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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01197066
First Posted: September 9, 2010
Last Update Posted: January 29, 2016
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.
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.
  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: Intervention Model: Single Group Assignment
Masking: None (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 7 years ]
    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 7 years ]
    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 7 years ]
    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 7 years ]
    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 7 years ]
    Treatment will continue until the drug is commercially available in the country.


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Certolizumab Pegol
Single Arm
Drug: Certolizumab Pegol
Certolizumab Pegol 200mg
Other Names:
  • CDP870
  • CIMZIA
  • Perstymab

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197066


Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: YoungMo Kang, MD, PhD Kyungpook National University
  More Information

Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01197066     History of Changes
Other Study ID Numbers: 101-KOA-0802i
First Submitted: March 17, 2010
First Posted: September 9, 2010
Last Update Posted: January 29, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents