Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01197066
First received: March 17, 2010
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Certolizumab Pegol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ⅲ Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To assess the safety of CZP for a long term period as additional medication to MTX, in patients with active RA, as measured by adverse events frequency, severity and nature; PE and vitals; and laboratory values, blood parameters and urine parameters. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Treatment will continue until the drug is commercially available in the country.


Secondary Outcome Measures:
  • To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Treatment will continue until the drug is commercially available in the country.

  • Improvement in patient's Health-Related Quality of Life (HRQOL) as measured by the 36-item Short Form Health Survey (SF-36) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Treatment will continue until the drug is commercially available in the country.

  • To assess the achievement of clinical remission measured by DAS28. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Treatment will continue until the drug is commercially available in the country.

  • The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Treatment will continue until the drug is commercially available in the country.


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Certolizumab Pegol
Single Arm
Drug: Certolizumab Pegol
Certolizumab Pegol 200mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24
  • Have a clear chest X-ray at the Entry visit
  • Negative urine pregnancy test at the Entry
  • Continue treatment on methotrexate

Exclusion Criteria:

  • Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
  • Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
  • At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i
  • NYHA (New York Heart Association) Class III or IV congestive heart failure
  • Current or history of tuberculosis
  • History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
  • History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease
  • High risk of infection
  • Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197066

Locations
Korea, Republic of
Catholic University Hospital of Daegu
Daegu, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Eulji University Hospital
Daejeon, Korea, Republic of, 302-799
Inha University Hospital
Inchon, Korea, Republic of
Chonnam National University Hospital
Kwangju, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Catholic University of Korea ST.Mary's Hospital
Seoul, Korea, Republic of, 150-713
Seoul national univeristy
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Hanyang Universoty Hospital
Seoul, Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
Gangnam Severance Hospital
Seoul, Korea, Republic of
KonKuk University Medical Center
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
Principal Investigator: SooKon Lee, MD, PhD Yonsei University Hospital
  More Information

No publications provided

Responsible Party: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01197066     History of Changes
Other Study ID Numbers: 101-KOA-0802i
Study First Received: March 17, 2010
Last Updated: August 30, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014