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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00544154
First Posted: October 16, 2007
Last Update Posted: September 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UCB Pharma
October 15, 2007
October 16, 2007
September 4, 2013
October 2002
January 2004   (Final data collection date for primary outcome measure)
American college of Rheumatolofy (ACR)-20 responder rate at Week 24
Same as current
Complete list of historical versions of study NCT00544154 on ClinicalTrials.gov Archive Site
  • Safety and tolerability
  • health outcomes measures
  • immunogenic profile of CDP870 plus methotrexate
  • systemic exposure of CDP870
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Arthritis, Rheumatoid
Drug: CDP870
Not Provided
Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, Davies O, Stahl HD, Alten R. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford). 2012 Jul;51(7):1226-34. doi: 10.1093/rheumatology/ker519. Epub 2012 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
247
January 2004
January 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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00544154
C87014
No
Not Provided
Not Provided
Not Provided
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center UCB Pharma
UCB Pharma
September 2009

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