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This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.
Psoriatic Arthritis participants receiving adalimumab are evaluated in a prospective, non-interventional study (NIS) for 2 years. Patients receive adalimumab 40 mg every other week (eow), per its label. Efficacy and safety parameters are measured routinely at baseline and after 3, 6, 9, 12, 18 and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriatic Arthritis | Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean 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, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. | Baseline and Months 3, 6, 9, 12, 18, and 24 |
| Mean Tender Joint Count (TJC) Over Time | Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not. | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Mean Swollen Joint Count (SJC) Over Time | Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not. | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time | Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient's hand was equal to 1% BSA. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants by Severity of Enthesitis Over Time | Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression. |
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Inclusion:
Exclusion:
-None
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Clinical routine patients with psoriatic arthritis
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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# 35035 | Aachen | 52062 | Germany | |||
| Site Reference ID/Investigator# 64288 |
| 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. | |
| 30010891 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Psoriatic Arthritis | Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Mean Target Lesion Score (TLS) Over Time | The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity). | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Number of Participants With Adverse Events (AEs) | Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion. | Baseline up to 24 months |
| Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Number of Participants by Severity of Dactylitis Over Time | Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to "sausage digit," involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression. | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Number of Participants by Severity of Nail Psoriasis Levels Over Time | Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression. | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Mean Erythrocyte Sedimentation Rate (ESR) Over Time | The Erythrocyte Sedimentation Rate (ESR) is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity. | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Mean C-Reactive Protein (CRP) Levels Over Time | The C-Reactive Protein (CRP) is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL. | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Patients Global Assessment of Disease Activity Over Time | Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status. | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Participants Assessment of Fatigue Over Time | Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status. | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Participants Assessment of Pain Over Time | Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status. | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time | A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function. | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Mean Number of Days Missed From Work Due to Psoriatic Arthritis | Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24). | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Percentage of Participants With In-Patient Hospitalization | Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24). | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
| Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication | Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs | Baseline, and Months 6 and 24 |
| Aachen |
| 52062 |
| Germany |
| Site Reference ID/Investigator# 35509 | Ahlen | 59227 | Germany |
| Site Reference ID/Investigator# 53118 | Ahrensburg | 22926 | Germany |
| Site Reference ID/Investigator# 35042 | Altenburg | 04600 | Germany |
| Site Reference ID/Investigator# 35045 | Altenholz | 24161 | Germany |
| Site Reference ID/Investigator# 35048 | Amberg | 92224 | Germany |
| Site Reference ID/Investigator# 96243 | Annaberg-Buchholz | 9456 | Germany |
| Site Reference ID/Investigator# 53205 | Arnstadt | 99310 | Germany |
| Site Reference ID/Investigator# 53091 | Artern | 06556 | Germany |
| Site Reference ID/Investigator# 33348 | Augsburg | 86150 | Germany |
| Site Reference ID/Investigator# 33357 | Bad Abbach | 93077 | Germany |
| Site Reference ID/Investigator# 35085 | Bad Aibling | 83043 | Germany |
| Site Reference ID/Investigator# 57895 | Bad Aibling | 83043 | Germany |
| Site Reference ID/Investigator# 91097 | Bad Bentheim | 48455 | Germany |
| Site Reference ID/Investigator# 35524 | Bad Bentheim | D-48455 | Germany |
| Site Reference ID/Investigator# 35572 | Bad Bramstedt | 24576 | Germany |
| Site Reference ID/Investigator# 64304 | Bad Bramstedt | 24576 | Germany |
| Site Reference ID/Investigator# 33371 | Bad Endbach | 35080 | Germany |
| Site Reference ID/Investigator# 53278 | Bad Endbach | 63065 | Germany |
| Site Reference ID/Investigator# 91084 | Bad Homburg | 61348 | Germany |
| Site Reference ID/Investigator# 33377 | Bad Iburg | 49186 | Germany |
| Site Reference ID/Investigator# 33381 | Bad Iburg | 49186 | Germany |
| Site Reference ID/Investigator# 53068 | Bad Kissingen | 97688 | Germany |
| Site Reference ID/Investigator# 33386 | Bad Kreuznach | 55543 | Germany |
| Site Reference ID/Investigator# 35574 | Bad Kreuznach | 55543 | Germany |
| Site Reference ID/Investigator# 33390 | Bad Liebenwerda | 04924 | Germany |
| Site Reference ID/Investigator# 33395 | Bad Münder am Deister | 31848 | Germany |
| Site Reference ID/Investigator# 96245 | Bad Münder am Deister | 31848 | Germany |
| Site Reference ID/Investigator# 91094 | Bad Nauheim | 61231 | Germany |
| Site Reference ID/Investigator# 35577 | Bad Neuenahr | 53474 | Germany |
| Site Reference ID/Investigator# 53181 | Bad Neuenahr | 53474 | Germany |
| Site Reference ID/Investigator# 57885 | Bad Oeynhausen | 32545 | Germany |
| Site Reference ID/Investigator# 33403 | Bad Rappenau | 74906 | Germany |
| Site Reference ID/Investigator# 53060 | Bad Salzungen | 36433 | Germany |
| Site Reference ID/Investigator# 91079 | Bad Salzungen | 36433 | Germany |
| Site Reference ID/Investigator# 53254 | Bad Schlema | 8301 | Germany |
| Site Reference ID/Investigator# 33416 | Bad Staffelstein | 96231 | Germany |
| Site Reference ID/Investigator# 33420 | Bad Sülze | 18334 | Germany |
| Site Reference ID/Investigator# 57890 | Bad Tölz | 83646 | Germany |
| Site Reference ID/Investigator# 33424 | Baden-Baden | 76530 | Germany |
| Site Reference ID/Investigator# 33428 | Bamberg | 96047 | Germany |
| Site Reference ID/Investigator# 33434 | Bautzen | 02625 | Germany |
| Site Reference ID/Investigator# 33437 | Bautzen | 02625 | Germany |
| Site Reference ID/Investigator# 53231 | Bayreuth | 95444 | Germany |
| Site Reference ID/Investigator# 33441 | Bayreuth | 95445 | Germany |
| Site Reference ID/Investigator# 33445 | Bayreuth | 95445 | Germany |
| Site Reference ID/Investigator# 68595 | Bergen | 18528 | Germany |
| Site Reference ID/Investigator# 33459 | Berlin | 10117 | Germany |
| Site Reference ID/Investigator# 35087 | Berlin | 10117 | Germany |
| Site Reference ID/Investigator# 53058 | Berlin | 10117 | Germany |
| Site Reference ID/Investigator# 53241 | Berlin | 10117 | Germany |
| Site Reference ID/Investigator# 53242 | Berlin | 10117 | Germany |
| Site Reference ID/Investigator# 33647 | Berlin | 10178 | Germany |
| Site Reference ID/Investigator# 57909 | Berlin | 10178 | Germany |
| Site Reference ID/Investigator# 53061 | Berlin | 10243 | Germany |
| Site Reference ID/Investigator# 53059 | Berlin | 10369 | Germany |
| Site Reference ID/Investigator# 68842 | Berlin | 10369 | Germany |
| Site Reference ID/Investigator# 33657 | Berlin | 10435 | Germany |
| Site Reference ID/Investigator# 53105 | Berlin | 10709 | Germany |
| Site Reference ID/Investigator# 98535 | Berlin | 10713 | Germany |
| Site Reference ID/Investigator# 34245 | Berlin | 10719 | Germany |
| Site Reference ID/Investigator# 33682 | Berlin | 10777 | Germany |
| Site Reference ID/Investigator# 68594 | Berlin | 10827 | Germany |
| Site Reference ID/Investigator# 34268 | Berlin | 10961 | Germany |
| Site Reference ID/Investigator# 33654 | Berlin | 12159 | Germany |
| Site Reference ID/Investigator# 64284 | Berlin | 12159 | Germany |
| Site Reference ID/Investigator# 35596 | Berlin | 12161 | Germany |
| Site Reference ID/Investigator# 35600 | Berlin | 12161 | Germany |
| Site Reference ID/Investigator# 53081 | Berlin | 12353 | Germany |
| Site Reference ID/Investigator# 53244 | Berlin | 12435 | Germany |
| Site Reference ID/Investigator# 91075 | Berlin | 12435 | Germany |
| Site Reference ID/Investigator# 64287 | Berlin | 12437 | Germany |
| Site Reference ID/Investigator# 34261 | Berlin | 12681 | Germany |
| Site Reference ID/Investigator# 33686 | Berlin | 13055 | Germany |
| Site Reference ID/Investigator# 64286 | Berlin | 13407 | Germany |
| Site Reference ID/Investigator# 52990 | Berlin | 13507 | Germany |
| Site Reference ID/Investigator# 52995 | Berlin | 13507 | Germany |
| Site Reference ID/Investigator# 35549 | Berlin | 13595 | Germany |
| Site Reference ID/Investigator# 53090 | Berlin | 14129 | Germany |
| Site Reference ID/Investigator# 35553 | Berlin | 14163 | Germany |
| Site Reference ID/Investigator# 57893 | Berlin-Weissensee | 13086 | Germany |
| Site Reference ID/Investigator# 35555 | Bernau | 16321 | Germany |
| Site Reference ID/Investigator# 53213 | Bernsbach | 8315 | Germany |
| Site Reference ID/Investigator# 34274 | Beverungen | 37688 | Germany |
| Site Reference ID/Investigator# 53085 | Bietigheim-Bissingen | 74321 | Germany |
| Site Reference ID/Investigator# 53268 | Bietigheim-Bissingen | 74321 | Germany |
| Site Reference ID/Investigator# 34284 | Blankenburg/Hart | 38889 | Germany |
| Site Reference ID/Investigator# 34287 | Blaubeuren Abbey | 89143 | Germany |
| Site Reference ID/Investigator# 34290 | Bocholt | 46399 | Germany |
| Site Reference ID/Investigator# 35640 | Bochum | 44789 | Germany |
| Site Reference ID/Investigator# 53196 | Bochum | 44789 | Germany |
| Site Reference ID/Investigator# 53179 | Bochum | 44791 | Germany |
| Site Reference ID/Investigator# 57908 | Bochum | 44803 | Germany |
| Site Reference ID/Investigator# 35643 | Bogen | 94327 | Germany |
| Site Reference ID/Investigator# 34301 | Bonn | 53111 | Germany |
| Site Reference ID/Investigator# 34295 | Bonn | 53177 | Germany |
| Site Reference ID/Investigator# 34306 | Braunschweig | 38100 | Germany |
| Site Reference ID/Investigator# 53234 | Breitenbrunn | 08359 | Germany |
| Site Reference ID/Investigator# 35608 | Bremen | 28209 | Germany |
| Site Reference ID/Investigator# 52987 | Bremen | 28209 | Germany |
| Site Reference ID/Investigator# 53107 | Bremen | 28209 | Germany |
| Site Reference ID/Investigator# 53247 | Bremen | 28239 | Germany |
| Site Reference ID/Investigator# 91073 | Bremerhaven | 27572 | Germany |
| Site Reference ID/Investigator# 34265 | Buch | 13125 | Germany |
| Site Reference ID/Investigator# 64291 | Buch | 13125 | Germany |
| Site Reference ID/Investigator# 68584 | Burgstädt | 09217 | Germany |
| Site Reference ID/Investigator# 81599 | Chemnitz | 09119 | Germany |
| Site Reference ID/Investigator# 34698 | Chemnitz | 09126 | Germany |
| Site Reference ID/Investigator# 57902 | Chemnitz | 9116 | Germany |
| Site Reference ID/Investigator# 35094 | Chemnitz | D-09130 | Germany |
| Site Reference ID/Investigator# 53262 | Cologne | 50679 | Germany |
| Site Reference ID/Investigator# 64298 | Cologne | 50679 | Germany |
| Site Reference ID/Investigator# 64293 | Cologne | 50733 | Germany |
| Site Reference ID/Investigator# 33988 | Cologne | 50823 | Germany |
| Site Reference ID/Investigator# 53193 | Cologne | 50931 | Germany |
| Site Reference ID/Investigator# 53071 | Cologne | 50937 | Germany |
| Site Reference ID/Investigator# 35236 | Cologne | 51067 | Germany |
| Site Reference ID/Investigator# 64300 | Cologne | 51103 | Germany |
| Site Reference ID/Investigator# 72857 | Cologne | 51109 | Germany |
| Site Reference ID/Investigator# 34710 | Cottbus | 03046 | Germany |
| Site Reference ID/Investigator# 53184 | Cottbus | 3048 | Germany |
| Site Reference ID/Investigator# 64303 | Darmstadt | 64283 | Germany |
| Site Reference ID/Investigator# 35620 | Darmstadt | 64295 | Germany |
| Site Reference ID/Investigator# 34724 | Deggendorf | 94469 | Germany |
| Site Reference ID/Investigator# 53209 | Delmenhorst | 27749 | Germany |
| Site Reference ID/Investigator# 53089 | Delmenhorst | 27753 | Germany |
| Site Reference ID/Investigator# 91077 | Dinslaken | 46535 | Germany |
| Site Reference ID/Investigator# 34741 | Dortmund | 44147 | Germany |
| Site Reference ID/Investigator# 35637 | Dortmund | 44147 | Germany |
| Site Reference ID/Investigator# 35633 | Dortmund | 44263 | Germany |
| Site Reference ID/Investigator# 57899 | Dresden | 01067 | Germany |
| Site Reference ID/Investigator# 35172 | Dresden | 01097 | Germany |
| Site Reference ID/Investigator# 34753 | Dresden | 01109 | Germany |
| Site Reference ID/Investigator# 53069 | Dresden | 01219 | Germany |
| Site Reference ID/Investigator# 34747 | Dresden | 01277 | Germany |
| Site Reference ID/Investigator# 34750 | Dresden | 01277 | Germany |
| Site Reference ID/Investigator# 34759 | Dresden | 01277 | Germany |
| Site Reference ID/Investigator# 68590 | Dresden | 01277 | Germany |
| Site Reference ID/Investigator# 53182 | Dresden | 01307 | Germany |
| Site Reference ID/Investigator# 91081 | Dresden | 1109 | Germany |
| Site Reference ID/Investigator# 68592 | Dresden | 1217 | Germany |
| Site Reference ID/Investigator# 57904 | Dresden | 1309 | Germany |
| Site Reference ID/Investigator# 34777 | Duisburg | 47055 | Germany |
| Site Reference ID/Investigator# 53072 | Duisburg | 47249 | Germany |
| Site Reference ID/Investigator# 98537 | Duisburg | 47249 | Germany |
| Site Reference ID/Investigator# 53266 | Düren | 52349 | Germany |
| Site Reference ID/Investigator# 34772 | Düsseldorf | 40211 | Germany |
| Site Reference ID/Investigator# 64302 | Düsseldorf | 40225 | Germany |
| Site Reference ID/Investigator# 34783 | Eberswalde | 16225 | Germany |
| Site Reference ID/Investigator# 53194 | Eberswalde | 16225 | Germany |
| Site Reference ID/Investigator# 53065 | Eisenach | 99817 | Germany |
| Site Reference ID/Investigator# 72856 | Eisenach | 99817 | Germany |
| Site Reference ID/Investigator# 53000 | Eisleben Lutherstadt | 06295 | Germany |
| Site Reference ID/Investigator# 35181 | Elmshorn | 25335 | Germany |
| Site Reference ID/Investigator# 53114 | Eppstein | 65817 | Germany |
| Site Reference ID/Investigator# 53221 | Erftstadt | 50374 | Germany |
| Site Reference ID/Investigator# 53070 | Erfurt | 99084 | Germany |
| Site Reference ID/Investigator# 53258 | Erfurt | 99084 | Germany |
| Site Reference ID/Investigator# 53259 | Erfurt | 99084 | Germany |
| Site Reference ID/Investigator# 57900 | Erfurt | 99084 | Germany |
| Site Reference ID/Investigator# 34808 | Erfurt | 99096 | Germany |
| Site Reference ID/Investigator# 35095 | Erfurt | 99096 | Germany |
| Site Reference ID/Investigator# 57901 | Erkrath | 40699 | Germany |
| Site Reference ID/Investigator# 34820 | Erlangen | 91056 | Germany |
| Site Reference ID/Investigator# 57896 | Erlangen | D-91054 | Germany |
| Site Reference ID/Investigator# 35195 | Essen | 45326 | Germany |
| Site Reference ID/Investigator# 35198 | Essen | 45356 | Germany |
| Site Reference ID/Investigator# 53219 | Esslingen am Neckar | 73732 | Germany |
| Site Reference ID/Investigator# 35201 | Feldafing | 82340 | Germany |
| Site Reference ID/Investigator# 35204 | Flensburg | 24937 | Germany |
| Site Reference ID/Investigator# 34832 | Forchheim | 91301 | Germany |
| Site Reference ID/Investigator# 35209 | Frankenberg | 09669 | Germany |
| Site Reference ID/Investigator# 64283 | Frankfurt | 60590 | Germany |
| Site Reference ID/Investigator# 34839 | Frankfurt | 60596 | Germany |
| Site Reference ID/Investigator# 35212 | Fraureuth | 08427 | Germany |
| Site Reference ID/Investigator# 91078 | Frechen | 50226 | Germany |
| Site Reference ID/Investigator# 35218 | Freiberg | 09599 | Germany |
| Site Reference ID/Investigator# 34853 | Freiburg im Breisgau | 79098 | Germany |
| Site Reference ID/Investigator# 34856 | Freiburg im Breisgau | 79098 | Germany |
| Site Reference ID/Investigator# 34860 | Freiburg im Breisgau | 79106 | Germany |
| Site Reference ID/Investigator# 35100 | Freystadt | 92342 | Germany |
| Site Reference ID/Investigator# 35223 | Friedrichroda | 99894 | Germany |
| Site Reference ID/Investigator# 68843 | Garching | 85748 | Germany |
| Site Reference ID/Investigator# 34878 | Gelsenkirchen | 45881 | Germany |
| Site Reference ID/Investigator# 68591 | Gelsenkirchen | 45897 | Germany |
| Site Reference ID/Investigator# 34882 | Gera | 07545 | Germany |
| Site Reference ID/Investigator# 57907 | Gera | 07545 | Germany |
| Site Reference ID/Investigator# 64285 | Gera | 07545 | Germany |
| Site Reference ID/Investigator# 64294 | Gera | 07545 | Germany |
| Site Reference ID/Investigator# 57897 | Gera | 07548 | Germany |
| Site Reference ID/Investigator# 53222 | Gera | 7546 | Germany |
| Site Reference ID/Investigator# 34886 | Giessen | 35392 | Germany |
| Site Reference ID/Investigator# 53116 | Gornau | 09405 | Germany |
| Site Reference ID/Investigator# 34895 | Goslar | 38642 | Germany |
| Site Reference ID/Investigator# 68589 | Gotha | 99867 | Germany |
| Site Reference ID/Investigator# 52998 | Göttingen | 37075 | Germany |
| Site Reference ID/Investigator# 35493 | Gräfelfing | 82166 | Germany |
| Site Reference ID/Investigator# 53224 | Greifswald | 17489 | Germany |
| Site Reference ID/Investigator# 57889 | Greifswald | 17489 | Germany |
| Site Reference ID/Investigator# 64289 | Greifswald | 17489 | Germany |
| Site Reference ID/Investigator# 34903 | Greifswald | 17491 | Germany |
| Site Reference ID/Investigator# 58122 | Greifswald | 17491 | Germany |
| Site Reference ID/Investigator# 53106 | Gronau | 48599 | Germany |
| Site Reference ID/Investigator# 91070 | Großenhain | 01558 | Germany |
| Site Reference ID/Investigator# 34911 | Güstrow | 18273 | Germany |
| Site Reference ID/Investigator# 34936 | Halle | 06108 | Germany |
| Site Reference ID/Investigator# 34939 | Halle | 06108 | Germany |
| Site Reference ID/Investigator# 53067 | Halle | 06108 | Germany |
| Site Reference ID/Investigator# 53236 | Halle | 06108 | Germany |
| Site Reference ID/Investigator# 81601 | Halle | 06108 | Germany |
| Site Reference ID/Investigator# 34921 | Halle | 06112 | Germany |
| Site Reference ID/Investigator# 34943 | Halle | 06120 | Germany |
| Site Reference ID/Investigator# 34931 | Halle | 06128 | Germany |
| Site Reference ID/Investigator# 53063 | Hamburg | 20144 | Germany |
| Site Reference ID/Investigator# 53183 | Hamburg | 20246 | Germany |
| Site Reference ID/Investigator# 96237 | Hamburg | 20246 | Germany |
| Site Reference ID/Investigator# 34969 | Hamburg | 20251 | Germany |
| Site Reference ID/Investigator# 53073 | Hamburg | 20354 | Germany |
| Site Reference ID/Investigator# 34951 | Hamburg | 20355 | Germany |
| Site Reference ID/Investigator# 53276 | Hamburg | 21031 | Germany |
| Site Reference ID/Investigator# 34957 | Hamburg | 21075 | Germany |
| Site Reference ID/Investigator# 96242 | Hamburg | 21109 | Germany |
| Site Reference ID/Investigator# 35451 | Hamburg | 22081 | Germany |
| Site Reference ID/Investigator# 53198 | Hamburg | 22081 | Germany |
| Site Reference ID/Investigator# 35113 | Hamburg | 22087 | Germany |
| Site Reference ID/Investigator# 35006 | Hamburg | 22089 | Germany |
| Site Reference ID/Investigator# 53186 | Hamburg | 22089 | Germany |
| Site Reference ID/Investigator# 53212 | Hamburg | 22111 | Germany |
| Site Reference ID/Investigator# 53206 | Hamburg | 22119 | Germany |
| Site Reference ID/Investigator# 34960 | Hamburg | 22147 | Germany |
| Site Reference ID/Investigator# 53199 | Hamburg | 22147 | Germany |
| Site Reference ID/Investigator# 35448 | Hamburg | 22179 | Germany |
| Site Reference ID/Investigator# 34954 | Hamburg | 22415 | Germany |
| Site Reference ID/Investigator# 34997 | Hamburg | 22459 | Germany |
| Site Reference ID/Investigator# 34993 | Hamburg | 22523 | Germany |
| Site Reference ID/Investigator# 53098 | Hamburg | 22529 | Germany |
| Site Reference ID/Investigator# 53279 | Hamburg | 22529 | Germany |
| Site Reference ID/Investigator# 72854 | Hamburg | 22607 | Germany |
| Site Reference ID/Investigator# 34982 | Hamburg | 22609 | Germany |
| Site Reference ID/Investigator# 34985 | Hamburg | 22609 | Germany |
| Site Reference ID/Investigator# 35110 | Hamburg | 22609 | Germany |
| Site Reference ID/Investigator# 53066 | Hamburg | 22609 | Germany |
| Site Reference ID/Investigator# 53248 | Hamburg | 22761 | Germany |
| Site Reference ID/Investigator# 34973 | Hamburg | 22767 | Germany |
| Site Reference ID/Investigator# 35018 | Hanau | 63450 | Germany |
| Site Reference ID/Investigator# 33711 | Hanover | 30159 | Germany |
| Site Reference ID/Investigator# 53100 | Hanover | 30159 | Germany |
| Site Reference ID/Investigator# 68582 | Hanover | 30159 | Germany |
| Site Reference ID/Investigator# 53083 | Hanover | 30161 | Germany |
| Site Reference ID/Investigator# 64301 | Hanover | 30625 | Germany |
| Site Reference ID/Investigator# 34022 | Hansestadt Salzwedel | 29410 | Germany |
| Site Reference ID/Investigator# 53256 | Harrislee | 24955 | Germany |
| Site Reference ID/Investigator# 33797 | Heidelberg | 69120 | Germany |
| Site Reference ID/Investigator# 33804 | Heidelberg | 69120 | Germany |
| Site Reference ID/Investigator# 35118 | Heidelberg | 69120 | Germany |
| Site Reference ID/Investigator# 91083 | Heidelberg | 69120 | Germany |
| Site Reference ID/Investigator# 33800 | Heidelberg | 69121 | Germany |
| Site Reference ID/Investigator# 33807 | Heidelberg | 69121 | Germany |
| Site Reference ID/Investigator# 33817 | Heilbad Heiligenstadt | 37308 | Germany |
| Site Reference ID/Investigator# 53057 | Heilbad Heiligenstadt | 37308 | Germany |
| Site Reference ID/Investigator# 64297 | Herne | 44623 | Germany |
| Site Reference ID/Investigator# 57894 | Herrsching am Ammersee | 82211 | Germany |
| Site Reference ID/Investigator# 68586 | Herten | 45699 | Germany |
| Site Reference ID/Investigator# 53272 | Hildburghausen | 98646 | Germany |
| Site Reference ID/Investigator# 53080 | Hilden | 40721 | Germany |
| Site Reference ID/Investigator# 53097 | Hildesheim | 31124 | Germany |
| Site Reference ID/Investigator# 33833 | Hof | 95028 | Germany |
| Site Reference ID/Investigator# 33841 | Hofheim | 65719 | Germany |
| Site Reference ID/Investigator# 114015 | Hohen Neuendorf | 16540 | Germany |
| Site Reference ID/Investigator# 33844 | Hohenfelde | 18209 | Germany |
| Site Reference ID/Investigator# 53084 | Holzkirchen | 83607 | Germany |
| Site Reference ID/Investigator# 53092 | Homburg | 66424 | Germany |
| Site Reference ID/Investigator# 91085 | Homburg | 66424 | Germany |
| Site Reference ID/Investigator# 53109 | Hoyerswerda | 02977 | Germany |
| Site Reference ID/Investigator# 33857 | Immenstadt im Allgäu | 87509 | Germany |
| Site Reference ID/Investigator# 98538 | Ingoldstadt | 85049 | Germany |
| Site Reference ID/Investigator# 33934 | Ingolstadt | 85049 | Germany |
| Site Reference ID/Investigator# 53111 | Ingolstadt | 85049 | Germany |
| Site Reference ID/Investigator# 53053 | Jena | 07740 | Germany |
| Site Reference ID/Investigator# 53055 | Jena | 07743 | Germany |
| Site Reference ID/Investigator# 5305 | Jena | 07745 | Germany |
| Site Reference ID/Investigator# 33941 | Jülich | 52428 | Germany |
| Site Reference ID/Investigator# 33945 | Kahla | 07768 | Germany |
| Site Reference ID/Investigator# 35123 | Kahla | 07768 | Germany |
| Site Reference ID/Investigator# 33949 | Kaiserslautern | 67655 | Germany |
| Site Reference ID/Investigator# 52992 | Kamenz | 01917 | Germany |
| Site Reference ID/Investigator# 33960 | Karlsruhe | 76133 | Germany |
| Site Reference ID/Investigator# 35483 | Karlstadt am Main | 97753 | Germany |
| Site Reference ID/Investigator# 53192 | Kassel | 34117 | Germany |
| Site Reference ID/Investigator# 33963 | Kassel | 34131 | Germany |
| Site Reference ID/Investigator# 33967 | Katzhütte | 98746 | Germany |
| Site Reference ID/Investigator# 53229 | Kiel | 24105 | Germany |
| Site Reference ID/Investigator# 72859 | Kleinmachnow | 14532 | Germany |
| Site Reference ID/Investigator# 53233 | Koblenz | 56068 | Germany |
| Site Reference ID/Investigator# 34001 | Königs Wusterhausen | 15711 | Germany |
| Site Reference ID/Investigator# 91076 | Krefeld | 47798 | Germany |
| Site Reference ID/Investigator# 91093 | Krefeld | 47798 | Germany |
| Site Reference ID/Investigator# 53108 | Krefeld | 47802 | Germany |
| Site Reference ID/Investigator# 34007 | Kressbronn | 88079 | Germany |
| Site Reference ID/Investigator# 34083 | Kronach | 96317 | Germany |
| Site Reference ID/Investigator# 53101 | Kyritz | 16866 | Germany |
| Site Reference ID/Investigator# 34004 | Lahr | 77933 | Germany |
| Site Reference ID/Investigator# 35244 | Landau | 76829 | Germany |
| Site Reference ID/Investigator# 64290 | Langenfeld | 40764 | Germany |
| Site Reference ID/Investigator# 53245 | Leinefelde | 37327 | Germany |
| Site Reference ID/Investigator# 53115 | Leipzig | 04103 | Germany |
| Site Reference ID/Investigator# 53087 | Leipzig | 04109 | Germany |
| Site Reference ID/Investigator# 34105 | Leipzig | 04129 | Germany |
| Site Reference ID/Investigator# 34108 | Leipzig | 04207 | Germany |
| Site Reference ID/Investigator# 53197 | Leipzig | 04207 | Germany |
| Site Reference ID/Investigator# 53052 | Leipzig | 04289 | Germany |
| Site Reference ID/Investigator# 53211 | Leipzig | 04299 | Germany |
| Site Reference ID/Investigator# 53088 | Leverkusen | 51373 | Germany |
| Site Reference ID/Investigator# 34122 | Lichtenstein | 09350 | Germany |
| Site Reference ID/Investigator# 53180 | Lingen | 49809 | Germany |
| Site Reference ID/Investigator# 35253 | Lippstadt | 59555 | Germany |
| Site Reference ID/Investigator# 96240 | Löbau | 02708 | Germany |
| Site Reference ID/Investigator# 35259 | Ludwigsfelde | 14974 | Germany |
| Site Reference ID/Investigator# 53195 | Ludwigshafen | 67063 | Germany |
| Site Reference ID/Investigator# 53249 | Ludwigslust | 19288 | Germany |
| Site Reference ID/Investigator# 53110 | Lübeck | 23538 | Germany |
| Site Reference ID/Investigator# 34135 | Lübeck | 23564 | Germany |
| Site Reference ID/Investigator# 53074 | Lüdenscheid | 58515 | Germany |
| Site Reference ID/Investigator# 96239 | Lüneburg | 21335 | Germany |
| Site Reference ID/Investigator# 34146 | Magdeburg | 39104 | Germany |
| Site Reference ID/Investigator# 34149 | Magdeburg | 39104 | Germany |
| Site Reference ID/Investigator# 91082 | Magdeburg | 39104 | Germany |
| Site Reference ID/Investigator# 64292 | Magdeburg | 39108 | Germany |
| Site Reference ID/Investigator# 68583 | Magdeburg | 39108 | Germany |
| Site Reference ID/Investigator# 53230 | Magdeburg | 39120 | Germany |
| Site Reference ID/Investigator# 64305 | Magdeburg | 39124 | Germany |
| Site Reference ID/Investigator# 53075 | Mainz | 55131 | Germany |
| Site Reference ID/Investigator# 68593 | Mainz | 55131 | Germany |
| Site Reference ID/Investigator# 34179 | Mannheim | 68165 | Germany |
| Site Reference ID/Investigator# 34191 | Marktredwitz | 95615 | Germany |
| Site Reference ID/Investigator# 34195 | Marl | 45768 | Germany |
| Site Reference ID/Investigator# 34199 | Meissen | 01662 | Germany |
| Site Reference ID/Investigator# 53269 | Melsungen | 34212 | Germany |
| Site Reference ID/Investigator# 53078 | Memmingen | 87700 | Germany |
| Site Reference ID/Investigator# 35284 | Menz | 39175 | Germany |
| Site Reference ID/Investigator# 35286 | Minden | 32429 | Germany |
| Site Reference ID/Investigator# 34207 | Mittelherwigsdorf | 02763 | Germany |
| Site Reference ID/Investigator# 57883 | Moenkeburg | 24248 | Germany |
| Site Reference ID/Investigator# 34217 | Mönchengladbach | 41061 | Germany |
| Site Reference ID/Investigator# 34212 | Mönchengladbach | 41199 | Germany |
| Site Reference ID/Investigator# 53095 | Mönchengladbach | 41199 | Germany |
| Site Reference ID/Investigator# 53261 | Mönchengladbach | 41236 | Germany |
| Site Reference ID/Investigator# 64282 | Munich | 80634 | Germany |
| Site Reference ID/Investigator# 34039 | Munich | 80639 | Germany |
| Site Reference ID/Investigator# 57892 | Munich | 80802 | Germany |
| Site Reference ID/Investigator# 64295 | Munich | 80802 | Germany |
| Site Reference ID/Investigator# 35294 | Munich | 81377 | Germany |
| Site Reference ID/Investigator# 34234 | Munich | 81547 | Germany |
| Site Reference ID/Investigator# 91080 | Munich | 81667 | Germany |
| Site Reference ID/Investigator# 34042 | Munich | 81925 | Germany |
| Site Reference ID/Investigator# 53270 | Munich | D-81541 | Germany |
| Site Reference ID/Investigator# 34223 | Mühlhausen | 99974 | Germany |
| Site Reference ID/Investigator# 35291 | Mülheim | 45468 | Germany |
| Site Reference ID/Investigator# 53235 | Mülheim | 45468 | Germany |
| Site Reference ID/Investigator# 34228 | Müllheim | 79379 | Germany |
| Site Reference ID/Investigator# 53062 | Münster | 48143 | Germany |
| Site Reference ID/Investigator# 68587 | Münster | 48143 | Germany |
| Site Reference ID/Investigator# 34047 | Münster | 48149 | Germany |
| Site Reference ID/Investigator# 53093 | Münster | 48149 | Germany |
| Site Reference ID/Investigator# 91096 | Münster | 48149 | Germany |
| Site Reference ID/Investigator# 53246 | Naila | 95119 | Germany |
| Site Reference ID/Investigator# 53271 | Nastätten | 56355 | Germany |
| Site Reference ID/Investigator# 35305 | Naumburg | 06618 | Germany |
| Site Reference ID/Investigator# 34051 | Naunhof | 04683 | Germany |
| Site Reference ID/Investigator# 34060 | Neubrandenburg | 17033 | Germany |
| Site Reference ID/Investigator# 34063 | Neuburg am Inn | 86633 | Germany |
| Site Reference ID/Investigator# 53220 | Neunkirchen | 66538 | Germany |
| Site Reference ID/Investigator# 35312 | Neuss | 41460 | Germany |
| Site Reference ID/Investigator# 34075 | Neustadt | 67434 | Germany |
| Site Reference ID/Investigator# 34079 | Niefern-Öschelbronn | 75223 | Germany |
| Site Reference ID/Investigator# 34157 | Nienburg | 31582 | Germany |
| Site Reference ID/Investigator# 57891 | Nienburg | 31582 | Germany |
| Site Reference ID/Investigator# 52997 | Nordhausen | 99734 | Germany |
| Site Reference ID/Investigator# 52999 | Nordhausen | 99734 | Germany |
| Site Reference ID/Investigator# 53277 | Nordhausen | 99734 | Germany |
| Site Reference ID/Investigator# 53054 | Nuremberg | 90429 | Germany |
| Site Reference ID/Investigator# 68588 | Nuremberg | 90429 | Germany |
| Site Reference ID/Investigator# 53112 | Nuremberg | 90482 | Germany |
| Site Reference ID/Investigator# 96244 | Oberhausen | 46145 | Germany |
| Site Reference ID/Investigator# 34172 | Oelsnitz | 09376 | Germany |
| Site Reference ID/Investigator# 53104 | Oelsnitz | 09376 | Germany |
| Site Reference ID/Investigator# 34175 | Offenburg | 77652 | Germany |
| Site Reference ID/Investigator# 33491 | Oldenburg | 26121 | Germany |
| Site Reference ID/Investigator# 57886 | Oldenburg | 26133 | Germany |
| Site Reference ID/Investigator# 91067 | Oschatz | 04758 | Germany |
| Site Reference ID/Investigator# 53207 | Osnabrück | 49074 | Germany |
| Site Reference ID/Investigator# 81600 | Osnabrück | 49076 | Germany |
| Site Reference ID/Investigator# 53228 | Ostseebad Damp | 24351 | Germany |
| Site Reference ID/Investigator# 35334 | Paderborn | 33098 | Germany |
| Site Reference ID/Investigator# 33507 | Parchim | 19370 | Germany |
| Site Reference ID/Investigator# 35339 | Passau | 94032 | Germany |
| Site Reference ID/Investigator# 72858 | Peitz | 03185 | Germany |
| Site Reference ID/Investigator# 53096 | Petershagen | 32469 | Germany |
| Site Reference ID/Investigator# 53086 | Pinneberg | 25421 | Germany |
| Site Reference ID/Investigator# 53232 | Pirna | 01796 | Germany |
| Site Reference ID/Investigator# 33522 | Planegg | 82152 | Germany |
| Site Reference ID/Investigator# 33527 | Plauen | 08523 | Germany |
| Site Reference ID/Investigator# 96278 | Plochingen | 73207 | Germany |
| Site Reference ID/Investigator# 33469 | Potsdam | 14467 | Germany |
| Site Reference ID/Investigator# 33465 | Potsdam | 14469 | Germany |
| Site Reference ID/Investigator# 96236 | Potsdam | 14471 | Germany |
| Site Reference ID/Investigator# 53281 | Potsdam | 14480 | Germany |
| Site Reference ID/Investigator# 33475 | Prüm | 54595 | Germany |
| Site Reference ID/Investigator# 33478 | Püttlingen | 66346 | Germany |
| Site Reference ID/Investigator# 53257 | Püttlingen | 66346 | Germany |
| Site Reference ID/Investigator# 91120 | Püttlingen | 66346 | Germany |
| Site Reference ID/Investigator# 53094 | Quedlinburg | 06484 | Germany |
| Site Reference ID/Investigator# 53265 | Querfurt | 6268 | Germany |
| Site Reference ID/Investigator# 33483 | Radebeul | 01445 | Germany |
| Site Reference ID/Investigator# 35346 | Radebeul | 01445 | Germany |
| Site Reference ID/Investigator# 53280 | Ratingen | 40882 | Germany |
| Site Reference ID/Investigator# 57888 | Ratingen | 40882 | Germany |
| Site Reference ID/Investigator# 33487 | Ratzeburg | 23909 | Germany |
| Site Reference ID/Investigator# 33889 | Regensburg | 93049 | Germany |
| Site Reference ID/Investigator# 57912 | Regensburg | 93049 | Germany |
| Site Reference ID/Investigator# 57911 | Regensburg | 93051 | Germany |
| Site Reference ID/Investigator# 53264 | Regensburg | 93053 | Germany |
| Site Reference ID/Investigator# 33901 | Rendsburg | 24768 | Germany |
| Site Reference ID/Investigator# 52991 | Ribnitz-Damgarten | 18311 | Germany |
| Site Reference ID/Investigator# 53267 | Riesa | 01587 | Germany |
| Site Reference ID/Investigator# 33910 | Riesa | 01589 | Germany |
| Site Reference ID/Investigator# 33913 | Rinteln | 31737 | Germany |
| Site Reference ID/Investigator# 33922 | Rostock | 18059 | Germany |
| Site Reference ID/Investigator# 33926 | Rostock | 18059 | Germany |
| Site Reference ID/Investigator# 33930 | Rothenburg | 02929 | Germany |
| Site Reference ID/Investigator# 53113 | Rudolstadt | 07407 | Germany |
| Site Reference ID/Investigator# 35361 | Rüdersdorf | 15562 | Germany |
| Site Reference ID/Investigator# 34015 | Saarbrücken | 66111 | Germany |
| Site Reference ID/Investigator# 91071 | Saarlouis | 66740 | Germany |
| Site Reference ID/Investigator# 35382 | Saint Martin | 67487 | Germany |
| Site Reference ID/Investigator# 34026 | Sande | 26452 | Germany |
| Site Reference ID/Investigator# 53208 | Schleiz | 7907 | Germany |
| Site Reference ID/Investigator# 91074 | Schlettau | 09487 | Germany |
| Site Reference ID/Investigator# 33533 | Schneeberg | 08289 | Germany |
| Site Reference ID/Investigator# 33538 | Schramberg | 78713 | Germany |
| Site Reference ID/Investigator# 33541 | Schutterwald | 77746 | Germany |
| Site Reference ID/Investigator# 35370 | Schwandorf in Bayern | 92421 | Germany |
| Site Reference ID/Investigator# 91072 | Schwandorf in Bayern | 92421 | Germany |
| Site Reference ID/Investigator# 57905 | Schwedt | 16303 | Germany |
| Site Reference ID/Investigator# 72855 | Schweina | 36448 | Germany |
| Site Reference ID/Investigator# 33548 | Schwerin | 19053 | Germany |
| Site Reference ID/Investigator# 35375 | Schwerin | 19053 | Germany |
| Site Reference ID/Investigator# 33554 | Schwerte | 58239 | Germany |
| Site Reference ID/Investigator# 33558 | Seesen | 38723 | Germany |
| Site Reference ID/Investigator# 33566 | Sinsheim | 74889 | Germany |
| Site Reference ID/Investigator# 33571 | Soltau | 29614 | Germany |
| Site Reference ID/Investigator# 53255 | Spelle | 48480 | Germany |
| Site Reference ID/Investigator# 33584 | Stadtbergen | 86391 | Germany |
| Site Reference ID/Investigator# 98539 | Stolberg | 52222 | Germany |
| Site Reference ID/Investigator# 53218 | Storkow | 15859 | Germany |
| Site Reference ID/Investigator# 53082 | Straubing | 94315 | Germany |
| Site Reference ID/Investigator# 33603 | Stuttgart | 70178 | Germany |
| Site Reference ID/Investigator# 33606 | Stuttgart | 70178 | Germany |
| Site Reference ID/Investigator# 33610 | Stuttgart | 70199 | Germany |
| Site Reference ID/Investigator# 33597 | Stuttgart | 70372 | Germany |
| Site Reference ID/Investigator# 53210 | Suhl | 98527 | Germany |
| Site Reference ID/Investigator# 53223 | Suhl | 98527 | Germany |
| Site Reference ID/Investigator# 35388 | Suhl | 98529 | Germany |
| Site Reference ID/Investigator# 33624 | Torgelow | 17358 | Germany |
| Site Reference ID/Investigator# 53077 | Treuenbrietzen | 14929 | Germany |
| Site Reference ID/Investigator# 57906 | Treuenbrietzen | 14929 | Germany |
| Site Reference ID/Investigator# 53200 | Tuttlingen | 78532 | Germany |
| Site Reference ID/Investigator# 57910 | Ueberlingen-Nussdorf | 88662 | Germany |
| Site Reference ID/Investigator# 33640 | Ulm | 89073 | Germany |
| Site Reference ID/Investigator# 33723 | Ulm | 89073 | Germany |
| Site Reference ID/Investigator# 81602 | Unna | 59423 | Germany |
| Site Reference ID/Investigator# 96241 | Varel | 26316 | Germany |
| Site Reference ID/Investigator# 98536 | Verden an der Aller | 27283 | Germany |
| Site Reference ID/Investigator# 72860 | Viersen | 41749 | Germany |
| Site Reference ID/Investigator# 33736 | Villingen-Schwenningen | 78054 | Germany |
| Site Reference ID/Investigator# 33741 | Waltrop | 45731 | Germany |
| Site Reference ID/Investigator# 53243 | Wannsee | 14109 | Germany |
| Site Reference ID/Investigator# 72853 | Wasserburg | 83512 | Germany |
| Site Reference ID/Investigator# 33748 | Weener | 26826 | Germany |
| Site Reference ID/Investigator# 33851 | Welzow | 03119 | Germany |
| Site Reference ID/Investigator# 35407 | Wiesbaden | 65189 | Germany |
| Site Reference ID/Investigator# 33764 | Wiesbaden | 65191 | Germany |
| Site Reference ID/Investigator# 52989 | Wiesbaden | 65191 | Germany |
| Site Reference ID/Investigator# 33771 | Wilhelmshaven | 26382 | Germany |
| Site Reference ID/Investigator# 53076 | Winsen | 21423 | Germany |
| Site Reference ID/Investigator# 33775 | Wismar | 23966 | Germany |
| Site Reference ID/Investigator# 33779 | Wittlich | 54516 | Germany |
| Site Reference ID/Investigator# 91095 | Wittmund | 26409 | Germany |
| Site Reference ID/Investigator# 96235 | Wolfenbüttel | 38300 | Germany |
| Site Reference ID/Investigator# 91068 | Wuppertal | 42103 | Germany |
| Site Reference ID/Investigator# 91069 | Wuppertal | 42103 | Germany |
| Site Reference ID/Investigator# 35419 | Wuppertal | 42105 | Germany |
| Site Reference ID/Investigator# 57884 | Wurzen | 04808 | Germany |
| Site Reference ID/Investigator# 33717 | Würzburg | 97070 | Germany |
| Site Reference ID/Investigator# 57903 | Würzburg | 97070 | Germany |
| Site Reference ID/Investigator# 53064 | Zeitz | 06712 | Germany |
| Site Reference ID/Investigator# 33863 | Zerbst | 39261 | Germany |
| Site Reference ID/Investigator# 33866 | Zeven | 27404 | Germany |
| Site Reference ID/Investigator# 64299 | Zschopau | 9405 | Germany |
| Site Reference ID/Investigator# 52996 | Zwickau | 08056 | Germany |
| Site Reference ID/Investigator# 33875 | Zwickau | 08060 | Germany |
| Site Reference ID/Investigator# 52993 | Zwickau | 08060 | Germany |
| Site Reference ID/Investigator# 53056 | Zwickau | 08060 | Germany |
| Site Reference ID/Investigator# 53102 | Zwickau | 08060 | Germany |
| Site Reference ID/Investigator# 52994 | Zwickau | 08066 | Germany |
| Site Reference ID/Investigator# 53226 | Zwickau | 8058 | Germany |
| Site Reference ID/Investigator# 53260 | Zwickau | 8060 | Germany |
| Site Reference ID/Investigator# 33879 | Zwiesel | 94227 | Germany |
| Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Gnann H, Greger G, Tony HP, Burkhardt H. Minimal disease activity is a stable measure of therapeutic response in psoriatic arthritis patients receiving treatment with adalimumab. Rheumatology (Oxford). 2018 Nov 1;57(11):1938-1946. doi: 10.1093/rheumatology/key203. |
| 27330166 | Derived | Behrens F, Koehm M, Thaci D, Gnann H, Greger G, Maria Wittig B, Burkhardt H. Anti-citrullinated protein antibodies are linked to erosive disease in an observational study of patients with psoriatic arthritis. Rheumatology (Oxford). 2016 Oct;55(10):1791-5. doi: 10.1093/rheumatology/kew229. Epub 2016 Jun 21. |
| 26669916 | Derived | Behrens F, Koehm M, Arndt U, Wittig BM, Greger G, Thaci D, Scharbatke E, Tony HP, Burkhardt H. Does Concomitant Methotrexate with Adalimumab Influence Treatment Outcomes in Patients with Psoriatic Arthritis? Data from a Large Observational Study. J Rheumatol. 2016 Mar;43(3):632-9. doi: 10.3899/jrheum.141596. Epub 2015 Dec 15. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Psoriatic Arthritis | Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Gender | NOTE: gender data were not available for all safety participants | 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 | Mean 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, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Months 3, 6, 9, 12, 18, and 24 |
|
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| Primary | Mean Tender Joint Count (TJC) Over Time | Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | Tender joints | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Mean Swollen Joint Count (SJC) Over Time | Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
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| Primary | Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time | Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient's hand was equal to 1% BSA. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | percentage of body surface area | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
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| Primary | Mean Target Lesion Score (TLS) Over Time | The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity). | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
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| Primary | Number of Participants With Adverse Events (AEs) | Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion. | Safety Set - All enrolled participants | Posted | Number | participants | Baseline up to 24 months |
|
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| Secondary | Number of Participants by Severity of Enthesitis Over Time | Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Number | participants | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
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| Secondary | Number of Participants by Severity of Dactylitis Over Time | Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to "sausage digit," involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Number | participants | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants by Severity of Nail Psoriasis Levels Over Time | Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Number | participants | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Erythrocyte Sedimentation Rate (ESR) Over Time | The Erythrocyte Sedimentation Rate (ESR) is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | mm/hour | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean C-Reactive Protein (CRP) Levels Over Time | The C-Reactive Protein (CRP) is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | mg/L | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Patients Global Assessment of Disease Activity Over Time | Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Participants Assessment of Fatigue Over Time | Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Participants Assessment of Pain Over Time | Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time | A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function. | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Number | percentage of participants | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of Days Missed From Work Due to Psoriatic Arthritis | Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24). | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Mean | Standard Deviation | days | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With In-Patient Hospitalization | Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24). | Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. | Posted | Number | percentage of particpants | Baseline, and Months 3, 6, 9, 12, 18, and 24 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication | Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs | FAS | Posted | Number | percentage of participants | Baseline, and Months 6 and 24 |
|
|
From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at >1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
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 | Psoriatic Arthritis | Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months. | 143 | 4,635 | 0 | 4,635 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cystitis klebsiella | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Mycotoxicosis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Appendectomy | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Adhesiolysis | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Analgesic therapy | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Antibiotics prophylaxis | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Aortic bypass | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Arthrodesis | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Bile duct stent insertion | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Breast operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dupuytren's contracture operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Foot operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Gallbladder operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hospitalization | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Intervertebral disc operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Joint arthroplasty | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Large intestine operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lung cyst removal | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Osteosynthesis | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pilonidal sinus repair | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Renal stone removal | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Shoulder operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Spinal operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Stent placement | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Thyroid operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Tonsillectomy | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Ureteral stent insertion | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Ureteric calculus removal | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Uterine operation | Surgical and medical procedures | MedDRA (12.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Movement disorder | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Injection site urticaria | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Obstruction | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Edema | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Acute right ventricular failure | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Endocardial disease | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lip edema | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Antiphospholipid antibodies positive | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Arthroscopy | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Biopsy liver | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Body temperature | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Immunology test | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Red blood cell sedimentation rate increased | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Ureteroscopy | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Post streptococcal glomerulonephritis | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Traumatic hematoma | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Post procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Temporal arteritis | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hepatocellular damage | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Genital rash | Reproductive system and breast disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Acute vestibular syndrome | Ear and labyrinth disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Eyelid edema | Eye disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Walking disability | Social circumstances | MedDRA (12.1) | Non-systematic Assessment |
|
Not provided
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 |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Month 12 [N=1850] |
|
| Month 18 [N=1572] |
|
| Month 24 [N=1315] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline, 0 days [N=3307] |
| |||||
| Baseline, <7 days [N=3307] |
| |||||
| Baseline, 7 to 14 days [N=3307] |
| |||||
| Baseline, >14 days [N=3307] |
| |||||
| Month 3, 0 days [N=3193] |
| |||||
| Month 3, <7 days [N=3193] |
| |||||
| Month 3, 7 to 14 days [N=3193] |
| |||||
| Month 3, >14 days [N=3193] |
| |||||
| Month 6, 0 days [N=2779] |
| |||||
| Month 6, <7 days [N=2779] |
| |||||
| Month 6, 7 to 14 days [N=2779] |
| |||||
| Month 6, >14 days [N=2779] |
| |||||
| Month 9, 0 days [N=2390] |
| |||||
| Month 9, <7 days [N=2390] |
| |||||
| Month 9, 7 to 14 days [N=2390] |
| |||||
| Month 9, >14 days [N=2390] |
| |||||
| Month 12, 0 days [N=2164] |
| |||||
| Month 12, <7 days [N=2164] |
| |||||
| Month 12, 7 to 14 days [N=2164] |
| |||||
| Month 12, >14 days [N=2164] |
| |||||
| Month 18, 0 days [N=1856] |
| |||||
| Month 18, <7 days [N=1856] |
| |||||
| Month 18, 7 to 14 days [N=1856] |
| |||||
| Month 18, >14 days [N=1856] |
| |||||
| Month 24, 0 days [N=1553] |
| |||||
| Month 24, <7 days [N=1553] |
| |||||
| Month 24, 7 to 14 days [N=1553] |
| |||||
| Month 24, >14 days [N=1553] |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline, MTX [N=3552] |
| |||||
| Month 6, MTX [N=2823] |
| |||||
| Month 24, MTX [N=1555] |
| |||||
| Baseline, Other DMARD [N=3552] |
| |||||
| Month 6, Other DMARD [N=2823] |
| |||||
| Month 24, Other DMARD [N=1555] |
|