Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01111240
• Collaborator: (none)
• Enrollment: 4,635
• Locations: 509
• Duration (Months): 100
• Patients Per Site: 9.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 4635 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Long Term Documentation to Demonstrate Long Term Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis Under Conditions of Daily Practice
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Psoriatic Arthritis Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Disease Activity Score (DAS)28 [Baseline and Months 3, 6, 9, 12, 18, and 24]

   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.

2. Mean Tender Joint Count (TJC) Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   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.

3. Mean Swollen Joint Count (SJC) Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   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.

4. Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   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.

5. Mean Target Lesion Score (TLS) Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   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).

6. Number of Participants With Adverse Events (AEs) [Baseline up to 24 months]

   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.

Secondary Outcome Measures

1. Number of Participants by Severity of Enthesitis Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   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.

2. Number of Participants by Severity of Dactylitis Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   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.

3. Number of Participants by Severity of Nail Psoriasis Levels Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   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.

4. Mean Erythrocyte Sedimentation Rate (ESR) Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   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.

5. Mean C-Reactive Protein (CRP) Levels Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   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.

6. Patients Global Assessment of Disease Activity Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.

7. Participants Assessment of Fatigue Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.

8. Participants Assessment of Pain Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.

9. Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time [Baseline, and Months 3, 6, 9, 12, 18, and 24]

   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.

10. 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]

11. Mean Number of Days Missed From Work Due to Psoriatic Arthritis [Baseline, and Months 3, 6, 9, 12, 18, and 24]

    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).

12. Percentage of Participants With In-Patient Hospitalization [Baseline, and Months 3, 6, 9, 12, 18, and 24]

    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).

13. Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication [Baseline, and Months 6 and 24]

    Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion:

• 18 years of age or older (younger patients may be enrolled at the discretion of physician)

• Diagnosis of Psoriatic Arthritis (or any indication at the discretion of physician) and initiating adalimumab therapy

• Signed/dated Informed Consent

Exclusion:

