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Cutaneous Lupus clinical trials

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NCT ID: NCT05048238 Completed - Clinical trials for Systemic Lupus Erythematosus

Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus

Start date: September 30, 2022
Phase: Phase 1
Study type: Interventional

This is a single-arm, single-site, proof-of-concept study that will evaluate the treatment of 10 participants with systemic lupus erythematosus (SLE) who have a history of cutaneous lupus with Tofacitinib.

NCT ID: NCT03639857 Terminated - Cutaneous Lupus Clinical Trials

Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone

Start date: August 17, 2018
Phase: N/A
Study type: Interventional

This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone.

NCT ID: NCT03288324 Completed - Clinical trials for Systemic Lupus Erythematosus

Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus

Start date: August 23, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This 76-week, 3-part Phase 1b/2 study is intended to evaluate the pharmacological properties (pharmacokinetics and pharmacodynamics), safety, tolerability and preliminary effectiveness of TOFA administrated to young adults (18-45 years) with moderately to severely active SLE-CL. Subjects will be studied at the Cincinnati Children's Hospital Medical Center (CCHMC) and in Cleveland at MetroHealth Medical Center.

NCT ID: NCT03276923 Recruiting - Clinical trials for Rheumatoid Arthritis

Maternal Autoimmune Disease Research Alliance (MADRA) Registry

MADRA
Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

This multi-site registry, centered at Duke University, will enroll pregnant women with autoimmune and rheumatologic diseases. The main goal of MADRA is to identify ways to improve the health of women with rheumatic diseases and their babies during pregnancy. Prior studies demonstrate the importance of increase inflammation prior to and during pregnancy on these outcomes. The future research will seek to better define these risk factors and to identify ways to may improve them.

NCT ID: NCT03122431 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases

Start date: June 5, 2017
Phase: Phase 4
Study type: Interventional

No drug treatment is completely free of risk and lack of response, adverse events and poor adherence may affect its effectiveness. Within this context, this project aims to evaluate the importance of monitoring blood levels and salivary drug used in rheumatic autoimmune diseases in the monitoring of adherence to therapy. In addition, this project intends to use the monitoring of drug levels, based on pharmacokinetic studies and pharmacokinetics/pharmacodynamics modeling, to broaden the understanding of the possible cellular, tissue and immunological mechanisms involved in efficacy and adverse effects of these drugs with the prospect of reducing the damage and maintain therapeutic efficacy. The high-performance liquid chromatography (HPLC) coupled to mass spectrometry, which will be used to evaluate hydroxychloroquine, thalidomide, glucocorticoids, is considered the gold standard technology to qualitative and quantitative analysis of drugs in blood and its comparison with the dosage in the saliva is an improvement in simplification of the process. For biological agents the focus will be on the understanding the loss of efficacy and the possible role of anti-TNF antibodies using ELISA capture methodology.This project will be divided into four sections with their respective sub-projects according to the medications that will be studied: hydroxychloroquine, thalidomide, biologic agents and glucocorticoids.

NCT ID: NCT02176148 Active, not recruiting - Cutaneous Lupus Clinical Trials

Cutaneous Lupus Medication Experience Study

Start date: December 2014
Phase:
Study type: Observational

Cutaneous lupus is a chronic, relapsing, auto-immune skin disease that can have many presentations. Its effect on physical appearance greatly affects patients' quality of life. In addition, 10% of patients with cutaneous lupus will develop systemic lupus. Topical therapies are the mainstay of cutaneous lupus treatment; however patients often find these treatments to be messy, inconvenient, or ineffective. In addition, for more severe disease patients are often placed on concurrent systemic therapies. The primary hypothesis of our study is that poor adherence contributes to poor treatment outcomes in patients with cutaneous lupus.

NCT ID: NCT01408199 Completed - Cutaneous Lupus Clinical Trials

Study To Evaluate The Safety And Efficacy Of Lenalidomide For Refractory Cutaneous Lupus

ORDI-02
Start date: January 2010
Phase: Phase 4
Study type: Interventional

Cutaneous Lupus is frequent. Approximately 70% of patients with SLE will develop cutaneous involvement at some point during course of their disease. In spite of the esthetic consequence during the acute phase, the main problem is still related to its disfiguring and incapacitating nature. Topical steroids and/or antimalarial therapy continue to be the conventional therapy. Unfortunately, approximately 30% will be refractory to these measures. For those patients, immunosuppressive therapy can be an alternative with controversial results. Several series have shown a 90% of clinical efficacy in patients treated with Thalidomide. Unfortunately, the main drawback has been the serious described side effects such as fetal malformations, polyneuropathy and drowsiness. Recently, a new thalidomide analogue, more potent, efficient and with better safety profile has been discovered. The main objective of the study is to evaluate the efficacy and safety of Lenalidomide for patients with Refractory cutaneous Lupus. Secondary objectives include evaluating the effect of this drug on the systemic manifestations of lupus disease, the adverse effects, frequency of flare after withdrawal, the sequela and the effect on the seric parameters. Methods: Twelve patients with refractory cutaneous lupus will be included. Lenalidomide will be started at 5mg/day and tapered progressively. Blood test and EMG will be performed at onset and at the end of follow up.

NCT ID: NCT01389895 Terminated - Lupus Clinical Trials

Safety Study of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus

Start date: October 2011
Phase: Phase 1
Study type: Interventional

This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple dose study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo. Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 140 mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be initiated after enrollment of Cohort 1 (210 mg) is completed.

NCT ID: NCT01164917 Terminated - Clinical trials for Systemic Lupus Erythematosus

Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

Start date: August 2010
Phase: Phase 1
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to receive AMG 811 and placebo in one of two sequences (ie, AMG 811 followed by placebo or placebo followed by AMG 811).

NCT ID: NCT00513591 Completed - Clinical trials for Rheumatoid Arthritis

Duke Autoimmunity in Pregnancy Registry

DAP Registry
Start date: August 2007
Phase:
Study type: Observational

It is difficult to predict how a women with an autoimmune disease will do during pregnancy. Some women will improve, others will worsen. Some pregnancies progress normally and others become very complicated. The Duke Autoimmunity in Pregnancy (DAP) Registry will enroll women with autoimmune diseases, such as lupus, rheumatoid arthritis, scleroderma, and Sjogren's syndrome who wish to become, or already are, pregnant. We will follow these women throughout pregnancy to better understand how their autoimmune disease affects their pregnancy, and vice versa.