A Study of the Safety and Effectiveness of Lyophilized 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:	NCT00175877

Purpose

An open ended study in which patients who completed the double-blind study (CDP870-027) are given certolizumab pegol and assessed for signs and symptoms of rheumatoid arthritis.

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: Certolizumab pegol (CDP870)	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
Official Title:	A Phase III Multi-Centre, Open-Label, Follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis

Further study details as provided by UCB:

Primary Outcome Measures:

To assess the safety of CDP870 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 continue to assess the tolerability and efficacy of CDP870 in combination with Methotrexate (MTX) in patients with active RA. [ Time Frame: 3 years ]
To continue to assess the effect of CDP870 on Physical Function and Health Outcome Measures in combination with MTX in patients with active RA. [ Time Frame: 3 years ]
To continue to monitor the plasma concentration and immunogenicity profile of CDP870 in combination with MTX in patients with active RA. [ Time Frame: 3 years ]

Enrollment:	857
Study Start Date:	June 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 Open Label	Biological: Certolizumab pegol (CDP870) 400mg of CDP870 sc every two weeks for at least six months and then 200 mg of CDP870 sc every two weeks.

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 Weeks 12 and 14 in CDP870-027, or must have completed the entire Week 52 assessment of CDP870 027 trial.

Exclusion Criteria:

RA Disease Related:

A diagnosis of any other inflammatory arthritis e.g. psoriatic arthritis or ankylosing spondylitis.
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 CDP870 on the patient's primary diagnosis of RA.
A history of an infected joint prosthesis at any time with prosthesis still in situ.
Concomitant medication exclusion
- Any biological therapy.
- Any experimental therapy, within or outside a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175877

Show 94 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:	C87028
Study First Received:	September 9, 2005
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00175877
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; 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; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Hungary: National Institute of Pharmacy; 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; Netherlands: Medicines Evaluation Board (MEB); New Zealand: Food Safety Authority; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration

Keywords provided by UCB:

Rheumatoid Arthritis, CDP870, 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