An observational study in Rheumatoid Arthritis, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-19.
Sponsored by Pfizer · Observational
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.
Observational prospective study Purely descriptive
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 62 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients seen in a rheumatology practice
Patients who:
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
Other: SC anti-TNF
SC anti-TNF
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 24
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 6, 12, 18, 24
Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score
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
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)
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
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)
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
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
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
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
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
| Milestone | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Started | 62 |
| Completed | 35 |
| Not completed | 27 |
| Withdrew: Non responders | 10 |
| Withdrew: Adverse event | 5 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Physician decision | 2 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Participant non-eligible | 1 |
| Withdrew: Lost to follow-up | 4 |
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.
| units on a scale | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| AIMS2-Physical Score (n=59) | 3.5 ± 1.7 |
| AIMS2-Affect Score (n=59) | 4.8 ± 1.7 |
| AIMS2-Symptom Score (n=58) | 7.3 ± 1.8 |
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.
| units on a scale | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| AIMS2-Physical Score (n=47) | 2.3 ± 1.7 |
| AIMS2-Affect Score (n=49) | 3.8 ± 1.9 |
| AIMS2-Symptom Score (n=49) | 5.1 ± 2.5 |
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.
| units on a scale | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| AIMS2-Physical Score | 2.1 ± 1.3 |
| AIMS2-Affect Score | 3.5 ± 1.8 |
| AIMS2-Symptom Score | 4.3 ± 2.7 |
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.
| units on a scale | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| AIMS2-Physical Score (n=30) | 2.6 ± 1.7 |
| AIMS2-Affect Score (n=31) | 3.4 ± 1.8 |
| AIMS2-Symptom Score (n=31) | 4.5 ± 2.1 |
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.
| units on a scale | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| AIMS2-Physical Score (n=31) | 2.2 ± 1.7 |
| AIMS2-Affect Score (n=31) | 3.2 ± 1.9 |
| AIMS2-Symptom Score (n=30) | 3.8 ± 2.3 |
Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
| units on a scale | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Baseline (n=56) | 6.4 ± 1.93 |
| Month 6 (n=47) | 4.7 ± 2.43 |
| Month 12 (n=42) | 4.4 ± 2.41 |
| Month 18 (n=31) | 4.3 ± 2.04 |
| Month 24 (n=30) | 4.6 ± 2.43 |
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
| units on a scale | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Baseline (n=55) | 4.93 ± 1.27 |
| Month 6 (n=41) | 3.21 ± 1.37 |
| Month 12 (n=37) | 3.05 ± 1.28 |
| Month 18 (n=24) | 3.04 ± 1.27 |
| Month 24 (n=23) | 2.44 ± 1.11 |
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.
| units on a scale | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Baseline (n=23) | 4.59 ± 1.28 |
| Month 6 (n=21) | 2.50 ± 1.06 |
| Month 12 (n=20) | 2.75 ± 1.27 |
| Month 18 (n=21) | 2.59 ± 0.83 |
| Month 24 (n=19) | 2.35 ± 1.11 |
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.
| units on a scale | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Baseline (n=59) | 30.17 ± 8.765 |
| Month 6 (n=49) | 22.99 ± 7.524 |
| Month 12 (n=44) | 22.45 ± 8.729 |
| Month 18 (n=32) | 23.60 ± 6.794 |
| Month 24 (n=31) | 22.84 ± 6.769 |
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.
| correlation coefficient | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Baseline: AIMS2 Physical vs VAS fatigue (n=56) | 0.497 |
| Baseline: AIMS2 Affect vs VAS fatigue (n=56) | 0.419 |
| Baseline: AIMS2 Symptom vs VAS fatigue (n=55) | 0.516 |
| Month 6: AIMS2 Physical vs VAS fatigue (n=45) | 0.617 |
| Month 6: AIMS2 Affect at vs VAS fatigue (n=47) | 0.714 |
| Month 6: AIMS2 Symptom vs VAS fatigue (n=47) | 0.624 |
| Month 12: AIMS2 Physical vs VAS fatigue (n=41) | 0.361 |
| Month 12: AIMS2 Affect vs VAS fatigue (n=41) | 0.365 |
| Month 12: AIMS2 Symptom vs VAS fatigue (n=41) | 0.330 |
| Month 18: AIMS2 Physical vs VAS fatigue (n=30) | 0.318 |
| Month 18: AIMS2 Affect vs VAS fatigue (n=31) | 0.428 |
| Month 18: AIMS2 Symptom vs VAS fatigue (n=31) | 0.376 |
| Month 24: AIMS2 Physical vs VAS fatigue (n=30) | 0.452 |
| Month 24: AIMS2 Affect vs VAS fatigue (n=30) | 0.591 |
| Month 24: AIMS2 Symptom vs VAS fatigue (n=29) | 0.429 |
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.
