Clinical trials: Auto Immune Disease
Rheumatoid Arthritis
An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
- Trial name
- NCT00346294
- Testing
- Etanercept
- Volunteers
- 115 people
- Sponsor
- Amgen
Muscular Diseases, Neuromuscular Manifestations
Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases
The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis…
- Conditions
- Muscular Diseases, Neuromuscular Manifestations, Autoimmune, Autoimmune Diseases
- Trial name
- NCT06626919
- Testing
- anito-cel, Cyclophosphamide, Fludarabine
- Where
- 14 sites in United States
- Volunteers
- 30 people
- Sponsor
- Kite, A Gilead Company
Inflammation
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study
The purpose of this study is to assess the effect of transvenous vagus nerve stimulation (tVNS) on the immune response. In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide [LPS]) elicits a…
- Trial name
- NoSIRS (NCT01944228)
- Testing
- Vagal Nerve Stimulation
- Where
- Netherlands
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection…
- Conditions
- Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- Trial name
- NCT04018599
- Testing
- 40 mg MSB11022
- Where
- 2 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Cryopyrin-Associated Periodic Syndromes (CAPS)
HL2351 CAPS Phase II Study
This is an open label, single arm trial to evaluate the efficacy, safety, and pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes (CAPS).
- Trial name
- NCT02853084
- Testing
- HL2351
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Handok Inc.
Rheumatoid Arthritis (RA)
Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
- Trial name
- NCT01618955
- Testing
- VIBEX MTX
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Antares Pharma Inc.
Immune Thrombocytopenia (ITP)
A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)
The primary objective of this study was to assess the efficacy of 3 dose levels of lusutrombopag (0.5 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.
- Trial name
- NCT01054443
- Testing
- Lusutrombopag
- Where
- 19 sites in United States
- Volunteers
- 20 people
- Sponsor
- Shionogi
Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS)
Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors
This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors.
- Trial name
- POR-BetaPlus (NCT01235455)
- Testing
- Interferon beta-1b (Betaseron, BAY86-5046)
- Where
- Portugal
- Volunteers
- 10 people
- Sponsor
- Bayer
Myasthenia Gravis, Generalized
Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)
This is a Phase IIb study to evaluate the safety and preliminary efficacy of Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis
- Trial name
- NCT04146051
- Testing
- Descartes-08
- Where
- 15 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Cartesian Therapeutics
Rheumatoid Arthritis
Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
The primary objective of the study is to evaluate the safety and tolerability of 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with active Rheumatoid Arthritis despite methotrexate therapy.
- Trial name
- NCT00425321
- Testing
- RWJ-445380 100 mg, RWJ-445380 200 mg, RWJ-445380 300 mg
- Where
- 42 sites in United States, Argentina and 5 more
- Volunteers
- 259 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Still's Disease, Adult-Onset
Therapeutic Use of Tadekinig Alfa in Adult-onset Still's Disease
The objective of this study is to assess safety, tolerability and early signs of efficacy of the investigational drug Tadekinig alfa in Adult-onset Still's disease, a rare polygenic auto-inflammatory disorder for which treatment…
- Trial name
- NCT02398435
- Testing
- Tadekinig alfa (recombinant human IL-18 binding protein)
- Where
- 20 sites in France, Germany and 1 more
- Volunteers
- 23 people
- Sponsor
- AB2 Bio Ltd.
Rheumatoid Arthritis
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis
This is a phase 3 study to evaluate the usability of the CT-P47 auto-injector in patients with moderate to severe active rheumatoid arthritis.
- Trial name
- NCT05725434
- Testing
- CT-P47 AI (tocilizumab), CT-P47 PFS (tocilizumab)
- Volunteers
- 30 people
- Sponsor
- Celltrion
Systemic Juvenile Idiopathic Arthritis
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile…
- Trial name
- NCT02396212
- Testing
- Canakinumab
- Where
- 7 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients
The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3…
- Trial name
- NCT03560739
- Testing
- ofatumumab with PRF, ofatumumab with AI
- Where
- 41 sites in United States, Austria and 7 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erthematosus, Auto Immune Disease
A Study of GR1803 in Systemic Lupus Erythematosus
to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus
- Trial name
- NCT07348055
- Testing
- GR1803 injection
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Generalized Myasthenia Gravis
A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Gravis
The purpose of this study is to evaluate the effectiveness, safety and tolerability of zilucoplan auto-injector (ZLP-AI) self-administration.
- Trial name
- NCT06471361
- Testing
- Zilucoplan
- Where
- 11 sites in United States, Poland and 1 more
- Volunteers
- 31 people
- Sponsor
- UCB Biopharma SRL
Chronic Small Plaque Psoriasis
Study to Investigate the Safety, Tolerability, Absorption, Distribution, Metabolism, and Elimination of RWJ-445380 Administered to Patients With Plaque Psoriasis
The primary objective of the study is to evaluate the safety and tolerability of 50, 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with plaque psoriasis
- Trial name
- NCT00396422
- Testing
- RWJ-445380
- Volunteers
- 60 people
- Sponsor
- Alza Corporation, DE, USA
Multiple Sclerosis
BAY86-5046 (Betaseron), Non Interventional Studies
This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.
- Trial name
- BETAEVAL (NCT02121444)
- Testing
- Interferon beta-1b (Betaferon, BAY 86-5046), BETACONNECT auto-injector.
- Where
- Germany
- Volunteers
- 151 people
- Sponsor
- Bayer
Rheumatoid Arthritis
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
- Trial name
- NCT04171414
- Testing
- CT-P17 SC AI (adalimumab)
- Where
- Poland
- Volunteers
- 62 people
- Sponsor
- Celltrion
Lupus Erythematosus, Systemic
A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
The purpose of this study is to evaluate the amount of tabalumab in the blood after it is given by two different injection methods - A traditional syringe or a spring loaded syringe for 12 weeks.
- Trial name
- NCT02041091
- Testing
- Tabalumab Auto-Injector, Tabalumab Prefilled Syringe
- Where
- 44 sites in United States, Puerto Rico and 1 more
- Volunteers
- 226 people
- Sponsor
- Eli Lilly and Company