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.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00160602
First received: September 8, 2005
Last updated: September 6, 2013
Last verified: February 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160602

  Show 71 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00160602     History of Changes
Other Study ID Numbers: C87050, EudraCT Number: 2005-002326-63
Study First Received: September 8, 2005
Last Updated: September 6, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Bulgarian Drug Agency
Chile: Instituto de Salud Pública 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, Inc.:
Rheumatoid Arthritis
Certolizumab Pegol, Cimzia

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Certolizumab pegol
Immunoglobulin Fab Fragments
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014