Clinical trial NCT00658047 (phase 2, status: completed)
Conditions: arthritis, rheumatoid
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: ch-1504, methotrexate (mtx)
SMILES: OC(=O)C(CC(=C)C(O)=O)NC(=O)C1=CC=C(CCC2=CC3=C(NC(=N)NC3=N)C=C2)C=C1, 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
Eligibility criteria:

        Inclusion; To be eligible for inclusion, each patient must fulfill the following criteria:

          -  Patients must be between the ages of 18 and 80;

          -  Have been diagnosed with active rheumatoid arthritis according to ACR criteria;

          -  Have at least 6 swollen joints (max = 66) and 6 tender joints (max = 68) at screening
             and baseline visits;

          -  Patients must have at least one of the following:

          -  C-reactive protein > 1.0 mg/dl at screening;

          -  erythrocyte sedimentation rate > 20 mm/Hr;

          -  Morning stiffness > 45 min. at screening;

          -  Patients must have blood test values per the following criteria:

          -  ALT, AST < 1.2 U/l x ULN

          -  Albumin > 2.5 g/dl

          -  Prothrombin Time < 1.2 INR

          -  Hb > 9.0 g/dl

          -  Hct > 35%

          -  WBC > 3000 μl (mm3)

          -  Neutrophils > 1000 μl (mm3)

          -  Platelets > 100000 μl

          -  Creatinine < 1.2 mg/dl

          -  Patients must have voluntarily signed the informed consent

        Exclusion; Patients are not eligible for this study if they fulfill one or more of the
        following criteria:

          -  Patients who received previous methotrexate therapy;

          -  Patients who received previous therapy with any biologic agent;

          -  Previous biologic therapy for a disease other than RA is permitted so long as their
             last dose was more than 120 days prior to baseline;

          -  Patients currently taking sulfasalazine;

          -  Previous sulfasalazine therapy is permitted so long as their last dose was more than
             30 days prior to baseline;

          -  Patients currently taking hydroxychloroquine;

          -  Previous hydroxychloroquine is permitted so long as their last dose was more than 120
             days prior to baseline;

          -  Female patients of child bearing potential who are pregnant or who are not using two
             methods of contraception (at least one barrier: i.e. condom) with their partner;

          -  Male patients who are sexually active and not using two methods of contraception (at
             least one barrier: i.e. condom) with their partner;

          -  Patients with any current active infection or infections requiring IV drug therapy
             within 30 days of baseline or oral therapy within 15 days of Baseline;

          -  Patients that have had any surgical procedures within 30 days of baseline;

          -  Patients with a history of HIV, Hepatitis B or C;

          -  Patients who consume more than 7 units of alcohol per week (1 unit = 5 ounces/150 ml
             of wine = 1.5 ounces/45 ml spirits = 12 ounces/360 ml of beer);

          -  Patients currently receiving any investigational drug or have received an
             investigational drug within 30 days of baseline or 5 half-lives of the investigational
             drug (whichever is longer);

          -  Patients with a history of cancer within the past 5 years other than a successfully
             treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical
             cancer in situ;

          -  Patients with a history of, or any, disease associated with an inflammatory arthritis
             other than RA;

          -  Patients with a chest X-ray that indicates the presence of pulmonary fibrosis (Chest
             x-ray may be taken with in 28 days of screening);

          -  Patients receiving Probenecid;

          -  Patients who have received any steroid injections within 30 days of baseline;

          -  Patients with concomitant diseases that are unstable (i.e. cardiac, pulmonary) or that
             may affect drug activity (i.e. absorption, reactions, change in kinetics);

          -  Patients considered by the investigator to be an unsuitable candidate to receive
             CH-1504;

          -  Wheelchair or bed-bound patients.