
Search Clinical Trials
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A Study of Olezarsen for the Treatment of Familial Chylomicronemia Syndrome (FCS) in Pediatric Part1
Ionis Pharmaceuticals, Inc.
Familial Chylomicronemia Syndrome
The primary purpose of the study is to evaluate the efficacy of olezarsen administered by
subcutaneous injection to pediatric participants with FCS. expand
The primary purpose of the study is to evaluate the efficacy of olezarsen administered by subcutaneous injection to pediatric participants with FCS. Type: Interventional Start Date: Jul 2026 |
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A Study of Luspatercept in People With Anemia
Memorial Sloan Kettering Cancer Center
Anemia
Chronic Kidney Disease
The researchers are doing this study to test whether luspatercept works to improve
hemoglobin levels in people with anemia caused by chronic kidney disease (CKD). The
researchers will also test whether luspatercept is a safe treatment that causes few or
mild side effects in participants. expand
The researchers are doing this study to test whether luspatercept works to improve hemoglobin levels in people with anemia caused by chronic kidney disease (CKD). The researchers will also test whether luspatercept is a safe treatment that causes few or mild side effects in participants. Type: Interventional Start Date: Jul 2026 |
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Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma
H. Lee Moffitt Cancer Center and Research Institute
Sarcoma
Osteosarcoma
This is a multicenter, open-label, Phase 1/2 study evaluating the safety, tolerability,
pharmacokinetics, pharmacodynamics, and antitumor activity of domatinostat in combination
with sirolimus in adolescents and adults with relapsed or refractory sarcoma and
osteosarcoma. expand
This is a multicenter, open-label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of domatinostat in combination with sirolimus in adolescents and adults with relapsed or refractory sarcoma and osteosarcoma. Type: Interventional Start Date: Jul 2026 |
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Immediate Neuromuscular Responses of the Obliquus Capitis Inferior Following Upper Cervical Manual1
Florida Gulf Coast University
Head and Neck
Headache
This study used a prospective, randomized, repeated-measures experimental design to
investigate the immediate effects of two upper cervical manual therapy interventions on
craniovertebral angle (CVA), clinician-perceived atlas position, and musculoskeletal
ultrasound-derived obliquus capitis inferi1 expand
This study used a prospective, randomized, repeated-measures experimental design to investigate the immediate effects of two upper cervical manual therapy interventions on craniovertebral angle (CVA), clinician-perceived atlas position, and musculoskeletal ultrasound-derived obliquus capitis inferior (OCI) muscle morphology Type: Interventional Start Date: May 2025 |
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Radiation After No Axillary Nodal Sampling
NYU Langone Health
Early-stage Breast Cancer
Invasive Ductal Carcinoma of Female Breast
This is a single arm, pilot, prospective study to evaluate the safety of partial breast
irradiation in women who undergo breast conserving surgery without sentinel lymph node
biopsy (SLNB) or axillary lymph node dissection (ALND). Baseline demographic and clinical
information will be collected. All1 expand
This is a single arm, pilot, prospective study to evaluate the safety of partial breast irradiation in women who undergo breast conserving surgery without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Baseline demographic and clinical information will be collected. All patients will complete the Breast Cancer Treatment Outcome Scale (BCTOS-13) questionnaire and the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity at baseline and at 2 years. All patients are required to have an axillary ultrasound prior to radiation start if this was not obtained pre-operatively. Type: Interventional Start Date: Jul 2026 |
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Evaluating Whether a Nausea Band Reduces Symptoms in Those With Chronic Nausea Vomiting
Ohio State University
Chronic Nausea
Chronic Nausea and Vomiting Syndrome
The goal of this clinical trial is to learn whether a wearable transcutaneous electrical
nerve stimulation (TENS) device called EmeTerm can help reduce nausea in adults who have
had nausea for 2 months or longer and who receive care at The Ohio State University. The
study will also evaluate whether1 expand
