Last updated 11 days ago
A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis
240 patients around the world
Available in Chile, United States, Argentina
The overall study duration for each participant will be approximately up to 149 days.
Sanofi
5Research sites
240Patients around the world
This study is for people with
Arthritis
Rheumatoid arthritis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months durationModerate-to-severely active RA, defined as:Moderate-to-severely active RA, defined as: persistently active disease >= 6 tender and >= 6 swollen joints, high sensitivity C-reactive protein > 5 mg/LModerate-to-severely active RA, defined as: persistently active disease >= 6 tender and >= 6 swollen jointsContinuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visitContinuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visit, MTX - 10 to 25 mg/week (or per local labeling requirements for the treatment of RA if the dose range differs, eg, for Japan, a stable dose of MTX is 6 to 16 mg/week) and folic/folinic acid (as part of MTX regimen)Moderate-to-severely active RA, defined as: high sensitivity C-reactive protein > 5 mg/LContinuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visit: MTX - 10 to 25 mg/week (or per local labeling requirements for the treatment of RA if the dose range differs, eg, for Japan, a stable dose of MTX is 6 to 16 mg/week) and folic/folinic acid (as part of MTX regimen)Inadequate clinical response to MTX at a dose of 10-25 mg/week after proper dose escalation according to local standards (eg, for Japan, a stable dose of MTX is 6 to 16 mg/week)BMI within the range [18 - 35] kg/m^2 (inclusive)
- Immunologic disorder other than RA, with the exception of secondary Sjogren's syndrome associated with RA, and medically controlled diabetes or thyroid disorder as per Investigator's judgementAny condition requiring oral, intravenous, IM, or intra-articular glucocorticoid therapyUncontrolled polymyalgia rheumatica or fibromyalgiaHistory of recurrent or recent serious infection (eg, pneumonia, septicemia) or infection(s) requiring hospitalization or treatment with IV anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1. Infections(s) requiring oral anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged durationHistory of moderate-to-severe congestive heart failure (NYHA Class III or IV), recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would put the participant at risk by participation in the protocolHistory of solid organ transplantHistory of alcohol or drug abuse within the past 2 yearsHistory of diagnosis of demyelinating disease such as but not limited to:History of diagnosis of demyelinating disease such as but not limited to: Multiple Sclerosis, Acute Disseminated Encephalomyelitis, Balo's Disease (Concentric Sclerosis), Charcot-Marie-Tooth Disease, Guillain-Barre Syndrome, human T-lymphotropic virus 1 Associated Myelopathy, Neuromyelitis Optica (Devic's Disease)Planned surgery during the treatment periodParticipants who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care)Vaccination with live or live-attenuated virus vaccine within 6 weeks prior to randomization or plan to receive one during the trialAny non-live vaccine (eg, COVID-19) within 14 days prior to randomization or plan to receive one during the trialParticipant with personal or family history of long QT syndromeActive malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skinPrevious or current use of biologic therapy or targeted synthetic disease modifying anti-rheumatic drugs (tsDMARD - such as JAK inhibitors) for RAUse of oral glucocorticoid greater than prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks prior to screening. The dose of oral glucocorticoid must remain stable.Use of parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to screeningInitiation or change in dose for nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to screeningPrior use of conventional disease-modifying anti-rheumatic drugs (cDMARDs) other than MTX
Sites
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Fundación CIDEA - Buenos Aires
Centro de Investigaciones Médicas Mar del Plata SRL
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
Investigaciones Reumatológicas y Osteológicas SRL
Recruiting
StudySPECIFI-RA
SponsorSanofi
Conditions
Rheumatoid arthritis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06073093
