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Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid arthritis | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Score (DAS) 28 | 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Percentage of Participants in DAS28 Remission | 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. | Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Significant Therapeutic Response | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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General population: patients with rheumatoid arthritis who resided in Germany. German regulations state that all patients are eligible for non-interventional studies; there are no exclusions. Adult patients (≥ 18 years of age) with RA who were preparing to initiate adalimumab therapy according to the product label were eligible for study enrollment. The eligibility criteria below reflect the approved label as stated in the German Summary of Product Characteristics (SPC) for Humira.
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| Name | Affiliation | Role |
|---|---|---|
| Bianca Wittig, MD | AbbVie Deutschland GmbH & Co. KG, Medical Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 35034 | Aachen | 52062 | Germany | |||
| Site Reference ID/Investigator# 35033 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31311386 | Derived | Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Wittig BM, Gnann H, Greger G, Tony HP, Burkhardt H. Addition or removal of concomitant methotrexate alters adalimumab effectiveness in rheumatoid arthritis but not psoriatic arthritis. Scand J Rheumatol. 2019 Sep;48(5):375-382. doi: 10.1080/03009742.2019.1600717. Epub 2019 Jul 16. | |
| 26990995 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rheumatoid Arthritis | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Percentage of Participants With Low, Moderate and High 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. 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Erythrocyte Sedimentation Rate (ESR) Over Time | Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| C-Reactive Protein (CRP) Levels Over Time | 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Tender Joint Count (TJC) Over Time | Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Swollen Joint Count (SJC) Over Time | Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Hannover Functional Questionnaire (FFbH) Over Time | 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Patients Global Assessment of Disease Activity Over Time | 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Participants Assessment of Pain Over Time | 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Participants Assessment of Fatigue Over Time | 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
| Percentage of Participants With Impairment in Daily Activities | Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks. | Baseline and Months 6, 18, 24, and 30 |
| Number of Days Missed From Work Due to Rheumatoid Arthritis | 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. | Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60 |
| Percentage of Participants With In-patient Hospitalization | 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. | Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60 |
| 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 |
| Aachen |
| 52064 |
| Germany |
| Site Reference ID/Investigator# 53919 | Achern | 77855 | Germany |
| Site Reference ID/Investigator# 53883 | Aichhalden | 78733 | Germany |
| Site Reference ID/Investigator# 35041 | Altenburg | 04600 | Germany |
| Site Reference ID/Investigator# 35050 | Amberg | 92224 | Germany |
| Site Reference ID/Investigator# 53974 | Amberg | 92224 | Germany |
| Site Reference ID/Investigator# 33347 | Augsburg | 86150 | Germany |
| Site Reference ID/Investigator# 33356 | Bad Abbach | 93077 | Germany |
| Site Reference ID/Investigator# 33359 | Bad Abbach | 93077 | Germany |
| Site Reference ID/Investigator# 33362 | Bad Aibling | 83043 | Germany |
| Site Reference ID/Investigator# 35084 | Bad Aibling | 83043 | Germany |
| Site Reference ID/Investigator# 53968 | Bad Aibling | 83043 | Germany |
| Site Reference ID/Investigator# 53966 | Bad Bellingen | 79415 | Germany |
| Site Reference ID/Investigator# 35523 | Bad Bentheim | D-48455 | Germany |
| Site Reference ID/Investigator# 35571 | Bad Bramstedt | 24576 | Germany |
| Site Reference ID/Investigator# 53903 | Bad Bramstedt | 24576 | Germany |
| Site Reference ID/Investigator# 53929 | Bad Buchau | 88422 | Germany |
| Site Reference ID/Investigator# 33370 | Bad Endbach | 35080 | Germany |
| Site Reference ID/Investigator# 33369 | Bad Endbach | 63065 | Germany |
| Site Reference ID/Investigator# 33380 | Bad Iburg | 49186 | Germany |
| Site Reference ID/Investigator# 33384 | Bad Kissingen | 97688 | Germany |
| Site Reference ID/Investigator# 33385 | Bad Kreuznach | 55543 | Germany |