-None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 35035	Aachen		Germany	52062
2	Site Reference ID/Investigator# 64288	Aachen		Germany	52062
3	Site Reference ID/Investigator# 35509	Ahlen		Germany	59227
4	Site Reference ID/Investigator# 53118	Ahrensburg		Germany	22926
5	Site Reference ID/Investigator# 35042	Altenburg		Germany	04600
6	Site Reference ID/Investigator# 35045	Altenholz		Germany	24161
7	Site Reference ID/Investigator# 35048	Amberg		Germany	92224
8	Site Reference ID/Investigator# 96243	Annaberg-Buchholz		Germany	9456
9	Site Reference ID/Investigator# 53205	Arnstadt		Germany	99310
10	Site Reference ID/Investigator# 53091	Artern		Germany	06556
11	Site Reference ID/Investigator# 33348	Augsburg		Germany	86150
12	Site Reference ID/Investigator# 33357	Bad Abbach		Germany	93077
13	Site Reference ID/Investigator# 35085	Bad Aibling		Germany	83043
14	Site Reference ID/Investigator# 57895	Bad Aibling		Germany	83043
15	Site Reference ID/Investigator# 91097	Bad Bentheim		Germany	48455
16	Site Reference ID/Investigator# 35524	Bad Bentheim		Germany	D-48455
17	Site Reference ID/Investigator# 35572	Bad Bramstedt		Germany	24576
18	Site Reference ID/Investigator# 64304	Bad Bramstedt		Germany	24576
19	Site Reference ID/Investigator# 33371	Bad Endbach		Germany	35080
20	Site Reference ID/Investigator# 53278	Bad Endbach		Germany	63065
21	Site Reference ID/Investigator# 91084	Bad Homburg		Germany	61348
22	Site Reference ID/Investigator# 33377	Bad Iburg		Germany	49186
23	Site Reference ID/Investigator# 33381	Bad Iburg		Germany	49186
24	Site Reference ID/Investigator# 53068	Bad Kissingen		Germany	97688
25	Site Reference ID/Investigator# 33386	Bad Kreuznach		Germany	55543
26	Site Reference ID/Investigator# 35574	Bad Kreuznach		Germany	55543
27	Site Reference ID/Investigator# 33390	Bad Liebenwerda		Germany	04924
28	Site Reference ID/Investigator# 33395	Bad Muender		Germany	31848
29	Site Reference ID/Investigator# 96245	Bad Muender		Germany	31848
30	Site Reference ID/Investigator# 91094	Bad Nauheim		Germany	61231
31	Site Reference ID/Investigator# 35577	Bad Neuenahr		Germany	53474
32	Site Reference ID/Investigator# 53181	Bad Neuenahr		Germany	53474
33	Site Reference ID/Investigator# 57885	Bad Oeynhausen		Germany	32545
34	Site Reference ID/Investigator# 33403	Bad Rappenau		Germany	74906
35	Site Reference ID/Investigator# 53060	Bad Salzungen		Germany	36433
36	Site Reference ID/Investigator# 91079	Bad Salzungen		Germany	36433
37	Site Reference ID/Investigator# 53254	Bad Schlema		Germany	8301
38	Site Reference ID/Investigator# 33416	Bad Staffelstein		Germany	96231
39	Site Reference ID/Investigator# 33420	Bad Sulze		Germany	18334
40	Site Reference ID/Investigator# 57890	Bad Toelz		Germany	83646
41	Site Reference ID/Investigator# 33424	Baden-Baden		Germany	76530
42	Site Reference ID/Investigator# 33428	Bamberg		Germany	96047
43	Site Reference ID/Investigator# 33434	Bautzen		Germany	02625
44	Site Reference ID/Investigator# 33437	Bautzen		Germany	02625
45	Site Reference ID/Investigator# 53231	Bayreuth		Germany	95444
46	Site Reference ID/Investigator# 33441	Bayreuth		Germany	95445
47	Site Reference ID/Investigator# 33445	Bayreuth		Germany	95445
48	Site Reference ID/Investigator# 68595	Bergen		Germany	18528
49	Site Reference ID/Investigator# 34265	Berlin-Buch		Germany	13125
50	Site Reference ID/Investigator# 64291	Berlin-Buch		Germany	13125
51	Site Reference ID/Investigator# 53243	Berlin-Wannsee		Germany	14109
52	Site Reference ID/Investigator# 57893	Berlin-Weissensee		Germany	13086
53	Site Reference ID/Investigator# 33459	Berlin		Germany	10117
54	Site Reference ID/Investigator# 35087	Berlin		Germany	10117
55	Site Reference ID/Investigator# 53058	Berlin		Germany	10117
56	Site Reference ID/Investigator# 53241	Berlin		Germany	10117
57	Site Reference ID/Investigator# 53242	Berlin		Germany	10117
58	Site Reference ID/Investigator# 33647	Berlin		Germany	10178
59	Site Reference ID/Investigator# 57909	Berlin		Germany	10178
60	Site Reference ID/Investigator# 53061	Berlin		Germany	10243
61	Site Reference ID/Investigator# 53059	Berlin		Germany	10369
62	Site Reference ID/Investigator# 68842	Berlin		Germany	10369
63	Site Reference ID/Investigator# 33657	Berlin		Germany	10435
64	Site Reference ID/Investigator# 53105	Berlin		Germany	10709
65	Site Reference ID/Investigator# 98535	Berlin		Germany	10713
66	Site Reference ID/Investigator# 34245	Berlin		Germany	10719
67	Site Reference ID/Investigator# 33682	Berlin		Germany	10777
68	Site Reference ID/Investigator# 68594	Berlin		Germany	10827
69	Site Reference ID/Investigator# 34268	Berlin		Germany	10961
70	Site Reference ID/Investigator# 33654	Berlin		Germany	12159
71	Site Reference ID/Investigator# 64284	Berlin		Germany	12159
72	Site Reference ID/Investigator# 35596	Berlin		Germany	12161
73	Site Reference ID/Investigator# 35600	Berlin		Germany	12161
74	Site Reference ID/Investigator# 53081	Berlin		Germany	12353
75	Site Reference ID/Investigator# 53244	Berlin		Germany	12435
76	Site Reference ID/Investigator# 91075	Berlin		Germany	12435
77	Site Reference ID/Investigator# 64287	Berlin		Germany	12437
78	Site Reference ID/Investigator# 34261	Berlin		Germany	12681
79	Site Reference ID/Investigator# 33686	Berlin		Germany	13055
80	Site Reference ID/Investigator# 64286	Berlin		Germany	13407
81	Site Reference ID/Investigator# 52990	Berlin		Germany	13507
82	Site Reference ID/Investigator# 52995	Berlin		Germany	13507
83	Site Reference ID/Investigator# 35549	Berlin		Germany	13595
84	Site Reference ID/Investigator# 53090	Berlin		Germany	14129
85	Site Reference ID/Investigator# 35553	Berlin		Germany	14163
86	Site Reference ID/Investigator# 35555	Bernau		Germany	16321
87	Site Reference ID/Investigator# 53213	Bernsbach		Germany	8315
88	Site Reference ID/Investigator# 34274	Beverungen		Germany	37688
89	Site Reference ID/Investigator# 53085	Bietigheim-Bissingen		Germany	74321
90	Site Reference ID/Investigator# 53268	Bietigheim-Bissingen		Germany	74321
91	Site Reference ID/Investigator# 34284	Blankenburg/Hart		Germany	38889
92	Site Reference ID/Investigator# 34287	Blaubeuren		Germany	89143
93	Site Reference ID/Investigator# 34290	Bocholt		Germany	46399
94	Site Reference ID/Investigator# 35640	Bochum		Germany	44789
95	Site Reference ID/Investigator# 53196	Bochum		Germany	44789
96	Site Reference ID/Investigator# 53179	Bochum		Germany	44791
97	Site Reference ID/Investigator# 57908	Bochum		Germany	44803
98	Site Reference ID/Investigator# 35643	Bogen		Germany	94327
99	Site Reference ID/Investigator# 34301	Bonn		Germany	53111
100	Site Reference ID/Investigator# 34295	Bonn		Germany	53177
101	Site Reference ID/Investigator# 34306	Braunschweig		Germany	38100
102	Site Reference ID/Investigator# 53234	Breitenbrunn		Germany	08359
103	Site Reference ID/Investigator# 35608	Bremen		Germany	28209
104	Site Reference ID/Investigator# 52987	Bremen		Germany	28209
105	Site Reference ID/Investigator# 53107	Bremen		Germany	28209
106	Site Reference ID/Investigator# 53247	Bremen		Germany	28239
107	Site Reference ID/Investigator# 91073	Bremerhaven		Germany	27572
108	Site Reference ID/Investigator# 68584	Burgstaedt		Germany	09217
109	Site Reference ID/Investigator# 81599	Chemnitz		Germany	09119
110	Site Reference ID/Investigator# 34698	Chemnitz		Germany	09126
111	Site Reference ID/Investigator# 57902	Chemnitz		Germany	9116
112	Site Reference ID/Investigator# 35094	Chemnitz		Germany	D-09130
113	Site Reference ID/Investigator# 53262	Cologne		Germany	50679
114	Site Reference ID/Investigator# 64298	Cologne		Germany	50679
115	Site Reference ID/Investigator# 64293	Cologne		Germany	50733
116	Site Reference ID/Investigator# 33988	Cologne		Germany	50823
117	Site Reference ID/Investigator# 53193	Cologne		Germany	50931
118	Site Reference ID/Investigator# 53071	Cologne		Germany	50937
119	Site Reference ID/Investigator# 35236	Cologne		Germany	51067
120	Site Reference ID/Investigator# 64300	Cologne		Germany	51103
121	Site Reference ID/Investigator# 72857	Cologne		Germany	51109
122	Site Reference ID/Investigator# 34710	Cottbus		Germany	03046
123	Site Reference ID/Investigator# 53184	Cottbus		Germany	3048
124	Site Reference ID/Investigator# 64303	Darmstadt		Germany	64283
125	Site Reference ID/Investigator# 35620	Darmstadt		Germany	64295
126	Site Reference ID/Investigator# 34724	Deggendorf		Germany	94469
127	Site Reference ID/Investigator# 53209	Delmenhorst		Germany	27749
128	Site Reference ID/Investigator# 53089	Delmenhorst		Germany	27753
129	Site Reference ID/Investigator# 91077	Dinslaken		Germany	46535
130	Site Reference ID/Investigator# 34741	Dortmund		Germany	44147
131	Site Reference ID/Investigator# 35637	Dortmund		Germany	44147
132	Site Reference ID/Investigator# 35633	Dortmund		Germany	44263
133	Site Reference ID/Investigator# 57899	Dresden		Germany	01067
134	Site Reference ID/Investigator# 35172	Dresden		Germany	01097
135	Site Reference ID/Investigator# 34753	Dresden		Germany	01109
136	Site Reference ID/Investigator# 53069	Dresden		Germany	01219
137	Site Reference ID/Investigator# 34747	Dresden		Germany	01277
138	Site Reference ID/Investigator# 34750	Dresden		Germany	01277
139	Site Reference ID/Investigator# 34759	Dresden		Germany	01277
140	Site Reference ID/Investigator# 68590	Dresden		Germany	01277
141	Site Reference ID/Investigator# 53182	Dresden		Germany	01307
142	Site Reference ID/Investigator# 91081	Dresden		Germany	1109
143	Site Reference ID/Investigator# 68592	Dresden		Germany	1217
144	Site Reference ID/Investigator# 57904	Dresden		Germany	1309
145	Site Reference ID/Investigator# 53266	Dueren		Germany	52349
146	Site Reference ID/Investigator# 34772	Duesseldorf		Germany	40211
147	Site Reference ID/Investigator# 64302	Duesseldorf		Germany	40225
148	Site Reference ID/Investigator# 34777	Duisburg		Germany	47055
149	Site Reference ID/Investigator# 53072	Duisburg		Germany	47249
150	Site Reference ID/Investigator# 98537	Duisburg		Germany	47249
151	Site Reference ID/Investigator# 34783	Eberswalde		Germany	16225
152	Site Reference ID/Investigator# 53194	Eberswalde		Germany	16225
153	Site Reference ID/Investigator# 53065	Eisenach		Germany	99817
154	Site Reference ID/Investigator# 72856	Eisenach		Germany	99817
155	Site Reference ID/Investigator# 35181	Elmshorn		Germany	25335
156	Site Reference ID/Investigator# 53114	Eppstein		Germany	65817
157	Site Reference ID/Investigator# 53221	Erftstadt		Germany	50374
158	Site Reference ID/Investigator# 53070	Erfurt		Germany	99084
159	Site Reference ID/Investigator# 53258	Erfurt		Germany	99084
160	Site Reference ID/Investigator# 53259	Erfurt		Germany	99084
161	Site Reference ID/Investigator# 57900	Erfurt		Germany	99084
162	Site Reference ID/Investigator# 34808	Erfurt		Germany	99096
163	Site Reference ID/Investigator# 35095	Erfurt		Germany	99096
164	Site Reference ID/Investigator# 57901	Erkrath		Germany	40699
165	Site Reference ID/Investigator# 34820	Erlangen		Germany	91056
166	Site Reference ID/Investigator# 57896	Erlangen		Germany	D-91054
167	Site Reference ID/Investigator# 35195	Essen		Germany	45326
168	Site Reference ID/Investigator# 35198	Essen		Germany	45356
169	Site Reference ID/Investigator# 53219	Esslingen		Germany	73732
170	Site Reference ID/Investigator# 35201	Feldafing		Germany	82340
171	Site Reference ID/Investigator# 35204	Flensburg		Germany	24937
172	Site Reference ID/Investigator# 34832	Forchheim		Germany	91301
173	Site Reference ID/Investigator# 35209	Frankenberg		Germany	09669
174	Site Reference ID/Investigator# 64283	Frankfurt		Germany	60590
175	Site Reference ID/Investigator# 34839	Frankfurt		Germany	60596
176	Site Reference ID/Investigator# 35212	Fraureuth		Germany	08427
177	Site Reference ID/Investigator# 91078	Frechen		Germany	50226
178	Site Reference ID/Investigator# 35218	Freiberg		Germany	09599
179	Site Reference ID/Investigator# 34853	Freiburg		Germany	79098
180	Site Reference ID/Investigator# 34856	Freiburg		Germany	79098
181	Site Reference ID/Investigator# 34860	Freiburg		Germany	79106
182	Site Reference ID/Investigator# 35100	Freystadt		Germany	92342
183	Site Reference ID/Investigator# 35223	Friedrichroda		Germany	99894
184	Site Reference ID/Investigator# 68843	Garching		Germany	85748
185	Site Reference ID/Investigator# 34878	Gelsenkirchen		Germany	45881
186	Site Reference ID/Investigator# 68591	Gelsenkirchen		Germany	45897
187	Site Reference ID/Investigator# 34882	Gera		Germany	07545
188	Site Reference ID/Investigator# 57907	Gera		Germany	07545
189	Site Reference ID/Investigator# 64285	Gera		Germany	07545
190	Site Reference ID/Investigator# 64294	Gera		Germany	07545
191	Site Reference ID/Investigator# 57897	Gera		Germany	07548
192	Site Reference ID/Investigator# 53222	Gera		Germany	7546
193	Site Reference ID/Investigator# 34886	Giessen		Germany	35392
194	Site Reference ID/Investigator# 52998	Goettingen		Germany	37075
195	Site Reference ID/Investigator# 53116	Gornau		Germany	09405
196	Site Reference ID/Investigator# 34895	Goslar		Germany	38642
197	Site Reference ID/Investigator# 68589	Gotha		Germany	99867
198	Site Reference ID/Investigator# 35493	Graefelfing		Germany	82166
199	Site Reference ID/Investigator# 53224	Greifswald		Germany	17489
200	Site Reference ID/Investigator# 57889	Greifswald		Germany	17489
201	Site Reference ID/Investigator# 64289	Greifswald		Germany	17489
202	Site Reference ID/Investigator# 34903	Greifswald		Germany	17491
203	Site Reference ID/Investigator# 58122	Greifswald		Germany	17491
204	Site Reference ID/Investigator# 53106	Gronau		Germany	48599
205	Site Reference ID/Investigator# 91070	Grossenhain		Germany	01558
206	Site Reference ID/Investigator# 34911	Guestrow		Germany	18273
207	Site Reference ID/Investigator# 34936	Halle		Germany	06108
208	Site Reference ID/Investigator# 34939	Halle		Germany	06108
209	Site Reference ID/Investigator# 53067	Halle		Germany	06108
210	Site Reference ID/Investigator# 53236	Halle		Germany	06108
211	Site Reference ID/Investigator# 81601	Halle		Germany	06108
212	Site Reference ID/Investigator# 34921	Halle		Germany	06112
213	Site Reference ID/Investigator# 34943	Halle		Germany	06120
214	Site Reference ID/Investigator# 34931	Halle		Germany	06128
215	Site Reference ID/Investigator# 53063	Hamburg		Germany	20144
216	Site Reference ID/Investigator# 53183	Hamburg		Germany	20246
217	Site Reference ID/Investigator# 96237	Hamburg		Germany	20246
218	Site Reference ID/Investigator# 34969	Hamburg		Germany	20251
219	Site Reference ID/Investigator# 53073	Hamburg		Germany	20354
220	Site Reference ID/Investigator# 34951	Hamburg		Germany	20355
221	Site Reference ID/Investigator# 53276	Hamburg		Germany	21031
222	Site Reference ID/Investigator# 34957	Hamburg		Germany	21075
223	Site Reference ID/Investigator# 96242	Hamburg		Germany	21109
224	Site Reference ID/Investigator# 35451	Hamburg		Germany	22081
225	Site Reference ID/Investigator# 53198	Hamburg		Germany	22081
226	Site Reference ID/Investigator# 35113	Hamburg		Germany	22087
227	Site Reference ID/Investigator# 35006	Hamburg		Germany	22089
228	Site Reference ID/Investigator# 53186	Hamburg		Germany	22089
229	Site Reference ID/Investigator# 53212	Hamburg		Germany	22111
230	Site Reference ID/Investigator# 53206	Hamburg		Germany	22119
231	Site Reference ID/Investigator# 34960	Hamburg		Germany	22147
232	Site Reference ID/Investigator# 53199	Hamburg		Germany	22147
233	Site Reference ID/Investigator# 35448	Hamburg		Germany	22179
234	Site Reference ID/Investigator# 34954	Hamburg		Germany	22415
235	Site Reference ID/Investigator# 34997	Hamburg		Germany	22459
236	Site Reference ID/Investigator# 34993	Hamburg		Germany	22523
237	Site Reference ID/Investigator# 53098	Hamburg		Germany	22529
238	Site Reference ID/Investigator# 53279	Hamburg		Germany	22529
239	Site Reference ID/Investigator# 72854	Hamburg		Germany	22607
240	Site Reference ID/Investigator# 34982	Hamburg		Germany	22609
241	Site Reference ID/Investigator# 34985	Hamburg		Germany	22609
242	Site Reference ID/Investigator# 35110	Hamburg		Germany	22609
243	Site Reference ID/Investigator# 53066	Hamburg		Germany	22609
244	Site Reference ID/Investigator# 53248	Hamburg		Germany	22761
245	Site Reference ID/Investigator# 34973	Hamburg		Germany	22767
246	Site Reference ID/Investigator# 35018	Hanau		Germany	63450
247	Site Reference ID/Investigator# 64301	Hannover		Germany	30625
248	Site Reference ID/Investigator# 33711	Hanover		Germany	30159
249	Site Reference ID/Investigator# 53100	Hanover		Germany	30159
250	Site Reference ID/Investigator# 68582	Hanover		Germany	30159
251	Site Reference ID/Investigator# 53083	Hanover		Germany	30161
252	Site Reference ID/Investigator# 53256	Harrislee		Germany	24955
253	Site Reference ID/Investigator# 33797	Heidelberg		Germany	69120
254	Site Reference ID/Investigator# 33804	Heidelberg		Germany	69120
255	Site Reference ID/Investigator# 35118	Heidelberg		Germany	69120
256	Site Reference ID/Investigator# 91083	Heidelberg		Germany	69120
