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The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients

NCT ID: NCT01213017

Last Updated: 2017-12-07

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active moderate to severe rheumatoid arthritis.

Detailed Description

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The primary objective of this study is to evaluate the efficacy of CSP used in combination with MTX in patients with active moderate to severe RA by evaluating change from baseline in synovitis and bone edema MRI scores at week 6.

Conditions

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Rheumatoid Arthritis

Keywords

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Certolizumab pegol Magnetic Resonance Imaging Rheumatoid Arthritis RAPID 3

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

Group Type EXPERIMENTAL

certolizumab pegol

Intervention Type DRUG

400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks

Interventions

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certolizumab pegol

400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks

Intervention Type DRUG

Other Intervention Names

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Cimzia

Eligibility Criteria

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Inclusion Criteria

* moderate to severe RA (DAS \> 4.4)
* at least two swollen and tender joints in one of the hand/ wrist
* patients must have failed at least one non-biologic or biologic DMARDs
* currently receiving MTX therapy

Exclusion Criteria

* concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

Oklahoma Medical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ewa Olech, MD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Medical Research Foundation

Norman B Gaylis, MD

Role: PRINCIPAL_INVESTIGATOR

Arthritis and Rheumatic Disease Specialties

Locations

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Arthritis and Rheumatic Disease Specialties

Aventura, Florida, United States

Site Status

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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OMRF-UCB-5-16-2010

Identifier Type: -

Identifier Source: org_study_id