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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

February 7, 2011
October 26, 2012
February 2011
January 2012   (final data collection date for primary outcome measure)
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 ]
Change from baseline (Week 0) in the modified ultrasound-7 joint (mUS7) sumscore at Week 12 [ Time Frame: Week 0, week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01292265 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12 [ Time Frame: Week 0, Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline (Week 0) in C-reactive protein (CRP) at Week 12 [ Time Frame: Week 0, Week12 ] [ Designated as safety issue: No ]
  • Change from baseline (Week 0) in erythrocyte sedimentation rate (ESR) at Week 12 [ Time Frame: Week 0, Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)
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.

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.
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
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
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.
Intervention: Biological: Certolizumab Pegol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01292265
RA0033
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP