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Trial record 51 of 2725 for:    Rheumatoid Arthritis

Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis 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: NCT01077258
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : April 8, 2014
Last Update Posted : April 25, 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 4208
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 for up to 24 months.
Period Title: Overall Study
Started 4208
Completed 1640
Not Completed 2568
Reason Not Completed
Lost to Follow-up             1390
Adverse drug reaction             218
Lack of Efficacy             663
Clinical remission             37
Other reasons             260
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
Overall Number of Baseline Participants 4208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4208 participants
54.6  (13.2)
[1]
Measure Description: Age data was available for 4147 participants
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4208 participants
Female 3199
Male 958
[1]
Measure Description: Gender data available for 4157 participants
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 4208 participants
4208
1.Primary Outcome
Title Change From Baseline in Disease Activity Score (DAS) 28
Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24
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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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (n=2620) -1.5  (1.3)
Month 6 (n=2243 -1.8  (1.4)
Month 9 (n=1877) -1.9  (1.4)
Month 12 (n=1776) -2.0  (1.4)
Month 18 (n=1519) -2.1  (1.4)
Month 24 (n=1248) -2.2  (1.4)
2.Primary Outcome
Title Percentage of Participants in DAS28 Remission
Hide Description Clinical remission is defined as a disease activity score (DAS) 28 score of < 2.6. 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 the patient’s assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Time Frame Months 3, 6, 9, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (n=2620) 18.1
Month 6 (n=2243) 22.0
Month 9 (n=1877) 26.1
Month 12 (n=1776) 27.2
Month 18 (n=1519) 29.8
Month 24 (n=1248) 34.6
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 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 the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (n=2620) 38.9
Month 6 (n=2243) 49.1
Month 9 (n=1877) 54.7
Month 12 (n=1776) 56.3
Month 18 (n=1519) 60.1
Month 24 (n=1248) 61.9
4.Secondary Outcome
Title Percentage of Participants With Low, Moderate and High Disease Activity
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 the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

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.

Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24
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Hide Analysis Population Description
Full analysis set with available data at each time point
Arm/Group Title Month 0 Month 3 Month 6 Month 9 Month 12 Month 18 Month 24
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Baseline
3 months after inclusion
6 months after inclusion
9 months after inclusion
12 months after inclusion
18 months after inclusion
24 months after inclusion
Overall Number of Participants Analyzed 2950 2620 2243 1877 1776 1519 1248
Measure Type: Number
Unit of Measure: percentage of participants
Low disease activity 0.0 30.2 36.5 41.8 43.7 46.7 51.4
Moderate disease ctivity 35.7 45.9 45.6 43.9 43.1 41.7 37.7
High disease activity 64.3 23.9 17.9 14.3 13.2 11.6 10.9
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, 9, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Mean (Standard Deviation)
Unit of Measure: mm/hour
Month 0 (n=2900) 32.1  (22.0)
Month 3 (n=2684) 23.2  (20.2)
Month 6 (n=2259) 22.1  (19.1)
Month 9 (n=1910) 21.6  (18.2)
Month 12 (n=1805) 21.4  (17.9)
Month 18 (n=1515) 21.0  (17.5)
Month 24 (n=1263) 21.2  (18.7)
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, 9, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Mean (Standard Deviation)
Unit of Measure: mg/L
