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Trial record 1 of 1 for:    NCT01292265
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A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA) (SWIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01292265
Recruitment Status : Terminated (Termination of study due to low enrollment. There were no safety issues.)
First Posted : February 9, 2011
Results First Posted : December 5, 2012
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Certolizumab Pegol Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12 [ Time Frame: From Baseline (Week 0) to Week 12 ]
  2. Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12 [ Time Frame: From Baseline (Week 0) to Week 12 ]
  3. Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12 [ Time Frame: From Baseline (Week 0) to Week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292265


Locations
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United States, California
10
Los Angeles, California, United States
4
Walnut Creek, California, United States
United States, Maryland
8
Wheaton, Maryland, United States
United States, New Jersey
1
Voorhees, New Jersey, United States
United States, New York
6
Rochester, New York, United States
United States, Wisconsin
7
Franklin, Wisconsin, United States
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01292265    
Other Study ID Numbers: RA0033
First Posted: February 9, 2011    Key Record Dates
Results First Posted: December 5, 2012
Last Update Posted: August 1, 2018
Last Verified: October 2012
Keywords provided by UCB Pharma:
Arthritis
Joint pain
Inflammation
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Certolizumab Pegol
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents