Clinical trials: Autoimmune Disorder
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), CIDP
Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The aim of the Pre-Approval Access program is to provide efgartigimod PH20 SC treatment to patients with CIDP who are ineligible to participate in a clinical study and have unmet medical need despite available treatment options.
- Trial name
- NCT04777734
- Testing
- Efgartigimod PH20 SC
- Sponsor
- argenx
Degenerative Osteoarthritis, Rheumatoid Arthritis
Orthopilot Elite Post-Market Clinical Follow-Up
Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Posttraumatic Arthropathy, Instability, Joint
- Trial name
- NCT03817632
- Testing
- Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1, Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
- Where
- 3 sites in Germany
- Volunteers
- 217 people
- Sponsor
- Aesculap AG
Multiple Sclerosis, Progressive Multifocal Leukoencephalopathy
Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
This study will evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by John Cunningham virus (JCV), among people with multiple sclerosis who have been treated with ozanimod.
- Trial name
- NCT07732907
- Testing
- Ozanimod
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Bristol-Myers Squibb
Multiple Sclerosis
Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).
- Trial name
- SUNBEAM (NCT02294058)
- Testing
- Ozanimod, Interferon beta-1a
- Where
- 224 sites in United States, Belarus and 23 more
- Volunteers
- 1,346 people
- Sponsor
- Celgene
Rheumatoid Arthritis, Plaque Psoriasis
Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept
The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis (PsO) patients who self inject etanercept for one of two experimental autoinjectors.
- Trial name
- NCT01875991
- Testing
- Etanercept via Autoinjector A, Etanercept via Autoinjector B
- Where
- 37 sites in United States, Canada
- Volunteers
- 217 people
- Sponsor
- Amgen
Type 1 Diabetes Mellitus
Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase
The purpose of this study is to evaluate consistency of accelerated insulin absorption and onset-of-action and shortened duration of action for bolus insulin infusions after pretreatment with 150 units (U) of Hylenex®…
- Trial name
- NCT01526733
- Testing
- Recombinant human hyaluronidase PH20, Insulin aspart, Insulin lispro
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Halozyme Therapeutics
Crohn Disease, Ulcerative Colitis
National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the…
- Conditions
- Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Trial name
- ReFLECT (NCT02925338)
- Testing
- QOL questionaire
- Where
- 67 sites in France
- Volunteers
- 1,431 people
- Sponsor
- Pfizer
Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).
- Trial name
- NCT03226678
- Testing
- APL-2
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Diabetes Mellitus, Type 1
INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes
INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a…
- Trial name
- NCT05904743
- Testing
- Afrezza, insulin degludec, Rapid-acting Insulin Analog
- Where
- 19 sites in United States
- Volunteers
- 141 people
- Sponsor
- Mannkind Corporation
Sjogren's Syndrome, Sjögren
R-2487 in Patients With Sjogren's Syndrome (SS)
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.
- Conditions
- Sjogren's Syndrome, Sjögren, Sjögren Syndrome, Unspecified
- Trial name
- R-2487-SS-01 (NCT06297213)
- Testing
- R-2487
- Volunteers
- 36 people
- Sponsor
- Rise Therapeutics LLC
Diabetes Mellitus, Type 1
Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days
Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days.
- Trial name
- NCT01969747
- Testing
- Empagliflozin medium, Empagliflozin low
- Where
- 2 sites in Austria, Germany
- Volunteers
- 75 people
- Sponsor
- Boehringer Ingelheim
Diabetic Neuropathies, Diabetes Mellitus, Insulin-Dependent
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
The purpose of this protocol is to determine if an investigational drug known as LY333531 is effective in treating nerve malfunction in diabetes.
- Conditions
- Diabetic Neuropathies, Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Non-Insulin-Dependent
- Trial name
- NCT00044408
- Testing
- Ruboxistaurin mesylate
- Where
- 35 sites in United States, Canada and 6 more
- Volunteers
- 200 people
- Sponsor
- Chromaderm, Inc.
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus
The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the action of a drug in the body over a period of time) of multiple intravenous (IV) administrations of CNTO 136 in patients with cutaneous lupus…
- Trial name
- NCT01702740
- Testing
- 1 mg/kg CNTO 136, 4 mg/kg CNTO 136, 10 mg/kg CNTO 136
- Volunteers
- 49 people
- Sponsor
- Centocor Research & Development, Inc.
Type 1 Diabetes Mellitus
Concurrent Use of Two Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Mellitus (T1DM)
The purpose of this pilot study is to evaluate performance of the SEVEN System and the Navigator System when both devices are worn concurrently by subjects with type 1 diabetes mellitus.
- Trial name
- NCT00939289
- Testing
- Continuous Glucose Monitoring
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- DexCom, Inc.
Systemic Lupus Erythematosus
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
- Trial name
- NCT01559090
- Testing
- MEDI-546
- Where
- 6 sites in Japan
- Volunteers
- 17 people
- Sponsor
- AstraZeneca
Type 1 Diabetes Mellitus
A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes
The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd also known as retogatein compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous…
- Trial name
- DIAGNODE-3 (NCT05018585)
- Testing
- Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®, Colecalciferol 2000 IU
- Where
- 60 sites in United States, Czechia and 7 more
- Volunteers
- 321 people
- Sponsor
- Diamyd Medical AB
Thyroid Eye Disease (TED)
Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease
This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.
- Trial name
- NCT07262476
- Testing
- MHB018A injection
- Where
- China
- Volunteers
- 258 people
- Sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
Rheumatoid Arthritis
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies.
- Trial name
- CHS-0214-02 (NCT02115750)
- Testing
- Etanercept, CHS-0214
- Where
- 141 sites in United States, Belarus and 10 more
- Volunteers
- 647 people
- Sponsor
- Coherus Oncology, Inc.
Rheumatoid Arthritis
Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis
The primary objective of this study is to evaluate the efficacy of andecaliximab (GS-5745) versus placebo as an add-on therapy to a tumor necrosis factor (TNF) inhibitor and methotrexate in adults with moderate to severe…
- Trial name
- NCT02862574
- Testing
- Andecaliximab, Methotrexate, TNF Inhibitor
- Where
- 8 sites in United States
- Volunteers
- 15 people
- Sponsor
- Gilead Sciences
Rheumatoid Arthritis
A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis
This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a stable dose of Methotrexate(MTX) and who have an…
- Trial name
- NCT03275025
- Testing
- YRA-1909 low dose, YRA-1909 mid dose, YRA-1909 high dose
- Where
- 14 sites in South Korea
- Volunteers
- 116 people
- Sponsor
- Yungjin Pharm. Co., Ltd.