The goal of this clinical trial is to learn whether a wearable transcutaneous electrical nerve stimulation (TENS) device called EmeTerm can help reduce nausea in adults who have had nausea for 2 months or longer and who receive care at The Ohio State University. The study will also evaluate whether use of the device affects other symptoms and aspects of wellbeing, including vomiting, abdominal pain, bloating, constipation, appetite, sleep, mood, stress, fatigue, quality of life, and hope. [34_Emeterm...rotocol_v3 | Word] The main questions it aims to answer are: Does using the EmeTerm device reduce the average weekly frequency of moderate to severe nausea compared with symptoms during a baseline observation period? [34_Emeterm...rotocol_v3 | Word] Does using the EmeTerm device reduce the duration of nausea, frequency of vomiting, and use of anti-nausea medications, and improve other gastrointestinal symptoms, wellbeing, and quality of life? [34_Emeterm...rotocol_v3 | Word] This is a single-arm study. Participants will serve as their own comparison by comparing symptoms during device use with symptoms recorded during the baseline period before using the device. [34_Emeterm...rotocol_v3 | Word] Participants will: Complete a screening survey and provide electronic informed consent if eligible. [34_Emeterm...rotocol_v3 | Word] Complete baseline questionnaires and record daily gastrointestinal symptoms for a 2-week baseline period. [34_Emeterm...rotocol_v3 | Word] Receive an EmeTerm wearable TENS device and instructions for its use. [34_Emeterm...rotocol_v3 | Word] Use the EmeTerm device for 12 weeks while continuing to record nausea and other gastrointestinal symptoms. [34_Emeterm...rotocol_v3 | Word] Complete weekly and monthly surveys about symptoms, stress, sleep, appetite, fatigue, quality of life, anxiety, depression, autonomic symptoms, device experience, and any adverse events. Type: Interventional Start Date: Feb 2023 |
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Tactile Pre-Visit Imagery
University of Southern California
Dental Anxiety in Children
Behavior Change
In pediatric dentistry, our primary goals are to prevent dental caries and, when
necessary, provide treatment in a safe and comforting environment that minimizes anxiety
for young patients. By familiarizing young patients with the steps involved in common
dental procedures, tactile pre-visit imager1 expand
In pediatric dentistry, our primary goals are to prevent dental caries and, when necessary, provide treatment in a safe and comforting environment that minimizes anxiety for young patients. By familiarizing young patients with the steps involved in common dental procedures, tactile pre-visit imagery booklets can reduce the fear of the unknown. Study Objective/Purpose: The purpose of this study is to determine whether tactile pre-visit imagery could reduce dental anxiety and fear in pediatric patients prior to their first restorative procedure. An additional aspect of this study entails assessing the patient's behavior and determining if it improves with the use of a tactile pre-visit imagery booklet. Type: Interventional Start Date: Jan 2026 |
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A Study to Characterize the Safety and Immunogenicity of AZD6489 in Participants 60 Years of Age an1
AstraZeneca
RSV Respiratory Syncytial Virus
This Phase I/II study is to characterize the safety and immunogenicity of 2 dose levels
of AZD6489, an investigational RSV recombinant prefusion F protein VLP vaccine. expand
This Phase I/II study is to characterize the safety and immunogenicity of 2 dose levels of AZD6489, an investigational RSV recombinant prefusion F protein VLP vaccine. Type: Interventional Start Date: Jul 2026 |
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Digital Health Implementation Strategies to Improve Lung Cancer Screening Among Safety-Net Clinics
University of Utah
Lung Cancer
The long-term goal of this program of research is to increase the reach of Lung Cancer
Screening (LCS) among low-resource healthcare settings and populations. The proposed
project, LUNG-IS, is a mixed-methods, pre-post quasi-experimental design conducted in
three Utah safety-net healthcare system c1 expand
The long-term goal of this program of research is to increase the reach of Lung Cancer Screening (LCS) among low-resource healthcare settings and populations. The proposed project, LUNG-IS, is a mixed-methods, pre-post quasi-experimental design conducted in three Utah safety-net healthcare system clinics. LUNG-IS employs a comprehensive conceptual model with theories, models, and frameworks of implementation and behavioral science, uses rigorous mixed-methods to evaluate factors that influence implementation of LCS, and uses patient navigation to facilitate clinic-community linkages. LUNG-IS leverages existing pathways to care and Centralized Hub infrastructure that enables eligibility assessment, LCS Shared Decision Making (SDM) with clinical decision support, screening referral, and screening logistics assistance to help overcome barriers to LCS completion. The Centralized Hub model uses ubiquitous technologies (i.e., text messaging/telehealth) to enable patients to be assessed for LCS eligibility, engage in SDM if eligible, and be referred for LCS. For patients who decide to complete LCS, they will be provided patient navigation via Community Health Workers designed to address logistical barriers, hesitancy, and financial constraints around completing LCS. Type: Interventional Start Date: Jan 2026 |