Month 0 (n=2899) 20.0  (36.6)
Month 3 (n=2677) 11.9  (31.9)
Month 6 (n=2289) 9.2  (19.5)
Month 9 (n=1936) 8.1  (15.8)
Month 12 (n=1813) 8.0  (17.7)
Month 18 (n=1537) 6.6  (11.9)
Month 24 (n=1297) 5.7  (10.9)
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, 9, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Mean (Standard Deviation)
Unit of Measure: tender joints
Month 0 (n=2950) 10.6  (6.7)
Month 3 (n=2778) 5.4  (6.1)
Month 6 (n=2393) 4.3  (5.4)
Month 9 (n=2010) 3.9  (5.4)
Month 12 (n=1886) 3.6  (5.0)
Month 18 (n=1621) 3.4  (4.9)
Month 24 (n=1339) 3.1  (4.5)
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, 9, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Mean (Standard Deviation)
Unit of Measure: swollen joints
Month 0 (n=2950) 7.7  (5.6)
Month 3 (n=2768) 3.7  (4.6)
Month 6 (n=2375) 3.0  (4.1)
Month 9 (n=2003) 2.6  (3.8)
Month 12 (n=1868) 2.4  (3.7)
Month 18 (n=1609) 2.1  (3.4)
Month 24 (n=1326) 2.0  (3.4)
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, 9, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 0 (n=2938) 61.9  (22.4)
Month 3 (n=2755) 68.4  (22.5)
Month 6 (n=2369) 70.4  (22.2)
Month 9 (n=1997) 71.3  (22.5)
Month 12 (n=1882) 71.9  (22.4)
Month 18 (n=1623) 72.4  (22.5)
Month 24 (n=1341) 72.7  (22.7)
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) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Time Frame Baseline and Months 3, 6, 9, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Mean (Standard Deviation)
Unit of Measure: cm
Month 0 (n=2950) 6.3  (1.9)
Month 3 (n=2731) 4.7  (2.2)
Month 6 (n=2353) 4.4  (2.1)
Month 9 (n=1975) 4.2  (2.1)
Month 12 (n=1869) 4.1  (2.1)
Month 18 (n=1609) 4.0  (2.1)
Month 24 (n=1339) 3.8  (2.1)
11.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) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Time Frame Baseline and Month 3, 6, 9, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Mean (Standard Deviation)
Unit of Measure: cm
Month 0 (n=2940) 5.8  (2.5)
Month 3 (n=2727) 4.5  (2.7)
Month 6 (n=2351) 4.2  (2.6)
Month 9 (n=1976) 4.0  (2.6)
Month 12 (n=1864) 4.0  (2.6)
Month 18 (n=1608) 3.9  (2.6)
Month 24 (n=1335) 3.7  (2.6)
12.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) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Mean (Standard Deviation)
Unit of Measure: cm
Month 0 (n=2942) 6.4  (2.1)
Month 3 (n=2732) 4.5  (2.4)
Month 6 (n=2356) 4.2  (2.4)
Month 9 (n=1973) 4.1  (2.4)
Month 12 (n=1866) 3.9  (2.4)
Month 18 (n=1609) 3.9  (2.4)
Month 24 (n=1339) 3.7  (2.4)
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 3, 6, 9, 18, and 24
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Hide Analysis Population Description
Full analysis set with available data at each time point
Arm/Group Title Month 0 Month 3 Month 6 Month 9 Month 18 Month 24
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Baseline
3 months after inclusion
6 months after inclusion
9 months after inclusion
18 months after inclusion
24 months after inclusion
Overall Number of Participants Analyzed 2864 2648 2288 1914 1513 1302
Measure Type: Number
Unit of Measure: percentage of participants
No days of impairment 19.7 35.8 40.3 45.7 51.4 52.1
Less than 7 days of impairment 28.5 36.3 35.5 33.3 30.0 30.4
7 to 14 days of impairment 28.8 16.1 14.9 13.2 12.0 10.8
More than 14 days of impairment 23.0 11.7 9.4 7.8 6.7 6.7
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. The Baseline measurement includes data for the prior 12 months.
Time Frame Baseline and Months 6, 12, 18, and 24
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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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Mean (Standard Deviation)
Unit of Measure: days
Month 0 (n=1168) 20.6  (52.4)
Month 6 (n=938) 9.9  (33.2)
Month 12 (n=728) 4.4  (21.3)
Month 18 (n=604) 5.2  (27.1)
Month 24 (n=507) 3.8  (17.9)
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 Month 6, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set 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 for up to 24 months.
Overall Number of Participants Analyzed 2950
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n=2893) 21.6
Month 6 (n=2293) 7.2
Month 12 (n=1844) 5.8
Month 18 (n=1584) 5.4
Month 24 (n=1320) 3.6
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, 9, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data at each time point (indicated by n)
Arm/Group Title Month 0 Month 3 Month 6 Month 9 Month 12 Month 18 Month 24
Hide Arm/Group Description:
Baseline
3 months after inclusion
6 months after inclusion
9 months after inclusion
12 months after inclusion
18 months after inclusion
24 months after inclusion
Overall Number of Participants Analyzed 2950 2820 2415 2041 1917 1651 1372
Measure Type: Number
Unit of Measure: percentage of participants
Methotrexate 54.0 52.3 53.2 53.1 53.2 52.9 51.0
Sulfasalazine 6.2 3.7 3.6 3.2 3.5 3.3 2.8
Hydroxychloroquine/Chloroquine 2.5 2.0 1.6 1.2 1.2 1.3 1.4
Leflunomide 22.1 18.0 15.9 15.3 15.0 14.1 12.7
Other disease-modifying antirheumatic drug 4.5 2.8 2.5 2.3 2.0 2.2 2.1
Analgesics 21.8 15.4 14.9 14.0 12.9 11.7 12.0
Non-steroidal anti-inflammatory drug 46.1 36.9 34.2 33.9 32.7 31.7 30.5
Cyclo-oxygenase 2 (COX-2) Inhibitors 12.4 10.4 10.2 9.6 9.2 9.6 9.7
Systemic glucocorticoids 80.9 73.4 69.1 65.7 62.1 58.8 57.4
Time Frame Adverse events (AEs) were collected throughout the 24-month period.
Adverse Event Reporting Description During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
 
Arm/Group Title Rheumatoid Arthritis
Hide Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
All-Cause Mortality
Rheumatoid Arthritis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rheumatoid Arthritis
Affected / at Risk (%)
Total   245/4208 (5.82%) 
Blood and lymphatic system disorders   
Anemia hemolytic autoimmune  1  1/4208 (0.02%) 
Leukopenia  1  1/4208 (0.02%) 
Pancytopenia  1  1/4208 (0.02%) 
Thrombocytopenia  1  1/4208 (0.02%) 
Cardiac disorders   
Cardiac failure  1  3/4208 (0.07%) 
Tachycardia  1  3/4208 (0.07%) 
Angina pectoris  1  2/4208 (0.05%) 
Congestive cardiomyopathy  1  2/4208 (0.05%) 
Myocardial infarction  1  2/4208 (0.05%) 
Palpitations  1  2/4208 (0.05%) 
Acute myocardial infarction  1  1/4208 (0.02%) 
Atrial tachycardia  1  1/4208 (0.02%) 
Pericardial effusion  1  1/4208 (0.02%) 
Pericarditis  1  1/4208 (0.02%) 
Eye disorders   
Eyelid edema  1  3/4208 (0.07%) 
Cataract  1  1/4208 (0.02%) 
Eyelid exfoliation  1  1/4208 (0.02%) 
Eyelids pruritus  1  1/4208 (0.02%) 
Visual acuity reduced  1  1/4208 (0.02%) 
Xerophthalmia  1  1/4208 (0.02%) 
Gastrointestinal disorders   
Nausea  1  5/4208 (0.12%) 
Diarrhea  1  4/4208 (0.10%) 
Abdominal discomfort  1  2/4208 (0.05%) 
Stomatitis  1  2/4208 (0.05%) 
Vomiting  1  2/4208 (0.05%) 
Abdominal pain lower  1  1/4208 (0.02%) 
Abdominal pain upper  1  1/4208 (0.02%) 
Acute abdomen  1  1/4208 (0.02%) 
Aphthous stomatitis  1  1/4208 (0.02%) 
Gastric ulcer  1  1/4208 (0.02%) 
Gastritis  1  1/4208 (0.02%) 
Gastroesophageal reflux disease  1  1/4208 (0.02%) 
Glossodynia  1  1/4208 (0.02%) 
Hematochezia  1  1/4208 (0.02%) 
Hypoesthesia oral  1  1/4208 (0.02%) 
Mouth ulceration  1  1/4208 (0.02%) 
Mouth edema  1  1/4208 (0.02%) 
Oral pain  1  1/4208 (0.02%) 
Pancreatitis acute  1  1/4208 (0.02%) 
Swollen tongue  1  1/4208 (0.02%) 
Tongue blistering  1  1/4208 (0.02%) 
Tongue disorder  1  1/4208 (0.02%) 
General disorders   
Infection site erythema  1  11/4208 (0.26%) 
Injection site pruritus  1  9/4208 (0.21%) 
Injection site reaction  1  5/4208 (0.12%) 
Unevaluable event  1  5/4208 (0.12%) 
Pyrexia  1  4/4208 (0.10%) 
Injection site pain  1  3/4208 (0.07%) 
Edema  1  2/4208 (0.05%) 
Fatigue  1  2/4208 (0.05%) 
Inflammation  1  2/4208 (0.05%) 
Injection site swelling  1  2/4208 (0.05%) 
Injection site urticaria  1  2/4208 (0.05%) 
Adverse drug reaction  1  1/4208 (0.02%) 
Chills  1  1/4208 (0.02%) 
Condition aggravated  1  1/4208 (0.02%) 
Death  1  1/4208 (0.02%) 
Disease recurrence  1  1/4208 (0.02%) 
Injection site induration  1  1/4208 (0.02%) 
Injection site scab  1  1/4208 (0.02%) 
Local swelling  1  1/4208 (0.02%) 
Malaise  1  1/4208 (0.02%) 
Mucosal dryness  1  1/4208 (0.02%) 
Obstruction  1  1/4208 (0.02%) 
Peripheral edema  1  1/4208 (0.02%) 
Hepatobiliary disorders   
Hepatotoxicity  1  1/4208 (0.02%) 
Immune system disorders   
Hypersensitivity  1  1/4208 (0.02%) 
Infections and infestations   
Nasopharyngitis  1  11/4208 (0.26%) 
Pneumonia  1  10/4208 (0.24%) 
Bronchitis  1  6/4208 (0.14%) 
Urinary tract infection  1  5/4208 (0.12%) 
Herpes zoster  1  4/4208 (0.10%) 
Oral herpes  1  4/4208 (0.10%) 
Bronchopneumonia  1  3/4208 (0.07%) 
Cellulitis  1  3/4208 (0.07%) 
Laryngitis  1  3/4208 (0.07%) 
Rash pustular  1  3/4208 (0.07%) 
Sinusitis  1  3/4208 (0.07%) 
Upper respiratory tract infection  1  3/4208 (0.07%) 
Gastrointestinal infection  1  2/4208 (0.05%) 
Infection  1  2/4208 (0.05%) 
Localized infection  1  2/4208 (0.05%) 
Respiratory tract infection  1  2/4208 (0.05%) 
Sepsis  1  2/4208 (0.05%) 
Tonsillitis  1  2/4208 (0.05%) 
Abscess limb  1  1/4208 (0.02%) 
Acute tonsillitis  1  1/4208 (0.02%) 
Chronic sinusitis  1  1/4208 (0.02%) 
Device-related infection  1  1/4208 (0.02%) 
Diverticulitis  1  1/4208 (0.02%) 
Encephalitis viral  1  1/4208 (0.02%) 
Fungal infection  1  1/4208 (0.02%) 
Furuncle  1  1/4208 (0.02%) 
Gastroenteritis  1  1/4208 (0.02%) 
Genital herpes  1  1/4208 (0.02%) 
Herpes simplex  1  1/4208 (0.02%) 
Herpes virus infection  1  1/4208 (0.02%) 
Infection susceptibility increased  1  1/4208 (0.02%) 
Mastoiditis  1  1/4208 (0.02%) 
Otitis media  1  1/4208 (0.02%) 
Pneumocystis jiroveci pneumonia  1  1/4208 (0.02%) 
Pneumonia staphylococcal  1  1/4208 (0.02%) 
Pyelonephritis  1  1/4208 (0.02%) 