257	Site Reference ID/Investigator# 33800	Heidelberg		Germany	69121
258	Site Reference ID/Investigator# 33807	Heidelberg		Germany	69121
259	Site Reference ID/Investigator# 33817	Heilbad Heiligenstadt		Germany	37308
260	Site Reference ID/Investigator# 53057	Heilbad Heiligenstadt		Germany	37308
261	Site Reference ID/Investigator# 64297	Herne		Germany	44623
262	Site Reference ID/Investigator# 57894	Herrsching		Germany	82211
263	Site Reference ID/Investigator# 68586	Herten		Germany	45699
264	Site Reference ID/Investigator# 53272	Hildburghausen		Germany	98646
265	Site Reference ID/Investigator# 53080	Hilden		Germany	40721
266	Site Reference ID/Investigator# 53097	Hildesheim		Germany	31124
267	Site Reference ID/Investigator# 33841	Hofheim		Germany	65719
268	Site Reference ID/Investigator# 33833	Hof		Germany	95028
269	Site Reference ID/Investigator# 114015	Hohen Neuendorf		Germany	16540
270	Site Reference ID/Investigator# 33844	Hohenfelde		Germany	18209
271	Site Reference ID/Investigator# 53084	Holzkirchen		Germany	83607
272	Site Reference ID/Investigator# 53092	Homburg		Germany	66424
273	Site Reference ID/Investigator# 91085	Homburg		Germany	66424
274	Site Reference ID/Investigator# 53109	Hoyerswerda		Germany	02977
275	Site Reference ID/Investigator# 33857	Immenstadt		Germany	87509
276	Site Reference ID/Investigator# 98538	Ingoldstadt		Germany	85049
277	Site Reference ID/Investigator# 33934	Ingolstadt		Germany	85049
278	Site Reference ID/Investigator# 53111	Ingolstadt		Germany	85049
279	Site Reference ID/Investigator# 53053	Jena		Germany	07740
280	Site Reference ID/Investigator# 53055	Jena		Germany	07743
281	Site Reference ID/Investigator# 5305	Jena		Germany	07745
282	Site Reference ID/Investigator# 33941	Juelich		Germany	52428
283	Site Reference ID/Investigator# 33945	Kahla		Germany	07768
284	Site Reference ID/Investigator# 35123	Kahla		Germany	07768
285	Site Reference ID/Investigator# 33949	Kaiserslautern		Germany	67655
286	Site Reference ID/Investigator# 52992	Kamenz		Germany	01917
287	Site Reference ID/Investigator# 33960	Karlsruhe		Germany	76133
288	Site Reference ID/Investigator# 35483	Karlstadt		Germany	97753
289	Site Reference ID/Investigator# 53192	Kassel		Germany	34117
290	Site Reference ID/Investigator# 33963	Kassel		Germany	34131
291	Site Reference ID/Investigator# 33967	Katzhuette		Germany	98746
292	Site Reference ID/Investigator# 53229	Kiel		Germany	24105
293	Site Reference ID/Investigator# 72859	Kleinmachnow		Germany	14532
294	Site Reference ID/Investigator# 53233	Koblenz		Germany	56068
295	Site Reference ID/Investigator# 34001	Koenigs Wusterhausen		Germany	15711
296	Site Reference ID/Investigator# 91076	Krefeld		Germany	47798
297	Site Reference ID/Investigator# 91093	Krefeld		Germany	47798
298	Site Reference ID/Investigator# 53108	Krefeld		Germany	47802
299	Site Reference ID/Investigator# 34007	Kressbronn		Germany	88079
300	Site Reference ID/Investigator# 34083	Kronach		Germany	96317
301	Site Reference ID/Investigator# 53101	Kyritz		Germany	16866
302	Site Reference ID/Investigator# 34004	Lahr		Germany	77933
303	Site Reference ID/Investigator# 35244	Landau		Germany	76829
304	Site Reference ID/Investigator# 64290	Langenfeld		Germany	40764
305	Site Reference ID/Investigator# 53245	Leinefelde		Germany	37327
306	Site Reference ID/Investigator# 53115	Leipzig		Germany	04103
307	Site Reference ID/Investigator# 53087	Leipzig		Germany	04109
308	Site Reference ID/Investigator# 34105	Leipzig		Germany	04129
309	Site Reference ID/Investigator# 34108	Leipzig		Germany	04207
310	Site Reference ID/Investigator# 53197	Leipzig		Germany	04207
311	Site Reference ID/Investigator# 53052	Leipzig		Germany	04289
312	Site Reference ID/Investigator# 53211	Leipzig		Germany	04299
313	Site Reference ID/Investigator# 53088	Leverkusen		Germany	51373
314	Site Reference ID/Investigator# 34122	Lichtenstein		Germany	09350
315	Site Reference ID/Investigator# 53180	Lingen		Germany	49809
316	Site Reference ID/Investigator# 35253	Lippstadt		Germany	59555
317	Site Reference ID/Investigator# 96240	Loebau		Germany	02708
318	Site Reference ID/Investigator# 35259	Ludwigsfelde		Germany	14974
319	Site Reference ID/Investigator# 53195	Ludwigshafen		Germany	67063
320	Site Reference ID/Investigator# 53249	Ludwigslust		Germany	19288
321	Site Reference ID/Investigator# 53110	Luebeck		Germany	23538
322	Site Reference ID/Investigator# 34135	Luebeck		Germany	23564
323	Site Reference ID/Investigator# 53074	Luedenscheid		Germany	58515
324	Site Reference ID/Investigator# 96239	Lueneburg		Germany	21335
325	Site Reference ID/Investigator# 53000	Lutherstadt Eisleben		Germany	06295
326	Site Reference ID/Investigator# 34146	Magdeburg		Germany	39104
327	Site Reference ID/Investigator# 34149	Magdeburg		Germany	39104
328	Site Reference ID/Investigator# 91082	Magdeburg		Germany	39104
329	Site Reference ID/Investigator# 64292	Magdeburg		Germany	39108
330	Site Reference ID/Investigator# 68583	Magdeburg		Germany	39108
331	Site Reference ID/Investigator# 53230	Magdeburg		Germany	39120
332	Site Reference ID/Investigator# 64305	Magdeburg		Germany	39124
333	Site Reference ID/Investigator# 53075	Mainz		Germany	55131
334	Site Reference ID/Investigator# 68593	Mainz		Germany	55131
335	Site Reference ID/Investigator# 34179	Mannheim		Germany	68165
336	Site Reference ID/Investigator# 34191	Marktredwitz		Germany	95615
337	Site Reference ID/Investigator# 34195	Marl		Germany	45768
338	Site Reference ID/Investigator# 34199	Meissen		Germany	01662
339	Site Reference ID/Investigator# 53269	Melsungen		Germany	34212
340	Site Reference ID/Investigator# 53078	Memmingen		Germany	87700
341	Site Reference ID/Investigator# 35284	Menz		Germany	39175
342	Site Reference ID/Investigator# 35286	Minden		Germany	32429
343	Site Reference ID/Investigator# 34207	Mittelherwigsdorf		Germany	02763
344	Site Reference ID/Investigator# 34217	Moenchengladbach		Germany	41061
345	Site Reference ID/Investigator# 34212	Moenchengladbach		Germany	41199
346	Site Reference ID/Investigator# 53095	Moenchengladbach		Germany	41199
347	Site Reference ID/Investigator# 53261	Moenchengladbach		Germany	41236
348	Site Reference ID/Investigator# 57883	Moenkeburg		Germany	24248
349	Site Reference ID/Investigator# 34223	Muehlhausen		Germany	99974
350	Site Reference ID/Investigator# 35291	Muelheim		Germany	45468
351	Site Reference ID/Investigator# 53235	Muelheim		Germany	45468
352	Site Reference ID/Investigator# 34228	Muellheim		Germany	79379
353	Site Reference ID/Investigator# 53062	Muenster		Germany	48143
354	Site Reference ID/Investigator# 68587	Muenster		Germany	48143
355	Site Reference ID/Investigator# 34047	Muenster		Germany	48149
356	Site Reference ID/Investigator# 53093	Muenster		Germany	48149
357	Site Reference ID/Investigator# 91096	Muenster		Germany	48149
358	Site Reference ID/Investigator# 64282	Munich		Germany	80634
359	Site Reference ID/Investigator# 34039	Munich		Germany	80639
360	Site Reference ID/Investigator# 57892	Munich		Germany	80802
361	Site Reference ID/Investigator# 64295	Munich		Germany	80802
362	Site Reference ID/Investigator# 35294	Munich		Germany	81377
363	Site Reference ID/Investigator# 34234	Munich		Germany	81547
364	Site Reference ID/Investigator# 91080	Munich		Germany	81667
365	Site Reference ID/Investigator# 34042	Munich		Germany	81925
366	Site Reference ID/Investigator# 53270	Munich		Germany	D-81541
367	Site Reference ID/Investigator# 53246	Naila		Germany	95119
368	Site Reference ID/Investigator# 53271	Nastaetten		Germany	56355
369	Site Reference ID/Investigator# 35305	Naumburg		Germany	06618
370	Site Reference ID/Investigator# 34051	Naunhof		Germany	04683
371	Site Reference ID/Investigator# 34060	Neubrandenburg		Germany	17033
372	Site Reference ID/Investigator# 34063	Neuburg		Germany	86633
373	Site Reference ID/Investigator# 53220	Neunkirchen		Germany	66538
374	Site Reference ID/Investigator# 35312	Neuss		Germany	41460
375	Site Reference ID/Investigator# 34075	Neustadt		Germany	67434
376	Site Reference ID/Investigator# 34079	Niefern-Oeschelbronn		Germany	75223
377	Site Reference ID/Investigator# 34157	Nienburg		Germany	31582
378	Site Reference ID/Investigator# 57891	Nienburg		Germany	31582
379	Site Reference ID/Investigator# 52997	Nordhausen		Germany	99734
380	Site Reference ID/Investigator# 52999	Nordhausen		Germany	99734
381	Site Reference ID/Investigator# 53277	Nordhausen		Germany	99734
382	Site Reference ID/Investigator# 53054	Nuremberg		Germany	90429
