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Efficacy Confirmation Trial of CDP870 Without Coadministration of MTX in Japanese RA
This study is currently recruiting participants.
Verified by Otsuka Pharmaceutical Co., Ltd., July 2009
First Received: November 14, 2008   Last Updated: July 23, 2009   History of Changes
Sponsors and Collaborators: Otsuka Pharmaceutical Co., Ltd.
UCB Japan CO., LTD.
Information provided by: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00791921
  Purpose

The objectives of this study are to verify the superiority in efficacy (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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Placebo of CDP870
Drug: CDP870
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of Mthotrexate (MTX) in Japanese Active Rheumatoid Arthritis (RA) Patients in Whom MTX Cannot be Administrated.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • ACR20 responder rate [ Time Frame: Week12, 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ACR20/50/70 responder rate [ Time Frame: Week1, 2, 4, 6, 8, 12,14, 16, 20, 24 ] [ Designated as safety issue: Yes ]
  • DAS28 (ESR) [ Time Frame: Week1, 2, 4, 6, 8, 12, 14, 16, 18, 20, 24 ] [ Designated as safety issue: Yes ]
  • Modified Total Sharp Score [ Time Frame: Week24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo: Placebo Comparator
Placebo of CDP870
Drug: Placebo of CDP870
Placebo given every 2 weeks until Week22 (SC)
CDP870 200mg: Experimental
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
Drug: CDP870
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 (SC)

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791921

Contacts
Contact: Drug Information Center opc_ctr@otsuka.jp

Locations
Japan
Recruiting
Kanto Region, Japan
Recruiting
Hokkaido Region, Japan
Recruiting
Chube Region, Japan
Recruiting
Kyushuh Region, Japan
Recruiting
Chugoku Region, Japan
Recruiting
Shikoku Region, Japan
Recruiting
Kinki Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
UCB Japan CO., LTD.
Investigators
Study Chair: Katsuhisa Saito OPCJ
  More Information

No publications provided

Responsible Party: Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd. ( Katsuhisa Saito, Senior Operating Officer )
Study ID Numbers: CDP870-275-08-003
Study First Received: November 14, 2008
Last Updated: July 23, 2009
ClinicalTrials.gov Identifier: NCT00791921     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Rheumatoid Arthritis
Certolizumab Pegol
Cimzia

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 10, 2009