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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 Pharma
ClinicalTrials.gov Identifier:
NCT01292265
First received: February 7, 2011
Last updated: October 26, 2012
Last verified: October 2012
Results First Received: October 26, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Intervention: Biological: Certolizumab Pegol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This study started in February 2011. It was subsequently terminated due to low enrollment.

Baseline characteristics refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Certolizumab Pegol (CZP) at least once.

There was a total of 3 subjects enrolled in this study.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    CZP 200 mg  
STARTED     3  
COMPLETED     3  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    CZP 200 mg  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  44  ± 4  
Gender  
[units: participants]
 
Female     3  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12   [ Time Frame: From Baseline (Week 0) to Week 12 ]

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

4.  Secondary:   Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12   [ Time Frame: From Baseline (Week 0) to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: UCB, Inc.
phone: +1 887 822 9493


No publications provided


Responsible Party: UCB Pharma
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