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

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ClinicalTrials.gov Identifier: NCT00993317
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : September 27, 2012
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 9, 2009
First Posted Date  ICMJE October 12, 2009
Results First Submitted Date  ICMJE May 22, 2012
Results First Posted Date  ICMJE September 27, 2012
Last Update Posted Date September 27, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
ACR20 responder rate [ Time Frame: Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
  • ACR 20 responder rate [ Time Frame: Week 12 ]
  • ACR50/70 responder rate [ Time Frame: Week 12, 24 ]
  • Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Placebo of CDP870
    Given every 2 weeks until Week22 (SC)
  • 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.

Study Arms  ICMJE
  • Placebo Comparator: Placebo of CDP870+MTX
    Interventions:
    • Drug: Placebo of CDP870
    • Drug: Methotrexate
  • Experimental: CDP870 200mg+MTX
    Interventions:
    • Drug: CDP870 200mg
    • Drug: Methotrexate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2011)
127
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2009)
126
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00993317
Other Study ID Numbers  ICMJE 101-KOA-0801i
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Korea Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Korea Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Soo-kon Lee, MD. PhD Severance Hospital
PRS Account Korea Otsuka Pharmaceutical Co., Ltd.
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP