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Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01451203
First received: September 25, 2011
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  Purpose

The Objective of this study is to assess the efficacy of CDP870 with MTX compared with MTX-alone in early MTX-naive RA patients with poor prognosis, using inhibition of radiographic progression in joints over a one-year period as a primary endpoint. Following a year of treatment with CDP870 plus MTX treatment, CDP870 will be discontinued, and the subjects will be monitored for one more year (the follow up period) to investigate the sustainability of efficacy of CDP870 during the MTX monotherapy for exploratory purpose.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: placebo of CDP870
Drug: CDP870
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Early MTX-naive Rheumatoid Arthritis Patients With Poor Prognosis

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Inhibition of radiographic progression [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Inhibition of radiographic progression [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]
  • Clinical remission rate [ Time Frame: week 24 , week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo given every q2 weeks
 Drug: placebo of CDP870
given every q2 weeks
Experimental: 2
400mg CDP870 given at Week0, 2. 4, and thereafter 200mg CDP870 given every q2 weeks
 Drug: CDP870
400mg CDP870 given at Week0, 2. 4, and thereafter 200mg CDP870 given every q2 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of the following criteria.

    1. Subjects must be at least 20 and under 65 years of age.
    2. Subjects who developed RA within one year.
    3. Subjects who have never received MTX before (MTX naive)
    4. Subjects whose disease activity is moderate or more (DAS28(ESR) > 3.2）
    5. Subjects must satisfy at least two of the three criteria (Anti-CCP antibody positive, Rheumatoid factor positive, Presence of X-ray erosion） for poor prognosis. The anti-CCP antibody positive is essential for every patient.

Exclusion Criteria:

  • Patients who have a diagnosis of any other type of inflammatory arthritis.
  • Patients who have a secondary, non-inflammatory type of arthritis.
  • Patients who have used with MTX, reflunomide, or any other biologics prior to the start of study drug administration.
  • 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 have a history of, malignant tumor
  • Female patients who are breastfeeding or pregnant, who are of childbearing potential
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451203

Locations
Japan
Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Shikoku Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
UCB Japan Co. Ltd.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01451203     History of Changes
Other Study ID Numbers: CDP870-275-11-001, JapicCTI-111636
Study First Received: September 25, 2011
Last Updated: November 19, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Early RA
Certolizumab Pegol
Cimzia

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

ClinicalTrials.gov processed this record on June 17, 2013