383	Site Reference ID/Investigator# 68588	Nuremberg		Germany	90429
384	Site Reference ID/Investigator# 53112	Nuremberg		Germany	90482
385	Site Reference ID/Investigator# 96244	Oberhausen		Germany	46145
386	Site Reference ID/Investigator# 34172	Oelsnitz		Germany	09376
387	Site Reference ID/Investigator# 53104	Oelsnitz		Germany	09376
388	Site Reference ID/Investigator# 34175	Offenburg		Germany	77652
389	Site Reference ID/Investigator# 33491	Oldenburg		Germany	26121
390	Site Reference ID/Investigator# 57886	Oldenburg		Germany	26133
391	Site Reference ID/Investigator# 91067	Oschatz		Germany	04758
392	Site Reference ID/Investigator# 53207	Osnabrueck		Germany	49074
393	Site Reference ID/Investigator# 81600	Osnabrueck		Germany	49076
394	Site Reference ID/Investigator# 53228	Ostseebad Damp		Germany	24351
395	Site Reference ID/Investigator# 35334	Paderborn		Germany	33098
396	Site Reference ID/Investigator# 33507	Parchim		Germany	19370
397	Site Reference ID/Investigator# 35339	Passau		Germany	94032
398	Site Reference ID/Investigator# 72858	Peitz		Germany	03185
399	Site Reference ID/Investigator# 53096	Petershagen		Germany	32469
400	Site Reference ID/Investigator# 53086	Pinneberg		Germany	25421
401	Site Reference ID/Investigator# 53232	Pirna		Germany	01796
402	Site Reference ID/Investigator# 33522	Planegg		Germany	82152
403	Site Reference ID/Investigator# 33527	Plauen		Germany	08523
404	Site Reference ID/Investigator# 96278	Plochingen		Germany	73207
405	Site Reference ID/Investigator# 33469	Potsdam		Germany	14467
406	Site Reference ID/Investigator# 33465	Potsdam		Germany	14469
407	Site Reference ID/Investigator# 96236	Potsdam		Germany	14471
408	Site Reference ID/Investigator# 53281	Potsdam		Germany	14480
409	Site Reference ID/Investigator# 33475	Pruem		Germany	54595
410	Site Reference ID/Investigator# 33478	Puettlingen		Germany	66346
411	Site Reference ID/Investigator# 53257	Puettlingen		Germany	66346
412	Site Reference ID/Investigator# 91120	Puettlingen		Germany	66346
413	Site Reference ID/Investigator# 53094	Quedlinburg		Germany	06484
414	Site Reference ID/Investigator# 53265	Querfurt		Germany	6268
415	Site Reference ID/Investigator# 33483	Radebeul		Germany	01445
416	Site Reference ID/Investigator# 35346	Radebeul		Germany	01445
417	Site Reference ID/Investigator# 53280	Ratingen		Germany	40882
418	Site Reference ID/Investigator# 57888	Ratingen		Germany	40882
419	Site Reference ID/Investigator# 33487	Ratzeburg		Germany	23909
420	Site Reference ID/Investigator# 33889	Regensburg		Germany	93049
421	Site Reference ID/Investigator# 57912	Regensburg		Germany	93049
422	Site Reference ID/Investigator# 57911	Regensburg		Germany	93051
423	Site Reference ID/Investigator# 53264	Regensburg		Germany	93053
424	Site Reference ID/Investigator# 33901	Rendsburg		Germany	24768
425	Site Reference ID/Investigator# 52991	Ribnitz-Damgarten		Germany	18311
426	Site Reference ID/Investigator# 53267	Riesa		Germany	01587
427	Site Reference ID/Investigator# 33910	Riesa		Germany	01589
428	Site Reference ID/Investigator# 33913	Rinteln		Germany	31737
429	Site Reference ID/Investigator# 33922	Rostock		Germany	18059
430	Site Reference ID/Investigator# 33926	Rostock		Germany	18059
431	Site Reference ID/Investigator# 33930	Rothenburg		Germany	02929
432	Site Reference ID/Investigator# 53113	Rudolstadt		Germany	07407
433	Site Reference ID/Investigator# 35361	Ruedersdorf		Germany	15562
434	Site Reference ID/Investigator# 34015	Saarbruecken		Germany	66111
435	Site Reference ID/Investigator# 91071	Saarlouis		Germany	66740
436	Site Reference ID/Investigator# 34022	Salzwedel		Germany	29410
437	Site Reference ID/Investigator# 34026	Sande		Germany	26452
438	Site Reference ID/Investigator# 53208	Schleiz		Germany	7907
439	Site Reference ID/Investigator# 91074	Schlettau		Germany	09487
440	Site Reference ID/Investigator# 33533	Schneeberg		Germany	08289
441	Site Reference ID/Investigator# 33538	Schramberg		Germany	78713
442	Site Reference ID/Investigator# 33541	Schutterwald		Germany	77746
443	Site Reference ID/Investigator# 35370	Schwandorf		Germany	92421
444	Site Reference ID/Investigator# 91072	Schwandorf		Germany	92421
445	Site Reference ID/Investigator# 57905	Schwedt		Germany	16303
446	Site Reference ID/Investigator# 72855	Schweina		Germany	36448
447	Site Reference ID/Investigator# 33548	Schwerin		Germany	19053
448	Site Reference ID/Investigator# 35375	Schwerin		Germany	19053
449	Site Reference ID/Investigator# 33554	Schwerte		Germany	58239
450	Site Reference ID/Investigator# 33558	Seesen		Germany	38723
451	Site Reference ID/Investigator# 33566	Sinsheim		Germany	74889
452	Site Reference ID/Investigator# 33571	Soltau		Germany	29614
453	Site Reference ID/Investigator# 53255	Spelle		Germany	48480
454	Site Reference ID/Investigator# 35382	St. Martin		Germany	67487
455	Site Reference ID/Investigator# 33584	Stadtbergen		Germany	86391
456	Site Reference ID/Investigator# 98539	Stolberg		Germany	52222
457	Site Reference ID/Investigator# 53218	Storkow		Germany	15859
458	Site Reference ID/Investigator# 53082	Straubing		Germany	94315
459	Site Reference ID/Investigator# 33603	Stuttgart		Germany	70178
460	Site Reference ID/Investigator# 33606	Stuttgart		Germany	70178
461	Site Reference ID/Investigator# 33610	Stuttgart		Germany	70199
462	Site Reference ID/Investigator# 33597	Stuttgart		Germany	70372
463	Site Reference ID/Investigator# 53210	Suhl		Germany	98527
464	Site Reference ID/Investigator# 53223	Suhl		Germany	98527
465	Site Reference ID/Investigator# 35388	Suhl		Germany	98529
466	Site Reference ID/Investigator# 33624	Torgelow		Germany	17358
467	Site Reference ID/Investigator# 53077	Treuenbrietzen		Germany	14929
468	Site Reference ID/Investigator# 57906	Treuenbrietzen		Germany	14929
469	Site Reference ID/Investigator# 53200	Tuttlingen		Germany	78532
470	Site Reference ID/Investigator# 57910	Ueberlingen-Nussdorf		Germany	88662
471	Site Reference ID/Investigator# 33640	Ulm		Germany	89073
472	Site Reference ID/Investigator# 33723	Ulm		Germany	89073
473	Site Reference ID/Investigator# 81602	Unna		Germany	59423
474	Site Reference ID/Investigator# 96241	Varel		Germany	26316
475	Site Reference ID/Investigator# 98536	Verden		Germany	27283
476	Site Reference ID/Investigator# 72860	Viersen		Germany	41749
477	Site Reference ID/Investigator# 33736	Villingen-Schwenningen		Germany	78054
478	Site Reference ID/Investigator# 33741	Waltrop		Germany	45731
479	Site Reference ID/Investigator# 72853	Wasserburg		Germany	83512
480	Site Reference ID/Investigator# 33748	Weener		Germany	26826
481	Site Reference ID/Investigator# 33851	Welzow		Germany	03119
482	Site Reference ID/Investigator# 35407	Wiesbaden		Germany	65189
483	Site Reference ID/Investigator# 33764	Wiesbaden		Germany	65191
484	Site Reference ID/Investigator# 52989	Wiesbaden		Germany	65191
485	Site Reference ID/Investigator# 33771	Wilhelmshaven		Germany	26382
486	Site Reference ID/Investigator# 53076	Winsen		Germany	21423
487	Site Reference ID/Investigator# 33775	Wismar		Germany	23966
488	Site Reference ID/Investigator# 33779	Wittlich		Germany	54516
489	Site Reference ID/Investigator# 91095	Wittmund		Germany	26409
490	Site Reference ID/Investigator# 96235	Wolfenbuettel		Germany	38300
491	Site Reference ID/Investigator# 33717	Wuerzburg		Germany	97070
492	Site Reference ID/Investigator# 57903	Wuerzburg		Germany	97070
493	Site Reference ID/Investigator# 91068	Wuppertal		Germany	42103
494	Site Reference ID/Investigator# 91069	Wuppertal		Germany	42103
495	Site Reference ID/Investigator# 35419	Wuppertal		Germany	42105
496	Site Reference ID/Investigator# 57884	Wurzen		Germany	04808
497	Site Reference ID/Investigator# 53064	Zeitz		Germany	06712
498	Site Reference ID/Investigator# 33863	Zerbst		Germany	39261
499	Site Reference ID/Investigator# 33866	Zeven		Germany	27404
500	Site Reference ID/Investigator# 64299	Zschopau		Germany	9405
501	Site Reference ID/Investigator# 52996	Zwickau		Germany	08056
502	Site Reference ID/Investigator# 33875	Zwickau		Germany	08060
503	Site Reference ID/Investigator# 52993	Zwickau		Germany	08060
504	Site Reference ID/Investigator# 53056	Zwickau		Germany	08060
505	Site Reference ID/Investigator# 53102	Zwickau		Germany	08060
506	Site Reference ID/Investigator# 52994	Zwickau		Germany	08066
507	Site Reference ID/Investigator# 53226	Zwickau		Germany	8058
508	Site Reference ID/Investigator# 53260	Zwickau		Germany	8060
509	Site Reference ID/Investigator# 33879	Zwiesel		Germany	94227

