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Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01299961
Recruitment Status : Completed
First Posted : February 21, 2011
Results First Posted : January 30, 2015
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Veena Ranganath, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Rheumatoid Arthritis
Intervention Drug: abatacept
Enrollment 25
Recruitment Details A total of 34 RA patients were recruited from the UCLA rheumatology clinics between September 2011 to February 2013. However, we had a total of 9 screen fails.
Pre-assignment Details Patients enrolled in the study were required to have RA, on stable RA medications, and naive to abatacept.
Arm/Group Title Subcutaneous Abatacept
Hide Arm/Group Description All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
Period Title: Overall Study
Started 25
Completed 19
Not Completed 6
Reason Not Completed
Adverse Event             3
Lack of Efficacy             2
Lost to Follow-up             1
Arm/Group Title Subcutaneous Abatacept
Hide Arm/Group Description All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
52.6  (13.4)
[1]
Measure Description: This is a the average age of the cohort that started the mediation, Abatacept 125mg sq qwk.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
23
  92.0%
Male
2
   8.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score
Hide Description The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.
Time Frame baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total of 19 patients completed 12 mos
Arm/Group Title Subcutaneous Abatacept
Hide Arm/Group Description:
All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.4  (13.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subcutaneous Abatacept
Comments Most involved side: Synovitis (S), tenosynovitis (T), and power Doppler (PD) of wrist (dorsal (D), palmar (P), and ulnar (U)); S and T of MCP 2,3 (P, plus D for T); PD of the MCP joints (P and D); S and PD of PIP 2, 3 (P, plus D for PD); S and PD for MTP 2, 4 (D). S and PD graded from 0 to 3, and max individual scores are 27 and 39, respectively. T graded on 0-1 scale; max T score is 5. High score is worse. The 7-joint US score is sum of T, S, and PD scores. Change calculated baseline- month 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.4
Parameter Dispersion
Type: Standard Deviation
Value: 13.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 12 Month Change in Power Doppler Ultrasound (PDUS) Scores
Hide Description There were seven different joints in the hands and wrists evaluated to score the PDUS.
Time Frame baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
As stated previously
Arm/Group Title Subcutaneous Abatacept
Hide Arm/Group Description:
All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.0  (3.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subcutaneous Abatacept
Comments 7 joints were scanned by power doppler ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. PDUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total PDUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline PDUS minus 12 month PDUS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.0
Parameter Dispersion
Type: Standard Deviation
Value: 3.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 12 Month Change in Gray-scale Ultrasound (GSUS)
Hide Description There were seven different joints in the hands and wrists evaluated to score the GSUS.
Time Frame baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subcutaneous Abatacept
Hide Arm/Group Description:
All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.2  (3.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subcutaneous Abatacept
Comments 7 joints were scanned by grey-scale ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. GSUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total GSUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline GSUS minus 12 month GSUS.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Parameter Dispersion
Type: Standard Deviation
Value: 3.7
Estimation Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subcutaneous Abatacept
Hide Arm/Group Description All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
All-Cause Mortality
Subcutaneous Abatacept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subcutaneous Abatacept
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Subcutaneous Abatacept
Affected / at Risk (%)
Total   0/25 (0.00%) 
This is a very small open-label study of 25 patients on a FDA approved drug, where efficacy (by standard validated measures) and safety were not the primary end points.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Veena K. Ranganath, MD, MS Assistant Clinical Professor
Organization: UCLA
Phone: 310-825-3061
EMail: vranganath@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Dr. Veena Ranganath, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01299961     History of Changes
Other Study ID Numbers: UCLA Rheumatology RA 001
IND 111281 ( Other Identifier: FDA )
First Submitted: February 18, 2011
First Posted: February 21, 2011
Results First Submitted: January 6, 2015
Results First Posted: January 30, 2015
Last Update Posted: June 10, 2015