Clinical trials: Systemic Lupus
Systemic Lupus Erythematosus
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and…
- Trial name
- SABLE (NCT01729455)
- Testing
- Benlysta, Standard of Care (SoC) Therapy
- Where
- 179 sites in United States, Argentina and 11 more
- Volunteers
- 3,138 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT03920267
- Testing
- BMS-986165
- Where
- 98 sites in United States, Argentina and 12 more
- Volunteers
- 261 people
- Sponsor
- Bristol-Myers Squibb
Arthritis, Gout
Phone-Based Based Walk With Ease Program for Adults With Arthritis
The objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of Walk With Ease intervention.
- Conditions
- Arthritis, Gout, Fibromyalgia, Rheumatoid Arthritis
- Trial name
- NCT05289544
- Testing
- Phone-Based Walk With Ease
- Where
- United States
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Cutaneous Lupus, Systemic Lupus Erythematosus
Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
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…
- Trial name
- NCT03288324
- Testing
- Tofacitinib
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Systemic Lupus Erythematosus
Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis
This is a multicenter prospective study to assess clinical characteristics, demographics, treatment and health-related quality of life (HRQoL) of lupus nephritis (LN) participants across 5 Gulf countries (United Arab Emirates…
- Trial name
- NCT04971590
- Testing
- Participant completed survey, Medical chart review
- Where
- 6 sites in Kuwait, Oman and 2 more
- Volunteers
- 193 people
- Sponsor
- GlaxoSmithKline
Lupus Erythematosus, Systemic
Women Empowered to Live With Lupus Study
The purpose of this research is to examine whether the Chronic Disease Self-management Program (CDSMP) would improve health outcomes and reduce health care use in African American women with systemic lupus erythematosus (SLE).
- Trial name
- WELL (NCT02988661)
- Testing
- Chronic Disease Self-management Program (CDSMP)
- Where
- United States
- Volunteers
- 699 people
- Sponsor
- Emory University
Lupus Nephritis
A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)
The purpose of this study was to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).
- Trial name
- NCT05781750
- Testing
- zetomipzomib
- Where
- 50 sites in United States, Argentina and 10 more
- Volunteers
- 84 people
- Sponsor
- Kezar Life Sciences, Inc.
Systemic Lupus Erythematosus
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus…
- Trial name
- NCT05162586
- Testing
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 456 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Lupus Nephritis, Systemic Lupus Erythematosus
A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis
This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
- Trial name
- MISSION (NCT03393013)
- Testing
- KZR-616
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 69 people
- Sponsor
- Kezar Life Sciences, Inc.
Systemic Lupus Erythematosus
A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus
This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study…
- Trial name
- NCT05917288
- Testing
- Belimumab, Standard of care
- Where
- 6 sites in China
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Breaking Implicit Bias Habits: An Individuation Pilot Study In Rheumatology
The first aim of this study is to test the efficacy of a real-time provider-based individuation intervention to improve the receipt of high-quality rheumatic disease care among Black/African American and lower socioeconomic…
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Inflammatory Arthritis, Osteoarthritis
- Trial name
- NCT05116163
- Testing
- Individuation Intervention plus implicit bias educational modules, Implicit bias educational modules
- Where
- 2 sites in United States
- Volunteers
- 201 people
- Sponsor
- Brigham and Women's Hospital
Systemic Lupus Erythematosus
Implementing the Decision-Aid for Lupus (IDEAL Strategy)
The study will attempt to put into practice a shared decision making (SDM) strategy, using an individualized, computerized decision- aid (DA) for Systemic lupus erythematosus (SLE).
- Trial name
- IDEAL (NCT03735238)
- Testing
- SMILE Computerized Decision-Aid
- Where
- United States
- Volunteers
- 1,895 people
- Sponsor
- University of Alabama at Birmingham
Systemic Lupus Erythematosus
Addressing Disparities in Lupus Care Through an Integrated Care Management Program
The aim of this study is to identify lupus patients receiving care at Brigham and Women's Hospital (BWH) who are at high risk for potentially avoidable acute care utilization, inconsistent ambulatory care use, and adverse…
- Trial name
- Rheum-iCMP (NCT03915652)
- Testing
- Rheum iCMP
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Brigham and Women's Hospital
Systemic Lupus Erythematosus
Study of Anti-Malarials in Incomplete Lupus Erythematosus
This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial that is designed to test whether treating patients who are at risk for development of lupus with hydroxychloroquine can slow accumulation…
- Trial name
- SMILE (NCT03030118)
- Testing
- Hydroxychloroquine
- Where
- 7 sites in United States
- Volunteers
- 187 people
- Sponsor
- Milton S. Hershey Medical Center
Systemic Lupus Erythematosus
Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus
The primary purpose of this study is to evaluate the potential effectiveness of 24 weeks of MMF within previously discovered immunologically defined subsets of SLE patients.
- Trial name
- DIVERT (NCT05306873)
- Testing
- Mycophenolate Mofetil, Voclosporin
- Where
- 10 sites in United States
- Volunteers
- 12 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Systemic Lupus Erythematosus, Quality of Life
Peer Approaches to Lupus Self-management
The Peer Approaches to Lupus Self-Management (PALS) study is a randomized, controlled in which 360 African American women with lupus will be recruited from the MUSC SLE database (60 mentors and 300 mentees).
- Conditions
- Systemic Lupus Erythematosus, Quality of Life, Behavior, Health
- Trial name
- PALS (NCT03734055)
- Testing
- Peer Mentoring, Social Support Group
- Where
- United States
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
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
Lupus Nephritis
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
This was a pivotal, randomized, double-blind, placebo-controlled trial evaluating at Week 52 the efficacy and safety of secukinumab versus placebo in patients with active lupus nephritis (ISN/RPS Class III or IV, with or without…
- Trial name
- SELUNE (NCT04181762)
- Testing
- secukinumab
- Where
- 105 sites in United States, Argentina and 32 more
- Volunteers
- 275 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease…
- Trial name
- PHOENYCS GO (NCT04294667)
- Testing
- DZP
- Where
- 177 sites in United States, Argentina and 23 more
- Volunteers
- 321 people
- Sponsor
- UCB Biopharma SRL
Lupus Erythematosus, Systemic
A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
- Trial name
- NCT03517722
- Testing
- Ustekinumab (approximately 6 mg/kg), Ustekinumab 90 mg
- Where
- 204 sites in United States, Argentina and 18 more
- Volunteers
- 516 people
- Sponsor
- Janssen Research & Development, LLC