Clinical trial NCT01651936 (phase 2, status: terminated)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: mk-8457 100 mg, methotrexate, dose-match placebo
SMILES: CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis for at least 6 months prior to screening

          -  Active rheumatoid arthritis as defined by the presence of >= 6 swollen joints (of 66
             count) and >= 6 tender joints (of 68 joint count)

          -  C-reactive protein blood level >0.9 mg/dL or an elevated erythrocyte sedimentation
             rate (ESR) >28 mm/hr and evidence of synovitis on imaging

          -  American College of Rheumatology Functional Class I, II, or III

          -  Received methotrexate for a minimum of 3 months prior to screening with a regionally
             appropriate stable weekly dose for at least 4 weeks prior to screening. The dose of
             methotrexate must remain stable through Week 24 of the study.

          -  Failed treatment with 1 or 2 anti-tumor necrosis factor alpha (anti-TNF-α) therapies
             or was intolerant to anti-TNF-α therapy prior to screening

          -  If using non-steroidal anti-inflammatory drugs or other analgesics, participant must
             be on a stable dose

          -  No history of either untreated latent or active tuberculosis (TB) prior to baseline

          -  Participants of reproductive potential must agree to remain abstinent or use 2
             acceptable methods of birth control

        Exclusion Criteria:

          -  Presence of inflammatory disease other than rheumatoid arthritis, including but not
             limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus,
             or Lyme disease

          -  Hospitalization due to an acute cardiovascular event, cardiovascular illness, or
             cardiovascular surgery within 6 months of screening

          -  Participant has a transplanted organ, excluding corneal transplant, performed > 3
             months prior to the first dose of trial medication

          -  History of, or current ongoing ,chronic or recurrent infectious disease

          -  Positive hepatitis B surface antigen or hepatitis C test result

          -  Human immunodeficiency virus (HIV) positive

          -  User of recreational or illicit drugs or has had a history (within the previous 2
             years) of drug or alcohol abuse or dependence

          -  Prior exposure to fostamatinib or other spleen tyrosine kinase inhibitors

          -  Prior exposure to 3 or more anti-TNF therapeutic agents

          -  Has been treated for RA with a marketed biologic agent (other than anti-TNF
             therapeutic agents) and failed the agent due to lack of efficacy

          -  Currently participating in another interventional clinical trial or has participated
             in an interventional clinical trial within 4 weeks prior to screening

          -  Severe opportunistic infection within the 6 months prior to screening