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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT01772069 Completed - Quality of Life Clinical Trials

Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus:Focusing on Fibromyalgia

Start date: January 2013
Phase: N/A
Study type: Observational

Systemic lupus erythematosus (SLE) patients show a high prevalence of fibromyalgia though rates vary considerably from one study to another (from 8.2% to 45%). Although fibromyalgia can bring out the disability in daily life, the majority of previous reports only ascertained no significant association between the presence of fibromyalgia and the severity of SLE. It is necessary to make unremitting effort to reduce the mortality and life-threatening disease flare-up due to SLE disease itself. Additionally, we think that physicians need to pay more attention to improve health-related quality of life (HRQoL) in the patients with SLE. HRQoL could be influenced by various factors such as depression, fibromyalgia, disease duration, disease activity and etc. To improve the HRQoL in SLE patients, it might be the clinically important and constructive theme to investigate that which is the most important factor among the fibromyalgia, depression, sleep quality, SLE activity and SLE duration. The objective of this study is to evaluate the degree of contribution of fibromyalgia for reduced HRQoL and to identify the status of managing fibromyalgia in Korean patients with SLE.

NCT ID: NCT01769937 Completed - Clinical trials for Lupus Erythematosus Systemic Exacerbation

Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus

ACTH
Start date: October 2012
Phase: Phase 4
Study type: Interventional

Systemic lupus erythematosus is a serious and potentially life-threatening condition with significant unmet medical need. The aim of this Investigator Initiated, single center, open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ) injection of H.P. Acthar Gel for 10 days with an optional 5 day rescue period for non-responders after day 10 dose. The primary objective of this study is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.

NCT ID: NCT01764594 Completed - Autoimmune Diseases Clinical Trials

Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

Start date: January 2013
Phase: Phase 1
Study type: Interventional

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

NCT ID: NCT01753401 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease

Start date: January 2013
Phase: Phase 4
Study type: Interventional

This Phase 4 study is being performed to examine the effects of Acthar for the indicated use of treatment of SLE. This study will enroll patients with steroid-dependent, persistently active SLE with arthritic and/or cutaneous involvement. The study will involve two periods: an 8-week double-blind period, to provide placebo-controlled safety, efficacy, and pharmacodynamic data, and an optional open-label period, to examine the prolonged effects of Acthar maintenance.

NCT ID: NCT01753193 Completed - Clinical trials for Lupus Erythematosus, Systemic

An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

Start date: March 28, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).

NCT ID: NCT01741012 Completed - Clinical trials for Systemic Lupus Erythematosus

Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients

GARDASIL
Start date: January 2013
Phase: Phase 1
Study type: Interventional

Cervical neoplasia is increased in women with SLE most likely due to cervical infection with human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18. Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with mild to moderate and minimally active or inactive SLE and measure how well they make protective antibodies after receiving the vaccine. In other words this will check how well the vaccine works in SLE.

NCT ID: NCT01705977 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab Assessment of Safety in SLE

BASE
Start date: November 27, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

NCT ID: NCT01702740 Completed - Clinical trials for Lupus Erythematosus, Systemic

A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus

Start date: March 2007
Phase: Phase 1
Study type: Interventional

The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the action of a drug in the body over a period of time) of multiple intravenous (IV) administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). The secondary goal of this study was to assess the pharmacodynamics (biochemical and physiological effects of a drug and the mechanisms of action), immune response, and clinical response.

NCT ID: NCT01697254 Completed - Clinical trials for Systemic Lupus Erythematosus

The CARRA Registry

CARRA Registry
Start date: August 2009
Phase: N/A
Study type: Observational [Patient Registry]

This CARRA Registry study will create a foundational database for rheumatic diseases of childhood using a novel informatics infrastructure developed as part of the larger clinical project. The creation of a CARRA-wide informatics infrastructure will enable efficient, observational, disease-related data capture across all CARRA sites for pediatric rheumatic diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more data intensive registries for observational studies, comparative effectiveness research, pharmaceutical clinical trials and translational research.

NCT ID: NCT01689350 Completed - Clinical trials for Systemic Lupus Erythematosus

A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment

SLE
Start date: October 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the genotype-based personal prescription of cyclophosphamide with the traditional prescription.