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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Certolizumab Pegol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Certolizumab Pegol<br>Single Arm | Drug: Certolizumab Pegol<br>* Certolizumab Pegol 200mg<br>* Other names: Perstymab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Treatment will continue until the drug is commercially available in the country. | Up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate. | Treatment will continue until the drug is commercially available in the country. | 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) | Treatment will continue until the drug is commercially available in the country. | Up to 7 years | 
| To assess the achievement of clinical remission measured by DAS28. | Treatment will continue until the drug is commercially available in the country. | Up to 7 years | 
| The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). | Treatment will continue until the drug is commercially available in the country. | Up to 7 years |