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Bianca Wittig, MD, Abbvie Deutschland GmbH & Co. KG, Medical Department

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01111240
• Other Study ID Numbers: HUM 05-3
• First Posted: Apr 27, 2010
• Last Update Posted: Dec 30, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by AbbVie (prior sponsor, Abbott): Humira; Long-term safety and effectiveness; Psoriatic Arthritis
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic

Study Results

Participant Flow

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Period Title: Overall Study
STARTED	4635
COMPLETED	3569
NOT COMPLETED	1066

Baseline Characteristics

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Overall Participants	4635
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.4 (11.8)
Gender (participants) [Number]
Female	2282 49.2%
Male	2297 49.6%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in Disease Activity Score (DAS)28
Description	The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, 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.
Time Frame	Baseline and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Month 3 [N=2757]	-1.7 (1.4)
Month 6 [N=2412]	-1.9 (1.5)
Month 9 [N=2028]	-1.9 (1.5)
Month 12 [N=1850]	-2.0 (1.5)
Month 18 [N=1572]	-2.0 (1.5)
Month 24 [N=1315]	-2.1 (1.6)

2. Primary Outcome

Title	Mean Tender Joint Count (TJC) Over Time
Description	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.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=3552]	15.0 (15.3)
Month 3 [N=3411]	7.5 (12.3)
Month 6 [N=2975]	6.1 (11.3)
Month 9 [N=2592]	5.5 (10.9)
Month 12 [N=2296]	5.2 (10.5)
Month 18 [N=1953]	5.2 (10.5)
Month 24 [N-1624]	4.9 (10.4)

3. Primary Outcome

Title	Mean Swollen Joint Count (SJC) Over Time
Description	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.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=3552]	8.3 (10.2)
Month 3 [N=3411]	3.0 (6.9)
Month 6 [N=2975]	2.4 (6.3)
Month 9 [N=2592	2.0 (5.5)
Month 12 [N=2296]	1.9 (5.6)
Month 18 [N=1953]	1.8 (5.2)
Month 24 [N=1624]	1.5 (4.5)

4. Primary Outcome

Title	Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time
Description	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.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=3289]	8.9 (8.4)
Month 3 [N=2737]	6.4 (11.2)
Month 6 [N=2385]	5.1 (9.7)
Month 9 [N=2025]	4.6 (9.9)
Month 12 [N=1844]	4.2 (9.3)
Month 18 [N=1530]	4.1 (8.9)
Month 24 [ N=1295]	4.0 (8.9)

5. Primary Outcome

Title	Mean Target Lesion Score (TLS) Over Time
Description	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).
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=2929]	6.1 (4.2)
Month 3 [N=2740]	3.2 (3.2)
Month 6 [N=2359]	2.7 (3.1)
Month 9 [N=1969]	2.4 (2.9)
Month 12 [N=1756]	2.3 (3.0)
Month 18 [N=1491]	2.2 (2.8)
Month 24 [N=1243]	2.1 (2.8)

6. Primary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	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.
Time Frame	Baseline up to 24 months

Outcome Measure Data

Analysis Population Description

Safety Set - All enrolled participants

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	4635
Drug-related AEs excluding SAEs	877 18.9%
SAEs	143 3.1%

7. Secondary Outcome

Title	Number of Participants by Severity of Enthesitis Over Time
Description	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.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline, Mild [N=3552]	422 9.1%
Baseline, Moderate [N=3552]	407 8.8%
Baseline, Severe [N=3552]	119 2.6%
Month 3, Mild [N=3432]	286 6.2%
Month 3, Moderate [N=3432]	130 2.8%
Month 3, Severe [N=3432]	31 0.7%
Month 6, Mild [N=2995]	230 5%
Month 6, Moderate [N=2995]	80 1.7%
Month 6, Severe [N=2995]	14 0.3%
Month 9, Mild [N=2548]	188 4.1%
Month 9, Moderate [N=2548]	53 1.1%
Month 9, Severe[N=2548]	12 0.3%
Month 12, Mild [N=2307]	179 3.9%
Month 12, Moderate [N=2307]	46 1%
Month 12, Severe [N=2307]	8 0.2%
Month 18, Mild [N=1966]	133 2.9%
Month 18, Moderate [N=1966]	49 1.1%
Month 18, Severe [N=1966]	11 0.2%
Month 24, Mild [N=1630]	107 2.3%
Month 24, Moderate [N=1630]	24 0.5%
Month 24, Severe [N=1630]	5 0.1%

8. Secondary Outcome

Title	Number of Participants by Severity of Dactylitis Over Time
Description	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.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline, Mild [N=3552]	452 9.8%
Baseline, Moderate [N=3552]	765 16.5%
Baseline, Severe [N=3552]	352 7.6%
Month 3, Mild [N=3432]	420 9.1%
Month 3, Moderate [N=3432]	228 4.9%
Month 3, Severe [N=3432]	42 0.9%
Month 6, Mild [N=2995]	313 6.8%
Month 6, Moderate [N=2995]	159 3.4%
Month 6, Severe [N=2995]	23 0.5%
Month 9, Mild [N=2548]	252 5.4%
Month 9, Moderate [N=2548]	114 2.5%
Month 9, Severe [N=2548]	17 0.4%
Month 12, Mild [N=2307]	219 4.7%
Month 12, Moderate [N=2307]	86 1.9%
Month 12, Severe [N=2307]	12 0.3%
Month 18, Mild [N=1966]	167 3.6%
Month 18, Moderate [N=1966]	61 1.3%
Month 18, Severe [N=1966]	8 0.2%
Month 24, Mild [N=1630]	153 3.3%
Month 24, Moderate [N=1630]	41 0.9%
Month 24, Severe [N=1630]	3 0.1%

9. Secondary Outcome

Title	Number of Participants by Severity of Nail Psoriasis Levels Over Time
Description	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.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline, Mild [N=3552]	843 18.2%
Baseline, Moderate [N=3552]	771 16.6%
Baseline, Severe [N=3552]	305 6.6%
Month 3, Mild [N=3432]	996 21.5%
Month 3, Moderate [N=3432]	446 9.6%
Month 3, Severe [N=3432]	99 2.1%
Month 6, Mild [N=2995]	814 17.6%
Month 6, Moderate [N=2995]	266 5.7%
Month 6, Severe [N=2995]	67 1.4%
Month 9, Mild [N=2548]	664 14.3%
Month 9, Moderate [N=2548]	150 3.2%
Month 9, Severe [N=2548]	46 1%
Month 12, Mild [N=2307]	595 12.8%
Month 12, Moderate [N=2307]	143 3.1%
Month 12, Severe [N=2307]	30 0.6%
Month 18, Mild [N=1966]	464 10%
Month 18, Moderate [N=1966]	123 2.7%
Month 18, Severe [N=1966]	21 0.5%
Month 24, Mild [N=1630]	393 8.5%
Month 24, Moderate [N=1630]	81 1.7%
Month 24, Severe [N=1630]	11 0.2%

10. Secondary Outcome

Title	Mean Erythrocyte Sedimentation Rate (ESR) Over Time
Description	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.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=3149]	23.3 (20.0)
Month 3 [N=2925]	14.3 (14.6)
Month 6 [N=2566]	14.2 (14.4)
Month 9 [N=2161]	14.3 (14.4)
Month 12 [N=1970]	14.5 (14.5)
Month 18 [N=1659]	14.5 (13.9)
Month 24 [N=1391]	14.5 (13.3)

11. Secondary Outcome

Title	Mean C-Reactive Protein (CRP) Levels Over Time
Description	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.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=3522]	12.8 (26.4)
Month 3 [N=3022]	6.2 (12.9)
Month 6 [N=2642]	5.9 (10.9)
Month 9 [N=2247]	5.6 (10.0)
Month 12 [N=2047]	6.0 (18.1)
Month 18 [N=1751]	5.4 (10.4)
Month 24 [N=1440]	5.4 (23.8)

12. Secondary Outcome

Title	Patients Global Assessment of Disease Activity Over Time
Description	Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=3534]	6.8 (1.8)
Month 3 [N=3397]	3.9 (2.3)
Month 6 [N=2973]	3.4 (2.4)
Month 9 [N=2520]	3.2 (2.3)
Month 12 [N=2289]	3.1 (2.2)
Month 18 [N=1952]	3.1 (2.3)
Month 24 [N=1624]	2.9 (2.2)

13. Secondary Outcome

Title	Participants Assessment of Fatigue Over Time
Description	Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=3385]	5.5 (2.7)
Month 3 [N=3250]	4.1 (2.7)
Month 6 [N=2829]	3.9 (2.7)
Month 9 [N=2435]	3.7 (2.7)
Month 12 [N=2200]	3.6 (2.6)
Month 18 [N=1897]	3.6 (2.7)
Month 24 [N=1570]	3.4 (2.6)

14. Secondary Outcome

Title	Participants Assessment of Pain Over Time
Description	Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=3387]	6.1 (2.2)
Month 3 [N=3249]	4.0 (2.5)
Month 6 [N=2827]	3.7 (2.5)
Month 9 [N=2436]	3.6 (2.5)
Month 12 [N=2204]	3.5 (2.5)
Month 18 [N=1897]	3.5 (2.6)
Month 24 [N=1573]	3.3 (2.4)

15. Secondary Outcome

Title	Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time
Description	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.
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=3401]	69.6 (21.1)
Month 3 [N=3257]	76.3 (20.7)
Month 6 [N=2835]	77.3 (20.9)
Month 9 [N=2431]	78.3 (20.8)
Month 12 [N=2213]	78.7 (21.1)
Month 18 [N=1897]	79.1 (20.8)
Month 24 [N=1580]	79.8 (20.5)

16. Secondary Outcome

Title	Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline, 0 days [N=3307]	29.3 0.6%
Baseline, <7 days [N=3307]	28.2 0.6%
Baseline, 7 to 14 days [N=3307]	21.7 0.5%
Baseline, >14 days [N=3307]	20.9 0.5%
Month 3, 0 days [N=3193]	49.0 1.1%
Month 3, <7 days [N=3193]	28.4 0.6%
Month 3, 7 to 14 days [N=3193]	13.4 0.3%
Month 3, >14 days [N=3193]	9.2 0.2%
Month 6, 0 days [N=2779]	55.4 1.2%
Month 6, <7 days [N=2779]	25.2 0.5%
Month 6, 7 to 14 days [N=2779]	11.3 0.2%
Month 6, >14 days [N=2779]	8.2 0.2%
Month 9, 0 days [N=2390]	58.5 1.3%
Month 9, <7 days [N=2390]	23.3 0.5%
Month 9, 7 to 14 days [N=2390]	10.6 0.2%
Month 9, >14 days [N=2390]	7.5 0.2%
Month 12, 0 days [N=2164]	59.8 1.3%
Month 12, <7 days [N=2164]	24.2 0.5%
Month 12, 7 to 14 days [N=2164]	9.7 0.2%
Month 12, >14 days [N=2164]	6.4 0.1%
Month 18, 0 days [N=1856]	59.9 1.3%
Month 18, <7 days [N=1856]	25.0 0.5%
Month 18, 7 to 14 days [N=1856]	9.1 0.2%
Month 18, >14 days [N=1856]	6.0 0.1%
Month 24, 0 days [N=1553]	61.6 1.3%
Month 24, <7 days [N=1553]	24.5 0.5%
Month 24, 7 to 14 days [N=1553]	8.6 0.2%
Month 24, >14 days [N=1553]	5.2 0.1%

17. Secondary Outcome

Title	Mean Number of Days Missed From Work Due to Psoriatic Arthritis
Description	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).
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Basline [N=2004]	22.6 (58.2)
Month 3 [N=1886]	5.1 (15.7)
Month 6 [N=1682]	3.8 (13.5)
Month 9 [N=1440]	3.0 (12.5)
Month 12 [N=1325]	2.5 (11.2)
Month 18 [N=1133]	3.4 (17.9)
Month 24 [N=929]	2.8 (16.9)

18. Secondary Outcome

Title	Percentage of Participants With In-Patient Hospitalization
Description	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).
Time Frame	Baseline, and Months 3, 6, 9, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline [N=3365]	17.7
Month 3 [ N=3232]	12.0
Month 6 [N=2804]	9.1
Month 9 [N=2417]	7.0
Month 12 [N=2183]	4.8
Month 18 [N=1877]	3.8
Month 24 [N=1568]	3.3

19. Secondary Outcome

Title	Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication
Description	Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs
Time Frame	Baseline, and Months 6 and 24

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
Measure Participants	3552
Baseline, MTX [N=3552]	43.7 0.9%
Month 6, MTX [N=2823]	43.2 0.9%
Month 24, MTX [N=1555]	42.7 0.9%
Baseline, Other DMARD [N=3552]	2.4 0.1%
Month 6, Other DMARD [N=2823]	1.4 0%
Month 24, Other DMARD [N=1555]	0.9 0%

