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

Completed

Conditions: Rheumatoid Arthritis

Interventions: Other: SC anti-TNF

Registration Number: NCT01521884

Lead Sponsor: Pfizer

Brief Summary: 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: Observational prospective study Purely descriptive

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA Patients treated with SC anti-TNF	SC anti-TNF	-

Primary Outcome Measures

Name	Time	Method
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline	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.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24	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.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6	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.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12	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.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18	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.

Secondary Outcome Measures

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