A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 342

Inclusion Criteria

•Subject must be =18 years of age on the day of signing the informed consent.
RA diagnosis and disease activity:
•Subject has a diagnosis of RA for at least 6 months prior to screening.
•Subject has active RA as defined by the presence of 6 swollen joints (of 66 joint count) AND 6 tender joints (of 68 joint count) at screening (Visit 1) and baseline (Visit 2).
•Subject has a C-reactive protein (CRP) blood level > 0.9 mg/dL from the central reference laboratory at screening.
•Subject is anti-cyclic citrullinated antibody positive and/or rheumatoid factor positive at screening.
•Subject is ACR functional Class I, II, or III.
•Subjects has received MTX for a minimum of 3 months with a regionally appropriate stable weekly dose (7.25-25 mg/wk for regions outside of Asia, 6–25 mg/week for Asia) for at least 4 wks prior to entering study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 419
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

•Subject has inflammatory disease other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease.
•Previous exposure to fostamatinib or other splenic tyrosine kinase (SYK) inhibitors.
•Previous exposure to TNF-alpha targeted therapy or any biological agents for RA.
•Subject has received any treatment listed below more recently than the indicated washout period prior to Screening.
Prohibited Medications, Supplements, and Other SubstancesWashout Period Prior to Screening
Disease modifying anti-rheumatic drugs such as but not limited to (not including cytotoxic agents):
Leflunomide, cyclosporine, mycophenolate mofetil, azathioprine, corticosteroids (parenteral, intra-articular), sulfasalazine, hydroxychloroquine30 days (8 weeks for leflunomide unless subject undergoes standard cholestyramine or activated charcoal washout)
Cytotoxic agents including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents3 months
Live vaccinations1 month
Investigational medications30 days or 5 half lives of the investigational agent whichever is longer
Bacille Calmette-Guerin (BCG) vaccination1 month

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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