Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment certolizumab pegol
Phase phase 3
Sponsor Korea Otsuka Pharmaceutical Co.,Ltd.
Start date March 2010
End date June 2016
Trial size 100 participants
Trial identifier NCT01197066, 101-KOA-0802i

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Single Arm
certolizumab pegol CDP870
Certolizumab Pegol 200mg

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate.
time frame: Up to 7 years
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
To assess the achievement of clinical remission measured by DAS28.
time frame: Up to 7 years
The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).
time frame: Up to 7 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator YoungMo Kang, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Korea Otsuka Pharmaceutical Co.,Ltd..