Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.

The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.

Inclusion Criteria:

• Subjects must have a diagnosis of adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria.

• Subjects must have active RA disease as defined by:

  • At least 6 tender joints and 6 swollen joints
  • ESR of 28 mm/hour or CRP of 2.0 mg/dL

• Subjects who have failed to respond or have been resistant to at least one DMARD (including MTX)

• Subjects in whom MTX cannot be administered for any of the reasons(incomplete response/safety concerns)

Exclusion Criteria:

• Patients who have a diagnosis of any other inflammatory arthritis
• Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
• Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
• Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
• Patients who currently have, or who have a history of, tuberculosis
• Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
• Patients who currently have, or who have a history of, malignancy
• Female patients who are breastfeeding or pregnant, who are of childbearing potential
• Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.