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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Certolizumab Pegol

• Registration Number: NCT01197066
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Certolizumab Pegol	Certolizumab Pegol	Single Arm

Primary Outcome Measures

Name	Time	Method
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.	Up to 7 years	Treatment will continue until the drug is commercially available in the country.

Secondary Outcome Measures

Name	Time	Method
To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate.	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)	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.	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).	Up to 7 years	Treatment will continue until the drug is commercially available in the country.