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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197066
• Other study ID #: 101-KOA-0802i
• Status: Completed
• Phase: Phase 3
• Start date: March 2010
• Est. completion date: November 2016

Study information

• Verified date: March 2017
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Certolizumab Pegol
Certolizumab Pegol 200mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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