Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)
Condition: Early Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: adalimumab; methotrexate
Intervention description: Pre-filled syringe every other week; weekly oral capsule dosing
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 395.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arthritis; Erosion; Humira; Adalimumab; Injection; Rheumatoid; Methotrexate

Summary:

      The purpose of this study is to determine the effects of different doses of methotrexate
      (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects at least 18 years of age

          -  Subject has a diagnosis of Rheumatoid Arthritis (RA) as defined by either the
             1987-revised American College of Rheumatology (ACR) classification criteria or the new
             ACR/ European League Against Rheumatism (EULAR) diagnostic criteria for RA 2010 and
             has a disease duration of less than 1 year from diagnosis by a licensed health care
             provider

          -  Subject must meet the following criteria:

               1. Disease Activity Score of C-reactive Protein (DAS28[CRP]) ≥ 3.2 (at the Baseline
                  visit only)

               2. At least 6 swollen joints out of 66 assessed (at the Screening and Baseline
                  visits)

               3. At least 8 tender joints out of 68 assessed (at the Screening and Baseline
                  visits)

               4. C-reactive protein (CRP) ≥ 1.5 mg/dL (at the Screening visit only), or
                  erythrocyte sedimentation rate (ESR) ≥ 28 mm/1h (at the Screening and Baseline
                  visits)

               5. Fulfill at least one of the following three criteria: Rheumatoid Factor (RF)
                  positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide
                  (anti-CCP) antibody positive

          -  Subject is judged to be in good health as determined by the Principal Investigator
             based upon the results of medical history, laboratory profile, physical examination,
             chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during Screening

        Exclusion Criteria:

          -  Subject has previous exposure to any systemic biologic therapy including adalimumab

          -  Subject has been previously treated with greater than 1 disease modifying
             antirheumatic drugs (DMARDs) or with methotrexate (MTX)

          -  Subject has undergone joint surgery within the preceding two months (at joints to be
             assessed within the study)

          -  Subject has chronic arthritis diagnosed before age 17 years

          -  History of invasive infection (e.g., listeriosis and histoplasmosis), chronic or
             active Hepatitis C infection, human immunodeficiency virus (HIV) infection,
             immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB)

          -  Hepatitis B virus: hepatitis B surface antigen (HBs Ag) positive (+) or detected
             sensitivity on the hepatitis B virus DNA (HBV DNA) polymerase chain reaction (PCR)
             qualitative test

          -  Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days
             prior to the Baseline Visit or oral anti-infectives within 14 days prior to the
             Baseline visit

          -  Female subject who is pregnant or breast-feeding or considering becoming pregnant