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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

October 15, 2007
February 22, 2010
June 2003
July 2004   (final data collection date for primary outcome measure)
American College of Rheumatology (ACR)-20 responder rate at Week 24 [ Time Frame: 24 weeks ]
American College of Rheumatology (ACR)-20 responder rate at Week 24
Complete list of historical versions of study NCT00548834 on ClinicalTrials.gov Archive Site
  • 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 ]
  • safety and tolerability every 4 weeks
  • effect of CDP870 on health outcomes measures
  • systemic exposures and immunogenic profile of CDP870
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: CDP870
Not Provided
Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, Goel N, Brezinschek HP, Innes A, Strand V. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009 Jun;68(6):805-11. Epub 2008 Nov 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
July 2004
July 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00548834
C87011
No
Not Provided
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center UCB, Inc.
UCB, Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP