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Efficacy Confirmation Trial of CDP870 as add-on Medication to 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:
NCT00791999
First received: November 14, 2008
Last updated: August 9, 2012
Last verified: August 2012
History of Changes

November 14, 2008
August 9, 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 NCT00791999 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, 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 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX.

The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.
Not Provided
Interventional
Phase 2
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
    400mg 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 Week22 (SC)
  • Drug: CDP870 100mg
    200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)
  • Drug: Placebo of CDP870
    given every 2 weeks until Week22 (SC)
  • Experimental: CDP870 100mg
    200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
    Intervention: Drug: CDP870 100mg
  • Experimental: CDP870 200mg
    400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
    Intervention: Drug: CDP870 200mg
  • Experimental: CDP870 400mg
    400mg CDP870 given every 2 weeks
    Intervention: Drug: CDP870 400mg
  • Placebo Comparator: Placebo
    Placebo given every 2 weeks
    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
316
January 2011
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 9 tender joints and 9 swollen joints
    • ESR of 30 mm/hour or CRP of 1.5 mg/dL
  • Subjects must have received treatment with MTX for at least 6 months prior to the start of study drug administration. The dose of MTX must have remain fixed for at least 2 months prior to the study and the dose of MTX should be within 6 to 8 mg/week.

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
 
NCT00791999
CDP870-275-08-001, JapicCTI-080665
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