| correlation coefficient | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Baseline: AIMS2 Physical vs DAS28-ESR (n=53) | 0.366 |
| Baseline: AIMS2 Affect vs DAS28-ESR (n=53) | 0.071 |
| Baseline: AIMS2 Symptom vs DAS28-ESR (n=52) | 0.427 |
| Month 6: AIMS2 Physical vs DAS28-ESR (n=38) | 0.254 |
| Month 6: AIMS2 Affect vs DAS28-ESR (n=40) | 0.561 |
| Month 6: AIMS2 Symptom vs DAS28-ESR (n=40) | 0.602 |
| Month 12: AIMS2 Physical vs DAS28-ESR (n=33) | 0.399 |
| Month 12: AIMS2 Affect vs DAS28-ESR (n=33) | 0.263 |
| Month 12: AIMS2 Symptom vs DAS28-ESR (n=33) | 0.285 |
| Month 18: AIMS2 Physical vs DAS28-ESR (n=20) | 0.334 |
| Month 18: AIMS2 Affect vs DAS28-ESR (n=21) | 0.205 |
| Month 18: AIMS2 Symptom vs DAS28-ESR (n=21) | 0.336 |
| Month 24: AIMS2 Physical vs DAS28-ESR (n=21) | 0.110 |
| Month 24: AIMS2 Affect vs DAS28-ESR (n=21) | 0.180 |
| Month 24: AIMS2 Symptom vs DAS28-ESR (n=20) | 0.233 |
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.
| correlation coefficient | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Baseline: AIMS2 Physical vs DAS 28-CRP (n=22) | 0.014 |
| Baseline: AIMS2 Affect vs DAS 28-CRP (n=22) | 0.238 |
| Baseline: AIMS2 Symptom vs DAS 28-CRP (n=22) | 0.097 |
| Month 6: AIMS2 Physical vs DAS 28-CRP (n=19) | 0.443 |
| Month 6: AIMS2 Affect vs DAS 28-CRP (n=20) | 0.344 |
| Month 6: AIMS2 Symptom vs DAS 28-CRP (n=20) | 0.583 |
| Month 12: AIMS2 Physical vs DAS 28-CRP (n=19) | 0.697 |
| Month 12: AIMS2 Affect vs DAS 28-CRP (n=19) | 0.425 |
| Month 12: AIMS2 Symptom vs DAS 28-CRP (n=19) | 0.541 |
| Month 18: AIMS2 Physical vs DAS 28-CRP (n=16) | 0.554 |
| Month 18: AIMS2 Affect vs DAS 28-CRP (n=16) | 0.368 |
| Month 18: AIMS2 Symptom vs DAS 28-CRP (n=16) | 0.617 |
| Month 24: AIMS2 Physical vs DAS 28-CRP (n=18) | 0.494 |
| Month 24: AIMS2 Affect vs DAS 28-CRP (n=18) | 0.487 |
| Month 24: AIMS2 Symptom vs DAS 28-CRP (n=18) | 0.478 |
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.
| correlation coefficient | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Baseline: DAS28-ESR vs VAS fatigue (n=50) | 0.370 |
| Month 6: DAS28-ESR vs VAS fatigue (n=38) | 0.394 |
| Month 12: DAS28-ESR vs VAS fatigue (n=34) | 0.215 |
| Month 18: DAS28-ESR vs VAS fatigue (n=21) | 0.073 |
| Month 24: DAS28-ESR vs VAS fatigue (n=21) | 0.401 |
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.
| correlation coefficient | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Baseline: DAS28-CRP vs VAS fatigue (n=22) | 0.096 |
| Month 6: DAS28-CRP vs VAS fatigue (n=19) | 0.291 |
| Month 12: DAS28-CRP vs VAS fatigue (n=19) | 0.271 |
| Month 18: DAS28-CRP vs VAS fatigue (n=16) | 0.193 |
| Month 24: DAS28-CRP vs VAS fatigue (n=17) | 0.300 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) | — | 1/62 (1.6%) | 4/62 (6.5%) |
| Event | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| SpondylodiscitisGeneral disorders | 1/62 |
| Event | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| AsthmaGeneral disorders | 1/62 |
| TachycardiaGeneral disorders | 1/62 |
| HeadacheGeneral disorders | 1/62 |
| NauseaGeneral disorders | 1/62 |
| Purulent rhinorrheaGeneral disorders | 1/62 |
Intention to treat (ITT) population included all participants for whom the primary endpoint or one of the secondary endpoints could be determined at baseline. Here "N" (Overall Number of Baseline Participants) includes participants with non-missing baseline data.
| Age, Continuous(years) | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Mean | 55.2 ± 11.28 |
| Sex: Female, Male(Participants) | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) |
|---|---|
| Female | 46 |
| Male | 15 |
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