Long-term Treatment Study of CDP870 without coadministration of MTX in Japanese RA patients

A Multicenter, Open-label, Long-term Safety Study of CDP870 to evaluate the Safety and Efficacy of CDP870 administered without coadministration of Methotrexate (MTX) over the Long Term in Patients with Active Rheumatoid Arthritis transferred from the Efficacy Confirmatory Study (Study 275-08-003)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220676

Enrollment

130

Registered

2009-02-18

Start date

2009-02-18

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 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjecs who participated in Study 275-08-003 and meet all of the criteria described below. - Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.

Exclusion criteria

Exclusion criteria: - Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003 - Patients who received live or attenuated vaccines during Study 275-08-003(Except for influenza or pneumococcal vaccines). - Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003. - Patients who required treatment for the same infection at two or more different times during Study 275-08-003 - Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months. - Patients whom the investigator has decided to be inappropriate for participation in the study

Design outcomes

Primary

Measure	Time frame
Adverce events At any time	—

Secondary

Measure	Time frame
ACR20/50/70 responder rate Week24, 52 DAS28(ESR) Week24, 52 Modified Total Sharp Score Week24	—

Outcome results

None listed

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