Clinical trials: SLE; Drug
Systemic Lupus Erythematosus, Lupus Erythematosus, Systemic
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving…
- Trial name
- NCT03724916
- Testing
- TAK-079
- Where
- 19 sites in United States
- Volunteers
- 23 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Systemic Lupus Erythematosus (SLE)
CCCR Lupus Patient Navigator Program
To address the health disparities in SLE outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on…
- Trial name
- NCT04461158
- Testing
- Patient Navigator Services
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Medical University of South Carolina
Systemic Lupus Erythematosus
Reducing Disparities in Medication Adherence in SLE
This is a pilot study to assess the feasibility of using Surescripts refill data during the clinical encounter to improve medication adherence in patients with systemic lupus erythematosus
- Trial name
- NCT03738826
- Testing
- Behavioral Intervention
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Duke University
Systemic Lupus Erythematosus
BENLYSTA® Special Drug Use Investigation
The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta")…
- Trial name
- NCT03370263
- Testing
- Benlysta
- Where
- Japan
- Volunteers
- 1,514 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 (acazicolcept) in adults with moderate to severe active…
- Trial name
- Synergy (NCT04835441)
- Testing
- ALPN-101
- Where
- 46 sites in United States, France and 5 more
- Volunteers
- 76 people
- Sponsor
- Alpine Immune Sciences Inc, A Subsidiary of Vertex
Systemic Lupus Erythematosus
Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus
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…
- Trial name
- NCT02319525
- Testing
- Computerized patient decision-aid, Usual care (lupus pamphlet)
- Where
- United States
- Volunteers
- 301 people
- Sponsor
- University of Alabama at Birmingham
Systemic Lupus Erythematosus
Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)
Hypothesis: A reason for repeated disappointing outcomes of clinical trials testing targeted immune biologics for lupus may be the heterogeneity of the disease, exacerbated by the variable effects on immune homeostasis of the…
- Trial name
- BOLD (NCT00987831)
- Testing
- Group B SLE one blood donation, Blood drawing only Group C, Group A SLE prospective study
- Where
- 2 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Oklahoma Medical Research Foundation
Healthy
Study of Belimumab Administered Subcutaneously to Healthy Subjects
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in…
- Trial name
- NCT01583530
- Testing
- Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, Single Dose Group: Belimumab SC 1 x 240 mg
- Where
- 4 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
Systemic Lupus Erythematous (SLE)
Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus
Background: The immune system is the body's defense against bacteria and other harmful invaders. In people with systemic lupus erythematosus (SLE), the immune system becomes overactive and attacks healthy cells by mistake.
- Trial name
- NCT04233164
- Testing
- Solu-Medrol 1mg/kg, Solu-Medrol 250 mg
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Systemic Lupus Erythematosus (SLE), Juvenile SLE
Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases
No drug treatment is completely free of risk and lack of response, adverse events and poor adherence may affect its effectiveness.
- Conditions
- Systemic Lupus Erythematosus (SLE), Juvenile SLE, Cutaneous Lupus
- Trial name
- NCT03122431
- Testing
- Thalidomide, Hydroxychloroquine reduced, standard dose of HCQ
- Where
- Brazil
- Volunteers
- 93 people
- Sponsor
- University of Sao Paulo General Hospital
Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous
A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms.
- Trial name
- NCT05879718
- Testing
- PF-06823859
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 8 people
- Sponsor
- Pfizer
SLE; Drug
Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE
The clinical trial is titled "A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients with Systemic Lupus Erythematosus".
- Trial name
- Lupus (NCT04643067)
- Testing
- KPG-818 low dose in phase 1b, KPG-818 mid dose in phase 1b, KPG-818 high dose in phase 1b
- Where
- 18 sites in United States
- Volunteers
- 64 people
- Sponsor
- Kangpu Biopharmaceuticals, Ltd.
Interstitial Lung Disease, Connective Tissue Disease
A Clinical Trial for CTD-ILD Treatment
The first objective of this protocol is to assess the tolerability and safety of N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung disease (CTD-ILD).
- Trial name
- NCT01424033
- Testing
- N-Acetylcysteine
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Michigan