Text Size

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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00548834
First received: October 15, 2007
Last updated: February 22, 2010
Last verified: February 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00548834     History of Changes
Other Study ID Numbers: C87011
Study First Received: October 15, 2007
Last Updated: February 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by UCB, Inc.:
CDP870
Certolizumab Pegol

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013