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Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
Anna Stanhewicz, PhD
Preeclampsia
Endothelial Function
Preeclampsia is a condition in pregnancy where a woman develops high blood pressure and
other complications. Women who develop preeclampsia are 4 times more likely to have heart
disease later in life. They are also more likely to have depression after pregnancy. Why
they are more likely to develop1 expand
Preeclampsia is a condition in pregnancy where a woman develops high blood pressure and other complications. Women who develop preeclampsia are 4 times more likely to have heart disease later in life. They are also more likely to have depression after pregnancy. Why they are more likely to develop these conditions is not known. It may be because their blood vessels were damaged during pregnancy. Changes in blood vessel health can predict heart disease. These changes have been recorded after pregnancy in women who had preeclampsia. These changes have also been recorded in women who have depression. In the previous phase of this award, we found that women who had preeclampsia in pregnancy had changes in blood vessel health after pregnancy. We also found that if these women were taking a medicine to treat depression, their blood vessel health was normal. This could mean that treatment for depression can also increase blood vessel health in women who had preeclampsia. In this project we will study how changes in blood vessel health are related to preeclampsia and depression in women who have had both. We will also study how medicine to treat depression can improve blood vessel health after preeclampsia. We will do this by measuring how blood vessels work in women who have had preeclampsia compared to women who did not, and in women who have depression and women who do not. This will tell us more about why risk for depression and heart disease is higher in women who have had preeclampsia. It will also help us understand if medicine for depression can reduce cardiovascular disease risk after preeclampsia. Type: Interventional Start Date: Aug 2026 |
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Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathi1
University of California, Los Angeles
Cataract
Cataract (Post-operative Cataract Surgery Follow-up)
This randomized controlled trial evaluates whether a standardized perioperative
neuroplastic intervention: the STEIN Protocol (Strategies and Techniques for Enhancing
Integration and Neuroplasticity), consisting of pain neuroscience education, guided
imagery, and paced breathing, reduces intraopera1 expand
This randomized controlled trial evaluates whether a standardized perioperative neuroplastic intervention: the STEIN Protocol (Strategies and Techniques for Enhancing Integration and Neuroplasticity), consisting of pain neuroscience education, guided imagery, and paced breathing, reduces intraoperative analgesic and anxiolytic requirements. Secondary outcomes include patient-reported pain, anxiety, satisfaction, and postoperative recovery following cataract surgery. Reduced intraoperative sedative and analgesic requirements may reflect improved patient comfort and autonomic regulation while minimizing medication-related adverse effects. Type: Interventional Start Date: Jun 2026 |
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Low Dose Radiotherapy for Osteoarthritis
Abramson Cancer Center at Penn Medicine
Osteoarthitis
This single institution, multi-site, single arm prospective study will enroll patients
with a history of OA and assess changes in pain and function after treatment with LDRT as
measured by patient-reported outcomes. expand
This single institution, multi-site, single arm prospective study will enroll patients with a history of OA and assess changes in pain and function after treatment with LDRT as measured by patient-reported outcomes. Type: Interventional Start Date: Jun 2026 |
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Consumer Evaluation of an Investigational Intermittent Catheter
Hollister Incorporated
Urinary Retention
Neurogenic Bladder
This clinical study is designed to evaluate the initial safety and performance of an
investigational intermittent urinary catheter in people who use intermittent
catheterization. Participants will use the study catheter and provide feedback on their
