Trial Outcomes & Findings for Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy (NCT NCT01521884)

NCT ID: NCT01521884

Last Updated: 2015-02-19

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2015-02-19

Participant Flow

Participant milestones

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Overall Study STARTED	62
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Overall Study Non Responders	10
Overall Study Adverse Event	5
Overall Study Pregnancy	1
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	2
Overall Study Protocol Violation	3
Overall Study Participant non-eligible	1
Overall Study Lost to Follow-up	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=61 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Age, Continuous	55.2 years STANDARD_DEVIATION 11.28 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline AIMS2-Physical Score (n=59)	3.5 units on a scale Standard Deviation 1.7
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline AIMS2-Affect Score (n=59)	4.8 units on a scale Standard Deviation 1.7
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline AIMS2-Symptom Score (n=58)	7.3 units on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6 AIMS2-Physical Score (n=47)	2.3 units on a scale Standard Deviation 1.7
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6 AIMS2-Affect Score (n=49)	3.8 units on a scale Standard Deviation 1.9
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6 AIMS2-Symptom Score (n=49)	5.1 units on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=42 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12 AIMS2-Physical Score	2.1 units on a scale Standard Deviation 1.3
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12 AIMS2-Affect Score	3.5 units on a scale Standard Deviation 1.8
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12 AIMS2-Symptom Score	4.3 units on a scale Standard Deviation 2.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18 AIMS2-Physical Score (n=30)	2.6 units on a scale Standard Deviation 1.7
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18 AIMS2-Affect Score (n=31)	3.4 units on a scale Standard Deviation 1.8
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18 AIMS2-Symptom Score (n=31)	4.5 units on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24 AIMS2-Physical Score (n=31)	2.2 units on a scale Standard Deviation 1.7
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24 AIMS2-Affect Score (n=31)	3.2 units on a scale Standard Deviation 1.9
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24 AIMS2-Symptom Score (n=30)	3.8 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Visual Analog Scale (VAS) Fatigue Score Month 12 (n=42)	4.4 units on a scale Standard Deviation 2.41
Visual Analog Scale (VAS) Fatigue Score Baseline (n=56)	6.4 units on a scale Standard Deviation 1.93
Visual Analog Scale (VAS) Fatigue Score Month 6 (n=47)	4.7 units on a scale Standard Deviation 2.43
Visual Analog Scale (VAS) Fatigue Score Month 18 (n=31)	4.3 units on a scale Standard Deviation 2.04
Visual Analog Scale (VAS) Fatigue Score Month 24 (n=30)	4.6 units on a scale Standard Deviation 2.43

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR) Baseline (n=55)	4.93 units on a scale Standard Deviation 1.27
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR) Month 6 (n=41)	3.21 units on a scale Standard Deviation 1.37
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR) Month 12 (n=37)	3.05 units on a scale Standard Deviation 1.28
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR) Month 18 (n=24)	3.04 units on a scale Standard Deviation 1.27
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR) Month 24 (n=23)	2.44 units on a scale Standard Deviation 1.11

SECONDARY outcome

Timeframe: 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-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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) Baseline (n=23)	4.59 units on a scale Standard Deviation 1.28
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) Month 6 (n=21)	2.50 units on a scale Standard Deviation 1.06
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) Month 12 (n=20)	2.75 units on a scale Standard Deviation 1.27
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) Month 18 (n=21)	2.59 units on a scale Standard Deviation 0.83
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) Month 24 (n=19)	2.35 units on a scale Standard Deviation 1.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=59 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Health Assessment Questionnaire (HAQ) Total Score Month 18 (n=32)	23.60 units on a scale Standard Deviation 6.794
Health Assessment Questionnaire (HAQ) Total Score Baseline (n=59)	30.17 units on a scale Standard Deviation 8.765
Health Assessment Questionnaire (HAQ) Total Score Month 6 (n=49)	22.99 units on a scale Standard Deviation 7.524
Health Assessment Questionnaire (HAQ) Total Score Month 12 (n=44)	22.45 units on a scale Standard Deviation 8.729
Health Assessment Questionnaire (HAQ) Total Score Month 24 (n=31)	22.84 units on a scale Standard Deviation 6.769

OTHER_PRE_SPECIFIED outcome

Timeframe: 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 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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 6: AIMS2 Affect at vs VAS fatigue (n=47)	0.714 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 18: AIMS2 Symptom vs VAS fatigue (n=31)	0.376 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 24: AIMS2 Physical vs VAS fatigue (n=30)	0.452 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 24: AIMS2 Affect vs VAS fatigue (n=30)	0.591 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 24: AIMS2 Symptom vs VAS fatigue (n=29)	0.429 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Baseline: AIMS2 Physical vs VAS fatigue (n=56)	0.497 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Baseline: AIMS2 Affect vs VAS fatigue (n=56)	0.419 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Baseline: AIMS2 Symptom vs VAS fatigue (n=55)	0.516 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 6: AIMS2 Physical vs VAS fatigue (n=45)	0.617 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 6: AIMS2 Symptom vs VAS fatigue (n=47)	0.624 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 12: AIMS2 Physical vs VAS fatigue (n=41)	0.361 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 12: AIMS2 Affect vs VAS fatigue (n=41)	0.365 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 12: AIMS2 Symptom vs VAS fatigue (n=41)	0.330 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 18: AIMS2 Physical vs VAS fatigue (n=30)	0.318 correlation coefficient
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score Month 18: AIMS2 Affect vs VAS fatigue (n=31)	0.428 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
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) Baseline: AIMS2 Physical vs DAS28-ESR (n=53)	0.366 correlation coefficient
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) Baseline: AIMS2 Affect vs DAS28-ESR (n=53)	0.071 correlation coefficient
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) Baseline: AIMS2 Symptom vs DAS28-ESR (n=52)	0.427 correlation coefficient
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) Month 6: AIMS2 Physical vs DAS28-ESR (n=38)	0.254 correlation coefficient
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) Month 6: AIMS2 Affect vs DAS28-ESR (n=40)	0.561 correlation coefficient
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) Month 6: AIMS2 Symptom vs DAS28-ESR (n=40)	0.602 correlation coefficient
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) Month 12: AIMS2 Physical vs DAS28-ESR (n=33)	0.399 correlation coefficient
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) Month 12: AIMS2 Symptom vs DAS28-ESR (n=33)	0.285 correlation coefficient
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) Month 18: AIMS2 Physical vs DAS28-ESR (n=20)	0.334 correlation coefficient
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) Month 18: AIMS2 Affect vs DAS28-ESR (n=21)	0.205 correlation coefficient
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) Month 18: AIMS2 Symptom vs DAS28-ESR (n=21)	0.336 correlation coefficient
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) Month 24: AIMS2 Physical vs DAS28-ESR (n=21)	0.110 correlation coefficient
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) Month 24: AIMS2 Affect vs DAS28-ESR (n=21)	0.180 correlation coefficient
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) Month 24: AIMS2 Symptom vs DAS28-ESR (n=20)	0.233 correlation coefficient
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) Month 12: AIMS2 Affect vs DAS28-ESR (n=33)	0.263 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: 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-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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
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) Baseline: AIMS2 Affect vs DAS 28-CRP (n=22)	0.238 correlation coefficient
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) Month 6: AIMS2 Physical vs DAS 28-CRP (n=19)	0.443 correlation coefficient
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) Month 6: AIMS2 Symptom vs DAS 28-CRP (n=20)	0.583 correlation coefficient
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) Month 12: AIMS2 Affect vs DAS 28-CRP (n=19)	0.425 correlation coefficient
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) Month 18: AIMS2 Physical vs DAS 28-CRP (n=16)	0.554 correlation coefficient
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) Month 18: AIMS2 Affect vs DAS 28-CRP (n=16)	0.368 correlation coefficient
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) Month 24: AIMS2 Symptom vs DAS 28-CRP (n=18)	0.478 correlation coefficient
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) Baseline: AIMS2 Physical vs DAS 28-CRP (n=22)	0.014 correlation coefficient
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) Baseline: AIMS2 Symptom vs DAS 28-CRP (n=22)	0.097 correlation coefficient
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) Month 6: AIMS2 Affect vs DAS 28-CRP (n=20)	0.344 correlation coefficient
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) Month 12: AIMS2 Physical vs DAS 28-CRP (n=19)	0.697 correlation coefficient
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) Month 12: AIMS2 Symptom vs DAS 28-CRP (n=19)	0.541 correlation coefficient
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) Month 18: AIMS2 Symptom vs DAS 28-CRP (n=16)	0.617 correlation coefficient
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) Month 24: AIMS2 Physical vs DAS 28-CRP (n=18)	0.494 correlation coefficient
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) Month 24: AIMS2 Affect vs DAS 28-CRP (n=18)	0.487 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
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 Baseline: DAS28-ESR vs VAS fatigue (n=50)	0.370 correlation coefficient
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 Month 6: DAS28-ESR vs VAS fatigue (n=38)	0.394 correlation coefficient
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 Month 12: DAS28-ESR vs VAS fatigue (n=34)	0.215 correlation coefficient
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 Month 18: DAS28-ESR vs VAS fatigue (n=21)	0.073 correlation coefficient
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 Month 24: DAS28-ESR vs VAS fatigue (n=21)	0.401 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: 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-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.

Outcome measures

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 Participants Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
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 Baseline: DAS28-CRP vs VAS fatigue (n=22)	0.096 correlation coefficient
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 Month 6: DAS28-CRP vs VAS fatigue (n=19)	0.291 correlation coefficient
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 Month 12: DAS28-CRP vs VAS fatigue (n=19)	0.271 correlation coefficient
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 Month 18: DAS28-CRP vs VAS fatigue (n=16)	0.193 correlation coefficient
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 Month 24: DAS28-CRP vs VAS fatigue (n=17)	0.300 correlation coefficient

Adverse Events

Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 participants at risk Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
General disorders Spondylodiscitis	1.6% 1/62 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.

Other adverse events

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n=62 participants at risk Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician's discretion based on summary of product characteristics, were followed up for 2 years.
General disorders Asthma	1.6% 1/62 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Tachycardia	1.6% 1/62 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Headache	1.6% 1/62 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Nausea	1.6% 1/62 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
General disorders Purulent rhinorrhea	1.6% 1/62 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER