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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT01649765 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

PLUTO
Start date: September 7, 2012
Phase: Phase 2
Study type: Interventional

This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus

NCT ID: NCT01642706 Recruiting - Clinical trials for Rheumatoid Arthritis

Regulatory B Cells in Inflammatory Rheumatisms and Biomarkers of Response to Biologic Treatments

Start date: July 2, 2012
Phase:
Study type: Observational

B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans.

NCT ID: NCT01632241 Completed - Clinical trials for Systemic Lupus Erythematosus

Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)

EMBRACE
Start date: February 19, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).

NCT ID: NCT01629784 Completed - Clinical trials for Cutaneous Lupus Erythematosus

Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus

Start date: May 2012
Phase: N/A
Study type: Interventional

Studies have shown that there are significant differences in severity and outcome of lupus in patients of colored skin compared with Caucasians. There are many factors that lead to this discrepancy: genetics, poverty, education level, as well as behavioral and cultural factors. Cutaneous Lupus Erythematosus (CLE) is a disease of flares and remissions with identifiable triggers. One of the most aggravating triggers in CLE is sun exposure. The investigators hypothesize that there are disparities in knowledge about photoprotection, leading to poorer outcomes in minority ethnic groups. This study aims to assess knowledge of risk factors and triggers, especially sun exposure, and the effects on quality of life of Caucasian and minority populations, by conducting an assessment survey and subsequent teaching intervention on appropriate skin protection techniques including appropriate sun screen application, and use of sun-protective clothing. After three months a survey to evaluate knowledge retention about and the application of the educational intervention will be conducted.

NCT ID: NCT01616472 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)

Start date: April 2012
Phase: N/A
Study type: Observational

The study is designed to assess the association between steroid exposure and five potentially steroid-related adverse events within a cohort of individuals with systemic lupus erythematosus (SLE). Study objectives are to quantify the fraction of the risk of new (i) diabetes, (ii) hypertension, (iii) cataracts, (iv) osteoporosis and (v) avascular necrosis that is attributable to cumulative corticosteroid exposure in SLE patients. The study will consist of five matched case-control analyses nested within the Hopkins Lupus Cohort. Cases will be incident SLE cases who have developed one of the case outcomes (diabetes, hypertension, cataracts, osteoporosis with fracture or vertebral collapse or avascular necrosis). Controls will be matched to cases on time since SLE diagnosis. The primary exposures to be assessed are cumulative dose of steroid (g) and cumulative duration of exposure to steroids. The extent of the risk associated with steroids will be explored through modeling of the relationship and through calculation of attributable risks of exposure (number of cases associated with the highest exposure quartile of each primary exposure).

NCT ID: NCT01597622 Completed - Clinical trials for Systemic Lupus Erythematosus

BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115

Start date: June 11, 2012
Phase: Phase 3
Study type: Interventional

This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their standard of care SLE therapy.

NCT ID: NCT01597492 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

Start date: May 31, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).

NCT ID: NCT01597050 Completed - Clinical trials for Lupus Erythematosus, Systemic

Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions

SKINDLE
Start date: August 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, efficacy and tolerability of topical R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) patients with active discoid lesions.

NCT ID: NCT01582880 Completed - Clinical trials for Rheumatoid Arthritis

Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).

NCT ID: NCT01559090 Completed - Clinical trials for Systemic Lupus Erythematosus

Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.

Start date: April 20, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.