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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT02330250 Completed - Clinical trials for Systemic Lupus Erythematosus

Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment

ADELES
Start date: July 2014
Phase: N/A
Study type: Interventional

This project aims to improve adherence rate through pharmaceutical care in patients with systemic lupus erythematosus (SLE) to help achieving therapeutic goals and finally to improve the quality of life of these patients.

NCT ID: NCT02321709 Completed - Clinical trials for Systemic Lupus Erythematosus

Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients

Start date: November 2014
Phase: Phase 1
Study type: Interventional

Primary Objective: To assess the tolerability and safety of SAR113244 in male and female lupus patients after every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244. Secondary Objectives: To assess in male and female lupus patients: - The pharmacokinetics of SAR113244. - The pharmacodynamics of SAR113244 for the following disease-related parameters: - Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index (SRI) (if applicable), Lupus-quality of life (QoL) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, anti-double stranded deoxyribonucleic acid antibody (anti-dsDNA Ab) and anti-nuclear antibody levels (ANA) and plasma complement levels (C3, C4), erythrocyte sedimentation (SED) rate and C-reactive protein. - Peripheral blood B and T cells subsets.

NCT ID: NCT02320357 Completed - Clinical trials for Systemic Lupus Erythematous

Pilot Study Related to the Effect of Clopidogrel on Plasmatic Soluble CD40 Ligand During Systemic Lupus Erythematous

CLOPUS
Start date: August 19, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

CD40 Ligand (CD40L) has been identified as a key feature in systemic lupus erythematosus (SLE) pathogenesis, a systemic autoimmune disease characterized by a multiorgan involvement. As platelets are a major source of soluble CD40L (sCD40L), we propose to study the effect of clopidogrel, a platelet inhibitor, on plasmatic sCD40L levels in SLE patients.

NCT ID: NCT02319525 Completed - Clinical trials for Systemic Lupus Erythematosus

Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

Start date: January 2014
Phase: N/A
Study type: Interventional

The study will compare the efficacy of the usual education materials to individualized computerized decision guide on decision conflict of patients with lupus nephritis making treatment decisions regarding immunosuppressive therapies.

NCT ID: NCT02307643 Completed - Clinical trials for Systemic Lupus Erythematosus

Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

Start date: February 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus

NCT ID: NCT02306629 Completed - Clinical trials for Systemic Lupus Erythematosus

Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood

Start date: November 2014
Phase: Phase 1
Study type: Interventional

To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.

NCT ID: NCT02291588 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

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

This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811 single subcutaneous and intravenous dose to subjects with SLE

NCT ID: NCT02284984 Completed - Clinical trials for Lupus Erythematosus, Systemic

Synergetic B-cell Immodulation in SLE

SYNBIoSe
Start date: March 2014
Phase: Phase 2
Study type: Interventional

The present study investigates the potential of a new therapeutic approach in lupus nephritis combining rituximab (anti-CD20) and belimumab (anti-BAFF). The main goal of the study is to assess the reduction (and seroconversion) of pathogenic autoantibodies, to evaluate clinical improvement and assess the safety and feasibility of long-term B-cell depletion.

NCT ID: NCT02281513 Completed - Physical Activity Clinical Trials

Activity and Nutrition Trial in Lupus to Energize and Renew

ANTLER
Start date: October 2014
Phase: N/A
Study type: Interventional

Participants from the Fatigue and Lifestyle Physical Activity and SLE Study will be approached to enroll in a 6 week pilot intervention. This study will look at the barriers and facilitators to increasing physical activity, improving dietary/nutritional intake, and improving sleep.This study will offer support and information for people with SLE to increase their physical activity, improve their dietary/nutritional intake, and improve their sleep and will utilize a smartphone application to self-monitor changes in these behaviors.

NCT ID: NCT02270957 Completed - Clinical trials for Systemic Lupus Erythematosus

Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches

ABC
Start date: January 2014
Phase: Phase 2
Study type: Interventional

This is a randomized, double blind, placebo controlled trial of abatacept for the treatment of lupus arthritis and other manifestations of lupus. Patients with lupus and at least 3 tender and 3 swollen joints and </= 20 mg prednisone have other background immune suppressants withdrawn at entry. They can elect to receive up to a total of 320 mg depomedrol (in two or more injections) between the screening visit and the visit 2 months after dosing begins. Abatacept (125 mg) or placebo is administered in weekly subcutaneous doses. After 3 months of treatment patients who are not responding may elect to receive open label abatacept with or without additional standard of care therapies. Such patients are considered non responders. The primary endpoint is the British Isles Lupus Assessment Group Index (BILAG)-linked Combined Lupus Assessment (BICLA) which will require a clinically significant improvement in arthritis and other active features of lupus