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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo of CDP870
CDP870 200mg
Methotrexate
Sponsored by
Korea Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring CDP870, Korea, CIMZIA

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyungpook National University Hospital
  • Catholic University Hospital of Daegu
  • Eulji University Hospital
  • Inha University Hospital
  • Chonnam National University Hospital
  • Pusan National University Hospital
  • Yonsei University Severance Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Catholic University of Korea ST.Mary's Hospital
  • Gangnam Severance Hospital
  • Hanyang Universoty Hospital
  • KonKuk University Medical Center
  • Seoul national univeristy
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo of CDP870+MTX

CDP870 200mg+MTX

Arm Description

Outcomes

Primary Outcome Measures

ACR20 Responses at 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
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
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
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
ACR70 Responses at Week24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
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.

Full Information

First Posted
October 9, 2009
Last Updated
September 25, 2012
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00993317
Brief Title
A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
CDP870, Korea, CIMZIA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo of CDP870+MTX
Arm Type
Placebo Comparator
Arm Title
CDP870 200mg+MTX
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo of CDP870
Intervention Description
Given every 2 weeks until Week22 (SC)
Intervention Type
Drug
Intervention Name(s)
CDP870 200mg
Other Intervention Name(s)
CIMZIA
Intervention Description
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC)
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
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.
Primary Outcome Measure Information:
Title
ACR20 Responses at Week 24
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
ACR 20 Responses at Week 12
Description
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.
Time Frame
Week 12
Title
ACR50 Responses at Week 12
Description
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.
Time Frame
Week 12
Title
ACR70 Responses at Week 12
Description
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.
Time Frame
Week12
Title
ACR50 Responses at Week 24
Time Frame
Week 24
Title
ACR70 Responses at Week24
Time Frame
Week 24
Title
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description
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.
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo-kon Lee, MD. PhD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Catholic University Hospital of Daegu
City
Daegu
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Daejeon
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Inchon
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Kwangju
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Catholic University of Korea ST.Mary's Hospital
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang Universoty Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KonKuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul national univeristy
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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