A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab, current formulation; Adalimumab, new formulation
Intervention description: Current formulation adalimumab 40 mg every other week; New formulation adalimumab 40 mg every other week
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pharmacodynamic,Pharmacokinetic

Summary:

      A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for
      pharmacodynamics, pharmacokinetics, and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject, 18 years or older who has a diagnosis of Rheumatoid Arthritis
             (RA) as defined by the 1987-revised American College of Rheumatology
             (ACR)-classification criteria or the new American College of Rheumatology
             (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for RA
             2010-classification criteria and has a disease duration for a minimum of 3 months.

          -  Subjects must be naïve to biologic therapy.

          -  Subject must meet the following criteria for the joint assessment: • At least 6
             swollen joints out of 66 assessed. • At least 6 tender joints out of 68 assessed.

          -  Prior Disease Modifying Antirheumatic Drug (DMARD) therapy: a) Subjects not on
             methotrexate at baseline must remain without methotrexate throughout the study.
             Subjects on prior Methotrexate (MTX) must have discontinued at least 28 days prior to
             Week 0 (Day 1). b) Subjects on Disease Modifying Antirheumatic Drug (DMARD) therapy
             other than Methotrexate (MTX) (except prednisone/prednisolone less than or equal to 10
             mg) must discontinue it for at least 28 days before the first dose of investigational
             product at Week 0 (Day 1).

          -  Female subjects are either not of childbearing potential, defined as postmenopausal
             for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
             oophorectomy and/or hysterectomy), or are practicing at least 1 of the following
             methods of birth control throughout the study and for at least 150 days after the last
             dose of study drug: • Condoms, sponge, foams, jellies, diaphragm or intrauterine
             device (IUD). • Hormonal contraceptives for 90 days prior to study drug
             administration. • Vasectomized partner(s).

          -  Subjects must be able and willing to self-administer subcutaneous (SC) injections or
             have a qualified person available to administer subcutaneous (SC) injections.

          -  Subject is judged to be in good general health as determined by the Principal
             Investigator based upon the results of medical history, physical examination,
             laboratory profile, chest x-ray (CXR), and 12 lead electrocardiogram (ECG) performed
             during Screening.

          -  Subject has a negative Tuberculosis (TB) screening assessment (including a (Purified
             Protein Derivative (PPD) test or QuantiFERON-Tuberculosis (TB) Gold test or
             equivalent) and negative chest x-ray (Posterior-Anterior (PA) and lateral view) at
             Screening. If a subject has evidence of a latent Tuberculosis (TB) infection, the
             subject must initiate and complete a minimum of 2 weeks of anti-Tuberculosis (TB)
             therapy or have documented completion of a course of anti-Tuberculosis (TB) therapy
             prior to Baseline.

          -  Subjects must be willing to provide written consent and to comply with the
             requirements of this study protocol.

        Exclusion Criteria:

          -  Subject has been treated with intra-articular or parenteral administration of
             corticosteroids in the preceding 4 weeks from Baseline visit. Inhaled corticosteroids
             for stable medical conditions are allowed. Oral of less than or equal to 10 mg/d
             prednisone equivalent are allowed.

          -  Subject has been treated with any investigational drug of a chemical or biological
             nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug
             prior to Baseline Visit.

          -  Subject has a history of acute inflammatory joint disease of different origin other
             than Rheumatoid Arthritis (RA) (e.g., seronegative spondyloarthropathy, psoriatic
             arthritis, Reiter's syndrome, systemic lupus erythematosus, gouty arthritis, or any
             arthritis with onset prior to age 17 years).

          -  Known hypersensitivity to adalimumab or its excipients.

          -  Subject currently uses or plans to use anti-retroviral therapy at any time during the
             study.

          -  History of demyelinating disease (including myelitis) or neurologic symptoms
             suggestive of demyelinating disease.

          -  History of invasive infection (e.g., listeriosis and histoplasmosis), human
             immunodeficiency syndrome (HIV).

          -  Chronic recurring infections or active Tuberculosis (TB).

          -  History of moderate to severe congestive heart failure (New York Heart Association
             (NYHA) class III or IV), recent cerebrovascular accident and any other condition
             which, in the opinion of the investigator, would put the subject at risk by
             participation in the protocol.

          -  Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other
             than a successfully treated non-metastatic cutaneous squamous cell or basal cell
             carcinoma or localized carcinoma in situ of the cervix.

          -  Subject received any live vaccine within 3 months prior to study drug administration.
             - Subject has a history of clinically significant hematologic (e.g., severe anemia,
             leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis,
             hepatitis).

          -  Positive pregnancy test at Screening or Baseline.

          -  Subject is considered by the investigator, for any reason, to be unsuitable candidate
             for the study