Clinical trial NCT01225393 (phase 2, status: completed)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: mlta3698a, adalimumab, leflunomide, methotrexate, placebo
SMILES: O, CC1=C(C=NO1)C(=O)NC1=CC=C(C=C1)C(F)(F)F, 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 RA according to the 1987 revised ACR Criteria for the Classification of
             RA for at least 6 months prior to screening

          -  Positive for rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibody, or
             both

          -  Active disease, defined as: CRP >= 1.0 mg/dL; swollen joint count >= 6 (66 joint
             count); tender joint count >= 6 (68 joint count)

          -  Previous inadequate clinical response to at least one disease-modifying anti-rheumatic
             drug (DMARD) consisting of either methotrexate (MTX) or leflunomide (LFU)

          -  For patients currently receiving corticosteroids: Treatment at a stable dose during
             last 4 weeks prior to screening

          -  For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs):
             Treatment at a stable dose during last 4 weeks prior to screening

          -  For patients currently receiving sulfasalazine or anti-malarials: Treatment initiated
             and continued for at least the last 6 months prior to screening and on a stable dose

          -  For patients of reproductive potential (males and females): Willing to use a highly
             effective birth control method for the duration of the study according to local
             guidelines

        Exclusion Criteria:

          -  Pregnant, planning to become pregnant during the study, or breastfeeding

          -  Clinically significant abnormal laboratory values or abnormal ECG or vital signs

          -  History of anaphylactic reactions

          -  Rheumatic autoimmune disease other than RA, or significant systemic involvement
             secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or
             Felty's syndrome), however patients with secondary Sjogren's syndrome are eligible for
             the study

          -  History of or current inflammatory joint disease other than RA (e.g., gout, reactive
             arthritis, psoriatic arthritis, seronegative spondyloarthritis, Lyme disease) or other
             systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel
             disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other
             overlap syndrome)

          -  Current or recent (within 4 weeks prior to screening) infection, including signs,
             symptoms or serology of any infection, including HIV, hepatitis B or C, tuberculosis

          -  Administration of a live, attenuated vaccine within 1 month before dosing or
             anticipation that such a live attenuated vaccine will be required during the study

          -  Previous treatment with anti-TNF biologics or other biologic agents, including
             anti-CD20-directed therapy (e.g. rituximab), anti-IL6-directed therapy (e.g.
             tocilizumab), or T cell-directed therapy (e.g. abatacept)