Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice
Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01078090
Collaborator
(none)
5,745
370
119
15.5
0.1
Study Details
Study Description
Brief Summary
Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Patients with Rheumatoid Arthritis and started treatment with adalimumab in a normal clinical setting according to the label were documented. The follow-up observation period was for 5 years and focused on safety information and maintenance of efficacy during the normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.
Study Design
Study Type:
Observational
Actual Enrollment
:
5745 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice
Study Start Date
:
Apr 1, 2003
Actual Primary Completion Date
:
Mar 1, 2013
Actual Study Completion Date
:
Mar 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Rheumatoid arthritis Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Disease Activity Score (DAS) 28 [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
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.
- Percentage of Participants in DAS28 Remission [Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
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.
Secondary Outcome Measures
- Percentage of Participants With a Significant Therapeutic Response [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
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.
- Percentage of Participants With Low, Moderate and High Disease Activity [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
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.
- Erythrocyte Sedimentation Rate (ESR) Over Time [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
- C-Reactive Protein (CRP) Levels Over Time [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
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.
- Tender Joint Count (TJC) Over Time [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
- Swollen Joint Count (SJC) Over Time [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
- Hannover Functional Questionnaire (FFbH) Over Time [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
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.
- Patients Global Assessment of Disease Activity Over Time [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
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.
- Participants Assessment of Pain Over Time [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
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.
- Participants Assessment of Fatigue Over Time [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
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.
- Percentage of Participants With Impairment in Daily Activities [Baseline and Months 6, 18, 24, and 30]
Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.
- Number of Days Missed From Work Due to Rheumatoid Arthritis [Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60]
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.
- Percentage of Participants With In-patient Hospitalization [Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60]
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.
- Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication [Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate.
-
Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before.
-
In case of incompatibility with methotrexate, adalimumab can be used as monotherapy
Exclusion Criteria:
- Hypersensitivity against the drug or one of the other ingredients; active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections); moderate to severe cardiac insufficiency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site Reference ID/Investigator# 35034 | Aachen | Germany | 52062 | |
| 2 | Site Reference ID/Investigator# 35033 | Aachen | Germany | 52064 | |
| 3 | Site Reference ID/Investigator# 53919 | Achern | Germany | 77855 | |
| 4 | Site Reference ID/Investigator# 53883 | Aichhalden | Germany | 78733 | |
| 5 | Site Reference ID/Investigator# 35041 | Altenburg | Germany | 04600 | |
| 6 | Site Reference ID/Investigator# 35050 | Amberg | Germany | 92224 | |
| 7 | Site Reference ID/Investigator# 53974 | Amberg | Germany | 92224 | |
| 8 | Site Reference ID/Investigator# 33347 | Augsburg | Germany | 86150 | |
| 9 | Site Reference ID/Investigator# 33356 | Bad Abbach | Germany | 93077 | |
| 10 | Site Reference ID/Investigator# 33359 | Bad Abbach | Germany | 93077 | |
| 11 | Site Reference ID/Investigator# 33362 | Bad Aibling | Germany | 83043 | |
| 12 | Site Reference ID/Investigator# 35084 | Bad Aibling | Germany | 83043 | |
| 13 | Site Reference ID/Investigator# 53968 | Bad Aibling | Germany | 83043 | |
| 14 | Site Reference ID/Investigator# 53966 | Bad Bellingen | Germany | 79415 | |
| 15 | Site Reference ID/Investigator# 35523 | Bad Bentheim | Germany | D-48455 | |
| 16 | Site Reference ID/Investigator# 35571 | Bad Bramstedt | Germany | 24576 | |
| 17 | Site Reference ID/Investigator# 53903 | Bad Bramstedt | Germany | 24576 | |
| 18 | Site Reference ID/Investigator# 53929 | Bad Buchau | Germany | 88422 | |
| 19 | Site Reference ID/Investigator# 33370 | Bad Endbach | Germany | 35080 | |
| 20 | Site Reference ID/Investigator# 33369 | Bad Endbach | Germany | 63065 | |
| 21 | Site Reference ID/Investigator# 33380 | Bad Iburg | Germany | 49186 | |
| 22 | Site Reference ID/Investigator# 33384 | Bad Kissingen | Germany | 97688 | |
| 23 | Site Reference ID/Investigator# 33385 | Bad Kreuznach | Germany | 55543 | |
| 24 | Site Reference ID/Investigator# 33389 | Bad Liebenwerda | Germany | 04924 | |
| 25 | Site Reference ID/Investigator# 53942 | Bad Mergentheim | Germany | 97980 | |
| 26 | Site Reference ID/Investigator# 33394 | Bad Muender | Germany | 31848 | |
| 27 | Site Reference ID/Investigator# 33398 | Bad Nauheim | Germany | 61231 | |
| 28 | Site Reference ID/Investigator# 33399 | Bad Neuenahr | Germany | 53474 | |
| 29 | Site Reference ID/Investigator# 35576 | Bad Neuenahr | Germany | 53474 | |
| 30 | Site Reference ID/Investigator# 53980 | Bad Pyrmont | Germany | 31812 | |
| 31 | Site Reference ID/Investigator# 33402 | Bad Rappenau | Germany | 74906 | |
| 32 | Site Reference ID/Investigator# 33410 | Bad Soden-Salmuenster | Germany | 63628 | |
| 33 | Site Reference ID/Investigator# 33415 | Bad Staffelstein | Germany | 96231 | |
| 34 | Site Reference ID/Investigator# 54804 | Bad Toelz | Germany | 83646 | |
| 35 | Site Reference ID/Investigator# 33423 | Baden-Baden | Germany | 76530 | |
| 36 | Site Reference ID/Investigator# 33427 | Bamberg | Germany | 96047 | |
| 37 | Site Reference ID/Investigator# 33436 | Bautzen | Germany | 02625 | |
| 38 | Site Reference ID/Investigator# 33440 | Bayreuth | Germany | 95445 | |
| 39 | Site Reference ID/Investigator# 53978 | Belm | Germany | 49191 | |
| 40 | Site Reference ID/Investigator# 33449 | Bensheim | Germany | 64625 | |
| 41 | Site Reference ID/Investigator# 34264 | Berlin-Buch | Germany | 13125 | |
| 42 | Site Reference ID/Investigator# 34250 | Berlin-Wannsee | Germany | 14109 | |
| 43 | Site Reference ID/Investigator# 33646 | Berlin | Germany | 10178 | |
| 44 | Site Reference ID/Investigator# 53902 | Berlin | Germany | 10247 | |
| 45 | Site Reference ID/Investigator# 33662 | Berlin | Germany | 10367 | |
| 46 | Site Reference ID/Investigator# 33695 | Berlin | Germany | 10711 | |
| 47 | Site Reference ID/Investigator# 34243 | Berlin | Germany | 10719 | |
| 48 | Site Reference ID/Investigator# 33681 | Berlin | Germany | 10777 | |
| 49 | Site Reference ID/Investigator# 35599 | Berlin | Germany | 12161 | |
| 50 | Site Reference ID/Investigator# 53959 | Berlin | Germany | 12200 | |
| 51 | Site Reference ID/Investigator# 33688 | Berlin | Germany | 12435 | |
| 52 | Site Reference ID/Investigator# 34260 | Berlin | Germany | 12681 | |
| 53 | Site Reference ID/Investigator# 33685 | Berlin | Germany | 13055 | |
| 54 | Site Reference ID/Investigator# 53948 | Berlin | Germany | 13055 | |
| 55 | Site Reference ID/Investigator# 53939 | Berlin | Germany | 13589 | |
| 56 | Site Reference ID/Investigator# 53971 | Berlin | Germany | 13595 | |
| 57 | Site Reference ID/Investigator# 53933 | Berlin | Germany | 14059 | |
| 58 | Site Reference ID/Investigator# 53884 | Berlin | Germany | 14089 | |
| 59 | Site Reference ID/Investigator# 33672 | Berlin | Germany | 14109 | |
| 60 | Site Reference ID/Investigator# 35552 | Berlin | Germany | 14163 | |
| 61 | Site Reference ID/Investigator# 35554 | Bernau | Germany | 16321 | |
| 62 | Site Reference ID/Investigator# 53899 | Biberach | Germany | 88400 | |
| 63 | Site Reference ID/Investigator# 34279 | Bielefeld | Germany | 33611 | |
| 64 | Site Reference ID/Investigator# 54810 | Bielefeld | Germany | 33617 | |
| 65 | Site Reference ID/Investigator# 35559 | Bietigheim-Bissingen | Germany | 74321 | |
| 66 | Site Reference ID/Investigator# 35560 | Bietigheim-Bissingen | Germany | 74321 | |
| 67 | Site Reference ID/Investigator# 34283 | Blankenburg/Hart | Germany | 38889 | |
| 68 | Site Reference ID/Investigator# 34286 | Blaubeuren | Germany | 89143 | |
| 69 | Site Reference ID/Investigator# 34289 | Bocholt | Germany | 46399 | |
| 70 | Site Reference ID/Investigator# 53946 | Bocholt | Germany | 46399 | |
| 71 | Site Reference ID/Investigator# 35567 | Bochum | Germany | 44789 | |
| 72 | Site Reference ID/Investigator# 35642 | Bogen | Germany | 94327 | |
| 73 | Site Reference ID/Investigator# 34300 | Bonn | Germany | 53111 | |
| 74 | Site Reference ID/Investigator# 53969 | Bonn | Germany | 53129 | |
| 75 | Site Reference ID/Investigator# 35647 | Bonn | Germany | 53175 | |
| 76 | Site Reference ID/Investigator# 35648 | Bonn | Germany | 53175 | |
| 77 | Site Reference ID/Investigator# 34294 | Bonn | Germany | 53177 | |
| 78 | Site Reference ID/Investigator# 34305 | Braunschweig | Germany | 38100 | |
| 79 | Site Reference ID/Investigator# 34310 | Braunschweig | Germany | 38100 | |
| 80 | Site Reference ID/Investigator# 35601 | Breitenbrunn | Germany | 08359 | |
| 81 | Site Reference ID/Investigator# 35607 | Bremen | Germany | 28209 | |
| 82 | Site Reference ID/Investigator# 53975 | Bremen | Germany | 28329 | |
| 83 | Site Reference ID/Investigator# 53934 | Buechen | Germany | 21514 | |
| 84 | Site Reference ID/Investigator# 34696 | Celle | Germany | 29221 | |
| 85 | Site Reference ID/Investigator# 34700 | Chemnitz | Germany | 09126 | |
| 86 | Site Reference ID/Investigator# 35092 | Chemnitz | Germany | D-09130 | |
| 87 | Site Reference ID/Investigator# 33990 | Cologne | Germany | 50679 | |
| 88 | Site Reference ID/Investigator# 33987 | Cologne | Germany | 50823 | |
| 89 | Site Reference ID/Investigator# 33996 | Cologne | Germany | 50931 | |
| 90 | Site Reference ID/Investigator# 33993 | Cologne | Germany | 50969 | |
| 91 | Site Reference ID/Investigator# 35238 | Cologne | Germany | 51067 | |
| 92 | Site Reference ID/Investigator# 35617 | Cottbus | Germany | 3048 | |
| 93 | Site Reference ID/Investigator# 53987 | Cuxhaven | Germany | 27474 | |
| 94 | Site Reference ID/Investigator# 53889 | Cuxhaven | Germany | 27476 | |
| 95 | Site Reference ID/Investigator# 35622 | Darmstadt | Germany | 64295 | |
| 96 | Site Reference ID/Investigator# 53885 | Delmenhorst | Germany | 27749 | |
| 97 | Site Reference ID/Investigator# 34726 | Demmin | Germany | 17109 | |
| 98 | Site Reference ID/Investigator# 53932 | Denkendorf | Germany | 73770 | |
| 99 | Site Reference ID/Investigator# 35636 | Dortmund | Germany | 44147 | |
| 100 | Site Reference ID/Investigator# 35632 | Dortmund | Germany | 44263 | |
| 101 | Site Reference ID/Investigator# 35171 | Dresden | Germany | 01097 | |
| 102 | Site Reference ID/Investigator# 34762 | Dresden | Germany | 01109 | |
| 103 | Site Reference ID/Investigator# 53958 | Dresden | Germany | 01159 | |
| 104 | Site Reference ID/Investigator# 34749 | Dresden | Germany | 01277 | |
| 105 | Site Reference ID/Investigator# 34763 | Dresden | Germany | 01307 | |
| 106 | Site Reference ID/Investigator# 34771 | Duesseldorf | Germany | 40211 | |