| Site Reference ID/Investigator# 33389 | Bad Liebenwerda | 04924 | Germany |
| Site Reference ID/Investigator# 53942 | Bad Mergentheim | 97980 | Germany |
| Site Reference ID/Investigator# 33394 | Bad Münder am Deister | 31848 | Germany |
| Site Reference ID/Investigator# 33398 | Bad Nauheim | 61231 | Germany |
| Site Reference ID/Investigator# 33399 | Bad Neuenahr | 53474 | Germany |
| Site Reference ID/Investigator# 35576 | Bad Neuenahr | 53474 | Germany |
| Site Reference ID/Investigator# 53980 | Bad Pyrmont | 31812 | Germany |
| Site Reference ID/Investigator# 33402 | Bad Rappenau | 74906 | Germany |
| Site Reference ID/Investigator# 33410 | Bad Soden-Salmünster | 63628 | Germany |
| Site Reference ID/Investigator# 33415 | Bad Staffelstein | 96231 | Germany |
| Site Reference ID/Investigator# 54804 | Bad Tölz | 83646 | Germany |
| Site Reference ID/Investigator# 33423 | Baden-Baden | 76530 | Germany |
| Site Reference ID/Investigator# 33427 | Bamberg | 96047 | Germany |
| Site Reference ID/Investigator# 33436 | Bautzen | 02625 | Germany |
| Site Reference ID/Investigator# 33440 | Bayreuth | 95445 | Germany |
| Site Reference ID/Investigator# 53978 | Belm | 49191 | Germany |
| Site Reference ID/Investigator# 33449 | Bensheim | 64625 | Germany |
| Site Reference ID/Investigator# 33646 | Berlin | 10178 | Germany |
| Site Reference ID/Investigator# 53902 | Berlin | 10247 | Germany |
| Site Reference ID/Investigator# 33662 | Berlin | 10367 | Germany |
| Site Reference ID/Investigator# 33695 | Berlin | 10711 | Germany |
| Site Reference ID/Investigator# 34243 | Berlin | 10719 | Germany |
| Site Reference ID/Investigator# 33681 | Berlin | 10777 | Germany |
| Site Reference ID/Investigator# 35599 | Berlin | 12161 | Germany |
| Site Reference ID/Investigator# 53959 | Berlin | 12200 | Germany |
| Site Reference ID/Investigator# 33688 | Berlin | 12435 | Germany |
| Site Reference ID/Investigator# 34260 | Berlin | 12681 | Germany |
| Site Reference ID/Investigator# 33685 | Berlin | 13055 | Germany |
| Site Reference ID/Investigator# 53948 | Berlin | 13055 | Germany |
| Site Reference ID/Investigator# 53939 | Berlin | 13589 | Germany |
| Site Reference ID/Investigator# 53971 | Berlin | 13595 | Germany |
| Site Reference ID/Investigator# 53933 | Berlin | 14059 | Germany |
| Site Reference ID/Investigator# 53884 | Berlin | 14089 | Germany |
| Site Reference ID/Investigator# 33672 | Berlin | 14109 | Germany |
| Site Reference ID/Investigator# 35552 | Berlin | 14163 | Germany |
| Site Reference ID/Investigator# 35554 | Bernau | 16321 | Germany |
| Site Reference ID/Investigator# 53899 | Biberach | 88400 | Germany |
| Site Reference ID/Investigator# 34279 | Bielefeld | 33611 | Germany |
| Site Reference ID/Investigator# 54810 | Bielefeld | 33617 | Germany |
| Site Reference ID/Investigator# 35559 | Bietigheim-Bissingen | 74321 | Germany |
| Site Reference ID/Investigator# 35560 | Bietigheim-Bissingen | 74321 | Germany |
| Site Reference ID/Investigator# 34283 | Blankenburg/Hart | 38889 | Germany |
| Site Reference ID/Investigator# 34286 | Blaubeuren Abbey | 89143 | Germany |
| Site Reference ID/Investigator# 34289 | Bocholt | 46399 | Germany |
| Site Reference ID/Investigator# 53946 | Bocholt | 46399 | Germany |
| Site Reference ID/Investigator# 35567 | Bochum | 44789 | Germany |
| Site Reference ID/Investigator# 35642 | Bogen | 94327 | Germany |
| Site Reference ID/Investigator# 34300 | Bonn | 53111 | Germany |
| Site Reference ID/Investigator# 53969 | Bonn | 53129 | Germany |
| Site Reference ID/Investigator# 35647 | Bonn | 53175 | Germany |
| Site Reference ID/Investigator# 35648 | Bonn | 53175 | Germany |
| Site Reference ID/Investigator# 34294 | Bonn | 53177 | Germany |
| Site Reference ID/Investigator# 34305 | Braunschweig | 38100 | Germany |
| Site Reference ID/Investigator# 34310 | Braunschweig | 38100 | Germany |
| Site Reference ID/Investigator# 35601 | Breitenbrunn | 08359 | Germany |
| Site Reference ID/Investigator# 35607 | Bremen | 28209 | Germany |
| Site Reference ID/Investigator# 53975 | Bremen | 28329 | Germany |
| Site Reference ID/Investigator# 34264 | Buch | 13125 | Germany |
| Site Reference ID/Investigator# 53934 | Büchen | 21514 | Germany |
| Site Reference ID/Investigator# 34696 | Celle | 29221 | Germany |
| Site Reference ID/Investigator# 34700 | Chemnitz | 09126 | Germany |
| Site Reference ID/Investigator# 35092 | Chemnitz | D-09130 | Germany |
| Site Reference ID/Investigator# 33990 | Cologne | 50679 | Germany |
| Site Reference ID/Investigator# 33987 | Cologne | 50823 | Germany |
| Site Reference ID/Investigator# 33996 | Cologne | 50931 | Germany |
| Site Reference ID/Investigator# 33993 | Cologne | 50969 | Germany |
| Site Reference ID/Investigator# 35238 | Cologne | 51067 | Germany |
| Site Reference ID/Investigator# 35617 | Cottbus | 3048 | Germany |
| Site Reference ID/Investigator# 53987 | Cuxhaven | 27474 | Germany |
| Site Reference ID/Investigator# 53889 | Cuxhaven | 27476 | Germany |
| Site Reference ID/Investigator# 35622 | Darmstadt | 64295 | Germany |
| Site Reference ID/Investigator# 53885 | Delmenhorst | 27749 | Germany |
| Site Reference ID/Investigator# 34726 | Demmin | 17109 | Germany |
| Site Reference ID/Investigator# 53932 | Denkendorf | 73770 | Germany |
| Site Reference ID/Investigator# 35636 | Dortmund | 44147 | Germany |
| Site Reference ID/Investigator# 35632 | Dortmund | 44263 | Germany |
| Site Reference ID/Investigator# 35171 | Dresden | 01097 | Germany |
| Site Reference ID/Investigator# 34762 | Dresden | 01109 | Germany |
| Site Reference ID/Investigator# 53958 | Dresden | 01159 | Germany |
| Site Reference ID/Investigator# 34749 | Dresden | 01277 | Germany |
| Site Reference ID/Investigator# 34763 | Dresden | 01307 | Germany |
| Site Reference ID/Investigator# 34776 | Duisburg | 47055 | Germany |
| Site Reference ID/Investigator# 53897 | Duisburg | 47167 | Germany |
| Site Reference ID/Investigator# 34771 | Düsseldorf | 40211 | Germany |
| Site Reference ID/Investigator# 34774 | Düsseldorf | 40225 | Germany |
| Site Reference ID/Investigator# 34779 | Ebensfeld | 96250 | Germany |
| Site Reference ID/Investigator# 34782 | Eberswalde | 16225 | Germany |
| Site Reference ID/Investigator# 54805 | Eisenberg | 07607 | Germany |
| Site Reference ID/Investigator# 35180 | Elmshorn | 25335 | Germany |
| Site Reference ID/Investigator# 34802 | Erftstadt | 50374 | Germany |
| Site Reference ID/Investigator# 34807 | Erfurt | 99096 | Germany |
| Site Reference ID/Investigator# 35097 | Erfurt | 99096 | Germany |
| Site Reference ID/Investigator# 35189 | Erfurt | 99096 | Germany |
| Site Reference ID/Investigator# 54811 | Erlangen | 91054 | Germany |
| Site Reference ID/Investigator# 34815 | Erlangen | 91056 | Germany |
| Site Reference ID/Investigator# 53925 | Essen | 45128 | Germany |
| Site Reference ID/Investigator# 34823 | Essen | 45239 | Germany |
| Site Reference ID/Investigator# 35194 | Essen | 45326 | Germany |
| Site Reference ID/Investigator# 53931 | Essen | 45329 | Germany |
| Site Reference ID/Investigator# 53945 | Essen | 45359 | Germany |
| Site Reference ID/Investigator# 34829 | Esslingen am Neckar | 73732 | Germany |
| Site Reference ID/Investigator# 35200 | Feldafing | 82340 | Germany |
| Site Reference ID/Investigator# 35203 | Flensburg | 24937 | Germany |
| Site Reference ID/Investigator# 34831 | Forchheim | 91301 | Germany |
| Site Reference ID/Investigator# 34851 | Frankfurt | 60590 | Germany |
| Site Reference ID/Investigator# 34838 | Frankfurt | 60596 | Germany |
| Site Reference ID/Investigator# 35211 | Fraureuth | 08427 | Germany |
| Site Reference ID/Investigator# 35217 | Freiberg | 09599 | Germany |
| Site Reference ID/Investigator# 34852 | Freiburg im Breisgau | 79098 | Germany |
| Site Reference ID/Investigator# 34855 | Freiburg im Breisgau | 79098 | Germany |
| Site Reference ID/Investigator# 53926 | Freiburg im Breisgau | 79098 | Germany |
| Site Reference ID/Investigator# 34859 | Freiburg im Breisgau | 79106 | Germany |
| Site Reference ID/Investigator# 35099 | Freystadt | 92342 | Germany |
| Site Reference ID/Investigator# 53960 | Friedberg | 61169 | Germany |
| Site Reference ID/Investigator# 35222 | Friedrichroda | 99894 | Germany |
| Site Reference ID/Investigator# 53976 | Geesthacht | 21502 | Germany |
| Site Reference ID/Investigator# 53890 | Geilenkirchen | 52511 | Germany |
| Site Reference ID/Investigator# 34877 | Gelsenkirchen | 45881 | Germany |
| Site Reference ID/Investigator# 53909 | Giessen | 35392 | Germany |
| Site Reference ID/Investigator# 53922 | Gladbeck | 45964 | Germany |
| Site Reference ID/Investigator# 34894 | Goslar | 38642 | Germany |
| Site Reference ID/Investigator# 35231 | Göttingen | 37073 | Germany |
| Site Reference ID/Investigator# 65622 | Göttingen | 37075 | Germany |
| Site Reference ID/Investigator# 34902 | Greifswald | 17491 | Germany |
| Site Reference ID/Investigator# 34910 | Güstrow | 18273 | Germany |
| Site Reference ID/Investigator# 35501 | Hagen | 58089 | Germany |
| Site Reference ID/Investigator# 34924 | Halle | 06108 | Germany |
| Site Reference ID/Investigator# 34935 | Halle | 06108 | Germany |
| Site Reference ID/Investigator# 34938 | Halle | 06108 | Germany |
| Site Reference ID/Investigator# 34920 | Halle | 06112 | Germany |
| Site Reference ID/Investigator# 34942 | Halle | 06120 | Germany |
| Site Reference ID/Investigator# 33819 | Halle | 06128 | Germany |
| Site Reference ID/Investigator# 35442 | Hamburg | 20144 | Germany |
| Site Reference ID/Investigator# 53984 | Hamburg | 20355 | Germany |
| Site Reference ID/Investigator# 33367 | Hamburg | 21031 | Germany |
| Site Reference ID/Investigator# 53900 | Hamburg | 21073 | Germany |
| Site Reference ID/Investigator# 34956 | Hamburg | 21075 | Germany |
| Site Reference ID/Investigator# 34962 | Hamburg | 22081 | Germany |
| Site Reference ID/Investigator# 35450 | Hamburg | 22081 | Germany |
| Site Reference ID/Investigator# 35112 | Hamburg | 22087 | Germany |
| Site Reference ID/Investigator# 34946 | Hamburg | 22089 | Germany |
| Site Reference ID/Investigator# 35001 | Hamburg | 22119 | Germany |
| Site Reference ID/Investigator# 34959 | Hamburg | 22147 | Germany |
| Site Reference ID/Investigator# 34977 | Hamburg | 22147 | Germany |
| Site Reference ID/Investigator# 34965 | Hamburg | 22391 | Germany |
| Site Reference ID/Investigator# 54806 | Hamburg | 22399 | Germany |
| Site Reference ID/Investigator# 33578 | Hamburg | 22529 | Germany |
| Site Reference ID/Investigator# 34967 | Hamburg | 22529 | Germany |
| Site Reference ID/Investigator# 34989 | Hamburg | 22529 | Germany |
| Site Reference ID/Investigator# 34981 | Hamburg | 22609 | Germany |
| Site Reference ID/Investigator# 34984 | Hamburg | 22609 | Germany |
| Site Reference ID/Investigator# 34996 | Hamburg | 22609 | Germany |
| Site Reference ID/Investigator# 53953 | Hamm | 59065 | Germany |
| Site Reference ID/Investigator# 35017 | Hanau | 63450 | Germany |
| Site Reference ID/Investigator# 33713 | Hanover | 30159 | Germany |
| Site Reference ID/Investigator# 35032 | Hanover | 30159 | Germany |
| Site Reference ID/Investigator# 35021 | Hanover | 30161 | Germany |
| Site Reference ID/Investigator# 33788 | Hanover | 30625 | Germany |
| Site Reference ID/Investigator# 34021 | Hansestadt Salzwedel | 29410 | Germany |
| Site Reference ID/Investigator# 33790 | Harrislee | 24955 | Germany |
| Site Reference ID/Investigator# 65629 | Haselünne | 49740 | Germany |
| Site Reference ID/Investigator# 33795 | Hattingen | 45525 | Germany |
| Site Reference ID/Investigator# 33796 | Heidelberg | 69120 | Germany |
| Site Reference ID/Investigator# 33806 | Heidelberg | 69121 | Germany |
| Site Reference ID/Investigator# 33811 | Heidelberg | D-69115 | Germany |
| Site Reference ID/Investigator# 33816 | Heilbad Heiligenstadt | 37308 | Germany |
| Site Reference ID/Investigator# 53911 | Herne | 44623 | Germany |
| Site Reference ID/Investigator# 53910 | Herne | 44625 | Germany |
| Site Reference ID/Investigator# 65623 | Herne | 44652 | Germany |
| Site Reference ID/Investigator# 33823 | Herrsching am Ammersee | 82211 | Germany |
| Site Reference ID/Investigator# 33831 | Hildesheim | 31124 | Germany |
| Site Reference ID/Investigator# 33836 | Hof | 95028 | Germany |
| Site Reference ID/Investigator# 33840 | Hofheim | 65719 | Germany |
| Site Reference ID/Investigator# 33843 | Hohenfelde | 18209 | Germany |
| Site Reference ID/Investigator# 54807 | Homburg | 66424 | Germany |
| Site Reference ID/Investigator# 53985 | Illingen | 66557 | Germany |
| Site Reference ID/Investigator# 33933 | Ingolstadt | 85049 | Germany |
| Site Reference ID/Investigator# 53938 | Jena | 07743 | Germany |
| Site Reference ID/Investigator# 5323 | Jena | 07745 | Germany |
| Site Reference ID/Investigator# 33940 | Jülich | 52428 | Germany |
| Site Reference ID/Investigator# 33944 | Kahla | 07768 | Germany |
| Site Reference ID/Investigator# 35124 | Kahla | 07768 | Germany |
| Site Reference ID/Investigator# 33948 | Kaiserslautern | 67655 | Germany |
| Site Reference ID/Investigator# 53935 | Kaltenkirchen | 24568 | Germany |
| Site Reference ID/Investigator# 33397 | Karlsruhe | 76133 | Germany |
| Site Reference ID/Investigator# 33954 | Karlsruhe | 76133 | Germany |
| Site Reference ID/Investigator# 35482 | Karlstadt am Main | 97753 | Germany |
| Site Reference ID/Investigator# 33962 | Kassel | 34131 | Germany |
| Site Reference ID/Investigator# 35239 | Kolkwitz | 3099 | Germany |
| Site Reference ID/Investigator# 34000 | Königs Wusterhausen | 15711 | Germany |
| Site Reference ID/Investigator# 34006 | Kressbronn | 88079 | Germany |
| Site Reference ID/Investigator# 34009 | Kronach | 96317 | Germany |
| Site Reference ID/Investigator# 34086 | Kyritz | 16866 | Germany |
| Site Reference ID/Investigator# 34003 | Lahr | 77933 | Germany |
| Site Reference ID/Investigator# 53937 | Leipzig | 04103 | Germany |
| Site Reference ID/Investigator# 65628 | Leipzig | 04109 | Germany |
| Site Reference ID/Investigator# 34107 | Leipzig | 04207 | Germany |
| Site Reference ID/Investigator# 34098 | Leipzig | 04299 | Germany |
| Site Reference ID/Investigator# 34119 | Leverkusen | 51373 | Germany |
| Site Reference ID/Investigator# 34121 | Lichtenstein | 09350 | Germany |
| Site Reference ID/Investigator# 35252 | Lippstadt | 59555 | Germany |
| Site Reference ID/Investigator# 53882 | Löhne | 49393 | Germany |
| Site Reference ID/Investigator# 53886 | Ludwigsburg | 71638 | Germany |
| Site Reference ID/Investigator# 35257 | Ludwigsfelde | 14974 | Germany |
| Site Reference ID/Investigator# 53906 | Ludwigslust | 19288 | Germany |
| Site Reference ID/Investigator# 34133 | Lübeck | 23552 | Germany |
| Site Reference ID/Investigator# 53943 | Lüdenscheid | 58311 | Germany |
| Site Reference ID/Investigator# 33407 | Lüneburg | 21335 | Germany |
| Site Reference ID/Investigator# 53888 | Lüneburg | 21335 | Germany |
| Site Reference ID/Investigator# 34148 | Magdeburg | 39104 | Germany |
| Site Reference ID/Investigator# 53981 | Magdeburg | 39110 | Germany |
| Site Reference ID/Investigator# 53913 | Magdeburg | 39120 | Germany |
| Site Reference ID/Investigator# 53928 | Mainz | 55116 | Germany |
| Site Reference ID/Investigator# 65631 | Mainz | 55116 | Germany |
| Site Reference ID/Investigator# 34184 | Mannheim | 68165 | Germany |
| Site Reference ID/Investigator# 34194 | Marl | 45768 | Germany |
| Site Reference ID/Investigator# 35283 | Menz | 39175 | Germany |
| Site Reference ID/Investigator# 53896 | Merxheim | 55627 | Germany |
| Site Reference ID/Investigator# 33418 | Minden | 32429 | Germany |
| Site Reference ID/Investigator# 34206 | Mittelherwigsdorf | 02763 | Germany |
| Site Reference ID/Investigator# 34219 | Moenkeberg | 24248 | Germany |
| Site Reference ID/Investigator# 34216 | Mönchengladbach | 41061 | Germany |
| Site Reference ID/Investigator# 53915 | Mönchengladbach | 41061 | Germany |
| Site Reference ID/Investigator# 34211 | Mönchengladbach | 41199 | Germany |
| Site Reference ID/Investigator# 34214 | Mönchengladbach | 41199 | Germany |
| Site Reference ID/Investigator# 53904 | Munich | 80331 | Germany |
| Site Reference ID/Investigator# 53956 | Munich | 80336 | Germany |
| Site Reference ID/Investigator# 34037 | Munich | 80639 | Germany |
| Site Reference ID/Investigator# 53962 | Munich | 80798 | Germany |
| Site Reference ID/Investigator# 53912 | Munich | 81547 | Germany |
| Site Reference ID/Investigator# 35296 | Munich | 81667 | Germany |
| Site Reference ID/Investigator# 53924 | Munich | 81667 | Germany |
| Site Reference ID/Investigator# 34041 | Munich | 81925 | Germany |
| Site Reference ID/Investigator# 34035 | Munich | D-81541 | Germany |
| Site Reference ID/Investigator# 34222 | Mühlhausen | 99974 | Germany |
| Site Reference ID/Investigator# 34044 | Münster | 48143 | Germany |
| Site Reference ID/Investigator# 53970 | Münster | 48143 | Germany |
| Site Reference ID/Investigator# 34046 | Münster | 48149 | Germany |
| Site Reference ID/Investigator# 34050 | Naunhof | 04683 | Germany |
| Site Reference ID/Investigator# 34059 | Neubrandenburg | 17033 | Germany |
| Site Reference ID/Investigator# 34062 | Neuburg am Inn | 86633 | Germany |
| Site Reference ID/Investigator# 34980 | Neunkirchen | 66538 | Germany |
| Site Reference ID/Investigator# 35311 | Neuss | 41460 | Germany |
| Site Reference ID/Investigator# 34072 | Neustadt | 67434 | Germany |
| Site Reference ID/Investigator# 65630 | Neuwied | 56564 | Germany |
| Site Reference ID/Investigator# 82694 | Niederbrombach | 55767 | Germany |
| Site Reference ID/Investigator# 34078 | Niefern-Öschelbronn | 75223 | Germany |
| Site Reference ID/Investigator# 34081 | Nienburg | 31582 | Germany |
| Site Reference ID/Investigator# 34082 | Nienburg | 31582 | Germany |
| Site Reference ID/Investigator# 53923 | Nuremberg | 90402 | Germany |
| Site Reference ID/Investigator# 34168 | Obergünzburg | 87634 | Germany |
| Site Reference ID/Investigator# 34174 | Offenburg | 77652 | Germany |
| Site Reference ID/Investigator# 33490 | Oldenburg | 26121 | Germany |
| Site Reference ID/Investigator# 53950 | Olsberg | 59939 | Germany |
| Site Reference ID/Investigator# 33499 | Osnabrück | D-49074 | Germany |
| Site Reference ID/Investigator# 54803 | Osnabrück | D-49074 | Germany |
| Site Reference ID/Investigator# 34715 | Ostseebad Damp | 24351 | Germany |
| Site Reference ID/Investigator# 35333 | Paderborn | 33098 | Germany |
| Site Reference ID/Investigator# 33503 | Papenburg | 26871 | Germany |
| Site Reference ID/Investigator# 33506 | Parchim | 19370 | Germany |
| Site Reference ID/Investigator# 33509 | Parsberg | 92331 | Germany |
| Site Reference ID/Investigator# 35338 | Passau | 94032 | Germany |
| Site Reference ID/Investigator# 33511 | Petershagen | 32469 | Germany |
| Site Reference ID/Investigator# 33519 | Pinneberg | 25421 | Germany |
| Site Reference ID/Investigator# 33520 | Pirna | 01796 | Germany |
| Site Reference ID/Investigator# 33521 | Planegg | 82152 | Germany |
| Site Reference ID/Investigator# 33526 | Plauen | 08523 | Germany |
| Site Reference ID/Investigator# 33468 | Potsdam | 14467 | Germany |
| Site Reference ID/Investigator# 33464 | Potsdam | 14469 | Germany |
| Site Reference ID/Investigator# 53940 | Pulheim | 50259 | Germany |
| Site Reference ID/Investigator# 33482 | Radebeul | 01445 | Germany |
| Site Reference ID/Investigator# 53964 | Raststatt | 76437 | Germany |
| Site Reference ID/Investigator# 33485 | Ratingen | 40882 | Germany |
| Site Reference ID/Investigator# 35134 | Ratingen | 40882 | Germany |
| Site Reference ID/Investigator# 54812 | Ratingen | 40882 | Germany |
| Site Reference ID/Investigator# 33888 | Regensburg | 93049 | Germany |
| Site Reference ID/Investigator# 33891 | Regensburg | 93049 | Germany |
| Site Reference ID/Investigator# 33881 | Regensburg | 93051 | Germany |
| Site Reference ID/Investigator# 33884 | Regensburg | 93051 | Germany |
| Site Reference ID/Investigator# 53930 | Regensburg | 93059 | Germany |
| Site Reference ID/Investigator# 53986 | Reichenbach | 08468 | Germany |
| Site Reference ID/Investigator# 53957 | Reken | 48734 | Germany |
| Site Reference ID/Investigator# 53920 | Remscheid | 42864 | Germany |
| Site Reference ID/Investigator# 33900 | Rendsburg | 24768 | Germany |
| Site Reference ID/Investigator# 33903 | Reutlingen | 72764 | Germany |
| Site Reference ID/Investigator# 53982 | Rheinfelden | 79618 | Germany |
| Site Reference ID/Investigator# 53908 | Rickenbach | 79736 | Germany |
| Site Reference ID/Investigator# 33393 | Riesa | 01589 | Germany |
| Site Reference ID/Investigator# 33912 | Rinteln | 31737 | Germany |
| Site Reference ID/Investigator# 33921 | Rostock | 18059 | Germany |
| Site Reference ID/Investigator# 33929 | Rothenburg | 02929 | Germany |
| Site Reference ID/Investigator# 34014 | Saarbrücken | 66111 | Germany |
| Site Reference ID/Investigator# 53916 | Schlangenbad | 65388 | Germany |
| Site Reference ID/Investigator# 34030 | Schneeberg | 08289 | Germany |
| Site Reference ID/Investigator# 33550 | Schwerin | 19053 | Germany |
| Site Reference ID/Investigator# 35374 | Schwerin | 19053 | Germany |
| Site Reference ID/Investigator# 33553 | Schwerte | 58239 | Germany |
| Site Reference ID/Investigator# 33557 | Seesen | 38723 | Germany |
| Site Reference ID/Investigator# 53944 | Siegen | 57072 | Germany |
| Site Reference ID/Investigator# 33565 | Sinsheim | 74889 | Germany |
| Site Reference ID/Investigator# 53927 | Solingen | 42651 | Germany |
| Site Reference ID/Investigator# 33570 | Soltau | 29614 | Germany |
| Site Reference ID/Investigator# 33583 | Stadtbergen | 86391 | Germany |
| Site Reference ID/Investigator# 33586 | Stadthagen | 31655 | Germany |
| Site Reference ID/Investigator# 53936 | Steinhagen | 33803 | Germany |
| Site Reference ID/Investigator# 33602 | Stuttgart | 70178 | Germany |
| Site Reference ID/Investigator# 33609 | Stuttgart | 70199 | Germany |
| Site Reference ID/Investigator# 33596 | Stuttgart | 70372 | Germany |
| Site Reference ID/Investigator# 35387 | Suhl | 98529 | Germany |
| Site Reference ID/Investigator# 54808 | Tarp | 24963 | Germany |
| Site Reference ID/Investigator# 35433 | Thum-Jahnsbach | 9419 | Germany |
| Site Reference ID/Investigator# 53951 | Tischenreuth | 95643 | Germany |
| Site Reference ID/Investigator# 33623 | Torgelow | 17358 | Germany |
| Site Reference ID/Investigator# 33628 | Treuenbrietzen | 14929 | Germany |
| Site Reference ID/Investigator# 53907 | Tübingen | 72072 | Germany |
| Site Reference ID/Investigator# 53893 | Twistringen | 27239 | Germany |
| Site Reference ID/Investigator# 33635 | Ueberlingen-Nussdorf | 88662 | Germany |
| Site Reference ID/Investigator# 53898 | Uhlstaedt-Kirchhasel | 07407 | Germany |
| Site Reference ID/Investigator# 33722 | Ulm | 89073 | Germany |
| Site Reference ID/Investigator# 65626 | Ulm | 89073 | Germany |
| Site Reference ID/Investigator# 33732 | Verden an der Aller | 27283 | Germany |
| Site Reference ID/Investigator# 53965 | Viersen | 41747 | Germany |
| Site Reference ID/Investigator# 33735 | Villingen-Schwenningen | 78054 | Germany |
| Site Reference ID/Investigator# 53914 | Vogelsang-Gommern | 39245 | Germany |
| Site Reference ID/Investigator# 53952 | Vreden | 48691 | Germany |
| Site Reference ID/Investigator# 54809 | Waldbronn | 76337 | Germany |
| Site Reference ID/Investigator# 33740 | Waltrop | 45731 | Germany |
| Site Reference ID/Investigator# 34250 | Wannsee | 14109 | Germany |
| Site Reference ID/Investigator# 33747 | Weener | 26826 | Germany |
| Site Reference ID/Investigator# 53891 | Weiden I.d. Oberpfalz | 92637 | Germany |
| Site Reference ID/Investigator# 53921 | Weißenfels | 06667 | Germany |
| Site Reference ID/Investigator# 33753 | Welzow | 03119 | Germany |
| Site Reference ID/Investigator# 35406 | Wiesbaden | 65189 | Germany |
| Site Reference ID/Investigator# 53941 | Wiesbaden | 65189 | Germany |
| Site Reference ID/Investigator# 33762 | Wiesbaden | 65191 | Germany |
| Site Reference ID/Investigator# 33770 | Wilhelmshaven | 26382 | Germany |
| Site Reference ID/Investigator# 53954 | Winsen | 21423 | Germany |
| Site Reference ID/Investigator# 53977 | Winsen | 21423 | Germany |
| Site Reference ID/Investigator# 33778 | Wittlich | 54516 | Germany |
| Site Reference ID/Investigator# 33783 | Wolfsburg | 38440 | Germany |
| Site Reference ID/Investigator# 53917 | Wuppertal | 42103 | Germany |
| Site Reference ID/Investigator# 35418 | Wuppertal | 42105 | Germany |
| Site Reference ID/Investigator# 33716 | Würzburg | 97070 | Germany |
| Site Reference ID/Investigator# 33862 | Zerbst | 39261 | Germany |
| Site Reference ID/Investigator# 33865 | Zeven | 27404 | Germany |
| Site Reference ID/Investigator# 33870 | Zwickau | 08060 | Germany |
| Site Reference ID/Investigator# 33878 | Zwiesel | 94227 | Germany |
| Scharbatke EC, Behrens F, Schmalzing M, Koehm M, Greger G, Gnann H, Burkhardt H, Tony HP. Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1607-1615. doi: 10.1002/acr.22884. Epub 2016 Oct 1. |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rheumatoid Arthritis | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data available for 5,727 participants | Mean | Standard Deviation | years |
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| Gender | Gender data missing for 2 participants | Number | participants |
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| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Disease Activity Score (DAS) 28 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
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| Primary | Percentage of Participants in DAS28 Remission | 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. | 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. | Posted | Number | percentage of participants | Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
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| Secondary | Percentage of Participants With a Significant Therapeutic Response | 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. | 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. | Posted | Number | percentage of participants | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
|
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| Secondary | Percentage of Participants With Low, Moderate and High 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. 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. | Full analysis set (FAS) participants with available data at each time point. | Posted | Number | percentage of participants | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
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| Secondary | Erythrocyte Sedimentation Rate (ESR) Over Time | Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. | 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. | Posted | Mean | Standard Deviation | mm/hour | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
|
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| Secondary | C-Reactive Protein (CRP) Levels Over Time | 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. | 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. | Posted | Mean | Standard Deviation | mg/L | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
|
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| Secondary | Tender Joint Count (TJC) Over Time | Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. | 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. | Posted | Mean | Standard Deviation | tender joints | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
|
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| Secondary | Swollen Joint Count (SJC) Over Time | Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. | 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. | Posted | Mean | Standard Deviation | swollen joints | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
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| Secondary | Hannover Functional Questionnaire (FFbH) Over Time | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
|
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| Secondary | Patients Global Assessment of Disease Activity Over Time | 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. | 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. | Posted | Mean | Standard Deviation | cm | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
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| Secondary | Participants Assessment of Pain Over Time | 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. | 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. | Posted | Mean | Standard Deviation | cm | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
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| Secondary | Participants Assessment of Fatigue Over Time | 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. | 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. | Posted | Mean | Standard Deviation | cm | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
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| Secondary | Percentage of Participants With Impairment in Daily Activities | Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks. | Full analysis set (FAS) participants with available data at each time point. | Posted | Number | percentage of participants | Baseline and Months 6, 18, 24, and 30 |
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| Secondary | Number of Days Missed From Work Due to Rheumatoid Arthritis | 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. | Full analysis set participants who were employed and with available data at each time point (indicated by n) | Posted | Mean | Standard Deviation | days | Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60 |
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| Secondary | Percentage of Participants With In-patient Hospitalization | 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. | Full analysis set participants who were employed and with available data at each time point (indicated by n) | Posted | Number | percentage of participants | Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60 |
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| Secondary | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | 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. | Posted | Number | percentage of participants | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 |
|
Adverse events were collected throughout the 60-month period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rheumatoid Arthritis | Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. | 163 | 5,745 | 58 | 5,745 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Papilloma virus infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Peritoneal tuberculosis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Actinomycosis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Localized infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Neuroborreliosis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pyothorax | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Surgery | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Synovectomy | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Foot operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Arthrodesis | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Joint arthroplasty | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Skin neoplasm excision | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Abscess drainage | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Ankle operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Bone operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Breast operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Bursa removal | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Coronary angioplasty | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Coronary artery bypass | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Hemorrhoid operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Hydrocele operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Osteosynthesis | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Osteotomy | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Prostatic operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Radiotherapy | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Renal transplant | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Skin graft | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Spinal operation | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Stent placement | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Transurethral incision of prostate | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Vertebroplasty | Surgical and medical procedures | MedDRA (12.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Chronic myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Hemangioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Lymphangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Malignant mesenteric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Accidental death | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Fat necrosis | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Peripheral edema | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Colitis erosive | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Duodenal ulcer hemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hyperkinesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nail bed inflammation | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Catheterization cardiac | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Decreased activity | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac assistance device user | Social circumstances | MedDRA (12.1) | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Month 18 (n=2397) |
|
| Month 24 (n=2099) |
|
| Month 30 (n=1810) |
|
| Month 36 (n=1564) |
|
| Month 48 (n=1261) |
|
| Month 60 (n=934) |
|
|
|
|
12 months after inclusion
| OG004 | Month 18 | 18 months after inclusion |
| OG005 | Month 24 | 24 months after inclusion |
| OG006 | Month 30 | 30 months after inclusion |
| OG007 | Month 36 | 36 months after inclusion |
| OG008 | Month 48 | 48 months after inclusion |
| OG009 | Month 60 | 60 months after inclusion |
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Month 24 |
24 months after inclusion |
| OG006 | Month 30 | 30 months after inclusion |
| OG007 | Month 36 | 36 months after inclusion |
| OG008 | Month 48 | 48 months after inclusion |
| OG009 | Month 60 | 60 months after inclusion |
|
|