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Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population

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ClinicalTrials.gov Identifier: NCT01782469
Recruitment Status : Terminated (Study stopped due to low enrollment)
First Posted : February 4, 2013
Results First Posted : July 30, 2015
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rheumatoid Arthritis (RA) Participants
Hide Arm/Group Description Male or female participants at least 18 years of age with diagnosis of RA
Period Title: Overall Study
Started 16
Completed 15
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Rheumatoid Arthritis (RA) Participants
Hide Arm/Group Description Male or female participants at least 18 years of age with diagnosis of RA
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
36.5  (9.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
7
  43.8%
Male
9
  56.3%
1.Primary Outcome
Title Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.
Hide Description Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.
Time Frame Baseline (Visit 1) to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Rheumatoid Arthritis (RA) Participants
Hide Arm/Group Description:
Male or female participants at least 18 years of age with diagnosis of RA
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.6  (4.98)
2.Secondary Outcome
Title Mean Percent Reduction in Ultrasonography Assessment Score
Hide Description Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36.
Time Frame Baseline (Visit 1) to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Rheumatoid Arthritis (RA) Participants
Hide Arm/Group Description:
Male or female participants at least 18 years of age with diagnosis of RA
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Percent reduction
Visit 2, n=16 -20.99  (18.4)
Visit 3, n=16 -35.60  (25.36)
Visit 4, n=16 -48.42  (19.88)
Visit 5, n=15 -56.91  (24.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rheumatoid Arthritis (RA) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Mean percent reduction in ultrasonography assessment score at Vist 2 as compared to Baseline (Visit 1)
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rheumatoid Arthritis (RA) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Mean percent reduction in ultrasonography assessment score at Vist 3 as compared to Baseline (Visit 1)
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rheumatoid Arthritis (RA) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Mean percent reduction in ultrasonography assessment score at Vist 4 as compared to Baseline (Visit 1)
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Rheumatoid Arthritis (RA) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Mean percent reduction in ultrasonography assessment score at Vist 5 as compared to Baseline (Visit 1)
Method Wilcoxon signed-rank test
Comments [Not Specified]
3.Secondary Outcome
Title Mean Number of Joints With Detected Erosions
Hide Description A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented.
Time Frame Baseline (Visit 1) to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Rheumatoid Arthritis (RA) Participants
Hide Arm/Group Description:
Male or female participants at least 18 years of age with diagnosis of RA
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: joints
Visit 1, n=16 9.38  (1.89)
Visit 2, n=16 8.69  (2.5)
Visit 3, n=16 7.69  (3.3)
Visit 4, n=16 6.75  (3.24)
Visit 5, n=15 6.07  (2.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rheumatoid Arthritis (RA) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .130
Comments Mean number of joints with erosions at Vist 2 as compared to Baseline (Visit 1)
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rheumatoid Arthritis (RA) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments Mean number of joints with erosions at Vist 3 as compared to Baseline (Visit 1)
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rheumatoid Arthritis (RA) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Mean number of joints with erosions at Vist 4 as compared to Baseline (Visit 1)
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Rheumatoid Arthritis (RA) Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Mean number of joints with erosions at Vist 5 as compared to Baseline (Visit 1)
Method Wilcoxon signed-rank test
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)
Hide Description The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC).
Time Frame Baseline (Visit 1) to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Rheumatoid Arthritis (RA) Participants
Hide Arm/Group Description:
Male or female participants at least 18 years of age with diagnosis of RA
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.75
(80.4 to 107.1)
5.Secondary Outcome
Title Mean Change in Health Assessment Questionnaire (HAQ) Score
Hide Description The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks.
Time Frame Baseline (Visit 1) to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to an error, HAQ data was not collected at 13 weeks. Therefore, only baseline data are reported.
Arm/Group Title Rheumatoid Arthritis (RA) Participants
Hide Arm/Group Description:
Male or female participants at least 18 years of age with diagnosis of RA
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.19  (0.65)
Time Frame Serious adverse events were collected from the time of informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment, up to 18 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rheumatoid Arthritis (RA) Participants
Hide Arm/Group Description Male or female participants at least 18 years of age with diagnosis of RA
All-Cause Mortality
Rheumatoid Arthritis (RA) Participants
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Rheumatoid Arthritis (RA) Participants
Affected / at Risk (%)
Total   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rheumatoid Arthritis (RA) Participants
Affected / at Risk (%)
Total   0/0 
[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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Information
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01782469    
Other Study ID Numbers: P13-708
First Submitted: January 31, 2013
First Posted: February 4, 2013
Results First Submitted: July 2, 2015
Results First Posted: July 30, 2015
Last Update Posted: July 30, 2015