experience, including ease of insertion, advancem1 expand
This clinical study is designed to evaluate the initial safety and performance of an investigational intermittent urinary catheter in people who use intermittent catheterization. Participants will use the study catheter and provide feedback on their experience, including ease of insertion, advancement through the urethra, bladder drainage, withdrawal, comfort, confidence, satisfaction, and overall ease of use. Safety will be evaluated through reported health changes and adverse events. Device performance and user experience will be assessed using participant questionnaires and comparisons with the participant's current intermittent catheter, including questions related to catheter handling, comfort during catheterization, perceived ability to empty the bladder, likelihood of future use, and product preference. The study is intended to generate descriptive information on the initial clinical use of the investigational catheter and to help characterize its safety, usability, comfort, satisfaction, and performance relative to participants' current intermittent catheter products. Type: Interventional Start Date: Jul 2026 |
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VisionWay Accessibility
Ohio State University
Persons With Visual Disabilities
The challenge of outdoor wayfinding, critical for People with Visual Impairments (PVI),
consists in helping users safely walk to a pre-determined nearby destination. The main
focus of existing solutions from research and industry is to leverage the user's
smartphone to receive safe moving direction1 expand
The challenge of outdoor wayfinding, critical for People with Visual Impairments (PVI), consists in helping users safely walk to a pre-determined nearby destination. The main focus of existing solutions from research and industry is to leverage the user's smartphone to receive safe moving directions either from a remote operator or smart app. However, multiple paths may exist to connect users with their destination, each one with unique characteristics in terms of accessibility and safety. Unfortunately, little to no attention has been paid in helping PVI decide, before even starting to walk, which path to take based on their accessibility. Thus, a barrier identified is that the followed path may not be accessible because sidewalk features such as potholes, uncontrolled crossing, interrupted sidewalks, and objects are not known in advance. The investigators' goal is to develop a mobile live, local, outside map framework called VisionWay, customized for PVI-user as a wayfinding tool to analyze, before starting to walk, the accessibility of candidate paths and choose one to the destination. Type: Interventional Start Date: Feb 2026 |
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Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
University of California, San Diego
Systemic Lupus Erthematosus (SLE)
To study the effect of anti-inflammatory diet on clinical and biological outcomes in
lupus expand
To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus Type: Interventional Start Date: Jul 2026 |
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A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of1
GlaxoSmithKline
Asthma
The purpose of this study is to compare how two different formulations of the study
medicine (GSK5784283) move through the body over time (pharmacokinetic [PK] study) in
healthy adults. The aim of the study is to see how the body processes GSK5784283 and
determine if the study medicine is safe, how1 expand
The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic [PK] study) in healthy adults. The aim of the study is to see how the body processes GSK5784283 and determine if the study medicine is safe, how well it is tolerated by the body and if the study medicines being tested work in the body in the same way. Type: Interventional Start Date: Jul 2026 |
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A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Sev1
Nektar Therapeutics
Moderate-to-Severe Atopic Dermatitis
This is an interventional, randomized, parallel group, treatment, Phase 3, double blind
study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older
with moderate to severe atopic dermatitis, as compared to placebo.
The estimated participant overall duration is approxim1 expand
This is an interventional, randomized, parallel group, treatment, Phase 3, double blind study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older with moderate to severe atopic dermatitis, as compared to placebo. The estimated participant overall duration is approximately 15 months. Type: Interventional Start Date: Aug 2026 |
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FLOAT for Healthcare PTSS
Laureate Institute for Brain Research, Inc.
