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Trial record 54 of 2725 for:    Rheumatoid Arthritis

Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in Taiwan (ROCKI)

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: NCT02616380
Recruitment Status : Completed
First Posted : November 26, 2015
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Enrollment 100
Recruitment Details One hundred participants with rheumatoid arthritis (RA) were enrolled at 7 sites in Taiwan.
Pre-assignment Details  
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Period Title: Overall Study
Started 100
Completed 97
Not Completed 3
Reason Not Completed
Lost to Follow-up             1
Other             2
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
54.0  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
87
  87.0%
Male
13
  13.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Heath Assessment Questionnaire – Disability Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 100 participants
1.06  (0.72)
[1]
Measure Description: The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), where higher scores represent a high-dependency disability.
1.Primary Outcome
Title Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24
Hide Description The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), with a higher score representing a high-dependency disability.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 24.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Participants Analyzed 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.44  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments The mean change was tested with a paired t-test without adjusting for baseline disease severity.
2.Secondary Outcome
Title Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24
Hide Description

The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).

The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included the following subscales: vitality, social functioning, role-emotional, and mental health.

Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement.

Time Frame Baseline, week 12, and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants still receiving adalimumab and with available data at each time point.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Component Score at Week 12 Number Analyzed 95 participants
5.72  (5.78)
Physical Component Score at Week 24 Number Analyzed 93 participants
8.09  (7.13)
Mental Component Score at Week 12 Number Analyzed 95 participants
3.67  (7.94)
Mental Component Score at Week 24 Number Analyzed 93 participants
5.85  (7.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Change From Baseline in Physical Component Score at Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Change From Baseline in Physical Component Score at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Change From Baseline in Mental Component Score at Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Change From Baseline in Mental Component Score at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24
Hide Description The EQ-5D-5L descriptive system comprises 5 dimensions of health-related quality of life states (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (‘no problems’, ‘some problems’, and ‘extreme problems') within a particular EQ-5D-3L dimension. The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement.
Time Frame Baseline, week 12, and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants still receiving adalimumab and with available data at each time point.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
12 weeks Number Analyzed 96 participants
0.23  (0.30)
24 weeks Number Analyzed 94 participants
0.33  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Change from Baseline in EQ-5D-3L at 12 weeks
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Change from Baseline in EQ-5D-3L at 24 weeks
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24
Hide Description The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.
Time Frame Baseline, week 12, and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants still receiving adalimumab and with available data at each time point. Overall work impairment was only assessed in participants who were employed.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: percent impairment
Overall Work Impairment at Week 12 Number Analyzed 40 participants
-18  (23)
Overall Work Impairment at Week 24 Number Analyzed 39 participants
-19  (23)
Activity Impairment at Week 12 Number Analyzed 95 participants
-14  (22)
Activity Impairment at Week 24 Number Analyzed 92 participants
-24  (25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Change From Baseline in Overall Work Impairment at Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Change From Baseline in Overall Work Impairment at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Change From Baseline in Activity Impairment at Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Change From Baseline in Activity Impairment at Week 24
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in HAQ DI Score at Week 12
Hide Description The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), with a higher score representing a high-dependency disability.
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 24.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Participants Analyzed 96
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.34  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments The mean change was tested with a paired t-test without adjusting for baseline disease severity.
6.Secondary Outcome
Title Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24
Hide Description

The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following 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 (best) to 3 (worst), with a higher score representing a high-dependency disability.

A clinically meaningful improvement was defined as an improvement of -0.22 points or greater in the HAQ-DI score.

Time Frame Baseline, week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants still receiving adalimumab and with available data at each time point.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 96 participants
60.4
Week 24 Number Analyzed 94 participants
59.6
7.Secondary Outcome
Title Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis
Hide Description The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
Any healthcare professional
99
  99.0%
Rheumatologist
97
  97.0%
Traditional medicine
7
   7.0%
Orthopaedist
5
   5.0%
Rehabilitation medicine
5
   5.0%
Family medicine
3
   3.0%
Internist
2
   2.0%
Emergency department
1
   1.0%
Other
11
  11.0%
8.Secondary Outcome
Title Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis
Hide Description The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
Any Procedure
95
  95.0%
Blood Sample Taken
87
  87.0%
Chest X-Ray
27
  27.0%
Urine Test
11
  11.0%
Liverfunction Test
11
  11.0%
Electroardiogram
9
   9.0%
Hand X-Ray
5
   5.0%
Spine X-Ray
4
   4.0%
Bone Scan
3
   3.0%
Shoulder X-Ray
1
   1.0%
Knee X-Ray
1
   1.0%
Magnetic Resonance Imaging (MRI)
1
   1.0%
Endoscopy
1
   1.0%
Tuberculin Skin Test
1
   1.0%
Sputum Tests
1
   1.0%
Other
8
   8.0%
9.Secondary Outcome
Title Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis
Hide Description The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.0%
10.Secondary Outcome
Title Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis
Hide Description The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
Any Concomitant Medication
100
 100.0%
Disease Modifying Antirheumatic Drug (DMARD)
96
  96.0%
Non-steroidal Anti-inflammatory Drug (NSAID)
73
  73.0%
Others
59
  59.0%
Time Frame Up to 34 weeks
Adverse Event Reporting Description The protocol required that all serious adverse events (SAEs) to be actively solicited. Non-serious adverse events were collected as spontaneous reports when the Sponsor was notified.
 
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
All-Cause Mortality
Adalimumab
Affected / at Risk (%)
Total   0/100 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab
Affected / at Risk (%)
Total   1/100 (1.00%) 
Injury, poisoning and procedural complications   
Hip fracture * 1  1/100 (1.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adalimumab
Affected / at Risk (%)
Total   1/100 (1.00%) 
Immune system disorders   
Allergic reaction * 1  1/100 (1.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02616380     History of Changes
Other Study ID Numbers: P15-778
First Submitted: November 25, 2015
First Posted: November 26, 2015
Results First Submitted: November 19, 2018
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019