A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA) (SWIFT)

July 4, 2018 updated by: UCB Pharma

A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab Pegol

To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
        • 10
      • Walnut Creek, California, United States
        • 4
    • Maryland
      • Wheaton, Maryland, United States
        • 8
    • New Jersey
      • Voorhees, New Jersey, United States
        • 1
    • New York
      • Rochester, New York, United States
        • 6
    • Wisconsin
      • Franklin, Wisconsin, United States
        • 7

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with adult-onset Rheumatoid Arthritis (RA) >6 months and <3 years
  • Active RA
  • Must have failed at least one disease modifying Anti Rheumatic Drug (DMARD) treatment
  • Subject can have attempted no more than one previous Anti Tumor Necrosis factor (anti-TNF) and discontinued due to drug intolerance

Exclusion Criteria:

  • Subject cannot have a second non-inflammatory musculoskeletal condition
  • Subject cannot have a diagnosis of any other inflammatory arthritis
  • Subject cannot have any previously infected prosthesis
  • Subject cannot have arthroplasties in any of the joints assessed in the study
  • Subject cannot have a history of chronic infections
  • Subject cannot have known Tuberculosis (TB) disease, high risk of acquiring TB, or latent TB infection
  • Subject cannot have a history of or current Lymphoproliferative disorder
  • Subject cannot have known Human Immunodeficiency Virus (HIV) infection
  • Subject cannot have received a live or attenuated vaccine within 8 weeks
  • Subject cannot have current or history of malignancy
  • Subject cannot have a history of blood disorders
  • Subject cannot have a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
  • Subjects must not have a history of adverse reaction to Polyethylene glycol (PEG), a protein medicinal product, or ultrasound gel applied to the skin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CZP 200 mg
Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
Biological: Certolizumab Pegol
Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
Other Names:
  • Cimzia
  • CZP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12
Time Frame: From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12
Time Frame: From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12
Time Frame: From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12
Time Frame: From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA0033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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