Abstract Number: 1163 • 2017 ACR/ARHP Annual Meeting
A First-in-Human Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Novel Anti-Interleukin 1 Biologic Agent, Rph-104, in Healthy Subjects
Background/Purpose: Interleukin-1 (IL-1) is highly active pro-inflammatory cytokine, which is responsible for clinical and laboratory findings in hereditary and acquired auto-inflammatory disorders. Blocking IL-1 activity…Abstract Number: 1195 • 2017 ACR/ARHP Annual Meeting
Efficacy and Safety of Subcutaneous Tanezumab in Patients with Knee or Hip Osteoarthritis (NCT01089725)
Background/Purpose : Tanezumab (TNZ) is a monoclonal antibody that inhibits nerve growth factor and reduces hip or knee osteoarthritis (OA) pain. A placebo-controlled phase 3…Abstract Number: 2445 • 2017 ACR/ARHP Annual Meeting
Efficacy and Safety of Rituximab Biosimilar, CT-P10, after a Single Switch from Innovator Rituximabs in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 72 Weeks
Background/Purpose: Similarity of pharmacokinetic, efficacy and safety between CT-P10 and reference rituximab (RTX) were shown in the phase 3 randomized controlled trial (NCT02149121) up to…Abstract Number: 2461 • 2017 ACR/ARHP Annual Meeting
Rituximab Is Effective in the Treatment of Rheumatoid Arthritis Irrespective of Body Mass Index; Up to 48 Weeks Results from Phase 3 Study
Background/Purpose: High body mass index (BMI) is known to be associated with inadequate clinical response to anti-TNF agents in RA patients.1 However, there are limited…Abstract Number: 2490 • 2017 ACR/ARHP Annual Meeting
Sustained Clinical Response in Refractory Rheumatoid Arthritis Patients with a Low-Dose Rituximab Retreatment Regimen. a Single Center Experience
Background/Purpose: : The standard dose of rituximab (RTX) in rheumatoid arthritis (RA) is two intravenous (iv) 1 g infusions, separated by two weeks. Recently, the…Abstract Number: 961 • 2016 ACR/ARHP Annual Meeting
Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis through 3 Years: Efficacy and Safety Results from a Phase 3 Trial
Background/Purpose: Secukinumab, an anti–interleukin-17A monoclonal antibody, provided rapid and significant improvements in the key clinical domains of psoriatic arthritis (PsA) in the FUTURE 1 study…Abstract Number: 1634 • 2016 ACR/ARHP Annual Meeting
Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks
Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Result from Phase 3…Abstract Number: 1635 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks
Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Result from Phase 3 Randomized Controlled Trial over 24…Abstract Number: 1645 • 2016 ACR/ARHP Annual Meeting
Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of ASP5094, an Anti-Alpha-9-Integrin Monoclonal Antibody, Following Single Intravenous Doses in Healthy Subjects
Background/Purpose: ASP5094 is a recombinant humanized anti-alpha-9 integrin IgG1 monoclonal antibody (mAb) under development for the treatment of rheumatoid arthritis. This first-in-human placebo‑controlled single ascending‑dose…Abstract Number: 1686 • 2016 ACR/ARHP Annual Meeting
Association of Early Skin Improvement with ACR Responses Among Biologic DMARD-Naive Psoriatic Arthritic Patients Treated with Ixekizumab
Background/Purpose: Ixekizumab (IXE) is a high-affinity monoclonal antibody that selectively targets interleukin-17A. In a phase 3 study, IXE was superior to placebo (PBO) in achieving…Abstract Number: 2757 • 2016 ACR/ARHP Annual Meeting
Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis: 104 Weeks Results from a Phase 3 Trial
Background/Purpose: Secukinumab, a fully human anti–IL-17A monoclonal antibody, significantly improved signs and symptoms of psoriatic arthritis (PsA) over 52 weeks (wks) in FUTURE 2 study (NCT01752634).1,2 Here…Abstract Number: 295 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Fasinumab for Osteoarthritic Pain in Patients with Moderate to Severe Osteoarthritis of the Knees or Hips
Background/Purpose: Osteoarthritis (OA) is an important cause of chronic pain in older adults. Fasinumab is a fully-human, high-affinity monoclonal antibody directed against the nerve growth…Abstract Number: 570 • 2015 ACR/ARHP Annual Meeting
Dose Selection of Namilumab, an Anti-GM-CSF Monoclonal Antibody: An Integrated Pharmacokinetic and Pharmacodynamic Approach for Phase II Studies in Patients with Rheumatoid Arthritis
Background/Purpose: Granulocyte macrophage-colony stimulating factor (GM-CSF) mediates a range of immunological and inflammatory processes, and plays a role in a variety of inflammatory diseases. Namilumab…Abstract Number: 972 • 2015 ACR/ARHP Annual Meeting
A Phase 2b Study Evaluating the Efficacy and Safety of Subcutaneously Administered Tregalizumab in Subjects with Active Rheumatoid Arthritis (RA) Despite Treatment with Methotrexate (MTX)
Background/Purpose: In autoimmune diseases reduced numbers and functional impairment of regulatory T cells (Tregs) have been observed (1). Tregalizumab (BT-061) is a humanized, anti-CD4 mAb,…Abstract Number: 1112 • 2015 ACR/ARHP Annual Meeting
Obinutuzumab Outperforms Rituximab at Inducing B-Cell Cytotoxicity in Vitro through Fc-Mediated Effector Mechanisms in Rheumatoid Arthritis and Systemic Lupus Erythematosus
Background/Purpose: Obinutuzumab (OBZ, a Type II anti-CD20 monoclonal antibody [mAb] with afucosylated Fc portion and enhanced affinity for Fcγ receptor III) is more efficient than…
ACR Meeting Abstracts