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

NCT ID: NCT01197066

Last Updated: 2022-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-11-30

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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Certolizumab Pegol

Single Arm

Group Type OTHER

Certolizumab Pegol

Intervention Type DRUG

Certolizumab Pegol 200mg

Interventions

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Certolizumab Pegol

Certolizumab Pegol 200mg

Intervention Type DRUG

Other Intervention Names

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CDP870 CIMZIA Perstymab

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YoungMo Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Other Identifiers

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101-KOA-0802i

Identifier Type: -

Identifier Source: org_study_id

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