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A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00993317
First Posted: October 12, 2009
Last Update Posted: September 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.
  Purpose
The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.

Condition Intervention Phase
Rheumatoid Arthritis Drug: Placebo of CDP870 Drug: CDP870 200mg Drug: Methotrexate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 24-week Study to Assess the Efficacy and Safety of Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

Resource links provided by NLM:


Further study details as provided by Korea Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • ACR20 Responses at Week 24 [ Time Frame: Week 24 ]
    Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.


Secondary Outcome Measures:
  • ACR 20 Responses at Week 12 [ Time Frame: Week 12 ]
    Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.

  • ACR50 Responses at Week 12 [ Time Frame: Week 12 ]
    Achieving ACR50 means 50% or greater improvement in the number of tender joints, a 50% or more improvement in the number of swollen joints and a 50% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.

  • ACR70 Responses at Week 12 [ Time Frame: Week12 ]
    Achieving ACR70 means 70% or greater improvement in the number of tender joints, a 70% or more improvement in the number of swollen joints and a 70% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.

  • ACR50 Responses at Week 24 [ Time Frame: Week 24 ]
  • ACR70 Responses at Week24 [ Time Frame: Week 24 ]
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline and Week 24 ]
    Range of HAQ-DI score: 0-3 This outcome measures changes of HAQ-DI score at Week 24 from Baseline. Lower score of HAQ-DI represents a better outcome.


Enrollment: 127
Study Start Date: October 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo of CDP870+MTX Drug: Placebo of CDP870
Given every 2 weeks until Week22 (SC)
Drug: Methotrexate

Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit.

The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly.

Experimental: CDP870 200mg+MTX Drug: CDP870 200mg
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC)
Other Name: CIMZIA
Drug: Methotrexate

Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit.

The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria
  • Active RA disease as defined by at least 9 tender joints and 9 swollen joints, ESR of 30 mm/hour or CRP of 1.5 mg/dL
  • MTX (with or without folic acid) for at least 24 weeks prior to the Baseline visit, The dose of MTX and route of administration must have been stable for at least 8 weeks prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.

Exclusion Criteria:

  • Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
  • Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
  • NYHA (New York Heart Association) Class III or IV congestive heart failure
  • current or history of, tuberculosis
  • history of chronic infection, recent serious or life-threatening infection (within 24 weeks , including herpes zoster), or any current sign or symptom that may indicate an infection (e.g., fever, cough)
  • High risk of infection
  • Have received any experimental non-biological therapy, within or outside a clinical trial in the 12 weeks prior to Baseline
  • Have received previous B-cell therapy (eg. Rituximab)
  • Have received any other biological therapy for RA within 24 weeks prior to Baseline visit, except for etanercept where a three month washout prior to baseline visit is acceptable
  • Have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
  • Failed to respond to previous treatment with an anti-TNF drug
  • Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993317


Locations
Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Catholic University Hospital of Daegu
Daegu, Korea, Republic of
Eulji University Hospital
Daejeon, Korea, Republic of, 302-799
Inha University Hospital
Inchon, Korea, Republic of
Chonnam National University Hospital
Kwangju, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Catholic University of Korea ST.Mary's Hospital
Seoul, Korea, Republic of, 150-713
Gangnam Severance Hospital
Seoul, Korea, Republic of
Hanyang Universoty Hospital
Seoul, Korea, Republic of
KonKuk University Medical Center
Seoul, Korea, Republic of
Seoul national univeristy
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Soo-kon Lee, MD. PhD Severance Hospital
  More Information

Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00993317     History of Changes
Other Study ID Numbers: 101-KOA-0801i
First Submitted: October 9, 2009
First Posted: October 12, 2009
Results First Submitted: May 22, 2012
Results First Posted: September 27, 2012
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.:
CDP870
Korea
CIMZIA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Certolizumab Pegol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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