Adverse Events

Time Frame	From baseline up to 24 months
Adverse Event Reporting Description	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.
Arm/Group Title	Psoriatic Arthritis
Arm/Group Description	Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
All Cause Mortality
	Psoriatic Arthritis
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Psoriatic Arthritis
	Affected / at Risk (%)	# Events
Total	143/4635 (3.1%)
Blood and lymphatic system disorders
Lymphadenopathy	2/4635 (0%)
Anemia	1/4635 (0%)
Leukocytosis	1/4635 (0%)
Splenic infarction	1/4635 (0%)
Cardiac disorders
Acute myocardial infarction	2/4635 (0%)
Arteriosclerosis coronary artery	2/4635 (0%)
Myocardial infarction	2/4635 (0%)
Acute coronary syndrome	1/4635 (0%)
Acute right ventricular failure	1/4635 (0%)
Arrhythmia	1/4635 (0%)
Cardiac failure	1/4635 (0%)
Cardiomyopathy	1/4635 (0%)
Coronary artery disease	1/4635 (0%)
Endocardial disease	1/4635 (0%)
Palpitations	1/4635 (0%)
Tachyarrhythmia	1/4635 (0%)
Ear and labyrinth disorders
Vertigo	2/4635 (0%)
Acute vestibular syndrome	1/4635 (0%)
Hearing impaired	1/4635 (0%)
Endocrine disorders
Hyperthyroidism	1/4635 (0%)
Eye disorders
Eyelid edema	1/4635 (0%)
Gastrointestinal disorders
Diarrhea	2/4635 (0%)
Large intestine perforation	2/4635 (0%)
Pancreatitis	2/4635 (0%)
Abdominal pain	1/4635 (0%)
Dysphagia	1/4635 (0%)
Enteritis	1/4635 (0%)
Inguinal hernia	1/4635 (0%)
Lip edema	1/4635 (0%)
Pancreatitis chronic	1/4635 (0%)
Upper gastrointestinal hemorrhage	1/4635 (0%)
General disorders
Pyrexia	3/4635 (0.1%)
Drug ineffective	2/4635 (0%)
Cardiac death	1/4635 (0%)
Fatigue	1/4635 (0%)
Feeling hot	1/4635 (0%)
Impaired healing	1/4635 (0%)
Injection site urticaria	1/4635 (0%)
Malaise	1/4635 (0%)
Obstruction	1/4635 (0%)
Edema	1/4635 (0%)
Edema peripheral	1/4635 (0%)
Hepatobiliary disorders
Cholecystitis	1/4635 (0%)
Hepatitis	1/4635 (0%)
Hepatocellular damage	1/4635 (0%)
Liver disorder	1/4635 (0%)
Immune system disorders
Anaphylactic reaction	1/4635 (0%)
Drug hypersensitivity	1/4635 (0%)
Hypersensitivity	1/4635 (0%)
Infections and infestations
Pneumonia	7/4635 (0.2%)
Erysipelas	3/4635 (0.1%)
Nasopharyngitis	3/4635 (0.1%)
Diverticulitis	2/4635 (0%)
Urinary tract infection	2/4635 (0%)
Abscess limb	1/4635 (0%)
Acute tonsillitis	1/4635 (0%)
Appendicitis	1/4635 (0%)
Bronchitis	1/4635 (0%)
Cellulitis	1/4635 (0%)
Cystitis klebsiella	1/4635 (0%)
Endocarditis	1/4635 (0%)
Escherichia sepsis	1/4635 (0%)
Gastroenteritis	1/4635 (0%)
Hepatitis B	1/4635 (0%)
Herpes zoster	1/4635 (0%)
Infection	1/4635 (0%)
Intervertebral discitis	1/4635 (0%)
Lobar pneumonia	1/4635 (0%)
Lung abscess	1/4635 (0%)
Mycotoxicosis	1/4635 (0%)
Necrotising fasciitis	1/4635 (0%)
Postoperative wound infection	1/4635 (0%)
Pyelonephritis	1/4635 (0%)
Rash pustular	1/4635 (0%)
Respiratory tract infection	1/4635 (0%)
Skin bacterial infection	1/4635 (0%)
Superinfection bacterial	1/4635 (0%)
Tracheobronchitis	1/4635 (0%)
Tuberculosis	1/4635 (0%)
Urosepsis	1/4635 (0%)
Injury, poisoning and procedural complications
Traumatic hematoma	2/4635 (0%)
Alcohol poisoning	1/4635 (0%)
Humerus fracture	1/4635 (0%)
Lower limb fracture	1/4635 (0%)
Post procedural hemorrhage	1/4635 (0%)
Investigations
C-reactive protein increased	2/4635 (0%)
Antiphospholipid antibodies positive	1/4635 (0%)
Arthroscopy	1/4635 (0%)
Biopsy liver	1/4635 (0%)
Blood creatine phosphokinase increased	1/4635 (0%)
Body temperature	1/4635 (0%)
General physical condition abnormal	1/4635 (0%)
Hepatic enzyme increased	1/4635 (0%)
Immunology test	1/4635 (0%)
Red blood cell sedimentation rate increased	1/4635 (0%)
Transaminases increased	1/4635 (0%)
Ureteroscopy	1/4635 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/4635 (0%)
Arthritis	2/4635 (0%)
Joint stiffness	2/4635 (0%)
Myalgia	2/4635 (0%)
Osteoarthritis	2/4635 (0%)
Spinal osteoarthritis	2/4635 (0%)
Intervertebral disc protrusion	1/4635 (0%)
Lupus-like syndrome	1/4635 (0%)
Myositis	1/4635 (0%)
Psoriatic arthropathy	1/4635 (0%)
Rotator cuff syndrome	1/4635 (0%)
Synovial cyst	1/4635 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	3/4635 (0.1%)
Hodgkin's disease	2/4635 (0%)
Cervix carcinoma	1/4635 (0%)
Leiomyoma	1/4635 (0%)
Lung neoplasm	1/4635 (0%)
Multiple myeloma	1/4635 (0%)
Pancreatic neoplasm	1/4635 (0%)
Prostate cancer	1/4635 (0%)
Tongue neoplasm malignant stage unspecified	1/4635 (0%)
Nervous system disorders
Cerebral infarction	2/4635 (0%)
Cerebrovascular accident	2/4635 (0%)
Convulsion	1/4635 (0%)
Dizziness	1/4635 (0%)
Grand mal convulsion	1/4635 (0%)
Headache	1/4635 (0%)
Hemiparesis	1/4635 (0%)
Loss of consciousness	1/4635 (0%)
Movement disorder	1/4635 (0%)
Myasthenia gravis	1/4635 (0%)
Neuralgia	1/4635 (0%)
Optic neuritis	1/4635 (0%)
Paresthesia	1/4635 (0%)
Polyneuropathy	1/4635 (0%)
Somnolence	1/4635 (0%)
Speech disorder	1/4635 (0%)
Syncope	1/4635 (0%)
Psychiatric disorders
Depression	2/4635 (0%)
Hallucination, auditory	1/4635 (0%)
Suicide attempt	1/4635 (0%)
Renal and urinary disorders
Renal colic	3/4635 (0.1%)
Hematuria	2/4635 (0%)
Calculus urinary	1/4635 (0%)
Cystitis noninfective	1/4635 (0%)
Nephrolithiasis	1/4635 (0%)
Post streptococcal glomerulonephritis	1/4635 (0%)
Renal cyst	1/4635 (0%)
Renal failure acute	1/4635 (0%)
Urinary tract obstruction	1/4635 (0%)
Reproductive system and breast disorders
Breast pain	1/4635 (0%)
Genital rash	1/4635 (0%)
Ovarian cyst ruptured	1/4635 (0%)
Uterovaginal prolapse	1/4635 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	3/4635 (0.1%)
Respiratory distress	2/4635 (0%)
Chronic obstructive pulmonary disease	1/4635 (0%)
Epistaxis	1/4635 (0%)
Hemoptysis	1/4635 (0%)
Pulmonary fibrosis	1/4635 (0%)
Respiratory failure	1/4635 (0%)
Skin and subcutaneous tissue disorders
Psoriasis	4/4635 (0.1%)
Pruritus	2/4635 (0%)
Dermatitis allergic	1/4635 (0%)
Erythema	1/4635 (0%)
Leukocytoclastic vasculitis	1/4635 (0%)
Rash	1/4635 (0%)
Rash generalized	1/4635 (0%)
Subcutaneous emphysema	1/4635 (0%)
Social circumstances
Walking disability	1/4635 (0%)
Surgical and medical procedures
Appendectomy	2/4635 (0%)
Carpal tunnel decompression	2/4635 (0%)
Cholecystectomy	2/4635 (0%)
Hip arthroplasty	2/4635 (0%)
Adhesiolysis	1/4635 (0%)
Analgesic therapy	1/4635 (0%)
Antibiotics prophylaxis	1/4635 (0%)
Aortic bypass	1/4635 (0%)
Arthrodesis	1/4635 (0%)
Bile duct stent insertion	1/4635 (0%)
Breast operation	1/4635 (0%)
Coronary arterial stent insertion	1/4635 (0%)
Dupuytren's contracture operation	1/4635 (0%)
Foot operation	1/4635 (0%)
Gallbladder operation	1/4635 (0%)
Hospitalization	1/4635 (0%)
Hysterectomy	1/4635 (0%)
Implantable defibrillator insertion	1/4635 (0%)
Intervertebral disc operation	1/4635 (0%)
Joint arthroplasty	1/4635 (0%)
Knee arthroplasty	1/4635 (0%)
Knee operation	1/4635 (0%)
Large intestine operation	1/4635 (0%)
Lung cyst removal	1/4635 (0%)
Osteosynthesis	1/4635 (0%)
Percutaneous coronary intervention	1/4635 (0%)
Pilonidal sinus repair	1/4635 (0%)
Renal stone removal	1/4635 (0%)
Shoulder operation	1/4635 (0%)
Spinal operation	1/4635 (0%)
Stent placement	1/4635 (0%)
Thyroid operation	1/4635 (0%)
Tonsillectomy	1/4635 (0%)
Ureteral stent insertion	1/4635 (0%)
Ureteric calculus removal	1/4635 (0%)
Uterine operation	1/4635 (0%)
Vascular disorders
Vasculitis	2/4635 (0%)
Circulatory collapse	1/4635 (0%)
Hypertension	1/4635 (0%)
Hypertensive crisis	1/4635 (0%)
Temporal arteritis	1/4635 (0%)
Other (Not Including Serious) Adverse Events
	Psoriatic Arthritis
	Affected / at Risk (%)	# Events
Total	0/4635 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.