Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA) - Full Text View

Sponsors and Collaborators:	UCB no collaborators
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00753454

Purpose

The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Certolizumab pegol	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Certolizumab pegol

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase IIIb, Multi-Center Open-Label, Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With Methotrexate in Patients With Active Rheumatoid Arthritis Who Participated in C87077.

Further study details as provided by UCB:

Primary Outcome Measures:

To continue to assess the safety of certolizumab pegol in combination with MTX as measured by adverse events frequency, severity and nature; PE and vitals; and laboratory values, blood parameters and urine parameters. [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate. [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]
To assess the reduction of disease activity measured by change from Baseline (in C87077) in DAS28, SDAI and CDAI scores. [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
To assess the achievement of clinical remission measured by DAS28 remission rate (<2.6), SDAI remission rate (≤3.3) and CDAI remission rate (≤2.8.). [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]
Reduction in fatigue as measured by the Fatigue Assessment Scale. [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]
Improvement in patient's Health-Related Quality of Life (HRQOL) as measured by the 36-item Short Form Health Survey (SF-36). [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]
The relief in arthritis pain as measured by the Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]
The reduction in disease activity as measured by the Patient's Global Assessment of Disease Activity-VAS. [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	201
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CDP870: Experimental Certolizumab pegol	Drug: Certolizumab pegol Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at entry, week 2 & week 4, followed by 200 mg every 2 weeks).

Eligibility

Criteria

Inclusion Criteria:

Patients with established adult rheumatoid arthritis currently on Methotrexate who participated in, and successfully completed, the C87077 trial or experienced flare after randomization

Exclusion Criteria:

All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment.
Previous clinical trials participation and previous biological therapy that could interfere with the results of the present clinical trial.
No participation in the C87077 trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753454

Locations

United States, Alabama

Huntsville, Alabama, United States
United States, Arizona

Tucson, Arizona, United States
United States, Arkansas

Little Rock, Arkansas, United States
United States, California

Palm Desert, California, United States

Los Angeles, California, United States
United States, Florida

Aventura, Florida, United States

Sarasota, Florida, United States

Gainesville, Florida, United States

Clearwater, Florida, United States
United States, Illinois

Vernon Hills, Illinois, United States
United States, Nebraska

Lincoln, Nebraska, United States
United States, New York

Syracuse, New York, United States

Albany, New York, United States
United States, North Carolina

Wilmington, North Carolina, United States

Charlotte, North Carolina, United States

Monroe, North Carolina, United States
United States, Oklahoma

Norman, Oklahoma, United States
United States, Pennsylvania

Duncansville, Pennsylvania, United States
United States, South Carolina

Simpsonville, South Carolina, United States
United States, Texas

Tyler, Texas, United States

San Antonio, Texas, United States

Sponsors and Collaborators

UCB

no collaborators

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C87084, Dose Flex II, Dose Flex Extension Trial
Study First Received:	June 5, 2008
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00753454 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency

Keywords provided by UCB:

Rheumatoid Arthritis
Joint Disease
Arthritis
Certolizumab pegol
Cimzia

Study placed in the following topic categories:

Immunoglobulin Fab Fragments
Antibodies
Autoimmune Diseases
Immunologic Factors
Musculoskeletal Diseases
Arthritis

Joint Diseases
Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases
Immunoglobulins

Additional relevant MeSH terms:

Immunoglobulin Fab Fragments
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Physiological Effects of Drugs
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009