R-2487 in Patients With Rheumatoid Arthritis
NCT05961592 · Arthritis, Rheumatoid
RecruitingThe goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Rheumatoid Arthritis. Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Rheumatoid Arthritis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.
PhasePhase 1
TypeInterventional
Age18 Years – 75 Years
WhereSan Diego, California, United States + 4 more
SponsorRise Therapeutics LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts RA-PRO PRAGMATIC TRIAL
NCT04692493 · Rheumatoid Arthritis
RecruitingThe 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAuburn, Alabama, United States + 48 more
SponsorUniversity of Alabama at Birmingham
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
NCT04751396 · Ankylosing Spondylitis, Autoimmune Disease, Crohn Disease
RecruitingThis study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.
Phase—
TypeObservational
Age18 Years
WhereHouston, Texas, United States
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
NCT05869955 · Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis
RecruitingThe purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
PhasePhase 1
TypeInterventional
Age18 Years
WhereAurora, Colorado, United States + 53 more
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
NCT03816345 · Autoimmune Disease, Crohn Disease, Dermatomyositis
RecruitingThis phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and/or effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 51 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)
NCT07137598 · Rheumatoid Arthritis
RecruitingThis study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and/or JAK inhibitors.
PhasePhase 2
TypeInterventional
Age18 Years
WherePeoria, Arizona, United States + 31 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
NCT07176390 · Arthritis, Rheumatoid
RecruitingResearchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people. This study will help find out if a study medicine called tulisokibart can treat symptoms of active RA in people who are taking MTX. In this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen RA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WhereGlendale, Arizona, United States + 60 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
NCT06570798 · Systemic Lupus Erythematosus, Active Refractory Rheumatoid Arthritis
RecruitingThe main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereScottsdale, Arizona, United States + 51 more
SponsorAmgen
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
NCT07276581 · Rheumatoid Arthritis
RecruitingPhase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
PhasePhase 2
TypeInterventional
Age18 Years
WhereGlendale, Arizona, United States + 138 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Myelin Disorders Biorepository Project
NCT03047369 · Leukodystrophy, White Matter Disease, Leukoencephalopathies
RecruitingThe Myelin Disorders Biorepository Project (MDBP) seeks to collect and analyze clinical data and biological samples from leukodystrophy patients worldwide to support ongoing and future research projects. The MDBP is one of the world's largest leukodystrophy biorepositories, having enrolled nearly 2,000 affected individuals since it was launched over a decade ago. Researchers working in the biorepository hope to use these materials to uncover new genetic etiologies for various leukodystrophies, develop biomarkers for use in future clinical trials, and better understand the natural history of these disorders. The knowledge gained from these efforts may help improve the diagnostic tools and treatment options available to patients in the future.
Phase—
TypeObservational
AgeAny
WhereLos Angeles, California, United States + 22 more
SponsorChildren's Hospital of Philadelphia
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
NCT05848258 · Rheumatoid Arthritis
RecruitingThe main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).
PhasePhase 2
TypeInterventional
Age18 Years
WhereHuntington Beach, California, United States + 56 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
NCT06972446 · Rheumatoid Arthritis
RecruitingRheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
PhasePhase 2
TypeInterventional
Age18 Years
WherePeoria, Arizona, United States + 69 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
NCT06329401 · Pulmonary Fibrosis, Progressive Pulmonary Fibrosis, Pulmonary Fibrosis Secondary to Systemic Sclerosis
RecruitingA randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 151 more
SponsorAvalyn Pharma Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
NCT02418442 · Rheumatic Joint Disease
RecruitingContinuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.
Phase—
TypeObservational
Age21 Years
WhereBirmingham, Alabama, United States + 81 more
SponsorDuke University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
NCT06747949 · Sjögren's Syndrome
RecruitingThe primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAvondale, Arizona, United States + 167 more
SponsorAmgen
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
NCT07404865 · Primary Sjogren's Disease
RecruitingPhase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
PhasePhase 3
TypeInterventional
Age18 Years – 75 Years
WhereChicago, Illinois, United States + 4 more
SponsorVor Biopharma
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of GS-0151 in Participants With Rheumatoid Arthritis
NCT06902519 · Rheumatoid Arthritis
RecruitingThe goal of this clinical study is to learn more about the study drug GS-0151. The study is done to find how safe, well-tolerated the drug is. This will also assess how the drug is absorbed, modified, distributed and cleared from the body (the pharmacokinetics (PK) of the drug), when given multiple times to participants with rheumatoid arthritis (RA). The primary objectives of this study is to assess the safety and tolerability of multiple ascending doses of GS-0151 in participants with RA and to characterize the PK of GS-0151 following multiple doses of GS-0151 in participants with RA.
PhasePhase 1
TypeInterventional
Age18 Years – 75 Years
WhereAnniston, Alabama, United States + 31 more
SponsorGilead Sciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
NCT07123038 · Rheumatoid Arthritis (RA), Hidradenitis Suppurativa (HS)
RecruitingTo assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
Phase—
TypeObservational
Age18 Years – 71 Years
WhereSan Francisco, California, United States + 9 more
SponsorSonoma Biotherapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
NCT05787821 · Knee Pain Chronic, Osteoarthritis, Knee, Rheumatoid Arthritis
RecruitingThe main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty
Phase—
TypeObservational
Age18 Years
WhereParker, Colorado, United States + 15 more
SponsorZimmer Biomet
▾Tap for detailsClick for full details — eligibility, all locations, contacts