Clinical trial NCT00396812 (phase 1/phase 2, status: terminated)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: rituximab
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    the perceived risk-benefit ratio for individuals with early active ra
  
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA, as defined by fulfilling at least four of seven American College of
             Rheumatology (ACR) criteria

          -  Positive for rheumatoid factor (RF) and/or anticyclic citrullinated peptide (CCP)

          -  The presence of arthritis symptoms for more than 6 weeks but less than 1 year

          -  Active RA, as defined by at least four swollen joints, at least four tender joints,
             and either an erythrocyte sedimentation rate (ESR) of greater than 30 mm/hr OR
             C-reactive protein level greater than 1.0 mg/dL (normal less than 0.4)

          -  Willing to adhere to the study requirements

          -  Willing to use acceptable effective forms of contraception

        Exclusion Criteria:

          -  Allergy to methotrexate (MTX)

          -  Previous exposure to anti-CD20 monoclonal antibody (mAb) or other type(s) of mAb
             therapy

          -  Previous disease-modifying anti-rheumatic drugs (DMARD) therapy

          -  Previous use of a biologic agent

          -  Currently taking daily oral steroid doses of greater than 7.5 milligrams (mg)

          -  Receipt of intra-articular injections within 4 weeks prior to study entry

          -  Current peptic ulcer disease (PUD)

          -  Unwilling to stop drinking alcohol (ETOH)

          -  History of alcohol or substance abuse

          -  Active infection, or chronic or persistent infection that might worsen with
             immunosuppressive treatment (e.g., Human Immunodeficiency Virus [HIV], hepatitis B
             virus [HBV], hepatitis C virus [HCV], tuberculosis [TB])

          -  Interstitial lung disease observed by chest x-ray [chest radiograph]

          -  Known coronary artery disease or significant cardiac arrhythmias or severe congestive
             heart failure (New York Heart Association [NYHA] classes III or IV)

          -  Definitive diagnosis of another autoimmune rheumatologic disease (e.g., systemic lupus
             erythematosus [SLE], scleroderma, primary Sjögren's syndrome, primary vasculitis)

          -  History of immunoglobulin E (IgE)-mediated or non-IgE-mediated hypersensitivity or
             known anaphylaxis to mouse proteins

          -  History of cancer. Exception: participants with previous resected basal or squamous
             cell carcinoma, treated cervical dysplasia, or treated in situ Grade I cervical cancer
             within 5 years prior to study entry are not excluded from study eligibility

          -  History of positive purified protein derivative (PPD) test (i.e., positive
             tuberculosis [TB] test) without treatment for TB infection or chemoprophylaxis for TB
             exposure

          -  History of inflamed pancreas

          -  Live vaccine within 3 months of study entry

          -  Certain abnormal laboratory values

          -  Require certain medications

          -  Any psychiatric disorder that would prevent a participant from providing informed
             consent

          -  Any condition or treatment (including biologic therapies) that, in the opinion of the
             investigator, may place the participant at unacceptable risk during the study

          -  Pregnancy