Topics

Safety Study of AMG 557 in Subjects With Lupus Arthritis

2015-04-06 08:36:30 | BioPortfolio

Summary

This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Lupus Arthritis, Systemic Lupus Erythematosus

Intervention

AMG 557, Matching Placebo

Location

Research Site
San Leandro
California
United States
94578

Status

Recruiting

Source

Amgen

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-04-06T08:36:30-0400

Clinical Trials [2803 Associated Clinical Trials listed on BioPortfolio]

Duke Lupus Registry

Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common...

Study of GL701 in Men With Systemic Lupus Erythematosus

Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug mea...

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

The purpose of this study is to determine if AMG 570 could be a useful therapeutic agent in the current treatment landscape where subjects with systemic lupus erythematosus (SLE) have ongo...

A Study of AMG 557 in Adults With Systemic Lupus Erythematosus

This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.

Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with...

PubMed Articles [5363 Associated PubMed Articles listed on BioPortfolio]

Treatment target in newly diagnosed Systemic Lupus Erythematosus.

To compare the effect of achievement and maintenance of lupus low disease activity state (LLDAS) and clinical remission (CR) in preventing early damage accrual in patients with systemic lupus erythema...

Spectrum of cutaneous lupus erythematosus in South Africans with systemic lupus erythematosus.

Cutaneous involvement is very common in systemic lupus erythematosus. We describe the prevalence and spectrum of lupus-specific (cutaneous lupus erythematosus) and non-specific cutaneous features amon...

Analysis of brain metabolites by gas chromatography-mass spectrometry reveals the risk-benefit concerns of prednisone in MRL/lpr lupus mice.

Neuropsychiatric systemic lupus erythematosus (NPSLE) is a common cause of disability in systemic lupus erythematosus (SLE). This study aims to investigate the metabolic changes in the hypothalamus an...

Blood ceramides as novel markers for renal impairment in systemic lupus erythematosus.

Lupus nephritis (LN) is the most common organ manifestation in systemic lupus erythematosus (SLE) and associated with a poor prognosis. Still, a noninvasive but reliable method to diagnose LN has not ...

Musculoskeletal Ultrasound in Systemic Lupus Erythematosus: Systematic Literature Review by the Lupus Task Force of the OMERACT Ultrasound Working Group.

To identify and synthesize the best available evidence on the application of musculoskeletal ultrasound (US) in patients with systemic lupus erythematosus (SLE) and to present the measurement properti...

Medical and Biotech [MESH] Definitions

A form of lupus erythematosus in which the skin may be the only organ involved or in which skin involvement precedes the spread into other body systems. It has been classified into three forms - acute (= LUPUS ERYTHEMATOSUS, SYSTEMIC with skin lesions), subacute, and chronic (= LUPUS ERYTHEMATOSUS, DISCOID).

A chronic form of cutaneous lupus erythematosus (LUPUS ERYTHEMATOSUS, CUTANEOUS) in which the skin lesions mimic those of the systemic form but in which systemic signs are rare. It is characterized by the presence of discoid skin plaques showing varying degrees of edema, erythema, scaliness, follicular plugging, and skin atrophy. Lesions are surrounded by an elevated erythematous border. The condition typically involves the face and scalp, but widespread dissemination may occur.

Antiphospholipid antibodies found in association with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; and in a variety of other diseases as well as in healthy individuals. The antibodies are detected by solid-phase IMMUNOASSAY employing the purified phospholipid antigen CARDIOLIPIN.

An antiphospholipid antibody found in association with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; and in a variety of other diseases as well as in healthy individuals. In vitro, the antibody interferes with the conversion of prothrombin to thrombin and prolongs the partial thromboplastin time. In vivo, it exerts a procoagulant effect resulting in thrombosis mainly in the larger veins and arteries. It further causes obstetrical complications, including fetal death and spontaneous abortion, as well as a variety of hematologic and neurologic complications.

Autoantibodies directed against phospholipids. These antibodies are characteristically found in patients with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; related autoimmune diseases, some non-autoimmune diseases, and also in healthy individuals.

More From BioPortfolio on "Safety Study of AMG 557 in Subjects With Lupus Arthritis"

Quick Search

Relevant Topics

Lupus
Lupus is a complex and poorly understood condition that affects many parts of the body and causes symptoms ranging from mild to life-threatening. There are several types of lupus. The main types are: discoid lupus erythematosus drug-induced lu...

Rheumatology
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Gout
According to the National Arthritis Data Workgroup, an estimated 6 million people in the United States report having experienced gout at some point in their lives. In fact, gout is the most common form of inflammatory arthritis in men over the age of 40....


Searches Linking to this Trial