Usability of an AI for M923 in Subjects With Moderate to Severe RA

Inclusion Criteria

• Participants ≥18 years old at the time of Screening
• Able to understand and communicate with the Investigator and comply with the requirements of the study, and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
• RA diagnosed for at least 6 months before Screening
• Meets classification criteria for rheumatoid arthritis (RA) by 2010 American College of Rheumatology/European League Against Rheumatism criteria
• Active disease at Screening and Baseline
• Participants must have at least 1 documented swollen and/or tender joint in their hand or wrist of the dominant hand as assessed by the Investigator or designated assessor
• Must be willing and able to attempt self-administration of subcutaneous (SC) injection(s)
• Male participants and their female partners must be willing to comply with the contraception restrictions for this study from the time of the first administration of investigational product (IP) until 3 months after the last dose.
• Female participants must have a negative pregnancy test at screening and on admission to the clinic, and must not be lactating and must be using an acceptable method of contraception throughout the study and for 3 months after the last dose, or be of non-childbearing potential. Non-pregnant female partners of male participants who are of childbearing potential should use an effective form of contraception.

Exclusion Criteria

• Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy.
• Prior use of rituximab
• Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening
• Current use of a conventional disease modifying anti-rheumatic drugs (DMARD) other than the following: methotrexate orally (≤25 mg/day), hydroxychloroquine (≤400 mg/day) or sulfasalazine (≤3 g/day)) at a stable dose for at least 4 weeks prior to Screening. If discontinued, methotrexate, hydroxychloroquine, and sulfasalazine must have been discontinued at least 4 weeks prior to Baseline. No other conventional DMARDs are permitted and no combination therapy is permitted.
• Prior use of cytotoxic or alkylating agents or immunosuppressants must have been discontinued for at least 90 days prior to Baseline
• Current use of oral corticosteroids at a dose >10 mg/day prednisone or equivalent or change of dose within 2 weeks prior to Screening
• Current use of more than 1 nonsteroidal anti-inflammatory drug.
• Prior use of injectable corticosteroids (intramuscular [IM], intra-articular [IA], or intravenous [IV]) within 6 weeks prior to Baseline
• Prior or current use of other self-injected drugs, eg, insulin
• All other prior non-RA concomitant treatments must be on a stable dose for at least 4 weeks before Baseline
• Meets Class IV Steinbrocker criteria for disability/activities of daily living
• Laboratory abnormalities at Screening deemed clinically significant by the Investigator and/or Sponsor.
• Presence of fibromyalgia, another autoimmune rheumatologic illness or inflammatory arthritis, eg, systemic lupus erythematosus, gout. The presence of secondary Sjogren's syndrome is permitted.
• Joint surgery within the last 8 weeks prior to Screening
• Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurologic disease, including pleural effusions or ascites, which in the opinion of the Investigator would preclude the participant from adhering to or completing the study or where participation in the study exposes the participant to unfavorable benefit/risk
• History or presence of signs and/or symptoms or a diagnosis of a demyelinating disorder
• History or presence of Class III or IV New York Heart Association congestive heart failure
• History or presence of symptoms suggestive of lym