLE patients
• Bi-annual study visits over a 3-year follow-up period
• Collecting data from routine clinic visits, e.g., treatment patterns, outcomes, health status, healthcare resource utilization
• No protocol specified treatment
• Optional biomarkers
• Inclusion:
  • > 18 years of age
  • Positive ANA or dsDNA
  • > 6 month treatment for active SLE beyond NSAIDs and analgesics
  • Moderate-to-severe SLE
• Exclusion:
•  Active severe lupus nephritis with hx of renal bx in past year showing active class III or class IV +/- class V lupus nephritis and/or urine protein:creatinine ratio >1

A five-year study of monthly MRA infusions in rheumatoid arthritis patients that may also be receiving Methotrexate. The primary objectives are to assess the long-term safety of MRA with regard to adverse events and laboratory result abnormalities; to explore the possibility to reduce concomitant steroid treatment; and to determine the long-term efficacy of MRA with regard to reduction in signs and symptoms. Secondary objectives of this study include exploring the pharmacokinetics, immunogenicity and pharmacodynamic parameters of MRA in this patient population.

This is a randomized, double-blind study of the safety and efficacy of ocrelizumab in subjects with rheumatoid arthritis (RA). The study consists of a 48-week, double-blind treatment period and a study extension period of at least a further 48 weeks (i.e. at least 96 weeks participation). If at this time the study subject’s peripheral blood B cell count has not returned to their baseline value or into the lower limit of normal (whichever is the lower), visits will continue every 12 weeks until this condition is met.

Patients that are withdrawn from either the double-blind treatment period or the study extension period enter safety follow up, which ends either at the point that 48 weeks have elapsed since the last exposure to blinded study medication/open label ocrelizumab treatment (as applicable) or at the time that their peripheral blood B cell count has returned to their baseline value or into the lower limit of normal (whichever is the lower), as applicable.

The primary objective of this study is to determine the efficacy and safety of ocrelizumab versus placebo in reducing signs and symptoms of RA, when used in combination with methotrexate in subjects with active RA who have an inadequate response to methotrexate therapy. Secondary objectives are to assess the efficacy of ocrelizumab to slow or inhibit structural damage in these patients (using radiographs); to assess the effect of ocrelizumab on physical function in this patient population; and to investigate the pharmacokinetics and pharmacodynamics of ocrelizumab.

This is a randomized, double-blind study of the safety and efficacy of ocrelizumab in subjects with rheumatoid arthritis (RA). The study consists of a 48-week double-blind treatment period and a study extension period of at least a further 48 weeks (i.e. at least 96 weeks participation). If at this time the study subject’s peripheral blood B cell count has not returned to their baseline value or into the lower limit of normal (whichever is the lower), visits will continue every 12 weeks until this condition is met.

Patients that are withdrawn from either the double-blind treatment period or the study extension period enter safety follow up, which ends either at the point that 48 weeks have elapsed since the last exposure to blinded study medication/open label ocrelizumab treatment (as applicable). If at this time the peripheral blood B cell count is still low, patients should continue visits every 12 weeks until the B cell count has returned to the baseline value or into the lower limit of the normal range (whichever is the lower).

The primary objective of this study is to determine the efficacy and safety of ocrelizumab versus placebo in reducing signs and symptoms of RA, when used in combination with methotrexate or leflunomide given either alone or in combination with other non-biologic DMARDs in subjects with active RA who have an inadequate response to at least one anti-TNF- ? therapy. Secondary objectives are to assess the efficacy of ocrelizumab to slow or inhibit structural damage in these patients (using radiographs); to assess the effect of ocrelizumab on physical function in this patient population; and to investigate the pharmacokinetics and pharmacodynamics of ocrelizumab.

This is a randomized, double-blind, multi-center study. This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 (SC) versus placebo in subjects with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.

Subjects may participate in this study for up to 26 weeks. Over the treatment period (Visits 1 to 8/Weeks 0 to 12), subjects are dosed every other week for 12 weeks with an initial loading dose of 120 mg, or placebo at Weeks 0 and 1. Subjects return to the clinic for a follow-up visit two weeks after the last dose (Visit 9/Week 14). Subjects who continue in the study until follow-up (Visit 9/ Week 14) are offered the option to enter a safety extension study (under a separate protocol) at that time. Subjects who do not enroll into the safety extension study are followed for safety assessments for an additional 12 weeks (until Visit 12/Week 26) under this protocol.

The primary objective of this study is to evaluate the efficacy of BG9924 when administered in combination with methotrexate (MTX) to subjects with active RA who have had an inadequate response to anti-TNF therapy. Secondary objectives are to assess the safety and tolerability of BG9924 in this patient population; to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile of BG9924 in this patient population; and to investigate the pharmacokinetics and pharmacodynamics of BG9924.