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

This study has been terminated.
(Termination of study due to low enrollment. There were no safety issues.)
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01292265
First received: February 7, 2011
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
 Biological: Certolizumab Pegol
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12 [ Time Frame: From Baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12 [ Time Frame: From Baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12 [ Time Frame: From Baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292265

Locations
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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01292265     History of Changes
Other Study ID Numbers: RA0033
Study First Received: February 7, 2011
Results First Received: October 26, 2012
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Arthritis
Joint pain
Inflammation
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013