Pyothorax  1  1/4208 (0.02%) 
Sinobronchitis  1  1/4208 (0.02%) 
Skin infection  1  1/4208 (0.02%) 
Staphylococcal infection  1  1/4208 (0.02%) 
Tooth abscess  1  1/4208 (0.02%) 
Vulvovaginal mycotic infection  1  1/4208 (0.02%) 
Injury, poisoning and procedural complications   
Rib fracture  1  3/4208 (0.07%) 
Foot fracture  1  2/4208 (0.05%) 
Humerus fracture  1  2/4208 (0.05%) 
Thoracic vertebral fracture  1  2/4208 (0.05%) 
Ankle fracture  1  1/4208 (0.02%) 
Bloody airway discharge  1  1/4208 (0.02%) 
Femur fracture  1  1/4208 (0.02%) 
Limb injury  1  1/4208 (0.02%) 
Spinal fracture  1  1/4208 (0.02%) 
Tendon rupture  1  1/4208 (0.02%) 
Wound secretion  1  1/4208 (0.02%) 
Investigations   
Arthroscopy  1  2/4208 (0.05%) 
Antinuclar antibody positive  1  1/4208 (0.02%) 
Arteriogram coronary  1  1/4208 (0.02%) 
DNA antibody positive  1  1/4208 (0.02%) 
Electrophoresis protein abnormal  1  1/4208 (0.02%) 
Hepatic enzyme increased  1  1/4208 (0.02%) 
Transaminase increased  1  1/4208 (0.02%) 
Metabolism and nutrition disorders   
Electrolyte imbalance  1  1/4208 (0.02%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1  3/4208 (0.07%) 
Joint effusion  1  3/4208 (0.07%) 
Bursitis  1  1/4208 (0.02%) 
Fasciitis  1  1/4208 (0.02%) 
Lupus-like syndrome  1  1/4208 (0.02%) 
Muscle spasms  1  1/4208 (0.02%) 
Muscular weakness  1  1/4208 (0.02%) 
Myalgia  1  1/4208 (0.02%) 
Neck pain  1  1/4208 (0.02%) 
Osteonecrosis  1  1/4208 (0.02%) 
Osteoporosis  1  1/4208 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin cancer  1  2/4208 (0.05%) 
Skin papilloma  1  2/4208 (0.05%) 
Breast cancer  1  1/4208 (0.02%) 
Bronchial carcinoma  1  1/4208 (0.02%) 
Gastric cancer  1  1/4208 (0.02%) 
Large intestine cancer  1  1/4208 (0.02%) 
Laryngeal cancer  1  1/4208 (0.02%) 
Metastases to central nervous system  1  1/4208 (0.02%) 
Metastases to liver  1  1/4208 (0.02%) 
Papillary tumor of renal pelvis  1  1/4208 (0.02%) 
Squamous cell carcinoma  1  1/4208 (0.02%) 
Transitional cell carcinoma  1  1/4208 (0.02%) 
Urteric cancer local  1  1/4208 (0.02%) 
Nervous system disorders   
Dizziness  1  6/4208 (0.14%) 
Cerebrovascular accident  1  3/4208 (0.07%) 
Headache  1  3/4208 (0.07%) 
Somnolence  1  3/4208 (0.07%) 
Anosmia  1  1/4208 (0.02%) 
Aphasia  1  1/4208 (0.02%) 
Carotid artery stenosis  1  1/4208 (0.02%) 
Hemiparesis  1  1/4208 (0.02%) 
Hypogeusia  1  1/4208 (0.02%) 
Neuralgia  1  1/4208 (0.02%) 
Neurological symptom  1  1/4208 (0.02%) 
Polyneuropathy  1  1/4208 (0.02%) 
Transient ischemic attack  1  1/4208 (0.02%) 
Psychiatric disorders   
Anxiety  1  2/4208 (0.05%) 
Restlessness  1  2/4208 (0.05%) 
Insomnia  1  1/4208 (0.02%) 
Panic reaction  1  1/4208 (0.02%) 
Sleep disorder  1  1/4208 (0.02%) 
Renal and urinary disorders   
Bladder tamponade  1  1/4208 (0.02%) 
Chromaturia  1  1/4208 (0.02%) 
Cystitis hemorrhagic  1  1/4208 (0.02%) 
