Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis

Efficacy and Safety of CDP870 400 mg in Combination With Methotrexate Compared to Methotrexate Alone in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Are Partial Responders to Methotrexate

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00544154

Enrollment

247

Registered

2007-10-16

Start date

2002-10-31

Completion date

2004-01-31

Last updated

2013-09-04

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

Conditions

Arthritis, Rheumatoid

Keywords

CDP870, Certolizumab pegol

Brief summary

The main purpose of the study was to determine the efficacy of CDP870 in treating RA signs/symptoms in patients who were partial responders to MTX. Other purposes were to show additional efficacy without increased toxicity and the immunogenic response to CDP870 during combined CDP870 and MTX therapy.

Interventions

DRUGCDP870

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* male/female, 18-75 years old, inclusive * diagnosis of adult-onset RA * had active disease * had received methotrexate * on a stable dose of folic acid

Exclusion criteria

* contraindication for methotrexate or anti-TNF

Design outcomes

Primary

Measure	Time frame
American college of Rheumatolofy (ACR)-20 responder rate at Week 24	—

Secondary

Measure	Time frame
Safety and tolerability	—
health outcomes measures	—
immunogenic profile of CDP870 plus methotrexate	—
systemic exposure of CDP870	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026