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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.)
Information provided by (Responsible Party):
UCB Pharma Identifier:
First received: February 7, 2011
Last updated: October 26, 2012
Last verified: October 2012
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: 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:

Further study details as provided by UCB Pharma:

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 ]

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 ]
  • Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12 [ Time Frame: 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 ]

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01292265

United States, California
Los Angeles, California, United States
Walnut Creek, California, United States
United States, Maryland
Wheaton, Maryland, United States
United States, New Jersey
Voorhees, New Jersey, United States
United States, New York
Rochester, New York, United States
United States, Wisconsin
Franklin, Wisconsin, United States
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Responsible Party: UCB Pharma 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

Keywords provided by UCB Pharma:
Joint pain
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 22, 2017