Back to resultsA 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA) (SWIFT)
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Certolizumab Pegol
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arthritis, Joint pain, Inflammation, Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- 10
- 4
- 8
- 1
- 6
- 7
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CZP 200 mg
Arm Description
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.
Outcomes
Primary Outcome Measures
Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12
Secondary Outcome Measures
Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12
Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12
Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01292265
Brief Title
A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)
Acronym
SWIFT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Termination of study due to low enrollment. There were no safety issues.
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Arthritis, Joint pain, Inflammation, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CZP 200 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Certolizumab Pegol
Other Intervention Name(s)
Cimzia, CZP
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12
Time Frame
From Baseline (Week 0) to Week 12
Title
Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12
Time Frame
From Baseline (Week 0) to Week 12
Title
Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12
Time Frame
From Baseline (Week 0) to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
10
City
Los Angeles
State/Province
California
Country
United States
Facility Name
4
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
8
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
1
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
6
City
Rochester
State/Province
New York
Country
United States
Facility Name
7
City
Franklin
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)
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