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Trial record 30 of 2725 for:    Rheumatoid Arthritis

Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01078090
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : April 23, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Enrollment 5745
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Period Title: Overall Study
Started 5745
Completed 1152
Not Completed 4593
Reason Not Completed
Lost to Follow-up             2363
Adverse drug reaction (ADR)             453
Lack of Efficacy             1193
ADR and lack of efficacy             61
Other             523
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Baseline Participants 5745
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5745 participants
54.8  (12.8)
[1]
Measure Description: Age data available for 5,727 participants
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5745 participants
Female 4428
Male 1315
[1]
Measure Description: Gender data missing for 2 participants
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 5745 participants
5745
1.Primary Outcome
Title Change From Baseline in Disease Activity Score (DAS) 28
Hide Description

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and general health (measured on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.

A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (n=3918) -1.6  (1.3)
Month 6 (n=3347) -1.8  (1.4)
Month 12 (n=2872) -2.0  (1.4)
Month 18 (n=2397) -2.1  (1.4)
Month 24 (n=2099) -2.2  (1.4)
Month 30 (n=1810) -2.3  (1.5)
Month 36 (n=1564) -2.3  (1.5)
Month 48 (n=1261) -2.3  (1.5)
Month 60 (n=934) -2.4  (1.5)
2.Primary Outcome
Title Percentage of Participants in DAS28 Remission
Hide Description Clinical remission is defined as a DAS28 score of < 2.6. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Time Frame Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (n=3918) 12.8
Month 6 (n=3347) 16.9
Month 12 (n=2872) 19.4
Month 18 (n=2397) 23.0
Month 24 (n=2099) 23.3
Month 30 (n=1810) 24.3
Month 36 (n=1564) 24.0
Month 48 (n=1261) 24.7
Month 60 (n=934) 25.6
3.Secondary Outcome
Title Percentage of Participants With a Significant Therapeutic Response
Hide Description

Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.

The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (n=3918) 40.8
Month 6 (n=3347) 50.5
Month 12 (n=2872) 53.6
Month 18 (n=2397) 58.7
Month 24 (n=2099) 60.3
Month 30 (n=1810) 63.3
Month 36 (n=1564) 64.6
Month 48 (n=1261) 64.2
Month 60 (n=934) 65.5
4.Secondary Outcome
Title Percentage of Participants With Low, Moderate and High Disease Activity
Hide Description

Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1.

The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) participants with available data at each time point.
Arm/Group Title Month 0 Month 3 Month 6 Month 12 Month 18 Month 24 Month 30 Month 36 Month 48 Month 60
Hide Arm/Group Description:
Baseline
3 months after inclusion
6 months after inclusion
12 months after inclusion
18 months after inclusion
24 months after inclusion
30 months after inclusion
36 months after inclusion
48 months after inclusion
60 months after inclusion
Overall Number of Participants Analyzed 4400 3918 3347 2872 2397 2099 1810 1564 1261 934
Measure Type: Number
Unit of Measure: percentage of participants
Low disease activity 0.0 23.9 29.8 33.0 38.7 38.5 41.5 40.5 40.7 41.9
Moderate disease activity 26.1 45.9 46.6 46.6 43.6 45.0 43.6 45.3 45.4 45.3
High disease activity 73.9 30.2 23.6 20.3 17.7 16.5 14.9 14.3 13.9 12.8
5.Secondary Outcome
Title Erythrocyte Sedimentation Rate (ESR) Over Time
Hide Description Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Mean (Standard Deviation)
Unit of Measure: mm/hour
Month 0 (n=4400) 34.5  (23.1)
Month 3 (n=4083) 24.7  (20.4)
Month 6 (n=3467) 23.8  (19.9)
Month 12 (n=2966) 22.8  (18.9)
Month 18 (n=2472) 22.0  (18.4)
Month 24 (n=2156) 21.6  (17.7)
Month 30 (n=1860) 21.4  (18.1)
Month 36 (n=1685) 20.9  (17.5)
Month 48 (n=1341) 21.5  (17.8)
Month 60 (n=998) 21.2  (17.6)
6.Secondary Outcome
Title C-Reactive Protein (CRP) Levels Over Time
Hide Description C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.
Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Mean (Standard Deviation)
Unit of Measure: mg/L
Month 0 (n=3852) 33.7  (63.8)
Month 3 (n=3209) 19.8  (56.3)
Month 6 (n=2671) 16.1  (29.9)
Month 12 (n=2192) 17.0  (89.8)
Month 18 (n=1770) 14.9  (68.0)
Month 24 (n=1573) 12.3  (27.3)
Month 30 (n=1355) 12.0  (26.4)
Month 36 (n=1211) 11.0  (22.8)
Month 48 (n=1000) 11.6  (27.8)
Month 60 (n=756) 9.2  (16.7)
7.Secondary Outcome
Title Tender Joint Count (TJC) Over Time
Hide Description Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Mean (Standard Deviation)
Unit of Measure: tender joints
Month 0 (n=4400) 12.3  (7.3)
Month 3 (n=4165) 6.4  (6.7)
Month 6 (n=3568) 5.4  (6.3)
Month 12 (n=3026) 4.9  (6.0)
Month 18 (n=2533) 4.4  (5.7)
Month 24 (n=2224) 4.2  (5.5)
Month 30 (n=1939) 4.1  (5.6)
Month 36 (n=1681) 4.0  (5.4)
Month 48 (n=1373) 3.9  (5.4)
Month 60 (n=1029) 3.9  (5.4)
8.Secondary Outcome
Title Swollen Joint Count (SJC) Over Time
Hide Description Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Mean (Standard Deviation)
Unit of Measure: swollen joints
Month 0 (n=4400) 9.5  (6.3)
Month 3 (n=4165) 4.7  (5.3)
Month 6 (n=3568) 3.9  (4.9)
Month 12 (n=3026) 3.5  (4.5)
Month 18 (n=2533) 3.1  (4.3)
Month 24 (n=2224) 2.7  (3.9)
Month 30 (n=1939) 2.7  (3.9)
Month 36 (n=1681) 2.7  (3.8)
Month 48 (n=1373) 2.4  (3.8)
Month 60 (n=1029) 2.3  (3.6)
9.Secondary Outcome
Title Hannover Functional Questionnaire (FFbH) Over Time
Hide Description A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0% indicates maximal impairment and 100% indicates maximal functional capacity.
Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 0 (n=4360) 57.7  (23.2)
Month 3 (n=4075) 65.1  (23.4)
Month 6 (n=3498) 67.1  (23.7)
Month 12 (n=2978) 68.3  (23.6)
Month 18 (n=2493) 69.4  (23.4)
Month 24 (n=2194) 69.9  (23.0)
Month 30 (n=1908) 70.1  (23.3)
Month 36 (n=1715) 70.4  (23.5)
Month 48 (n=1394) 70.0  (23.7)
Month 60 (n=1048) 69.9  (24.1)
10.Secondary Outcome
Title Patients Global Assessment of Disease Activity Over Time
Hide Description Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Mean (Standard Deviation)
Unit of Measure: cm
Month 0 (n=4400) 6.6  (1.9)
Month 3 (n=4076) 4.8  (2.2)
Month 6 (n=3483) 4.5  (2.2)
Month 12 (n=2968) 4.3  (2.1)
Month 18 (n=2489) 4.1  (2.1)
Month 24 (n=2196) 4.1  (2.1)
Month 30 (n=1903) 4.0  (2.1)
Month 36 (n=1712) 3.9  (2.1)
Month 48 (n=1386) 3.9  (2.1)
Month 60 (n=1047) 3.9  (2.1)
11.Secondary Outcome
Title Participants Assessment of Pain Over Time
Hide Description Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Mean (Standard Deviation)
Unit of Measure: cm
Month 0 (n=4388) 6.8  (2.0)
Month 3 (n=4079) 4.7  (2.4)
Month 6 (n=3484) 4.3  (2.4)
Month 12 (n=2966) 4.1  (2.3)
Month 18 (n=2491) 3.9  (2.3)
Month 24 (n=2190) 3.9  (2.3)
Month 30 (n=1904) 3.8  (2.3)
Month 36 (n=1712) 3.7  (2.3)
Month 48 (n=1383) 3.8  (2.3)
Month 60 (n=1048) 3.7  (2.3)
12.Secondary Outcome
Title Participants Assessment of Fatigue Over Time
Hide Description Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Mean (Standard Deviation)
Unit of Measure: cm
Month 0 (n=4389) 6.0  (2.6)
Month 3 (n=4076) 4.5  (2.7)
Month 6 (n=3491) 4.2  (2.7)
Month 12 (n=2950) 4.0  (2.6)
Month 18 (n=2491) 3.8  (2.6)
Month 24 (n=2188) 3.8  (2.6)
Month 30 (n=1906) 3.7  (2.5)
Month 36 (n=1706) 3.6  (2.5)
Month 48 (n=1381) 3.6  (2.5)
Month 60 (n=1039) 3.6  (2.5)
13.Secondary Outcome
Title Percentage of Participants With Impairment in Daily Activities
Hide Description Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.
Time Frame Baseline and Months 6, 18, 24, and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) participants with available data at each time point.
Arm/Group Title Month 0 Month 6 Month 18 Month 24 Month 30
Hide Arm/Group Description:
Baseline
6 months after inclusion
18 months after inclusion
24 months after inclusion
30 months after inclusion
Overall Number of Participants Analyzed 4315 3428 2387 2150 1860
Measure Type: Number
Unit of Measure: percentage of participants
No days of impairment 17.9 38.8 45.8 44.5 45.2
Less than 7 days of impairment 28.2 34.7 33.5 35.3 36.0
7 to 14 days of impairment 28.0 16.1 13.4 13.1 12.8
More than 14 days of impairment 25.9 10.4 7.2 7.1 6.0
14.Secondary Outcome
Title Number of Days Missed From Work Due to Rheumatoid Arthritis
Hide Description Participants reported the number of days they had missed from work in the prior 6 months due to rheumatoid arthritis. The Baseline measurement includes data for the prior 12 months.
Time Frame Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set participants who were employed and with available data at each time point (indicated by n)
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Mean (Standard Deviation)
Unit of Measure: days
Month 0 (n=1503) 51.0  (78.7)
Month 6 (n=1173) 11.6  (35.5)
Month 12 (n=1016) 8.6  (30.9)
Month 18 (n=840) 6.8  (26.0)
Month 24 (n=744) 4.9  (19.8)
Month 30 (n=637) 5.2  (19.8)
Month 36 (n=566) 5.2  (21.9)
Month 48 (n=452) 4.8  (23.6)
Month 60 (n=339) 1.8  (9.5)
15.Secondary Outcome
Title Percentage of Participants With In-patient Hospitalization
Hide Description The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.
Time Frame Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set participants who were employed and with available data at each time point (indicated by n)
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
Overall Number of Participants Analyzed 4400
Measure Type: Number
Unit of Measure: percentage of participants
Month 0 (n=4341) 27.6
Month 6 (n=3401) 10.9
Month 12 (n=2924) 7.4
Month 18 (n=2467) 6.7
Month 24 (n=2177) 6.4
Month 30 (n=1900) 5.3
Month 36 (n=1706) 6.2
Month 48 (n=1370) 5.0
Month 60 (n=1037) 5.3
16.Secondary Outcome
Title Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Hide Description [Not Specified]
Time Frame Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Arm/Group Title Month 0 Month 3 Month 6 Month 12 Month 18 Month 24 Month 30 Month 36 Month 48 Month 60
Hide Arm/Group Description:
Baseline
3 months after inclusion
6 months after inclusion
12 months after inclusion
18 months after inclusion
24 months after inclusion
30 months after inclusion
36 months after inclusion
48 months after inclusion
60 months after inclusion
Overall Number of Participants Analyzed 4400 4229 3611 3067 2569 2250 1966 1772 1435 1079
Measure Type: Number
Unit of Measure: percentage of participants
Methotrexate 54.0 51.9 52.2 54.4 53.9 54.8 55.3 54.9 53.7 54.6
Sulfasalazin 6.1 3.9 3.4 3.0 2.6 2.4 2.1 2.5 2.2 1.4
Hydroxychloroquine/Chloroquine 4.0 2.6 2.0 1.6 1.5 2.0 1.6 1.6 1.6 1.3
Leflunomide 20.7 15.9 13.6 13.3 12.4 11.6 11.9 10.8 9.6 8.9
Other disease-modifying antirheumatic drug 5.9 3.2 2.6 2.9 2.5 2.7 2.2 2.2 1.7 1.6
Analgesics 26.9 19.1 17.4 17.1 16.2 16.4 14.1 14.8 14.7 14.2
Non-steroidal anti-inflammatory drug 44.7 36.7 36.3 36.3 37.2 37.2 36.8 35.9 35.1 35.4
Cyclo-oxygenase 2 (COX-2) Inhibitors 20.0 15.8 14.5 12.8 11.4 11.1 10.6 10.2 10.2 9.8
Systemic glucocorticoids 85.6 78.1 75.4 73.1 70.1 68.6 64.5 63.1 59.4 58.1
Time Frame Adverse events were collected throughout the 60-month period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
All-Cause Mortality
Rheumatoid Arthritis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rheumatoid Arthritis
Affected / at Risk (%)
Total   163/5745 (2.84%) 
Blood and lymphatic system disorders   
Anemia  1  1/5745 (0.02%) 
Thrombocytopenia  1  1/5745 (0.02%) 
Cardiac disorders   
Coronary artery disease  1  3/5745 (0.05%) 
Atrial fibrillation  1  2/5745 (0.03%) 
Cardiac failure  1  2/5745 (0.03%) 
Left ventricular failure  1  2/5745 (0.03%) 
Myocardial infarction  1  2/5745 (0.03%) 
Acute coronary syndrome  1  1/5745 (0.02%) 
Acute myocardial infarction  1  1/5745 (0.02%) 
Angina unstable  1  1/5745 (0.02%) 
Atrioventricular block complete  1  1/5745 (0.02%) 
Coronary artery stenosis  1  1/5745 (0.02%) 
Hypertensive heart disease  1  1/5745 (0.02%) 
Ventricular tachycardia  1  1/5745 (0.02%) 
Eye disorders   
Dry eye  1  2/5745 (0.03%) 
Gastrointestinal disorders   
Abdominal pain  1  2/5745 (0.03%) 
Dry mouth  1  2/5745 (0.03%) 
Colitis erosive  1  1/5745 (0.02%) 
Diarrhea  1  1/5745 (0.02%) 
Diverticular perforation  1  1/5745 (0.02%) 
Duodenal ulcer hemorrhage  1  1/5745 (0.02%) 
Enteritis  1  1/5745 (0.02%) 
Gastritis  1  1/5745 (0.02%) 
Gastrointestinal disorder  1  1/5745 (0.02%) 
Ileus paralytic  1  1/5745 (0.02%) 
Intestinal perforation  1  1/5745 (0.02%) 
Pancreatitis  1  1/5745 (0.02%) 
Peritonitis  1  1/5745 (0.02%) 
Vomiting  1  1/5745 (0.02%) 
General disorders   
Death  1  5/5745 (0.09%) 
Impaired healing  1  3/5745 (0.05%) 
Multi-organ failure  1  3/5745 (0.05%) 
Inflammation  1  2/5745 (0.03%) 
Accidental death  1  1/5745 (0.02%) 
Cardiac death  1  1/5745 (0.02%) 
Fat necrosis  1  1/5745 (0.02%) 
Injection site erythema  1  1/5745 (0.02%) 
Injection site swelling  1  1/5745 (0.02%) 
Local swelling  1  1/5745 (0.02%) 
Peripheral edema  1  1/5745 (0.02%) 
Pyrexia  1  1/5745 (0.02%) 
Sudden cardiac death  1  1/5745 (0.02%) 
Hepatobiliary disorders   
Bile duct stone  1  2/5745 (0.03%) 
Cholecystitis  1  2/5745 (0.03%) 
Cholangitis  1  1/5745 (0.02%) 
Hepatitis toxic  1  1/5745 (0.02%) 
Infections and infestations   
Pneumonia  1  9/5745 (0.16%) 
Sepsis  1  9/5745 (0.16%) 
Arthritis bacterial  1  3/5745 (0.05%) 
Oral herpes  1  3/5745 (0.05%) 
Cellulitis  1  2/5745 (0.03%) 
Disseminated tuberculosis  1  2/5745 (0.03%) 
Endocarditis  1  2/5745 (0.03%) 
Escherichia sepsis  1  2/5745 (0.03%) 
Fungal infection  1  2/5745 (0.03%) 
Herpes zoster  1  2/5745 (0.03%) 
Infection  1  2/5745 (0.03%) 
Papilloma virus infection  1  2/5745 (0.03%) 
Peritoneal tuberculosis  1  2/5745 (0.03%) 
Pneumonia primary atypical  1  2/5745 (0.03%) 
Sinusitis  1  2/5745 (0.03%) 
Tooth infection  1  2/5745 (0.03%) 
Urinary tract infection  1  2/5745 (0.03%) 
Urosepsis  1  2/5745 (0.03%) 
Abscess  1  1/5745 (0.02%) 
Abscess limb  1  1/5745 (0.02%) 
Abscess neck  1  1/5745 (0.02%) 
Actinomycosis  1  1/5745 (0.02%) 
Bronchopneumonia  1  1/5745 (0.02%) 
Chronic sinusitis  1  1/5745 (0.02%) 
Diverticulitis  1  1/5745 (0.02%) 
Empyema  1  1/5745 (0.02%) 
Gastroenteritis norovirus  1  1/5745 (0.02%) 
Hepatitis B  1  1/5745 (0.02%) 
Intervertebral discitis  1  1/5745 (0.02%) 
Liver abscess  1  1/5745 (0.02%) 
Localized infection  1  1/5745 (0.02%) 
Neuroborreliosis  1  1/5745 (0.02%) 
Orchitis  1  1/5745 (0.02%) 
Psoas abscess  1  1/5745 (0.02%) 
Pulmonary tuberculosis  1  1/5745 (0.02%) 
Pyothorax  1  1/5745 (0.02%) 
Septic shock  1  1/5745 (0.02%) 
Streptococcal sepsis  1  1/5745 (0.02%) 
Subcutaneous abscess  1  1/5745 (0.02%) 
Tracheobronchitis  1  1/5745 (0.02%) 
Tuberculosis  1  1/5745 (0.02%) 
Wound infection  1  1/5745 (0.02%) 
Injury, poisoning and procedural complications   
Contusion  1  2/5745 (0.03%) 
Femoral neck fracture  1  1/5745 (0.02%) 
Joint sprain  1  1/5745 (0.02%) 
Traumatic fracture  1  1/5745 (0.02%) 
Upper limb fracture  1  1/5745 (0.02%) 
Wound  1  1/5745 (0.02%) 
Investigations   
Transaminases increased  1  2/5745 (0.03%) 
Catheterization cardiac  1  1/5745 (0.02%) 
Platelet count decreased  1  1/5745 (0.02%) 
Weight decreased  1  1/5745 (0.02%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  3/5745 (0.05%) 
Bone pain  1  2/5745 (0.03%) 
Intervertebral disc protrusion  1  1/5745 (0.02%) 
Joint stiffness  1  1/5745 (0.02%) 
Osteonecrosis  1  1/5745 (0.02%) 
Rheumatoid arthritis  1  1/5745 (0.02%) 
Rotator cuff syndrome  1  1/5745 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1  4/5745 (0.07%) 
Prostate cancer  1  2/5745 (0.03%) 
Brain neoplasm  1  1/5745 (0.02%) 
Bronchial carcinoma  1  1/5745 (0.02%) 
Chronic myeloid leukemia  1  1/5745 (0.02%) 
Hemangioblastoma  1  1/5745 (0.02%) 
Lung adenocarcinoma  1  1/5745 (0.02%) 
Lymphangioma  1  1/5745 (0.02%) 
Lymphoma  1  1/5745 (0.02%) 
Malignant melanoma  1  1/5745 (0.02%) 
Malignant mesenteric neoplasm  1  1/5745 (0.02%) 
Metastases to liver  1  1/5745 (0.02%) 
Metastatic malignant melanoma  1  1/5745 (0.02%) 
Neuroendocrine carcinoma of the skin  1  1/5745 (0.02%) 
Non-Hodgkin’s lymphoma  1  1/5745 (0.02%) 
Ovarian cancer  1  1/5745 (0.02%) 
Renal cancer  1  1/5745 (0.02%) 
Small cell lung cancer stage unspecified  1  1/5745 (0.02%) 
Nervous system disorders   
Syncope  1  2/5745 (0.03%) 
Cerebellar infarction  1  1/5745 (0.02%) 
Cerebral infarction  1  1/5745 (0.02%) 
Cerebrovascular accident  1  1/5745 (0.02%) 
