A5012283576- Rheumatoid Arthritis Research and Therapies
- Autoimmune and Inflammatory Disorders Research
- Systemic Lupus Erythematosus Research
- Spondyloarthritis Studies and Treatments
- Psoriasis: Treatment and Pathogenesis
- Chronic Lymphocytic Leukemia Research
- Lymphoma Diagnosis and Treatment
- Monoclonal and Polyclonal Antibodies Research
- Biosimilars and Bioanalytical Methods
- Health Systems, Economic Evaluations, Quality of Life
- Fibromyalgia and Chronic Fatigue Syndrome Research
- Osteoarthritis Treatment and Mechanisms
- Systemic Sclerosis and Related Diseases
- Pharmaceutical studies and practices
- Delphi Technique in Research
- Inflammatory mediators and NSAID effects
- Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
- Cytokine Signaling Pathways and Interactions
- Peripheral Neuropathies and Disorders
- T-cell and B-cell Immunology
- Musculoskeletal pain and rehabilitation
- Atherosclerosis and Cardiovascular Diseases
- Musculoskeletal synovial abnormalities and treatments
- Pharmacological Effects of Natural Compounds
- Gout, Hyperuricemia, Uric Acid
Stanford University
2016-2025
Palo Alto University
2015-2024
Stanford Medicine
2014-2022
American College of Rheumatology
1995-2022
University of North Carolina at Chapel Hill
2022
Durham VA Medical Center
2022
Emory University
2022
University of Toronto
2000-2021
University of Rochester Medical Center
2021
Monash Medical Centre
2021
Trials of rheumatoid arthritis (RA) treatments report the average response in multiple outcome measures for treated patients. It is more clinically relevant to test whether individual patients improve with treatment, and this identifies a single primary efficacy measure. Multiple definitions improvement are currently use different trials. The goal study was promulgate definition RA trials.Using American College Rheumatology (ACR) core set trials, we tested 40 improvement, using 3-step...
Lack of standardization outcome measures limits the usefulness clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set per condition, containing relevant patients and decision makers. Since 1992, Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed sets for many rheumatologic conditions, actively involving since 2002. Its expanding scope required an explicit formulation its underlying conceptual...
Abstract Objective To evaluate the efficacy and safety of 2 dosage regimens lyophilized certolizumab pegol (a novel PEGylated anti–tumor necrosis factor agent) as adjunctive therapy to methotrexate (MTX) in patients with active rheumatoid arthritis (RA) an inadequate response MTX alone. Methods In this 52‐week, phase III, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group trial, 982 were randomized 2:2:1 receive treatment subcutaneous at initial 400 mg given weeks 0,...
OMERACT is the acronym for an international, informally organized network initiated in 1992 aimed at improving outcome measurement rheumatology. Chaired by executive committee, it organizes consensus conferences a 2-yearly cycle that circles globe. Data driven recommendations are prepared and updated expert working groups. Recommendations include core sets of measures most major rheumatologic conditions. Since 2002 patients have been actively engaged process.
<h3>Background:</h3> Certolizumab pegol is a PEGylated tumour necrosis factor inhibitor. <h3>Objective:</h3> To evaluate the efficacy and safety of certolizumab versus placebo, plus methotrexate (MTX), in patients with active rheumatoid arthritis (RA). <h3>Methods:</h3> An international, multicentre, phase 3, randomised, double-blind, placebo-controlled study adult-onset RA. Patients (n = 619) were randomised 2:2:1 to subcutaneous (liquid formulation) 400 mg at weeks 0, 2 4 followed by 200...
Abstract Objective To describe a new systemic lupus erythematosus (SLE) responder index (SRI) based on belimumab phase II SLE trial and demonstrate its potential utility in clinical trials. Methods Data from randomized, double‐blind, placebo‐controlled study 449 patients of 3 doses (1, 4, 10 mg/kg) or placebo plus standard care therapy (SOC) over 56‐week period were analyzed. The Safety Estrogens Lupus Erythematosus: National Assessment (SELENA) version the Systemic Erythematosus Disease...
Abstract Objective Bisphosphonates have slowed the progression of osteoarthritis (OA) in animal models and decreased pain states high bone turnover. The Knee OA Structural Arthritis (KOSTAR) study, which is largest study to date investigating a potential structure‐modifying drug, tested efficacy risedronate providing symptom relief slowing disease patients with knee OA. Methods group comprised 2,483 medial compartment 2–4 mm joint space width (JSW), as determined using fluoroscopically...
<h3>Objective</h3> To determine the relationship of disease activity to infections in patients with rheumatoid arthritis (RA). <h3>Methods</h3> From CORRONA database, incidence physician-reported RA on stable disease-modifying antirheumatic drug, biological, and corticosteroid therapy for at least 6 months was ascertained. Two composite measures were defined: clinical index (CDAI) score 28 (DAS28). Incident rate ratios (IRR) calculated using generalised estimating equation Poisson regression...
To identify a suitable dosing regimen of the CD22-targeted monoclonal antibody epratuzumab in adults with moderately to severely active systemic lupus erythematosus (SLE).A phase IIb, multicentre, randomised controlled study (NCT00624351) was conducted 227 patients (37-39 per arm) receiving either: placebo, 200 mg cumulative dose (cd) (100 every other week (EOW)), 800 cd (400 EOW), 2400 (600 weekly), (1200 or 3600 (1800 EOW). The primary endpoint (not powered for significance) 12 responder...
Objective To develop new composite disease activity indices for psoriatic arthritis (PsA). Methods Data from routine clinic visits at multiple centres were collected in a systematic manner. included all domains identified as important randomised controlled trials PsA. Decisions to change treatment used surrogates high activity. New developed by linear regression (psoriatic score: PASDAS) and empirically, utilising physician-defined cut-offs (arithmetic mean of desirability functions: AMDF)....
The SELECT-EARLY trial was undertaken to study the effect of upadacitinib, an oral, reversible Janus kinase 1-selective inhibitor, as monotherapy in patients with predominantly early rheumatoid arthritis who were naive for or had limited exposure methotrexate (MTX).
Abstract Objective . To assess the safety and effectiveness of leflunomide versus placebo in patients with active rheumatoid arthritis (RA) treated for 6 months. Methods Four hundred two were randomly assigned to receive or at 5 mg, 10 25 mg daily. A washout period 6–12 weeks from prior second‐line therapy was required. Results Statistically significant improvement primary secondary outcome measures, as well by responder analyses, occurred 10‐mg 25‐mg dosage groups compared placebo....
To examine the safety and pharmacokinetics of clinical response to leflunomide, a de novo pyrimidine synthesis inhibitor, when administered patients with active rheumatoid arthritis (RA) who have been receiving long-term methotrexate therapy.This was an open-label, 52-week study in which 30 RA that remained despite therapy at 17+/-4 mg/week (mean +/- SD) for > or =6 months were given 10-20 mg/day. Patients assessed adverse effects, pharmacokinetic measurements leflunomide methotrexate, by...
Objective To determine whether treatment with leflunomide (LEF), methotrexate (MTX), or sulfasalazine (SSZ) for 6–12 months retards progression of radiographic damage and to identify clinical variables that correlate progression. Methods Radiographs the hands feet were performed at baseline end study early exit in 3 randomized controlled trials. Protocol US301 was a 12-month trial LEF MTX compared placebo 482 patients 3:3:2 ratio. MN301 6 SSZ 358 patients, ratio, continued blinded active...