Micturition urgency  1  1/4208 (0.02%) 
Nephritis  1  1/4208 (0.02%) 
Nephrolithiasis  1  1/4208 (0.02%) 
Reproductive system and breast disorders   
Erectile dysfunction  1  1/4208 (0.02%) 
Uterine prolapse  1  1/4208 (0.02%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  14/4208 (0.33%) 
Dyspnea  1  7/4208 (0.17%) 
Pleural effusion  1  2/4208 (0.05%) 
Pulmonary embolism  1  2/4208 (0.05%) 
Alveolitis  1  1/4208 (0.02%) 
Alveolitis allergic  1  1/4208 (0.02%) 
Dry throat  1  1/4208 (0.02%) 
Hypercapnia  1  1/4208 (0.02%) 
Interstitial lung disease  1  1/4208 (0.02%) 
Oropharyngeal pain  1  1/4208 (0.02%) 
Pleurisy  1  1/4208 (0.02%) 
Pneumothorax  1  1/4208 (0.02%) 
Respiratory distress  1  1/4208 (0.02%) 
Throat irritation  1  1/4208 (0.02%) 
Upper airway obstruction  1  1/4208 (0.02%) 
Skin and subcutaneous tissue disorders   
Rash  1  10/4208 (0.24%) 
Alopecia  1  6/4208 (0.14%) 
Pruritus  1  5/4208 (0.12%) 
Dermatitis allergic  1  4/4208 (0.10%) 
Eczema  1  3/4208 (0.07%) 
Pruritus generalized  1  3/4208 (0.07%) 
Rash pruritic  1  3/4208 (0.07%) 
Erythema  1  2/4208 (0.05%) 
Nail discoloration  1  2/4208 (0.05%) 
Pustular psoriasis  1  2/4208 (0.05%) 
Skin reaction  1  2/4208 (0.05%) 
Acne  1  1/4208 (0.02%) 
Angioedema  1  1/4208 (0.02%) 
Cutaneous vasculitis  1  1/4208 (0.02%) 
Dermatitis acneiform  1  1/4208 (0.02%) 
Dry skin  1  1/4208 (0.02%) 
Lichenoid keratosis  1  1/4208 (0.02%) 
Psoriasis  1  1/4208 (0.02%) 
Rash generalized  1  1/4208 (0.02%) 
Skin discomfort  1  1/4208 (0.02%) 
Skin nodule  1  1/4208 (0.02%) 
Skin ulcer  1  1/4208 (0.02%) 
Swelling face  1  1/4208 (0.02%) 
Urticaria  1  1/4208 (0.02%) 
Surgical and medical procedures   
Hospitalization  1  6/4208 (0.14%) 
Joint arthroplasty  1  4/4208 (0.10%) 
Synovectomy  1  3/4208 (0.07%) 
Injection  1  2/4208 (0.05%) 
Surgery  1  2/4208 (0.05%) 
Antibiotic therapy  1  1/4208 (0.02%) 
Arthrodesis  1  1/4208 (0.02%) 
Esophageal operation  1  1/4208 (0.02%) 
Mastoid operation  1  1/4208 (0.02%) 
Mastoidectomy  1  1/4208 (0.02%) 
Rehabilitation therapy  1  1/4208 (0.02%) 
Sinus operation  1  1/4208 (0.02%) 
Spinal operation  1  1/4208 (0.02%) 
Stent placement  1  1/4208 (0.02%) 
Therapy cessation  1  1/4208 (0.02%) 
Vertebroplasty  1  1/4208 (0.02%) 
Vascular disorders   
Hypertension  1  3/4208 (0.07%) 
Flushing  1  1/4208 (0.02%) 
Venous thrombosis  1  1/4208 (0.02%) 
Venous thrombosis limb  1  1/4208 (0.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v12.1
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   0/4208 (0.00%) 
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: NCT01077258     History of Changes
Other Study ID Numbers: P10-448
First Submitted: February 25, 2010
First Posted: March 1, 2010
Results First Submitted: February 28, 2014
Results First Posted: April 8, 2014
Last Update Posted: April 25, 2014