Posttraumatic Stress Symptoms
Burnout
Burnout, Healthcare Workers
First Responders
PTSD
This early-stage pilot trial aims to examine the feasibility, tolerability, and safety of
Floatation-REST, or Reduced Environmental Stimulation Therapy via floatation in frontline
healthcare workers, first responders, and emergency medical personnel who experience
post-traumatic stress symptoms. expand
This early-stage pilot trial aims to examine the feasibility, tolerability, and safety of Floatation-REST, or Reduced Environmental Stimulation Therapy via floatation in frontline healthcare workers, first responders, and emergency medical personnel who experience post-traumatic stress symptoms. Type: Interventional Start Date: Jun 2026 |
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A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmaco1
Revagenix, Inc.
Healthy Participants
Non-cystic Fibrosis Bronchiectasis
This is a Phase 1a/1b study to test the safety, tolerability, microbiological response,
and pharmacokinetics of inhaled Rev-56 compared to placebo in adult healthy participants
and non-cystic fibrosis bronchiectasis (NCFB) patients with P. aeruginosa, respectively.
Phase 1a (Part A) will evaluate1 expand
This is a Phase 1a/1b study to test the safety, tolerability, microbiological response, and pharmacokinetics of inhaled Rev-56 compared to placebo in adult healthy participants and non-cystic fibrosis bronchiectasis (NCFB) patients with P. aeruginosa, respectively. Phase 1a (Part A) will evaluate single doses of inhaled Rev-56 in adult healthy participants and includes up to 5 cohorts. Eligible participants will be randomized to active treatment or placebo in a 3:1 randomization scheme. Phase 1b (Part B) will evaluate the safety, tolerability, microbiological response, and pharmacokinetics of multiple doses of inhaled Rev-56 in NCFB patients with P. aeruginosa and includes 2 cohorts evaluating once daily dosing and twice daily dosing, respectively. Eligible participants will be randomized to active treatment or placebo in a 2:1 randomization scheme. Type: Interventional Start Date: Jul 2026 |
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Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
Massachusetts General Hospital
Lateral Ankle Instability
Chronic Lateral Ankle Instability
Brostrom Procedure
ATFL
Anterior Talofibular Ligament
The purpose of this investigation is to evaluate pre- and post-operative patient reported
outcomes and functional scores after open non-augmented Broström repair or open Broström
repair augmented with the BioBrace Implant. expand
The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after open non-augmented Broström repair or open Broström repair augmented with the BioBrace Implant. Type: Interventional Start Date: Jun 2026 |
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Oil Pulling Reduction
The University of Texas Health Science Center at San Antonio
Good Health
Gingival Inflammation and Bleeding
Dental Plaque
The goal of this study is to scientifically evaluate the efficacy of this oil pulling
oral rinse in reducing dental plaque, gingival inflammation, gingival bleeding, and
selectively reducing caries- and periodontal disease-associated bacteria compared to a
marketed mouthwash and a placebo oral rinse expand
The goal of this study is to scientifically evaluate the efficacy of this oil pulling oral rinse in reducing dental plaque, gingival inflammation, gingival bleeding, and selectively reducing caries- and periodontal disease-associated bacteria compared to a marketed mouthwash and a placebo oral rinse Type: Interventional Start Date: Jul 2026 |
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mHealth to Improve Medication Adherence Among Latina Breast Cancer Patients Experiencing Non-Medica1
The University of Texas Health Science Center at San Antonio
Treatment Adherence
Background: Hormonal therapy (HT) is highly effective for nearly all breast cancer
patients with hormone receptor-positive tumors, which are about 80% of all breast cancer
diagnoses. Long-term use of HT reduces cancer recurrence rates and cuts the risk of
mortality nearly in half during the second1 expand
