Track topics on Twitter Track topics that are important to you
The purpose of this study is to assess the pharmacokinetics of two oral dosing regimens of SCIO-469, with and without methotrexate, in patients with active rheumatoid arthritis.
SCIO-469 is being developed for the treatment of active rheumatoid arthritis, a disease that occurs mostly in women; therefore, female patients with active rheumatoid arthritis are selected as the study population. This study is the first detailed pharmacokinetic evaluation (study of a drug in the body to watch how the drug is absorbed, distributed, metabolized and eliminated over a period of time) of SCIO-469 in a new capsule formulation. Methotrexate is frequently prescribed as treatment for patients with rheumatoid arthritis; thus, SCIO-469 could potentially be used along with methotrexate. It is not known how methotrexate affects the pharmacokinetics of SCIO-469; therefore, the study is designed to include patients who are taking stable doses of methotrexate and patients who are not taking methotrexate. This is a Phase II, randomized (study medication assigned by chance), double-blind (neither the patient or the physician knows which study treatment the patient is receiving), parallel-group study designed to assess the pharmacokinetics, safety, and tolerability of SCIO-469 in female patients with active rheumatoid arthritis. Sixteen patients will be enrolled in the study, with eight receiving stable doses of methotrexate and eight not receiving methotrexate. No other disease-modifying anti-rheumatic drugs (DMARDs) are allowed. Pharmacokinetics will be evaluated for SCIO-469 and its metabolites, testing for significant differences by occasion (Day 1 or Day 12), treatment (30 mg three times a day or 90 mg once a day), and stratum (methotrexate or non methotrexate). Safety assessments for this study include clinical adverse events, concomitant medications, and clinical assessments (medical history, physical examination, vital and orthostatic vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations [serum chemistry, urinalysis, hematology, liver function and other tests, and pregnancy test]). Patients receiving stable doses of methotrexate (taken once a week, either orally or by injection) and those not receiving methotrexate will be randomized into one of two oral capsule SCIO-469 dosing regimens: 30 mg three times a day and 90 mg once a day. Patients will take study drug for 11 of 12 days, with no study drug taken on Day 2. On Day 19, seven days after the end of treatment, patients will undergo a follow-up assessment of safety variables.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Oral SCIO-469 capsule
Published on BioPortfolio: 2014-08-27T03:37:01-0400
SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis factor-alpha (TNF-alpha), interleukin-1 ...
The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients. SCIO-469 belongs to a new class of treatments that inhibit p...
This is a multicenter, randomized, double blind, double-dummy and controlled clinical trial aimed to compare the clinical efficacy and safety of Kunxian Capsule, a compound of Chinese trad...
This clinical study, using SCIO, will assess subjects with toenail onychomycosis confirmed by KOH and culture positive, identify the change of SCIO score after Sporanox capsule administrat...
The primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active Rheumato...
Topical NSAIDs have less systemic absorption than oral NSAIDs. We examined the risk of cardiovascular events associated with nonselective topical NSAIDs versus oral NSAIDs among patients with rheumato...
Studies that demonstrate an association between rheumatoid arthritis (RA) and dysbiotic oral microbiomes are often confounded by the presence of extensive periodontitis in these individuals. Therefore...
We would like to thank Masi and colleagues for their interest in our paper as well as for the interesting comments regarding the potential usefulness of neuroendocrine immune (NEI) testing in patients...
Juvenile idiopathic arthritis (JIA) is comprised of seven heterogeneous categories of chronic childhood arthritides. About 5% of children with JIA have rheumatoid factor (RF) positive arthritis, which...
Rheumatoid arthritis (RA) as an inflammatory autoimmune disease affects the synovial joints as well as other organs and tissues. Since aberrant expression of MIC molecules has been observed in RA pati...
Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.
Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.
A variable mixture of the mono- and disodium salts of gold thiomalic acid used mainly for its anti-inflammatory action in the treatment of rheumatoid arthritis. It is most effective in active progressive rheumatoid arthritis and of little or no value in the presence of extensive deformities or in the treatment of other forms of arthritis.
Systemic-onset rheumatoid arthritis in adults. It differs from classical rheumatoid arthritis in that it is more often marked by acute febrile onset, and generalized lymphadenopathy and hepatosplenomegaly are more prominent.
Antibodies found in adult RHEUMATOID ARTHRITIS patients that are directed against GAMMA-CHAIN IMMUNOGLOBULINS.
Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...