Clinical trial NCT01116141 (phase 2, status: completed)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: ch-4051, methotrexate (mtx), folic acid
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, NC1=NC(=O)C2=NC(CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)=CN=C2N1
Eligibility criteria:

        Inclusion Criteria:

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

          -  Have diagnosed active rheumatoid arthritis according to ACR criteria functional class
             I-III;

          -  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 > 28 mm/Hr;

          -  Patients must have been taking methotrexate between 15 and 25 mg/week for at least 3
             months and at a stable dose for at least 6 weeks;

          -  Patients must be either Rheumatoid Factor (RF) or anti-cyclic citrullinated peptide
             (anti-CCP) positive;

          -  Patients must have voluntarily signed the informed consent.

        Exclusion Criteria:

          -  Patients who received previous therapy with any biologic agent;

          -  Patients currently taking any disease modifying anti-rheumatic drug (DMARD) other than
             MTX;

          -  Previous non-biologic DMARD therapy is permitted as long as their last dose was at
             least 30 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;

          -  Patients with Hepatitis B surface antigen positive and/or Hepatitis C antibody
             positive;

          -  Patients who consume more than 4 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 pulmonary fibrosis (Chest x-ray must be taken within 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, in the investigator's opinion, that have any significant renal or hepatic
             impairment;

          -  Patients with a serum creatinine level > 1.5 mg/dl at screening;

          -  Patients with an ALT >1.5 ULN at screening;

          -  Patients considered by the investigator to be an unsuitable candidate to receive
             CH-4051;

          -  Wheelchair or bed-bound patients.