Background: Hormonal therapy (HT) is highly effective for nearly all breast cancer patients with hormone receptor-positive tumors, which are about 80% of all breast cancer diagnoses. Long-term use of HT reduces cancer recurrence rates and cuts the risk of mortality nearly in half during the second decade after diagnosis. Despite proven benefits, 33% of women who are prescribed HT do not take it as prescribed (<80% take their daily dosage). Latina patients are disproportionately affected by non-medical drivers of health (NMDoH) that keep them from adhering to HT and are at higher risk of breast cancer recurrence and mortality. Objective: The goal of this 4-year randomized controlled study is to assess the effectiveness of the bilingual, culturally tailored, interactive HT Helper App, in combination with patient navigation (PN), on improving adherence to HT among Latina breast cancer patients experiencing any NMDoH barriers, such as income, health insurance, education, health literacy, and language, that impact their medication adherence. This theory-based intervention will increase patient education, enhance self-efficacy, facilitate communication with the medical team and coordination of resources to address NMDoH barriers, and help patients develop self-care skills for optimal adherence to HT, ensuring patients the most equitable treatment outcomes possible, including improvement in quality of life, survival, and life expectancy. Specific Aims/Hypothesis: 1) Conduct a 3-group randomized study to assess the effectiveness of the HT Helper App + PN vs. PN alone vs. usual care, on HT adherence; and 2) Assess the effect of each study condition on patient self-efficacy to identify side effects, use self-care to manage side effects, and communicate with the medical team. We hypothesize that the HT Helper App + PN and the PN alone groups will have greater rates of HT adherence and higher patient self-efficacy than the usual care group; with the HT Helper App + PN achieving better results than both PN alone and the usual care groups. Study Design. The proposed study involves a parallel 3-group randomized controlled trial with 5-time assessments (baseline, 3, 6, 12, and 18 months) and will enroll 159 breast cancer patients who are prescribed HT and are attending the breast clinic at the Mays Cancer Center at UT Health San Antonio. Intervention components are based on Social Cognitive Theory and elements of Motivational Interviewing. Cancer Relevance. This innovative multi-level intervention will improve adherence to HT by addressing NMDoH and promote equitable breast cancer outcomes, including reduced recurrence and improved quality of life, overall survival, and life expectancy among underserved Latina patients. The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using oral anticancer medications. Type: Interventional Start Date: Sep 2025 |
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Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
Ocular Aesthetics, LLC dba Ocular Clinical Trials
Dry Eye
The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves
contact lens comfort in contact lens wearers. expand
The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers. Type: Interventional Start Date: Jul 2026 |
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DBC-664 in Adult Patients With Solid Tumors
Duboce Biopharmaceuticals, Inc.
Malignant Germ Cell Tumor
Lung Adenocarcinoma
Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma
Urothelial Carcinoma
Endometrial Adenocarcinoma
DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate
the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of
DBC-664 in patients with endometrial cancer, ovarian cancer, and other advanced solid
tumors . This study is divided into 21 expand
DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian cancer, and other advanced solid tumors . This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2). In each part, patients who meet specific eligibility criteria will be enrolled. Type: Interventional Start Date: Jun 2026 |
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Phase 1b/2 Study of IV Sarilumab in Adult With RA
Sanofi
Rheumatoid Arthritis
This is a Phase 1/Phase 2 study with:
- 5-arms design for Part A;
- and a single arm for Part B.
The purpose of this study is to measure PK parameters and safety with sarilumab
intravenous (IV) with or without concomitant oral conventional synthetic
Disease-Modifying Antirheumatic Drugs (c1 expand
This is a Phase 1/Phase 2 study with: - 5-arms design for Part A; - and a single arm for Part B. The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older. Study details include: - The study duration will be up to 64 weeks. - The treatment duration will be up to 6 months for each study phase. - Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit. - For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits. - For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit. - Part B has 13 visits, including a post-treatment EOS follow-up visit. Type: Interventional Start Date: Jul 2026 |