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A Study of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
This study has been completed.
Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00160602
  Purpose

A 24 week study in which patients are given study medication 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
Drug: 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, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group 24-Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate.

Further study details as provided by UCB:

Primary Outcome Measures:
  • Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24.

Secondary Outcome Measures:
  • Assess Safety and Tolerability of two dose regimens of certolizumab pegol in combination with MTX and MTX alone in patients with RA; prevention of joint damage in patients with RA; Health Outcomes Measures

Estimated Enrollment: 590
Study Start Date: June 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Patients must be at least 18 years old at the screening visit.
  • Patients must have a diagnosis of adult-onset RA of at least six months duration but not longer than fifteen years as defined by the 1987 American College of Rheumatology classification criteria.
  • Patients must have active RA disease as defined by:

    • 9 tender joints at Screening and Baseline.
    • 9 swollen joints at Screening and Baseline. and fulfilling 1 of the following 2 criteria during the screening period:
    • 30 mm/hour ESR (Westergren), or CRP >15 mg/L.
  • Patients must have received treatment with MTX (with or without folic acid) for at least 6 months prior to the Baseline visit. The dose of MTX and route of administration must have been stable for at least 2 months prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.
  • Patients must be willing to complete an X-ray of the hands and feet 24 weeks after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent.

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)
  • Female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug.
  • Patients with a history of tuberculosis or positive chest X-ray for tuberculosis or positive
  • Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bed ridden or wheelchair bound).
  • 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: NCT00160602

  Show 71 Study Locations
Sponsors and Collaborators
UCB
Investigators
Study Director: Jeffrey White, MD UCB
  More Information

Study ID Numbers: C87050, EudraCT Number: 2005-002326-63
Study First Received: September 8, 2005
Last Updated: March 7, 2008
ClinicalTrials.gov Identifier: NCT00160602  
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
Autoimmune Diseases
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Folic Acid
Signs and Symptoms
Antibodies
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Immunoglobulins

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009