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

This study has been completed.
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
First received: October 15, 2007
Last updated: September 3, 2013
Last verified: September 2009

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.

Condition Intervention Phase
Arthritis, Rheumatoid
Drug: CDP870
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • American college of Rheumatolofy (ACR)-20 responder rate at Week 24

Secondary Outcome Measures:
  • Safety and tolerability
  • health outcomes measures
  • immunogenic profile of CDP870 plus methotrexate
  • systemic exposure of CDP870

Enrollment: 247
Study Start Date: October 2002
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00544154

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00544154     History of Changes
Other Study ID Numbers: C87014
Study First Received: October 15, 2007
Last Updated: September 3, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by UCB Pharma:
Certolizumab pegol

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

ClinicalTrials.gov processed this record on March 26, 2015