Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00548834

Enrollment

220

Registered

2007-10-24

Start date

2003-06-30

Completion date

2004-07-31

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

Rheumatoid Arthritis

Keywords

CDP870, Certolizumab Pegol

Brief summary

The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.

Interventions

DRUGCDP870

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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 Rheumatology (ACR)-20 responder rate at Week 24	24 weeks

Secondary

Measure	Time frame
safety and tolerability every 4 weeks	Every 4 weeks
effect of CDP870 on health outcomes measures	24 weeks
systemic exposures and immunogenic profile of CDP870	24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026