Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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Observational prospective study Purely descriptive

Official Title
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Longitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: SC anti-TNF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA Patients treated with SC anti-TNF<br> | Other: SC anti-TNF<br>* SC anti-TNF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at 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. | Baseline | 
| Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6 | 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 | 
| Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at 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. | Month 12 | 
| Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at 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. | Month 18 | 
| Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at 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. | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Fatigue Score | 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 | 
| Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR) | 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 | Baseline, Month 6, 12, 18, 24 | 
| Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) | 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. | Baseline, Month 6, 12, 18, 24 | 
| Health Assessment Questionnaire (HAQ) Total Score | 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. | Baseline, Month 6, 12, 18, 24 |