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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT01551069 Completed - Clinical trials for Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus

Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion

Start date: March 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: - To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI [Cutaneous Lupus Erythematosus Disease Area and Severity Index] activity score is ≥4) concomitant treatment with or without corticosteroid. Secondary Objectives: - To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of HCQ versus placebo as the reference group in patients with CLE and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant treatment with or without corticosteroid. - To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in patients with CLE and SLE with active skin manifestation concomitant treatment with or without corticosteroid. - To investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with corticosteroid - To investigate efficacy of once daily regimen of HCQ on systemic symptoms, musculoskeletal symptoms and immunological parameters in SLE patients.

NCT ID: NCT01549184 Completed - Clinical trials for Systemic Lupus Erythematosus

Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia

HCQITP
Start date: December 2010
Phase: N/A
Study type: Observational

Retrospective study of the safety and efficacy of hydroxychloroquine among patients with immune Thrombopenia (ITP).

NCT ID: NCT01541670 Terminated - Clinical trials for Systemic Lupus Erythematosus

Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis

Start date: November 28, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.

NCT ID: NCT01534403 Completed - Clinical trials for Systemic Lupus Erythematosus

Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects

Start date: January 2012
Phase: Phase 2
Study type: Interventional

The study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 [NCT01449071] phase I/II trial.

NCT ID: NCT01532310 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab (BENLYSTA®) Pregnancy Registry

Start date: July 16, 2012
Phase:
Study type: Observational [Patient Registry]

This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.

NCT ID: NCT01520155 Completed - Clinical trials for Systemic Lupus Erythematosus

CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)

CASTLE
Start date: December 2011
Phase: N/A
Study type: Observational

The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.

NCT ID: NCT01516450 Completed - Clinical trials for Systemic Lupus Erythematosus

Japanese phase1 Study of Belimumab (IV vs SC)

Start date: December 26, 2011
Phase: Phase 1
Study type: Interventional

This study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous administration of GSK1550188. Serial blood samples for the determination of GSK1550188 concentration will be collected and safety assessments will be performed for each treatment group

NCT ID: NCT01515163 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

Exercise and Systemic Lupus Erythematosus

Start date: May 2010
Phase: N/A
Study type: Interventional

The investigators hypothesize that a three-month aerobic exercise training program will positively affect the lipid profile, insulin sensitivity , cytokine profile, the cardiovascular parameters and muscle strength in SLE patients.

NCT ID: NCT01510067 Recruiting - Clinical trials for Cutaneous Lupus Erythematosus (CLE)

Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus

Start date: December 2006
Phase:
Study type: Observational

The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site database between the University of Pennsylvania and the University of Texas Southwestern (UTSW).

NCT ID: NCT01509989 Completed - Clinical trials for Systemic Lupus Erythematosus

International Prospective Study on Adherence to Treatment in Patients With Active Systemic Lupus Erythematosus

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

The treatment of systemic lupus erythematosus (SLE) may change in the future due to the availability of new biological treatments, especially monoclonal antibodies in patients with active disease. However, one of the main causes of treatment failure in SLE is the lack of treatment adherence since "drugs don't work in patients who don't take them." Hydroxychloroquine (HCQ-Plaquenil) has a long terminal elimination half- life, and investigators have demonstrated that patients who do not take HCQ for a long time have undetectable or very-low blood HCQ concentrations (< 200 ng/ml). The rate of severe non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active disease: 8 out of 35 (23%) in patients with a SLEDAI ≥6 and 6 out of 20 (30%) in patients with a SLEDAI ≥12. Investigators will evaluate the importance of non-adherence to the treatment in a large population of SLE patients with active disease. This will be done with blood HCQ monitoring in a translational multicentric prospective study.