Rheumatoid Arthritis (RA) is an autoimmune disorder that causes swollen and painful joints, particularly in the hands, feet, wrists and elbows. Other symptoms of RA include inflammation of the lungs and heart, as well as low red blood cell count. The cause of this disorder is not known for certain, but can be a result of differing genetic and environmental factors. RA affects between 0.5 to 1% of adults in the developed world.
Do you suffer from discomfort or pain caused by Rheumatoid Arthritis?
This study is designed to assess efficacy and safety of treatment with an experimental medication for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naïve.
Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX.
Study details include a run-in period (6 weeks ± 3 days) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular study-related follow up on your RA to monitor the effectiveness of the care you’ll receive. The results of this research will be used to determine whether or not the medication being studied will be of benefit to others with early RA. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Have a 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 duration
- Have moderate-to-severely active RA, defined as:
- persistently active disease >= 6 tender and >= 6 swollen joints
- high sensitivity C-reactive protein > 5 mg/L
- Have been on continuous 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)
- Have had an 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)
- Have a BMI within the range [18 – 35] kg/m^2 (inclusive)
You may not qualify to participate in this study if you:
- Have any 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 judgement
- Have any condition requiring oral, intravenous, IM, or intra-articular glucocorticoid therapy
- Have uncontrolled polymyalgia rheumatica or fibromyalgia
- Have a history 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 D1
- Have any known 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 duration
- Have any history 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 protocol
- Have any history of solid organ transplant
- Have any history of alcohol or drug abuse within the past 2 years
- Have any 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)
- Have a planned surgery during the treatment period
- Are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care)
- Have had any vaccination with live or live-attenuated virus vaccine within 6 weeks prior to randomization or plan to receive one during the trial
- Have received any non-live vaccine (eg, COVID-19) within 14 days prior to randomization or plan to receive one during the trial
- Are a participant with personal or family history of long QT syndrome
- Have any active 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 skin
- Previously or currently use any biologic therapy or targeted synthetic disease modifying anti-rheumatic drugs (tsDMARD – such as JAK inhibitors) for RA
- Use 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 parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to screening
- Have any initiation or change in dose for nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to screening
- Use conventional disease-modifying anti-rheumatic drugs (cDMARDs) other than MTX
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
