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Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
CDP870
Placebo of CDP870
Sponsored by
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 Rheumatoid Arthritis, Certolizumab Pegol, Cimzia

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have a diagnosis of 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.

  • Subjects must have active RA disease as defined by:

    • At least 6 tender joints and 6 swollen joints
    • ESR of 28 mm/hour or CRP of 2.0 mg/dL
  • Subjects who have failed to respond or have been resistant to at least one DMARD (including MTX)
  • Subjects in whom MTX cannot be administered for any of the reasons(incomplete response/safety concerns)

Exclusion Criteria:

  • Patients who have a diagnosis of any other inflammatory arthritis
  • Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
  • Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
  • Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
  • Patients who currently have, or who have a history of, tuberculosis
  • Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
  • Patients who currently have, or who have a history of, malignancy
  • Female patients who are breastfeeding or pregnant, who are of childbearing potential
  • Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CDP870 200mg

Placebo

Arm Description

400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks

Placebo of CDP870

Outcomes

Primary Outcome Measures

American College of Rheumatology 20% (ACR20) Response at Week 12
ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)

Secondary Outcome Measures

American College of Rheumatology 20% (ACR20) Response at Week 24
ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)

Full Information

First Posted
November 14, 2008
Last Updated
August 5, 2012
Sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborators
UCB Japan Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00791921
Brief Title
Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborators
UCB Japan Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Certolizumab Pegol, Cimzia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDP870 200mg
Arm Type
Experimental
Arm Description
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo of CDP870
Intervention Type
Drug
Intervention Name(s)
CDP870
Intervention Description
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC)
Intervention Type
Drug
Intervention Name(s)
Placebo of CDP870
Intervention Description
Placebo given every 2 weeks until Week22 (SC)
Primary Outcome Measure Information:
Title
American College of Rheumatology 20% (ACR20) Response at Week 12
Description
ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
American College of Rheumatology 20% (ACR20) Response at Week 24
Description
ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have a diagnosis of 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. Subjects must have active RA disease as defined by: At least 6 tender joints and 6 swollen joints ESR of 28 mm/hour or CRP of 2.0 mg/dL Subjects who have failed to respond or have been resistant to at least one DMARD (including MTX) Subjects in whom MTX cannot be administered for any of the reasons(incomplete response/safety concerns) Exclusion Criteria: Patients who have a diagnosis of any other inflammatory arthritis Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia) Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy) Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure Patients who currently have, or who have a history of, tuberculosis Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease) Patients who currently have, or who have a history of, malignancy Female patients who are breastfeeding or pregnant, who are of childbearing potential Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
OPCJ
Official's Role
Study Chair
Facility Information:
City
Chube Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Hokkaido Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kinki Region
Country
Japan
City
Kyushuh Region
Country
Japan
City
Shikoku Region
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24981319
Citation
Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Iwai K, Sakamaki Y, van der Heijde D, Miyasaka N, Koike T. Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis: the HIKARI randomized, placebo-controlled trial. Mod Rheumatol. 2014 Jul;24(4):552-60. doi: 10.3109/14397595.2013.843764. Epub 2013 Nov 1.
Results Reference
derived

Learn more about this trial

Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

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