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

Inclusion Criteria:

1. Participants ≥18 years old at the time of Screening

2. 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.

3. RA diagnosed for at least 6 months before Screening

4. Meets classification criteria for rheumatoid arthritis (RA) by 2010 American College
of Rheumatology/European League Against Rheumatism criteria

5. Active disease at Screening and Baseline

6. 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

7. Must be willing and able to attempt self-administration of subcutaneous (SC)
injection(s)

8. 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.

9. 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:

1. Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy.

2. Prior use of rituximab

3. Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening

4. 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.

5. Prior use of cytotoxic or alkylating agents or immunosuppressants must have been
discontinued for at least 90 days prior to Baseline

6. Current use of oral corticosteroids at a dose >10 mg/day prednisone or equivalent or
change of dose within 2 weeks prior to Screening

7. Current use of more than 1 nonsteroidal anti-inflammatory drug.

8. Prior use of injectable corticosteroids (intramuscular [IM], intra-articular [IA], or
intravenous [IV]) within 6 weeks prior to Baseline

9. Prior or current use of other self-injected drugs, eg, insulin

10. All other prior non-RA concomitant treatments must be on a stable dose for at least 4
weeks before Baseline

11. Meets Class IV Steinbrocker criteria for disability/activities of daily living

12. Laboratory abnormalities at Screening deemed clinically significant by the
Investigator and/or Sponsor.

13. Presence of fibromyalgia, another autoimmune rheumatologic illness or inflammatory
arthritis, eg, systemic lupus erythematosus, gout. The presence of secondary Sjogren's
syndrome is permitted.

14. Joint surgery within the last 8 weeks prior to Screening

15. 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

16. History or presence of signs and/or symptoms or a diagnosis of a demyelinating
disorder

17. History or presence of Class III or IV New York Heart Association congestive heart
failure

18. History or presence of symptoms suggestive of lymphoproliferative disorders, lymphoma,
leukemia, myeloproliferative disorders, or multiple myeloma

19. Existing malignancy or history of any malignancy except adequately treated or excised
non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in
situ, with no more than 3 lifetime basal cell or squamous cell carcinomas

20. Chronic infections, recurrent infections (3 or more of the same infection requiring
anti-infective treatment in any rolling 12-month period); any recent infection (ie, in
the last 30 days) requiring hospitalization or any infection requiring parenteral
anti-infective therapy within 30 days or oral infective therapies within 14 days of
Baseline; herpes zoster within 6 months of Baseline or more than 2 lifetime episodes
of herpes zoster; or history of systemic fungal infection or opportunistic infection
(eg, coccidioidomycosis, histoplasmosis, toxoplasmosis)

21. History or presence of human immunodeficiency virus (HIV), Hepatitis B or C virus

22. History of active tuberculosis (TB) or untreated or inadequately treated latent TB.

23. Participant has been exposed to an investigational product (IP) within 30 days (or 5
half-lives) prior to enrollment, whichever is longer, or is scheduled to participate
in another clinical study involving an IP or investigational device during the course
of this study

24. Participant is a family member or employee of the Investigator or Baxalta or its
partners