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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: Certolizumab Pegol
Enrollment 3
Recruitment Details

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 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.
Arm/Group Title CZP 200 mg
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title CZP 200 mg
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
44  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
3
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12
Hide Description [Not Specified]
Time Frame From Baseline (Week 0) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.
Arm/Group Title CZP 200 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12
Hide Description [Not Specified]
Time Frame From Baseline (Week 0) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.
Arm/Group Title CZP 200 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12
Hide Description [Not Specified]
Time Frame From Baseline (Week 0) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.
Arm/Group Title CZP 200 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12
Hide Description [Not Specified]
Time Frame From Baseline (Week 0) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.
Arm/Group Title CZP 200 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Events (AEs) were collected during the course of the trial, which was approximately 12 weeks per subject. Since only 3 subjects were enrolled in this study, only AE data will be summarized in a table, with frequency counts and percentages.
Adverse Event Reporting Description Adverse Events 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.
 
Arm/Group Title CZP 200 mg
Hide Arm/Group Description 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.
All-Cause Mortality
CZP 200 mg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
CZP 200 mg
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CZP 200 mg
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Infections and infestations   
Nasopharyngitis * 1  1/3 (33.33%)  1
Investigations   
Transaminases increased * 1  1/3 (33.33%)  1
Blood creatine phosphokinase increased * 1  1/3 (33.33%)  1
Skin and subcutaneous tissue disorders   
Pruritus * 1  1/3 (33.33%)  1
Urticaria * 1  1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
[Not Specified]
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.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB, Inc.
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01292265    
Other Study ID Numbers: RA0033
First Submitted: February 7, 2011
First Posted: February 9, 2011
Results First Submitted: October 26, 2012
Results First Posted: December 5, 2012
Last Update Posted: August 1, 2018