Efficacy Confirmation Trial of CDP870 as Add-on Medication to MTX in Japanese RA

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as Add-on Medication to Methotrexate (MTX) in Japanese Active Rheumatoid Arthritis (RA) Patients Who Have an Incomplete Response to MTX.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220641

Enrollment

300

Registered

2008-12-05

Start date

2008-12-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

investigational material(s) Generic name etc : CDP870 400mg INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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-TNF-alpha drugs or who previously failed to respond to treatment with 1 or more aint-TNF-alpha drugs.

Design outcomes

Primary

Measure	Time frame
ACR20 responder rate Week12, 24	—

Secondary

Measure	Time frame
ACR20/50/70 responder rate Week1, 2, 4, 6, 8, 12, 14, 16, 20, 24 DAS28 (ESR) Week1, 2, 4, 6, 8, 12, 14, 16, 20, 24 Modified Total Sharp Score Week24	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026