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Trial record 1 of 2 for:    NCT00544154
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Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis

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.
 
ClinicalTrials.gov Identifier: NCT00544154
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : September 4, 2013
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: CDP870 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2002
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. American college of Rheumatolofy (ACR)-20 responder rate at Week 24

Secondary Outcome Measures :
  1. Safety and tolerability
  2. health outcomes measures
  3. immunogenic profile of CDP870 plus methotrexate
  4. systemic exposure of CDP870

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544154


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00544154    
Other Study ID Numbers: C87014
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
CDP870
Certolizumab pegol
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Certolizumab Pegol
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents