Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

Otsuka

Status and phase: Completed; Phase 3; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: CDP870 400mg; Drug: Placebo of CDP870; Drug: CDP870 100mg; Drug: CDP870 200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00791999

JapicCTI-080665 (Other Identifier)

CDP870-275-08-001

Details and patient eligibility

About

The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.

Enrollment: 316 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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 9 tender joints and 9 swollen joints
  • ESR of 30 mm/hour or CRP of 1.5 mg/dL

• Subjects must have received treatment with MTX for at least 6 months prior to the start of study drug administration. The dose of MTX must have remain fixed for at least 2 months prior to the study and the dose of MTX should be within 6 to 8 mg/week.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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316 participants in 4 patient groups, including a placebo group

CDP870 100mg

Experimental group

Description:

200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks

Treatment:

Drug: CDP870 100mg

CDP870 200mg

Experimental group

Description:

400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks

Treatment:

Drug: CDP870 200mg

CDP870 400mg

Experimental group

Description:

400mg CDP870 given every 2 weeks

Treatment:

Drug: CDP870 400mg

Placebo

Placebo Comparator group

Description:

Placebo given every 2 weeks

Treatment:

Drug: Placebo of CDP870