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Efficacy and safety of an interleukin 6 monoclonal antibody for the treatment of systemic lupus erythematosus: a phase II dose-ranging randomised controlled trial
Objectives This phase II trial evaluated the efficacy and safety of an interleukin (IL) 6 monoclonal antibody for systemic lupus erythematosus (SLE). Methods Patients with active disease wereExpand
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Reassessment of tigecycline bone concentrations in volunteers undergoing elective orthopedic procedures
The goal of the this study was to re‐evaluate tigecycline bone concentrations in subjects undergoing elective orthopedic surgery, using multiple doses and a more robust bone assay than was used in aExpand
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Safety and Efficacy of SBI-087, a Subcutaneous Agent for B Cell Depletion, in Patients with Active Rheumatoid Arthritis: Results from a Phase II Randomized, Double-blind, Placebo-controlled Study
Objective. To evaluate subcutaneous SBI-087 to treat rheumatoid arthritis (RA). Methods. A total of 210 adult patients with active RA were randomized to receive either 200 mg SBI-087 or placeboExpand
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OP0024 Safety and efficacy of SBI-087 in subjects with active rheumatoid arthritis in a phase 2 randomized, double-blind, placebo-controlled study
Background SBI-087 is a humanized CD20-directed SMIP™ (mono-specific protein therapeutic) that has been shown to deplete B cells in a dose dependent manner in Phase 1 studies in subjects with stableExpand
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Variability in Antinuclear Antibody Testing to Assess Patient Eligibility for Clinical Trials of Novel Treatments for Systemic Lupus Erythematosus
In the development of novel therapies for systemic lupus erythematosus, antinuclear antibody (ANA) positivity represents a criterion for trial eligibility. Since as many as 30% of patients enrolledExpand
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Methotrexate withdrawal in patients with rheumatoid arthritis who achieve low disease activity with tofacitinib modified-release 11 mg once daily plus methotrexate (ORAL Shift): a randomised, phase
Summary Background Tofacitinib is an oral Janus kinase (JAK) inhibitor used for the treatment of rheumatoid arthritis. We assessed the efficacy and safety of tofacitinib after methotrexate withdrawalExpand
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OP0185 Significant Clinical Improvement and Reduction of Severe Flares Following Administration of an IL-6 Monoclonal Antibody in Systemic Lupus Erythematosus (SLE) Subjects with High Disease Activity
Background PF-04236921 is a fully human monoclonal antibody (mAb) that binds to circulating IL-6 and neutralizes its activity. This may be beneficial in reducing the disease manifestations of activeExpand
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Comparative Sirolimus Pharmacokinetics After Single‐Dose Administration of Two Prototype 0.5‐mg Tablets in Healthy Volunteers
Availability of a lower dose tablet would add to the dosing flexibility of currently available 1‐ and 2‐mg sirolimus tablets for optimal concentrations and patient compliance. A randomized, 3‐periodExpand
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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of SBI-087, a CD20-Directed B-cell Depleting Agent: Phase 1 Dose Escalating Studies in Patients With Either Mild Rheumatoid
PURPOSE SBI-087 is a Small Modular Immunopharmaceutical Protein™(SMIP™) drug that binds to CD20 and has been reported to deplete B cells in murine/primate studies. The safety, tolerability andExpand
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LB0004 METHOTREXATE WITHDRAWAL IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO ACHIEVE LOW DISEASE ACTIVITY WITH TOFACITINIB MODIFIED-RELEASE 11 MG ONCE DAILY + METHOTREXATE: A RANDOMISED NON-INFERIORITY
Background Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). The impact of methotrexate (MTX) withdrawal in patients (pts) with RA who achieve low disease activityExpand
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