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

This study has been completed.
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00791921
First received: November 14, 2008
Last updated: August 5, 2012
Last verified: August 2012

November 14, 2008
August 5, 2012
November 2008
January 2010   (final data collection date for primary outcome measure)
American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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)
ACR20 responder rate [ Time Frame: Week12, 24 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00791921 on ClinicalTrials.gov Archive Site
American College of Rheumatology 20% (ACR20) Response at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
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)
  • 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 ]
Not Provided
Not Provided
 
Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: CDP870
    400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC)
  • Drug: Placebo of CDP870
    Placebo given every 2 weeks until Week22 (SC)
  • Experimental: CDP870 200mg
    400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
    Intervention: Drug: CDP870
  • Placebo Comparator: Placebo
    Placebo of CDP870
    Intervention: Drug: Placebo of CDP870
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00791921
CDP870-275-08-003
No
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
UCB Japan Co. Ltd.
Study Chair: Katsuhisa Saito OPCJ
Otsuka Pharmaceutical Co., Ltd.
August 2012

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