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

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ClinicalTrials.gov Identifier: NCT01521884
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : February 19, 2015
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Time Perspective: Prospective
Condition Rheumatoid Arthritis
Intervention Other: SC anti-TNF
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 62
Completed 35
Not Completed 27
Reason Not Completed
Non Responders             10
Adverse Event             5
Pregnancy             1
Withdrawal by Subject             1
Physician Decision             2
Protocol Violation             3
Participant non-eligible             1
Lost to Follow-up             4
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description 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 Number of Baseline Participants 61
Hide Baseline Analysis Population Description
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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants
55.2  (11.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
46
  75.4%
Male
15
  24.6%
1.Primary Outcome
Title Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
2.Primary Outcome
Title Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
3.Primary Outcome
Title Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
AIMS2-Physical Score 2.1  (1.3)
AIMS2-Affect Score 3.5  (1.8)
AIMS2-Symptom Score 4.3  (2.7)
4.Primary Outcome
Title Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
5.Primary Outcome
Title Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
6.Secondary Outcome
Title Visual Analog Scale (VAS) Fatigue Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
7.Secondary Outcome
Title Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
8.Secondary Outcome
Title Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
9.Secondary Outcome
Title Health Assessment Questionnaire (HAQ) Total Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
10.Other Pre-specified Outcome
Title Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: correlation coefficient
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
11.Other Pre-specified Outcome
Title 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)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: correlation coefficient
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
12.Other Pre-specified Outcome
Title 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)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: correlation coefficient
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
13.Other Pre-specified Outcome
Title 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
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: correlation coefficient
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
14.Other Pre-specified Outcome
Title 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
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description:
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 Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: correlation coefficient
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
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Hide Arm/Group Description 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.
All-Cause Mortality
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Affected / at Risk (%)
Total   1/62 (1.61%) 
General disorders   
Spondylodiscitis * 1  1/62 (1.61%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Affected / at Risk (%)
Total   4/62 (6.45%) 
General disorders   
Asthma * 1  1/62 (1.61%) 
Tachycardia * 1  1/62 (1.61%) 
Headache * 1  1/62 (1.61%) 
Nausea * 1  1/62 (1.61%) 
Purulent rhinorrhea * 1  1/62 (1.61%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Designation of primary and secondary endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01521884     History of Changes
Other Study ID Numbers: 0881A1-4748
B1801046 ( Other Identifier: Alias Study Number )
First Submitted: August 19, 2011
First Posted: January 31, 2012
Results First Submitted: February 3, 2015
Results First Posted: February 19, 2015
Last Update Posted: February 19, 2015