A Study of the Safety of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00160641

Purpose

An open ended study in which patients who completed the double-blind study (CDP870-050) are given Certolizumab pegol and assessed for signs and symptoms of rheumatoid arthritis. X-rays are performed to assess the progress of joint damage during the study.

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: Certolizumab Pegol	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Certolizumab pegol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase III Multi-Center, Open-Label, Follow-up Study, to Assess the Efficacy and Safety of Liquid Certolizumab Pegol (CDP870) as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050.

Further study details as provided by UCB:

Primary Outcome Measures:

To assess the safety of certolizumab pegol, in patients with active rheumatoid arthritis (RA) by measuring ACR 20/50/70 responder rates every 12 weeks [ Time Frame: 3 years ]

Secondary Outcome Measures:

To assess the tolerability and efficacy of certolizumab pegol in patients with active RA. [ Time Frame: 3 years ]
To assess the effect of liquid certolizumab pegol on physical function and Health Outcome measures. [ Time Frame: 3 years ]
To monitor the pharmacokinetic and immunogenicity profile of liquid certolizumab pegol [ Time Frame: 3 years ]

Enrollment:	582
Study Start Date:	December 2005
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Certolizumab Pegol 200 mg subcutaneous every 2 weeks for a duration of 3 years

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have either failed to achieve an ACR20 response at Week 12 (confirmed at Week 14) in the CDP870-050 trial or must have completed the entire CDP870-050 trial through Week 24.
Patients must have a clear chest X-ray at the Entry visit (Week 24 Completion/Week 16 Withdrawal visit of CDP870-050).
Patients must continue treatment on methotrexate with or without folic acid throughout the study, unless given prior approval by UCB for discontinuation.

Exclusion Criteria:

Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
Patients must not have a secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia) that, in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of liquid certolizumab pegol on the patient's primary diagnosis of RA.
Female patients who are breast feeding, pregnant, or plan to become pregnant during the study and for 12 weeks following the last dose of study drug.
Patients at a high risk of infection in the Investigator's opinion (e.g. patients with leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections, and patients who are permanently bed ridden or wheelchair bound).
Patients with a history of tuberculosis or positive chest X-ray for tuberculosis at the Entry visit.
Patients with known human immunodeficiency virus (HIV) infection.
Patients with an active malignancy of any type or a history of malignancy (except basal cell carcinoma of the skin that has been excised prior to study start).
Patients with a current or recent history, as determined by the investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the trial.
Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160641

Show 55 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C87051, EudraCT Number: 2005-002629-30
Study First Received:	September 8, 2005
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00160641
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Bulgaria: Bulgarian Drug Agency; Chile: Instituto de Salud Publica de Chile; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Israel: Israeli Health Ministry Pharmaceutical Administration; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Mexico: National Institute of Public Health, Health Secretariat; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration

Keywords provided by UCB:

Rheumatoid Arthritis
Certolizumab Pegol, Cimzia

Study placed in the following topic categories:

Immunoglobulin Fab Fragments
Signs and Symptoms
Antibodies
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009