| 107 | Site Reference ID/Investigator# 34774 | Duesseldorf | Germany | 40225 | |
| 108 | Site Reference ID/Investigator# 34776 | Duisburg | Germany | 47055 | |
| 109 | Site Reference ID/Investigator# 53897 | Duisburg | Germany | 47167 | |
| 110 | Site Reference ID/Investigator# 34779 | Ebensfeld | Germany | 96250 | |
| 111 | Site Reference ID/Investigator# 34782 | Eberswalde | Germany | 16225 | |
| 112 | Site Reference ID/Investigator# 54805 | Eisenberg | Germany | 07607 | |
| 113 | Site Reference ID/Investigator# 35180 | Elmshorn | Germany | 25335 | |
| 114 | Site Reference ID/Investigator# 34802 | Erftstadt | Germany | 50374 | |
| 115 | Site Reference ID/Investigator# 34807 | Erfurt | Germany | 99096 | |
| 116 | Site Reference ID/Investigator# 35097 | Erfurt | Germany | 99096 | |
| 117 | Site Reference ID/Investigator# 35189 | Erfurt | Germany | 99096 | |
| 118 | Site Reference ID/Investigator# 54811 | Erlangen | Germany | 91054 | |
| 119 | Site Reference ID/Investigator# 34815 | Erlangen | Germany | 91056 | |
| 120 | Site Reference ID/Investigator# 53925 | Essen | Germany | 45128 | |
| 121 | Site Reference ID/Investigator# 34823 | Essen | Germany | 45239 | |
| 122 | Site Reference ID/Investigator# 35194 | Essen | Germany | 45326 | |
| 123 | Site Reference ID/Investigator# 53931 | Essen | Germany | 45329 | |
| 124 | Site Reference ID/Investigator# 53945 | Essen | Germany | 45359 | |
| 125 | Site Reference ID/Investigator# 34829 | Esslingen | Germany | 73732 | |
| 126 | Site Reference ID/Investigator# 35200 | Feldafing | Germany | 82340 | |
| 127 | Site Reference ID/Investigator# 35203 | Flensburg | Germany | 24937 | |
| 128 | Site Reference ID/Investigator# 34831 | Forchheim | Germany | 91301 | |
| 129 | Site Reference ID/Investigator# 34851 | Frankfurt | Germany | 60590 | |
| 130 | Site Reference ID/Investigator# 34838 | Frankfurt | Germany | 60596 | |
| 131 | Site Reference ID/Investigator# 35211 | Fraureuth | Germany | 08427 | |
| 132 | Site Reference ID/Investigator# 35217 | Freiberg | Germany | 09599 | |
| 133 | Site Reference ID/Investigator# 34852 | Freiburg | Germany | 79098 | |
| 134 | Site Reference ID/Investigator# 34855 | Freiburg | Germany | 79098 | |
| 135 | Site Reference ID/Investigator# 53926 | Freiburg | Germany | 79098 | |
| 136 | Site Reference ID/Investigator# 34859 | Freiburg | Germany | 79106 | |
| 137 | Site Reference ID/Investigator# 35099 | Freystadt | Germany | 92342 | |
| 138 | Site Reference ID/Investigator# 53960 | Friedberg | Germany | 61169 | |
| 139 | Site Reference ID/Investigator# 35222 | Friedrichroda | Germany | 99894 | |
| 140 | Site Reference ID/Investigator# 53976 | Geesthacht | Germany | 21502 | |
| 141 | Site Reference ID/Investigator# 53890 | Geilenkirchen | Germany | 52511 | |
| 142 | Site Reference ID/Investigator# 34877 | Gelsenkirchen | Germany | 45881 | |
| 143 | Site Reference ID/Investigator# 53909 | Giessen | Germany | 35392 | |
| 144 | Site Reference ID/Investigator# 53922 | Gladbeck | Germany | 45964 | |
| 145 | Site Reference ID/Investigator# 35231 | Goettingen | Germany | 37073 | |
| 146 | Site Reference ID/Investigator# 65622 | Goettingen | Germany | 37075 | |
| 147 | Site Reference ID/Investigator# 34894 | Goslar | Germany | 38642 | |
| 148 | Site Reference ID/Investigator# 34902 | Greifswald | Germany | 17491 | |
| 149 | Site Reference ID/Investigator# 34910 | Guestrow | Germany | 18273 | |
| 150 | Site Reference ID/Investigator# 35501 | Hagen | Germany | 58089 | |
| 151 | Site Reference ID/Investigator# 34924 | Halle | Germany | 06108 | |
| 152 | Site Reference ID/Investigator# 34935 | Halle | Germany | 06108 | |
| 153 | Site Reference ID/Investigator# 34938 | Halle | Germany | 06108 | |
| 154 | Site Reference ID/Investigator# 34920 | Halle | Germany | 06112 | |
| 155 | Site Reference ID/Investigator# 34942 | Halle | Germany | 06120 | |
| 156 | Site Reference ID/Investigator# 33819 | Halle | Germany | 06128 | |
| 157 | Site Reference ID/Investigator# 35442 | Hamburg | Germany | 20144 | |
| 158 | Site Reference ID/Investigator# 53984 | Hamburg | Germany | 20355 | |
| 159 | Site Reference ID/Investigator# 33367 | Hamburg | Germany | 21031 | |
| 160 | Site Reference ID/Investigator# 53900 | Hamburg | Germany | 21073 | |
| 161 | Site Reference ID/Investigator# 34956 | Hamburg | Germany | 21075 | |
| 162 | Site Reference ID/Investigator# 34962 | Hamburg | Germany | 22081 | |
| 163 | Site Reference ID/Investigator# 35450 | Hamburg | Germany | 22081 | |
| 164 | Site Reference ID/Investigator# 35112 | Hamburg | Germany | 22087 | |
| 165 | Site Reference ID/Investigator# 34946 | Hamburg | Germany | 22089 | |
| 166 | Site Reference ID/Investigator# 35001 | Hamburg | Germany | 22119 | |
| 167 | Site Reference ID/Investigator# 34959 | Hamburg | Germany | 22147 | |
| 168 | Site Reference ID/Investigator# 34977 | Hamburg | Germany | 22147 | |
| 169 | Site Reference ID/Investigator# 34965 | Hamburg | Germany | 22391 | |
| 170 | Site Reference ID/Investigator# 54806 | Hamburg | Germany | 22399 | |
| 171 | Site Reference ID/Investigator# 33578 | Hamburg | Germany | 22529 | |
| 172 | Site Reference ID/Investigator# 34967 | Hamburg | Germany | 22529 | |
| 173 | Site Reference ID/Investigator# 34989 | Hamburg | Germany | 22529 | |
| 174 | Site Reference ID/Investigator# 34981 | Hamburg | Germany | 22609 | |
| 175 | Site Reference ID/Investigator# 34984 | Hamburg | Germany | 22609 | |
| 176 | Site Reference ID/Investigator# 34996 | Hamburg | Germany | 22609 | |
| 177 | Site Reference ID/Investigator# 53953 | Hamm | Germany | 59065 | |
| 178 | Site Reference ID/Investigator# 35017 | Hanau | Germany | 63450 | |
| 179 | Site Reference ID/Investigator# 33788 | Hannover | Germany | 30625 | |
| 180 | Site Reference ID/Investigator# 33713 | Hanover | Germany | 30159 | |
| 181 | Site Reference ID/Investigator# 35032 | Hanover | Germany | 30159 | |
| 182 | Site Reference ID/Investigator# 35021 | Hanover | Germany | 30161 | |
| 183 | Site Reference ID/Investigator# 33790 | Harrislee | Germany | 24955 | |
| 184 | Site Reference ID/Investigator# 65629 | Haseluenne | Germany | 49740 | |
| 185 | Site Reference ID/Investigator# 33795 | Hattingen | Germany | 45525 | |
| 186 | Site Reference ID/Investigator# 33796 | Heidelberg | Germany | 69120 | |
| 187 | Site Reference ID/Investigator# 33806 | Heidelberg | Germany | 69121 | |
| 188 | Site Reference ID/Investigator# 33811 | Heidelberg | Germany | D-69115 | |
| 189 | Site Reference ID/Investigator# 33816 | Heilbad Heiligenstadt | Germany | 37308 | |
| 190 | Site Reference ID/Investigator# 53911 | Herne | Germany | 44623 | |
| 191 | Site Reference ID/Investigator# 53910 | Herne | Germany | 44625 | |
| 192 | Site Reference ID/Investigator# 65623 | Herne | Germany | 44652 | |
| 193 | Site Reference ID/Investigator# 33823 | Herrsching | Germany | 82211 | |
| 194 | Site Reference ID/Investigator# 33831 | Hildesheim | Germany | 31124 | |
| 195 | Site Reference ID/Investigator# 33840 | Hofheim | Germany | 65719 | |
| 196 | Site Reference ID/Investigator# 33836 | Hof | Germany | 95028 | |
| 197 | Site Reference ID/Investigator# 33843 | Hohenfelde | Germany | 18209 | |
| 198 | Site Reference ID/Investigator# 54807 | Homburg | Germany | 66424 | |
| 199 | Site Reference ID/Investigator# 53985 | Illingen | Germany | 66557 | |
| 200 | Site Reference ID/Investigator# 33933 | Ingolstadt | Germany | 85049 | |
| 201 | Site Reference ID/Investigator# 53938 | Jena | Germany | 07743 | |
| 202 | Site Reference ID/Investigator# 5323 | Jena | Germany | 07745 | |
| 203 | Site Reference ID/Investigator# 33940 | Juelich | Germany | 52428 | |
| 204 | Site Reference ID/Investigator# 33944 | Kahla | Germany | 07768 | |
| 205 | Site Reference ID/Investigator# 35124 | Kahla | Germany | 07768 | |
| 206 | Site Reference ID/Investigator# 33948 | Kaiserslautern | Germany | 67655 | |
| 207 | Site Reference ID/Investigator# 53935 | Kaltenkirchen | Germany | 24568 | |
| 208 | Site Reference ID/Investigator# 33397 | Karlsruhe | Germany | 76133 | |
| 209 | Site Reference ID/Investigator# 33954 | Karlsruhe | Germany | 76133 | |
| 210 | Site Reference ID/Investigator# 35482 | Karlstadt | Germany | 97753 | |
| 211 | Site Reference ID/Investigator# 33962 | Kassel | Germany | 34131 | |
| 212 | Site Reference ID/Investigator# 34000 | Koenigs Wusterhausen | Germany | 15711 | |
| 213 | Site Reference ID/Investigator# 35239 | Kolkwitz | Germany | 3099 | |
| 214 | Site Reference ID/Investigator# 34006 | Kressbronn | Germany | 88079 | |
| 215 | Site Reference ID/Investigator# 34009 | Kronach | Germany | 96317 | |
| 216 | Site Reference ID/Investigator# 34086 | Kyritz | Germany | 16866 | |
| 217 | Site Reference ID/Investigator# 34003 | Lahr | Germany | 77933 | |
| 218 | Site Reference ID/Investigator# 53937 | Leipzig | Germany | 04103 | |
| 219 | Site Reference ID/Investigator# 65628 | Leipzig | Germany | 04109 | |
| 220 | Site Reference ID/Investigator# 34107 | Leipzig | Germany | 04207 | |
| 221 | Site Reference ID/Investigator# 34098 | Leipzig | Germany | 04299 | |
| 222 | Site Reference ID/Investigator# 34119 | Leverkusen | Germany | 51373 | |
| 223 | Site Reference ID/Investigator# 34121 | Lichtenstein | Germany | 09350 | |
| 224 | Site Reference ID/Investigator# 35252 | Lippstadt | Germany | 59555 | |
| 225 | Site Reference ID/Investigator# 53882 | Lohne | Germany | 49393 | |
| 226 | Site Reference ID/Investigator# 53886 | Ludwigsburg | Germany | 71638 | |
| 227 | Site Reference ID/Investigator# 35257 | Ludwigsfelde | Germany | 14974 | |
| 228 | Site Reference ID/Investigator# 53906 | Ludwigslust | Germany | 19288 | |
| 229 | Site Reference ID/Investigator# 34133 | Luebeck | Germany | 23552 | |
| 230 | Site Reference ID/Investigator# 53943 | Luedenscheid | Germany | 58311 | |
| 231 | Site Reference ID/Investigator# 33407 | Lueneburg | Germany | 21335 | |
| 232 | Site Reference ID/Investigator# 53888 | Lueneburg | Germany | 21335 | |
| 233 | Site Reference ID/Investigator# 34148 | Magdeburg | Germany | 39104 | |
| 234 | Site Reference ID/Investigator# 53981 | Magdeburg | Germany | 39110 | |
| 235 | Site Reference ID/Investigator# 53913 | Magdeburg | Germany | 39120 | |
| 236 | Site Reference ID/Investigator# 53928 | Mainz | Germany | 55116 | |
| 237 | Site Reference ID/Investigator# 65631 | Mainz | Germany | 55116 | |
| 238 | Site Reference ID/Investigator# 34184 | Mannheim | Germany | 68165 | |
| 239 | Site Reference ID/Investigator# 34194 | Marl | Germany | 45768 | |
| 240 | Site Reference ID/Investigator# 35283 | Menz | Germany | 39175 | |
| 241 | Site Reference ID/Investigator# 53896 | Merxheim | Germany | 55627 | |
| 242 | Site Reference ID/Investigator# 33418 | Minden | Germany | 32429 | |
| 243 | Site Reference ID/Investigator# 34206 | Mittelherwigsdorf | Germany | 02763 | |
| 244 | Site Reference ID/Investigator# 34216 | Moenchengladbach | Germany | 41061 | |
| 245 | Site Reference ID/Investigator# 53915 | Moenchengladbach | Germany | 41061 | |
| 246 | Site Reference ID/Investigator# 34211 | Moenchengladbach | Germany | 41199 | |
| 247 | Site Reference ID/Investigator# 34214 | Moenchengladbach | Germany | 41199 | |
| 248 | Site Reference ID/Investigator# 34219 | Moenkeberg | Germany | 24248 | |
| 249 | Site Reference ID/Investigator# 34222 | Muehlhausen | Germany | 99974 | |
| 250 | Site Reference ID/Investigator# 34044 | Muenster | Germany | 48143 | |
| 251 | Site Reference ID/Investigator# 53970 | Muenster | Germany | 48143 | |
| 252 | Site Reference ID/Investigator# 34046 | Muenster | Germany | 48149 | |
| 253 | Site Reference ID/Investigator# 53904 | Munich | Germany | 80331 | |
| 254 | Site Reference ID/Investigator# 53956 | Munich | Germany | 80336 | |
| 255 | Site Reference ID/Investigator# 34037 | Munich | Germany | 80639 | |
| 256 | Site Reference ID/Investigator# 53962 | Munich | Germany | 80798 | |
| 257 | Site Reference ID/Investigator# 53912 | Munich | Germany | 81547 | |
| 258 | Site Reference ID/Investigator# 35296 | Munich | Germany | 81667 | |
| 259 | Site Reference ID/Investigator# 53924 | Munich | Germany | 81667 | |
| 260 | Site Reference ID/Investigator# 34041 | Munich | Germany | 81925 | |
| 261 | Site Reference ID/Investigator# 34035 | Munich | Germany | D-81541 | |
| 262 | Site Reference ID/Investigator# 34050 | Naunhof | Germany | 04683 | |
| 263 | Site Reference ID/Investigator# 34059 | Neubrandenburg | Germany | 17033 | |
| 264 | Site Reference ID/Investigator# 34062 | Neuburg | Germany | 86633 | |
| 265 | Site Reference ID/Investigator# 34980 | Neunkirchen | Germany | 66538 | |
| 266 | Site Reference ID/Investigator# 35311 | Neuss | Germany | 41460 | |
| 267 | Site Reference ID/Investigator# 34072 | Neustadt | Germany | 67434 | |
| 268 | Site Reference ID/Investigator# 65630 | Neuwied | Germany | 56564 | |
| 269 | Site Reference ID/Investigator# 82694 | Niederbrombach | Germany | 55767 | |
| 270 | Site Reference ID/Investigator# 34078 | Niefern-Oeschelbronn | Germany | 75223 | |
| 271 | Site Reference ID/Investigator# 34081 | Nienburg | Germany | 31582 | |
| 272 | Site Reference ID/Investigator# 34082 | Nienburg | Germany | 31582 | |
| 273 | Site Reference ID/Investigator# 53923 | Nuremberg | Germany | 90402 | |
| 274 | Site Reference ID/Investigator# 34168 | Oberguenzburg | Germany | 87634 | |
| 275 | Site Reference ID/Investigator# 34174 | Offenburg | Germany | 77652 | |
| 276 | Site Reference ID/Investigator# 33490 | Oldenburg | Germany | 26121 | |
| 277 | Site Reference ID/Investigator# 53950 | Olsberg | Germany | 59939 | |
| 278 | Site Reference ID/Investigator# 33499 | Osnabrueck | Germany | D-49074 | |
| 279 | Site Reference ID/Investigator# 54803 | Osnabrueck | Germany | D-49074 | |
| 280 | Site Reference ID/Investigator# 34715 | Ostseebad Damp | Germany | 24351 | |
| 281 | Site Reference ID/Investigator# 35333 | Paderborn | Germany | 33098 | |
| 282 | Site Reference ID/Investigator# 33503 | Papenburg | Germany | 26871 | |
| 283 | Site Reference ID/Investigator# 33506 | Parchim | Germany | 19370 | |
| 284 | Site Reference ID/Investigator# 33509 | Parsberg | Germany | 92331 | |
| 285 | Site Reference ID/Investigator# 35338 | Passau | Germany | 94032 | |
| 286 | Site Reference ID/Investigator# 33511 | Petershagen | Germany | 32469 | |
| 287 | Site Reference ID/Investigator# 33519 | Pinneberg | Germany | 25421 | |
| 288 | Site Reference ID/Investigator# 33520 | Pirna | Germany | 01796 | |
| 289 | Site Reference ID/Investigator# 33521 | Planegg | Germany | 82152 | |
| 290 | Site Reference ID/Investigator# 33526 | Plauen | Germany | 08523 | |
| 291 | Site Reference ID/Investigator# 33468 | Potsdam | Germany | 14467 | |
| 292 | Site Reference ID/Investigator# 33464 | Potsdam | Germany | 14469 | |
| 293 | Site Reference ID/Investigator# 53940 | Pulheim | Germany | 50259 | |
| 294 | Site Reference ID/Investigator# 33482 | Radebeul | Germany | 01445 | |
| 295 | Site Reference ID/Investigator# 53964 | Raststatt | Germany | 76437 | |
| 296 | Site Reference ID/Investigator# 33485 | Ratingen | Germany | 40882 | |
| 297 | Site Reference ID/Investigator# 35134 | Ratingen | Germany | 40882 | |
| 298 | Site Reference ID/Investigator# 54812 | Ratingen | Germany | 40882 | |
| 299 | Site Reference ID/Investigator# 33888 | Regensburg | Germany | 93049 | |
| 300 | Site Reference ID/Investigator# 33891 | Regensburg | Germany | 93049 | |
| 301 | Site Reference ID/Investigator# 33881 | Regensburg | Germany | 93051 | |
| 302 | Site Reference ID/Investigator# 33884 | Regensburg | Germany | 93051 | |
| 303 | Site Reference ID/Investigator# 53930 | Regensburg | Germany | 93059 | |
| 304 | Site Reference ID/Investigator# 53986 | Reichenbach | Germany | 08468 | |
| 305 | Site Reference ID/Investigator# 53957 | Reken | Germany | 48734 | |
| 306 | Site Reference ID/Investigator# 53920 | Remscheid | Germany | 42864 | |
| 307 | Site Reference ID/Investigator# 33900 | Rendsburg | Germany | 24768 | |
| 308 | Site Reference ID/Investigator# 33903 | Reutlingen | Germany | 72764 | |
| 309 | Site Reference ID/Investigator# 53982 | Rheinfelden | Germany | 79618 | |
| 310 | Site Reference ID/Investigator# 53908 | Rickenbach | Germany | 79736 | |
| 311 | Site Reference ID/Investigator# 33393 | Riesa | Germany | 01589 | |
| 312 | Site Reference ID/Investigator# 33912 | Rinteln | Germany | 31737 | |
| 313 | Site Reference ID/Investigator# 33921 | Rostock | Germany | 18059 | |
| 314 | Site Reference ID/Investigator# 33929 | Rothenburg | Germany | 02929 | |
| 315 | Site Reference ID/Investigator# 34014 | Saarbruecken | Germany | 66111 | |
| 316 | Site Reference ID/Investigator# 34021 | Salzwedel | Germany | 29410 | |
| 317 | Site Reference ID/Investigator# 53916 | Schlangenbad | Germany | 65388 | |
| 318 | Site Reference ID/Investigator# 34030 | Schneeberg | Germany | 08289 | |
| 319 | Site Reference ID/Investigator# 33550 | Schwerin | Germany | 19053 | |
| 320 | Site Reference ID/Investigator# 35374 | Schwerin | Germany | 19053 | |
| 321 | Site Reference ID/Investigator# 33553 | Schwerte | Germany | 58239 | |
| 322 | Site Reference ID/Investigator# 33557 | Seesen | Germany | 38723 | |
| 323 | Site Reference ID/Investigator# 53944 | Siegen | Germany | 57072 | |
| 324 | Site Reference ID/Investigator# 33565 | Sinsheim | Germany | 74889 | |
| 325 | Site Reference ID/Investigator# 53927 | Solingen | Germany | 42651 | |
| 326 | Site Reference ID/Investigator# 33570 | Soltau | Germany | 29614 | |
| 327 | Site Reference ID/Investigator# 33583 | Stadtbergen | Germany | 86391 | |
| 328 | Site Reference ID/Investigator# 33586 | Stadthagen | Germany | 31655 | |
| 329 | Site Reference ID/Investigator# 53936 | Steinhagen | Germany | 33803 | |
| 330 | Site Reference ID/Investigator# 33602 | Stuttgart | Germany | 70178 | |
| 331 | Site Reference ID/Investigator# 33609 | Stuttgart | Germany | 70199 | |
| 332 | Site Reference ID/Investigator# 33596 | Stuttgart | Germany | 70372 | |
| 333 | Site Reference ID/Investigator# 35387 | Suhl | Germany | 98529 | |
| 334 | Site Reference ID/Investigator# 54808 | Tarp | Germany | 24963 | |
| 335 | Site Reference ID/Investigator# 35433 | Thum-Jahnsbach | Germany | 9419 | |
| 336 | Site Reference ID/Investigator# 53951 | Tischenreuth | Germany | 95643 | |
| 337 | Site Reference ID/Investigator# 33623 | Torgelow | Germany | 17358 | |
| 338 | Site Reference ID/Investigator# 33628 | Treuenbrietzen | Germany | 14929 | |
| 339 | Site Reference ID/Investigator# 53907 | Tuebingen | Germany | 72072 | |
| 340 | Site Reference ID/Investigator# 53893 | Twistringen | Germany | 27239 | |
| 341 | Site Reference ID/Investigator# 33635 | Ueberlingen-Nussdorf | Germany | 88662 | |
| 342 | Site Reference ID/Investigator# 53898 | Uhlstaedt-Kirchhasel | Germany | 07407 | |
| 343 | Site Reference ID/Investigator# 33722 | Ulm | Germany | 89073 | |
| 344 | Site Reference ID/Investigator# 65626 | Ulm | Germany | 89073 | |
| 345 | Site Reference ID/Investigator# 33732 | Verden | Germany | 27283 | |
| 346 | Site Reference ID/Investigator# 53965 | Viersen | Germany | 41747 | |
| 347 | Site Reference ID/Investigator# 33735 | Villingen-Schwenningen | Germany | 78054 | |
| 348 | Site Reference ID/Investigator# 53914 | Vogelsang-Gommern | Germany | 39245 | |
| 349 | Site Reference ID/Investigator# 53952 | Vreden | Germany | 48691 | |
| 350 | Site Reference ID/Investigator# 54809 | Waldbronn | Germany | 76337 | |
| 351 | Site Reference ID/Investigator# 33740 | Waltrop | Germany | 45731 | |
| 352 | Site Reference ID/Investigator# 33747 | Weener | Germany | 26826 | |
| 353 | Site Reference ID/Investigator# 53891 | Weiden i.d. Oberpfalz | Germany | 92637 | |
| 354 | Site Reference ID/Investigator# 53921 | Weissenfels | Germany | 06667 | |
| 355 | Site Reference ID/Investigator# 33753 | Welzow | Germany | 03119 | |
| 356 | Site Reference ID/Investigator# 35406 | Wiesbaden | Germany | 65189 | |
| 357 | Site Reference ID/Investigator# 53941 | Wiesbaden | Germany | 65189 | |
| 358 | Site Reference ID/Investigator# 33762 | Wiesbaden | Germany | 65191 | |
| 359 | Site Reference ID/Investigator# 33770 | Wilhelmshaven | Germany | 26382 | |
| 360 | Site Reference ID/Investigator# 53977 | Winsen (Luhe) | Germany | 21423 | |
| 361 | Site Reference ID/Investigator# 53954 | Winsen | Germany | 21423 | |
| 362 | Site Reference ID/Investigator# 33778 | Wittlich | Germany | 54516 | |
| 363 | Site Reference ID/Investigator# 33783 | Wolfsburg | Germany | 38440 | |
| 364 | Site Reference ID/Investigator# 33716 | Wuerzburg | Germany | 97070 | |
| 365 | Site Reference ID/Investigator# 53917 | Wuppertal | Germany | 42103 | |
| 366 | Site Reference ID/Investigator# 35418 | Wuppertal | Germany | 42105 | |
| 367 | Site Reference ID/Investigator# 33862 | Zerbst | Germany | 39261 | |
| 368 | Site Reference ID/Investigator# 33865 | Zeven | Germany | 27404 | |
| 369 | Site Reference ID/Investigator# 33870 | Zwickau | Germany | 08060 | |
| 370 | Site Reference ID/Investigator# 33878 | Zwiesel | Germany | 94227 |
Sponsors and Collaborators
- AbbVie (prior sponsor, Abbott)
Investigators
- Study Director: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier:
NCT01078090
Other Study ID Numbers:
- HUM 03-1
First Posted:
Mar 2, 2010
Last Update Posted:
May 8, 2014
Last Verified:
Apr 1, 2014
Keywords provided by AbbVie (prior sponsor, Abbott)
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Rheumatoid Arthritis |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Rheumatoid Arthritis |
|---|---|
| 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 Participants | 5745 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
54.8
(12.8)
|
| Gender (participants) [Number] | |
| Female |
4428
77.1%
|
| Male |
1315
22.9%
|
| Region of Enrollment (participants) [Number] | |
| Germany |
5745
100%
|
Outcome Measures
| Title | Change From Baseline in Disease Activity Score (DAS) 28 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| 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)
|
| Title | Percentage of Participants in DAS28 Remission |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| Month 3 (n=3918) |
12.8
0.2%
|
| Month 6 (n=3347) |
16.9
0.3%
|
| Month 12 (n=2872) |
19.4
0.3%
|
| Month 18 (n=2397) |
23.0
0.4%
|
| Month 24 (n=2099) |
23.3
0.4%
|
| Month 30 (n=1810) |
24.3
0.4%
|
| Month 36 (n=1564) |
24.0
0.4%
|
| Month 48 (n=1261) |
24.7
0.4%
|
| Month 60 (n=934) |
25.6
0.4%
|
| Title | Percentage of Participants With a Significant Therapeutic Response |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| Month 3 (n=3918) |
40.8
0.7%
|
| Month 6 (n=3347) |
50.5
0.9%
|
| Month 12 (n=2872) |
53.6
0.9%
|
| Month 18 (n=2397) |
58.7
1%
|
| Month 24 (n=2099) |
60.3
1%
|
| Month 30 (n=1810) |
63.3
1.1%
|
| Month 36 (n=1564) |
64.6
1.1%
|
| Month 48 (n=1261) |
64.2
1.1%
|
| Month 60 (n=934) |
65.5
1.1%
|
| Title | Percentage of Participants With Low, Moderate and High Disease Activity |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Measure Participants | 4400 | 3918 | 3347 | 2872 | 2397 | 2099 | 1810 | 1564 | 1261 | 934 |
| Low disease activity |
0.0
0%
|
23.9
NaN
|
29.8
NaN
|
33.0
NaN
|
38.7
NaN
|
38.5
NaN
|
41.5
NaN
|
40.5
NaN
|
40.7
NaN
|
41.9
NaN
|
| Moderate disease activity |
26.1
0.5%
|
45.9
NaN
|
46.6
NaN
|
46.6
NaN
|
43.6
NaN
|
45.0
NaN
|
43.6
NaN
|
45.3
NaN
|
45.4
NaN
|
45.3
NaN
|
| High disease activity |
73.9
1.3%
|
30.2
NaN
|
23.6
NaN
|
20.3
NaN
|
17.7
NaN
|
16.5
NaN
|
14.9
NaN
|
14.3
NaN
|
13.9
NaN
|
12.8
NaN
|
| Title | Erythrocyte Sedimentation Rate (ESR) Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| 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)
|
| Title | C-Reactive Protein (CRP) Levels Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| 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)
|
| Title | Tender Joint Count (TJC) Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| 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)
|
| Title | Swollen Joint Count (SJC) Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| 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)
|
| Title | Hannover Functional Questionnaire (FFbH) Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| 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)
|
| Title | Patients Global Assessment of Disease Activity Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| 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)
|
| Title | Participants Assessment of Pain Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| 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)
|
| Title | Participants Assessment of Fatigue Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| 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)
|
| Title | Percentage of Participants With Impairment in Daily Activities |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| Arm/Group Description | Baseline | 6 months after inclusion | 18 months after inclusion | 24 months after inclusion | 30 months after inclusion |
| Measure Participants | 4315 | 3428 | 2387 | 2150 | 1860 |
| No days of impairment |
17.9
0.3%
|
38.8
NaN
|
45.8
NaN
|
44.5
NaN
|
45.2
NaN
|
| Less than 7 days of impairment |
28.2
0.5%
|
34.7
NaN
|
33.5
NaN
|
35.3
NaN
|
36.0
NaN
|
| 7 to 14 days of impairment |
28.0
0.5%
|
16.1
NaN
|
13.4
NaN
|
13.1
NaN
|
12.8
NaN
|
| More than 14 days of impairment |
25.9
0.5%
|
10.4
NaN
|
7.2
NaN
|
7.1
NaN
|
6.0
NaN
|
| Title | Number of Days Missed From Work Due to Rheumatoid Arthritis |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| 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)
|
| Title | Percentage of Participants With In-patient Hospitalization |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Measure Participants | 4400 |
| Month 0 (n=4341) |
27.6
0.5%
|
| Month 6 (n=3401) |
10.9
0.2%
|
| Month 12 (n=2924) |
7.4
0.1%
|
| Month 18 (n=2467) |
6.7
0.1%
|
| Month 24 (n=2177) |
6.4
0.1%
|
| Month 30 (n=1900) |
5.3
0.1%
|
| Month 36 (n=1706) |
6.2
0.1%
|
| Month 48 (n=1370) |
5.0
0.1%
|
| Month 60 (n=1037) |
5.3
0.1%
|
| Title | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication |
|---|---|
| Description | |
| Time Frame | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Measure Participants | 4400 | 4229 | 3611 | 3067 | 2569 | 2250 | 1966 | 1772 | 1435 | 1079 |
| Methotrexate |
54.0
0.9%
|
51.9
NaN
|
52.2
NaN
|
54.4
NaN
|
53.9
NaN
|
54.8
NaN
|
55.3
NaN
|
54.9
NaN
|
53.7
NaN
|
54.6
NaN
|
| Sulfasalazin |
6.1
0.1%
|
3.9
NaN
|
3.4
NaN
|
3.0
NaN
|
2.6
NaN
|
2.4
NaN
|
2.1
NaN
|
2.5
NaN
|
2.2
NaN
|
1.4
NaN
|
| Hydroxychloroquine/Chloroquine |
4.0
0.1%
|
2.6
NaN
|
2.0
NaN
|
1.6
NaN
|
1.5
NaN
|
2.0
NaN
|
1.6
NaN
|
1.6
NaN
|
1.6
NaN
|
1.3
NaN
|
| Leflunomide |
20.7
0.4%
|
15.9
NaN
|
13.6
NaN
|
13.3
NaN
|
12.4
NaN
|
11.6
NaN
|
11.9
NaN
|
10.8
NaN
|
9.6
NaN
|
8.9
NaN
|
| Other disease-modifying antirheumatic drug |
5.9
0.1%
|
3.2
NaN
|
2.6
NaN
|
2.9
NaN
|
2.5
NaN
|
2.7
NaN
|
2.2
NaN
|
2.2
NaN
|
1.7
NaN
|
1.6
NaN
|
| Analgesics |
26.9
0.5%
|
19.1
NaN
|
17.4
NaN
|
17.1
NaN
|
16.2
NaN
|
16.4
NaN
|
14.1
NaN
|
14.8
NaN
|
14.7
NaN
|
14.2
NaN
|
| Non-steroidal anti-inflammatory drug |
44.7
0.8%
|
36.7
NaN
|
36.3
NaN
|
36.3
NaN
|
37.2
NaN
|
37.2
NaN
|
36.8
NaN
|
35.9
NaN
|
35.1
NaN
|
35.4
NaN
|
| Cyclo-oxygenase 2 (COX-2) Inhibitors |
20.0
0.3%
|
15.8
NaN
|
14.5
NaN
|
12.8
NaN
|
11.4
NaN
|
11.1
NaN
|
10.6
NaN
|
10.2
NaN
|
10.2
NaN
|
9.8
NaN
|
| Systemic glucocorticoids |
85.6
1.5%
|
78.1
NaN
|
75.4
NaN
|
73.1
NaN
|
70.1
NaN
|
68.6
NaN
|
64.5
NaN
|
63.1
NaN
|
59.4
NaN
|
58.1
NaN
|
Adverse Events
| Time Frame | Adverse events were collected throughout the 60-month period. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Rheumatoid Arthritis | |
| 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 (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Rheumatoid Arthritis | ||
| Affected / at Risk (%) | # Events | |
| Total | 163/5745 (2.8%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 1/5745 (0%) | |
| Thrombocytopenia | 1/5745 (0%) | |
| Cardiac disorders | ||
| Coronary artery disease | 3/5745 (0.1%) | |
| Atrial fibrillation | 2/5745 (0%) | |
| Cardiac failure | 2/5745 (0%) | |
| Left ventricular failure | 2/5745 (0%) | |
| Myocardial infarction | 2/5745 (0%) | |
| Acute coronary syndrome | 1/5745 (0%) | |
| Acute myocardial infarction | 1/5745 (0%) | |
| Angina unstable | 1/5745 (0%) | |
| Atrioventricular block complete | 1/5745 (0%) | |
| Coronary artery stenosis | 1/5745 (0%) | |
| Hypertensive heart disease | 1/5745 (0%) | |
| Ventricular tachycardia | 1/5745 (0%) | |
| Eye disorders | ||
| Dry eye | 2/5745 (0%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 2/5745 (0%) | |
| Dry mouth | 2/5745 (0%) | |
| Colitis erosive | 1/5745 (0%) | |
| Diarrhea | 1/5745 (0%) | |
| Diverticular perforation | 1/5745 (0%) | |
| Duodenal ulcer hemorrhage | 1/5745 (0%) | |
| Enteritis | 1/5745 (0%) | |
| Gastritis | 1/5745 (0%) | |
| Gastrointestinal disorder | 1/5745 (0%) | |
| Ileus paralytic | 1/5745 (0%) | |
| Intestinal perforation | 1/5745 (0%) | |
| Pancreatitis | 1/5745 (0%) | |
| Peritonitis | 1/5745 (0%) | |
| Vomiting | 1/5745 (0%) | |
| General disorders | ||
| Death | 5/5745 (0.1%) | |
| Impaired healing | 3/5745 (0.1%) | |
| Multi-organ failure | 3/5745 (0.1%) | |
| Inflammation | 2/5745 (0%) | |
| Accidental death | 1/5745 (0%) | |
| Cardiac death | 1/5745 (0%) | |
| Fat necrosis | 1/5745 (0%) | |
| Injection site erythema | 1/5745 (0%) | |
| Injection site swelling | 1/5745 (0%) | |
| Local swelling | 1/5745 (0%) | |
| Peripheral edema | 1/5745 (0%) | |
| Pyrexia | 1/5745 (0%) | |
| Sudden cardiac death | 1/5745 (0%) | |
| Hepatobiliary disorders | ||
| Bile duct stone | 2/5745 (0%) | |
| Cholecystitis | 2/5745 (0%) | |
| Cholangitis | 1/5745 (0%) | |
| Hepatitis toxic | 1/5745 (0%) | |
| Infections and infestations | ||
| Pneumonia | 9/5745 (0.2%) | |
| Sepsis | 9/5745 (0.2%) | |
| Arthritis bacterial | 3/5745 (0.1%) | |
| Oral herpes | 3/5745 (0.1%) | |
| Cellulitis | 2/5745 (0%) | |
| Disseminated tuberculosis | 2/5745 (0%) | |
| Endocarditis | 2/5745 (0%) | |
| Escherichia sepsis | 2/5745 (0%) | |
| Fungal infection | 2/5745 (0%) | |
| Herpes zoster | 2/5745 (0%) | |
| Infection | 2/5745 (0%) | |
| Papilloma virus infection | 2/5745 (0%) | |
| Peritoneal tuberculosis | 2/5745 (0%) | |
| Pneumonia primary atypical | 2/5745 (0%) | |
| Sinusitis | 2/5745 (0%) | |
| Tooth infection | 2/5745 (0%) | |
| Urinary tract infection | 2/5745 (0%) | |
| Urosepsis | 2/5745 (0%) | |
| Abscess | 1/5745 (0%) | |
| Abscess limb | 1/5745 (0%) | |
| Abscess neck | 1/5745 (0%) | |
| Actinomycosis | 1/5745 (0%) | |
| Bronchopneumonia | 1/5745 (0%) | |
| Chronic sinusitis | 1/5745 (0%) | |
| Diverticulitis | 1/5745 (0%) | |
| Empyema | 1/5745 (0%) | |
| Gastroenteritis norovirus | 1/5745 (0%) | |
| Hepatitis B | 1/5745 (0%) | |
| Intervertebral discitis | 1/5745 (0%) | |
| Liver abscess | 1/5745 (0%) | |
| Localized infection | 1/5745 (0%) | |
| Neuroborreliosis | 1/5745 (0%) | |
| Orchitis | 1/5745 (0%) | |
| Psoas abscess | 1/5745 (0%) | |
| Pulmonary tuberculosis | 1/5745 (0%) | |
| Pyothorax | 1/5745 (0%) | |
| Septic shock | 1/5745 (0%) | |
| Streptococcal sepsis | 1/5745 (0%) | |
| Subcutaneous abscess | 1/5745 (0%) | |
| Tracheobronchitis | 1/5745 (0%) | |
| Tuberculosis | 1/5745 (0%) | |
| Wound infection | 1/5745 (0%) | |
| Injury, poisoning and procedural complications | ||
| Contusion | 2/5745 (0%) | |
| Femoral neck fracture | 1/5745 (0%) | |
| Joint sprain | 1/5745 (0%) | |
| Traumatic fracture | 1/5745 (0%) | |
| Upper limb fracture | 1/5745 (0%) | |
| Wound | 1/5745 (0%) | |
| Investigations | ||
| Transaminases increased | 2/5745 (0%) | |
| Catheterization cardiac | 1/5745 (0%) | |
| Platelet count decreased | 1/5745 (0%) | |
| Weight decreased | 1/5745 (0%) | |
| Musculoskeletal and connective tissue disorders | ||
| Myalgia | 3/5745 (0.1%) | |
| Bone pain | 2/5745 (0%) | |
| Intervertebral disc protrusion | 1/5745 (0%) | |
| Joint stiffness | 1/5745 (0%) | |
| Osteonecrosis | 1/5745 (0%) | |
| Rheumatoid arthritis | 1/5745 (0%) | |
| Rotator cuff syndrome | 1/5745 (0%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Breast cancer | 4/5745 (0.1%) | |
| Prostate cancer | 2/5745 (0%) | |
| Brain neoplasm | 1/5745 (0%) | |
| Bronchial carcinoma | 1/5745 (0%) | |
| Chronic myeloid leukemia | 1/5745 (0%) | |
| Hemangioblastoma | 1/5745 (0%) | |
| Lung adenocarcinoma | 1/5745 (0%) | |
| Lymphangioma | 1/5745 (0%) | |
| Lymphoma | 1/5745 (0%) | |
| Malignant melanoma | 1/5745 (0%) | |
| Malignant mesenteric neoplasm | 1/5745 (0%) | |
| Metastases to liver | 1/5745 (0%) | |
| Metastatic malignant melanoma | 1/5745 (0%) | |
| Neuroendocrine carcinoma of the skin | 1/5745 (0%) | |
| Non-Hodgkin's lymphoma | 1/5745 (0%) | |
| Ovarian cancer | 1/5745 (0%) | |
| Renal cancer | 1/5745 (0%) | |
| Small cell lung cancer stage unspecified | 1/5745 (0%) | |
| Nervous system disorders | ||
| Syncope | 2/5745 (0%) | |
| Cerebellar infarction | 1/5745 (0%) | |
| Cerebral infarction | 1/5745 (0%) | |
| Cerebrovascular accident | 1/5745 (0%) | |
| Coma | 1/5745 (0%) | |
| Hyperkinesia | 1/5745 (0%) | |
| Migraine | 1/5745 (0%) | |
| Paraparesis | 1/5745 (0%) | |
| Paresis | 1/5745 (0%) | |
| Tremor | 1/5745 (0%) | |
| Psychiatric disorders | ||
| Sleep disorder | 2/5745 (0%) | |
| Decreased activity | 1/5745 (0%) | |
| Mental disorder due to a general medical condition | 1/5745 (0%) | |
| Suicide attempt | 1/5745 (0%) | |
| Renal and urinary disorders | ||
| Renal failure acute | 3/5745 (0.1%) | |
| Nephrolithiasis | 1/5745 (0%) | |
| Renal failure chronic | 1/5745 (0%) | |
| Renal impairment | 1/5745 (0%) | |
| Reproductive system and breast disorders | ||
| Benign prostatic hyperplasia | 1/5745 (0%) | |
| Epididymitis | 1/5745 (0%) | |
| Vaginal hemorrhage | 1/5745 (0%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Pulmonary embolism | 3/5745 (0.1%) | |
| Asthma | 1/5745 (0%) | |
| Chronic obstructive pulmonary disease | 1/5745 (0%) | |
| Emphysema | 1/5745 (0%) | |
| Interstitial lung disease | 1/5745 (0%) | |
| Pulmonary edema | 1/5745 (0%) | |
| Skin and subcutaneous tissue disorders | ||
| Hyperhidrosis | 2/5745 (0%) | |
| Urticaria | 2/5745 (0%) | |
| Angioedema | 1/5745 (0%) | |
| Nail bed inflammation | 1/5745 (0%) | |
| Social circumstances | ||
| Cardiac assistance device user | 1/5745 (0%) | |
| Surgical and medical procedures | ||
| Knee arthroplasty | 7/5745 (0.1%) | |
| Surgery | 6/5745 (0.1%) | |
| Synovectomy | 4/5745 (0.1%) | |
| Foot operation | 3/5745 (0.1%) | |
| Arthrodesis | 2/5745 (0%) | |
| Joint arthroplasty | 2/5745 (0%) | |
| Skin neoplasm excision | 2/5745 (0%) | |
| Abscess drainage | 1/5745 (0%) | |
| Ankle operation | 1/5745 (0%) | |
| Bone operation | 1/5745 (0%) | |
| Breast operation | 1/5745 (0%) | |
| Bursa removal | 1/5745 (0%) | |
| Cardiac pacemaker insertion | 1/5745 (0%) | |
| Cholecystectomy | 1/5745 (0%) | |
| Coronary angioplasty | 1/5745 (0%) | |
| Coronary artery bypass | 1/5745 (0%) | |
| Hemorrhoid operation | 1/5745 (0%) | |
| Hip arthroplasty | 1/5745 (0%) | |
| Hydrocele operation | 1/5745 (0%) | |
| Hysterectomy | 1/5745 (0%) | |
| Osteosynthesis | 1/5745 (0%) | |
| Osteotomy | 1/5745 (0%) | |
| Prostatic operation | 1/5745 (0%) | |
| Radiotherapy | 1/5745 (0%) | |
| Renal transplant | 1/5745 (0%) | |
| Skin graft | 1/5745 (0%) | |
| Spinal operation | 1/5745 (0%) | |
| Stent placement | 1/5745 (0%) | |
| Transurethral incision of prostate | 1/5745 (0%) | |
| Vertebroplasty | 1/5745 (0%) | |
| Vascular disorders | ||
| Axillary vein thrombosis | 1/5745 (0%) | |
| Jugular vein thrombosis | 1/5745 (0%) | |
| Subclavian vein thrombosis | 1/5745 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Rheumatoid Arthritis | ||
| Affected / at Risk (%) | # Events | |
| Total | 58/5745 (1%) | |
| Skin and subcutaneous tissue disorders | ||
| Rash | 58/5745 (1%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 (prior sponsor, Abbott)
ClinicalTrials.gov Identifier:
NCT01078090
Other Study ID Numbers:
- HUM 03-1
First Posted:
Mar 2, 2010
Last Update Posted:
May 8, 2014
Last Verified:
Apr 1, 2014