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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT02265744 Completed - Lupus Clinical Trials

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

Start date: November 13, 2014
Phase: Phase 2
Study type: Interventional

Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

NCT ID: NCT02219269 Completed - Cancer Clinical Trials

A Complex Contraception Registry

Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

The investigators will conduct a prospective observational cohort study to investigate factors that influence contraceptive method utilization among women with medical conditions. The investigators will also investigate how women with medical conditions access to contraception and family planning fellowship trained specialist. After the baseline questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate continuation and satisfaction with the contraceptive method. This study is unique because it will allow us to explore doing collaborative family planning research at the multiple UC medical campuses.

NCT ID: NCT02217137 Completed - Dry Eye Clinical Trials

Tear Proteins, Conjunctival Cells and Imaging Eyes in Rheumatoid Arthritis and Systemic Lupus Erythematosus Patients

Start date: June 2014
Phase: N/A
Study type: Observational

Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) are chronic systemic autoimmune diseases that have been reported to affect the ocular surface of patients [1,2]. However, the nature of the disturbances of the ocular surface immunity and their relationship to systemic disease severity are poorly understood. This study aims to profile the ocular surface inflammation of RA and SLE patients by a., analysing levels of tear cytokine, and b., investigating conjunctival cells, and c. clinical imaging for conjunctival redness and tear stability. 20 consecutive RA patients and 20 consecutive SLE patients will be recruited from the Singapore General Hospital Rheumatology clinic. 20 age matched controls for SLE and another 20 age matched controls for RA will be recruited. All participants will undergo 1. Tear collection with Schirmer strips 2. EyePRIMTM (Opia Technologies) Impression Cytology Device for conjunctival sampling 3. Clinical ocular surface assessment with Oculus Keratograph 5M 4. Collection of blood via venipuncture (optional) 5. Retrieval of Clinical Information of participants The association of cytokines in the tears with various cellular and immune markers, as well as clinical signs of inflammation and tear stability will be investigated. This will be useful for further longitudinal studies of treatment in autoimmmune disease patients.

NCT ID: NCT02194400 Completed - Clinical trials for Systemic Lupus Erythematosus

Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus

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

A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous infusions of RSLV-132 in subjects with inactive to mild SLE.

NCT ID: NCT02185040 Completed - Clinical trials for Systemic Lupus Erythematosus

A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.

Start date: September 16, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether CC-220 is effective for the treatment of skin, joint and serological manifestations of systemic lupus erythematosus.

NCT ID: NCT02162992 Completed - Clinical trials for Lupus Erythematosus, Systemic

Systemic Lupus Erythematous and Heart Conduction Disorders

Start date: April 2014
Phase:
Study type: Observational

Connective tissue diseases have been related to heart conduction disorders. The anti-Ro/SSA antibodies are thought to have a pathogenic role, and they most prevalent in systemic lupus erythematous (SLE). The aim of this study is to evaluate the relationship between SLE, arrhythmias and its serologic profile.

NCT ID: NCT02151409 Completed - Healthy Clinical Trials

Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects

Start date: June 2008
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to develop a complement system targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic autoimmune diseases.

NCT ID: NCT02125695 Completed - Healthy Clinical Trials

Pilot Tape Harvesting Study

Start date: May 2014
Phase: N/A
Study type: Observational

The main objectives of the study are: To determine if RNA recovery from tape harvesting allows for the identification of a disease gene signature (e.g., interferon [IFN] signature for lupus) or other biomarkers that may differentiate affected from normal or unaffected skin; To determine if the lupus gene signature is differentially expressed in the epidermis from active discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus (SCLE) lesions when compared with unaffected skin from the same participants and from the skin of healthy volunteers (HVs); To determine if the atopic dermatitis (AD) gene signature is differentially expressed in the epidermis from active AD lesions when compared with unaffected skin from the same participants and from the skin of HVs; and To correlate the levels of transcripts of targeted genes in the skin by tape harvesting with those obtained from the blood.

NCT ID: NCT02124798 Completed - Clinical trials for Systemic Lupus Erythematosus

A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector

Start date: May 20, 2014
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the suitability of the autoinjector for self-administration of belimumab by subjects with SLE in real-life conditions. The study will assess the use of the autoinjector inside the clinic setting and outside the clinic setting. The study will also assess the safety and tolerability of belimumab administered subcutaneously (SC) via the autoinjector. Subjects will self-administer belimumab SC into the thigh or abdomen using the autoinjector device for 8 weekly doses. Subjects will return for a follow-up visit 4 weeks after the last SC dose of belimumab. All injections will be assessed by the investigators for success based on direct observation and/or the subject diary. A total of 118 subjects (treated with at least one dose of study drug) are planned to be enrolled in this study.

NCT ID: NCT02119156 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients

Start date: May 13, 2014
Phase: Phase 3
Study type: Interventional

This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.