Usability of an AI for M923 in Subjects With Moderate to Severe RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: M923; Autoinjector
Intervention description: Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α); Subcutaneous administration
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the usability of an auto-injector (AI) for the
      delivery of M923 in patients with rheumatoid arthritis (RA)
    

Eligibility criteria:

        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