Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00791999
Recruitment Status : Completed
First Posted : November 17, 2008
Results First Posted : August 6, 2012
Last Update Posted : August 10, 2012
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 14, 2008
First Posted Date  ICMJE November 17, 2008
Results First Submitted Date  ICMJE June 18, 2012
Results First Posted Date  ICMJE August 6, 2012
Last Update Posted Date August 10, 2012
Study Start Date  ICMJE November 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Baseline, 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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
ACR20 responder rate [ Time Frame: Week12, 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
American College of Rheumatology 20% (ACR20) Response at Week 24 [ Time Frame: Baseline, 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
  • ACR20/50/70 responder rate [ Time Frame: Week1, 2, 4, 6, 8, 12, 14, 16, 20, 24 ]
  • DAS28 (ESR) [ Time Frame: Week1, 2, 4, 6, 8, 12, 14, 16, 20, 24 ]
  • Modified Total Sharp Score [ Time Frame: Week24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Shoji T, Sakamaki Y, van der Heijde D, Miyasaka N, Koike T. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial. Mod Rheumatol. 2014 Sep;24(5):715-24. doi: 10.3109/14397595.2013.864224. Epub 2013 Dec 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2012)
316
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2008)
300
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791999
Other Study ID Numbers  ICMJE CDP870-275-08-001
JapicCTI-080665 ( Other Identifier: JAPIC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE UCB Japan Co. Ltd.
Investigators  ICMJE
Study Chair: Katsuhisa Saito OPCJ
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date August 2012

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