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

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 (CZP) as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study # 101-KOA-0801i

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

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.

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:	July 2, 2012
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 May 22, 2013