- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01521884
Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy
February 3, 2015 updated by: Pfizer
Longitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy
People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL.
In this study we are measuring the impact of SC biologics on these parameters.
Study Overview
Detailed Description
Observational prospective study Purely descriptive
Study Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Leuven, Belgium, 3000
- UZ Gasthuisberg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients seen in a rheumatology practice
Description
Inclusion Criteria:
Patients who:
- Are active RA patients (as judged by treating MD)
- Are 18 years of age or older at time of consent
- Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX
Exclusion Criteria:
Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.
Participation in other clinical or observational trials
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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RA Patients treated with SC anti-TNF
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SC anti-TNF
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
Time Frame: Baseline
|
AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Baseline
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6
Time Frame: Month 6
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
|
Month 6
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
Time Frame: Month 12
|
AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 12
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
Time Frame: Month 18
|
AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 18
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
Time Frame: Month 24
|
AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) Fatigue Score
Time Frame: Baseline, Month 6, 12, 18, 24
|
Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)
Time Frame: Baseline, Month 6, 12, 18, 24
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DAS28-ESR was calculated from the number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]).
Total score range: 0-10, higher score=more disease activity (DA).
DAS28-ESR less than equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high DA
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Baseline, Month 6, 12, 18, 24
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Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
Time Frame: Baseline, Month 6, 12, 18, 24
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DAS28-CRP was calculated from the number of swollen joints ( SJC) and tender joints (TJC) count using 28 joint count and CRP (milligram per liter [mg/L]).
Total score range: 0-10, higher score= more disease activity.
DAS28 (CRP) : <3.2= low disease activity, >3.2 to 5.1 = moderate to high disease activity and less than (<)2.6 = remission.
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Baseline, Month 6, 12, 18, 24
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Health Assessment Questionnaire (HAQ) Total Score
Time Frame: Baseline, Month 6, 12, 18, 24
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HAQ: 20-item participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities.
Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as sum of item scores.
HAQ total score was 0 to 60 (as used in Belgium), where greater score indicated greater difficulty.
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Baseline, Month 6, 12, 18, 24
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score
Time Frame: Baseline, Month 6, 12, 18, 24
|
Spearman correlation coefficient between AIMS2 component score and VAS fatigue score (AIMS2 component score versus [vs] VAS fatigue) was calculated.
AIMS2 : 78-item questionnaire assessing 12 scales.
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and VAS score: Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)
Time Frame: Baseline, Month 6,1 2, 18, 24
|
Pearson correlation coefficient between AIMS2 component score and DAS28-ESR score (AIMS2 component score vs DAS28-ESR) was calculated.
AIMS2: 78-item questionnaire assessing 12 scales.
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]).
Total score range: 0-10, higher score= more disease activity.
DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA.
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Baseline, Month 6,1 2, 18, 24
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Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
Time Frame: Baseline, Month 6, 12, 18, 24
|
Pearson correlation coefficient between AIMS2 component score and DAS28-CRP score (AIMS2 component score vs DAS28-CRP) was calculated.
AIMS2: 78-item questionnaire assessing 12 scales.
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L).
Total score range: 0-10, higher score= more disease activity.
DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission.
|
Baseline, Month 6, 12, 18, 24
|
Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR) and Visual Analog Scale (VAS) Fatigue Score
Time Frame: Baseline, Month 6, 12, 18, 24
|
Spearman correlation coefficient between DAS28-ESR and VAS fatigue (DAS28-ESR vs VAS score) was calculated.
DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]).
Total score range: 0-10, higher score= more disease activity.
DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA and VAS fatigue = Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
|
Baseline, Month 6, 12, 18, 24
|
Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) and Visual Analog Scale (VAS) Fatigue Score
Time Frame: Baseline, Month 6, 12, 18, 24
|
Spearman correlation coefficient between DAS28-CRP and VAS score (DAS28-CRP vs VAS score) was calculated.
DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L).
Total score range: 0-10, higher score= more disease activity.
DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission and VAS= Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
August 19, 2011
First Submitted That Met QC Criteria
January 30, 2012
First Posted (Estimate)
January 31, 2012
Study Record Updates
Last Update Posted (Estimate)
February 19, 2015
Last Update Submitted That Met QC Criteria
February 3, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0881A1-4748
- B1801046 (Other Identifier: Alias Study Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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