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

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.

Time frame: Baseline

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.

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.

Time frame: Month 12

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here N (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.

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.

Time frame: Month 18

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.

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.

Time frame: Month 24

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.

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.

Time frame: Month 6

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.

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.

Time frame: Baseline, Month 6, 12, 18, 24

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score.

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

Time frame: Baseline, Month 6, 12, 18, 24

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component 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.

Time frame: Baseline, Month 6, 12, 18, 24

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score.

Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.

Time frame: Baseline, Month 6, 12, 18, 24

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score.

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.

Time frame: Baseline, Month 6, 12, 18, 24

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.

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.

Time frame: Baseline, Month 6,1 2, 18, 24

Population: ITT population, Here n = participants evaluable for this measure for specified component score and N (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.

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.

Time frame: Baseline, Month 6, 12, 18, 24

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.

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.

Time frame: Baseline, Month 6, 12, 18, 24

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score.

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.

Time frame: Baseline, Month 6, 12, 18, 24

Population: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here n = participants who were evaluable for this measure for specified component score.