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Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of 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: NCT00548834
Recruitment Status : Completed
First Posted : October 24, 2007
Last Update Posted : September 4, 2013
Sponsor:
Information provided by:

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2003
Primary Completion Date : July 2004
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. American College of Rheumatology (ACR)-20 responder rate at Week 24 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. safety and tolerability every 4 weeks [ Time Frame: Every 4 weeks ]
  2. effect of CDP870 on health outcomes measures [ Time Frame: 24 weeks ]
  3. systemic exposures and immunogenic profile of CDP870 [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

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): NCT00548834


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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00548834     History of Changes
Other Study ID Numbers: C87011
First Posted: October 24, 2007    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: February 2010

Keywords provided by UCB Pharma:
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
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents