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

This study has been completed.

First Received: October 15, 2007 Last Updated: March 7, 2008 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00548834

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: CDP870	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by UCB:

Primary Outcome Measures:

American College of Rheumatology (ACR)-20 responder rate at Week 24 [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

safety and tolerability every 4 weeks [ Time Frame: Every 4 weeks ]
effect of CDP870 on health outcomes measures [ Time Frame: 24 weeks ]
systemic exposures and immunogenic profile of CDP870 [ Time Frame: 24 weeks ]

Estimated Enrollment:	220
Study Start Date:	June 2003
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548834

Sponsors and Collaborators

UCB

Investigators

Study Director:

Elliot Chartash

UCB

More Information

No publications provided

Study ID Numbers:	C87011
Study First Received:	October 15, 2007
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00548834 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by UCB:

CDP870
Certolizumab Pegol

Study placed in the following topic categories:

Signs and Symptoms
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009