Coma  1  1/5745 (0.02%) 
Hyperkinesia  1  1/5745 (0.02%) 
Migraine  1  1/5745 (0.02%) 
Paraparesis  1  1/5745 (0.02%) 
Paresis  1  1/5745 (0.02%) 
Tremor  1  1/5745 (0.02%) 
Psychiatric disorders   
Sleep disorder  1  2/5745 (0.03%) 
Decreased activity  1  1/5745 (0.02%) 
Mental disorder due to a general medical condition  1  1/5745 (0.02%) 
Suicide attempt  1  1/5745 (0.02%) 
Renal and urinary disorders   
Renal failure acute  1  3/5745 (0.05%) 
Nephrolithiasis  1  1/5745 (0.02%) 
Renal failure chronic  1  1/5745 (0.02%) 
Renal impairment  1  1/5745 (0.02%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/5745 (0.02%) 
Epididymitis  1  1/5745 (0.02%) 
Vaginal hemorrhage  1  1/5745 (0.02%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  3/5745 (0.05%) 
Asthma  1  1/5745 (0.02%) 
Chronic obstructive pulmonary disease  1  1/5745 (0.02%) 
Emphysema  1  1/5745 (0.02%) 
Interstitial lung disease  1  1/5745 (0.02%) 
Pulmonary edema  1  1/5745 (0.02%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  2/5745 (0.03%) 
Urticaria  1  2/5745 (0.03%) 
Angioedema  1  1/5745 (0.02%) 
Nail bed inflammation  1  1/5745 (0.02%) 
Social circumstances   
Cardiac assistance device user  1  1/5745 (0.02%) 
Surgical and medical procedures   
Knee arthroplasty  1  7/5745 (0.12%) 
Surgery  1  6/5745 (0.10%) 
Synovectomy  1  4/5745 (0.07%) 
Foot operation  1  3/5745 (0.05%) 
Arthrodesis  1  2/5745 (0.03%) 
Joint arthroplasty  1  2/5745 (0.03%) 
Skin neoplasm excision  1  2/5745 (0.03%) 
Abscess drainage  1  1/5745 (0.02%) 
Ankle operation  1  1/5745 (0.02%) 
Bone operation  1  1/5745 (0.02%) 
Breast operation  1  1/5745 (0.02%) 
Bursa removal  1  1/5745 (0.02%) 
Cardiac pacemaker insertion  1  1/5745 (0.02%) 
Cholecystectomy  1  1/5745 (0.02%) 
Coronary angioplasty  1  1/5745 (0.02%) 
Coronary artery bypass  1  1/5745 (0.02%) 
Hemorrhoid operation  1  1/5745 (0.02%) 
Hip arthroplasty  1  1/5745 (0.02%) 
Hydrocele operation  1  1/5745 (0.02%) 
Hysterectomy  1  1/5745 (0.02%) 
Osteosynthesis  1  1/5745 (0.02%) 
Osteotomy  1  1/5745 (0.02%) 
Prostatic operation  1  1/5745 (0.02%) 
Radiotherapy  1  1/5745 (0.02%) 
Renal transplant  1  1/5745 (0.02%) 
Skin graft  1  1/5745 (0.02%) 
Spinal operation  1  1/5745 (0.02%) 
Stent placement  1  1/5745 (0.02%) 
Transurethral incision of prostate  1  1/5745 (0.02%) 
Vertebroplasty  1  1/5745 (0.02%) 
Vascular disorders   
Axillary vein thrombosis  1  1/5745 (0.02%) 
Jugular vein thrombosis  1  1/5745 (0.02%) 
Subclavian vein thrombosis  1  1/5745 (0.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Rheumatoid Arthritis
Affected / at Risk (%)
Total   58/5745 (1.01%) 
Skin and subcutaneous tissue disorders   
Rash  1  58/5745 (1.01%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01078090     History of Changes
Other Study ID Numbers: HUM 03-1
First Submitted: February 26, 2010
First Posted: March 2, 2010
Results First Submitted: March 19, 2014
Results First Posted: April 23, 2014
Last Update Posted: May 8, 2014