Observation of Treatment With Certolizumab Pegol in Daily Practice
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01069419
- Lead Sponsor
- UCB Pharma GmbH
- Brief Summary
This is an observational, non-interventional, non-comparative, post-authorization safety study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need of treatment with a biological product.
- Detailed Description
The purpose of this study is to assess the clinical efficacy of Cimzia in achieving clinical remission after two years of therapy. The observational nature of the study leaves the therapeutic decision exclusively within the discretion of the treating physician.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1117
- Patients eligible for treatment with Cimzia as defined in EU approved SmPC
- Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6 From Baseline to Visit 9 (around Week 104) The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient's Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints.
For the analysis, DAS28 values were categorized into the following groups:
* DAS28 \< 2.6: clinical remission
* DAS28 from 2.6 to ≤ 3.2: low disease activity
* DAS28 from \> 3.2 to 5.1: moderate disease activity
* DAS28 \> 5.1: high disease activity
- Secondary Outcome Measures
Name Time Method Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI) From Baseline to Visit 9 (around Week 104) The CDAI was calculated with the equation:
CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient's Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician's Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS) From Baseline to Visit 9 (around Week 104) Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Visit 9 (around Week 104) The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
Trial Locations
- Locations (163)
13
🇩🇪Bad Neuenahr-Ahrweiler, Germany
87
🇩🇪Bad Staffelstein, Germany
115
🇩🇪Bautzen, Germany
153
🇩🇪Augsburg, Germany
137
🇩🇪Bad Kreuznach, Germany
166
🇩🇪Bad Endbach, Germany
174
🇩🇪Altenburg, Germany
163
🇩🇪Berlin, Germany
20
🇩🇪Bad Doberan, Germany
66
🇩🇪Bad Kissingen, Germany
70
🇩🇪Amberg, Germany
122
🇩🇪Attendorn, Germany
179
🇩🇪Berlin, Germany
21
🇩🇪Bayreuth, Germany
119
🇩🇪Bad Liebenwerda, Germany
125
🇩🇪Deggendorf, Germany
4
🇩🇪Bad Nauheim, Germany
8
🇩🇪Bad Iburg, Germany
133
🇩🇪Bad Bramstedt, Germany
167
🇩🇪Bad Buchau, Germany
28
🇩🇪Chemnitz, Germany
136
🇩🇪Frankenberg-Sachsen, Germany
25
🇩🇪Berlin, Germany
12
🇩🇪Berlin, Germany
26
🇩🇪Berlin, Germany
54
🇩🇪Berlin, Germany
19
🇩🇪Bamberg, Germany
53
🇩🇪Frankfurt, Germany
37
🇩🇪Essen, Germany
2
🇩🇪Erlangen, Germany
116
🇩🇪Hamburg, Germany
139
🇩🇪Hamburg, Germany
127
🇩🇪Leipzig, Germany
140
🇩🇪Ludwigslust, Germany
172
🇩🇪Nürnberg, Germany
23
🇩🇪Oberhausen, Germany
165
🇩🇪Würselen, Germany
111
🇩🇪Ulm, Germany
65
🇩🇪Ulm, Germany
106
🇩🇪Weener, Germany
152
🇩🇪Würzburg, Germany
177
🇩🇪Weißenfels, Germany
74
🇩🇪Wiesbaden, Germany
1
🇩🇪Berlin, Germany
98
🇩🇪Dresden, Germany
173
🇩🇪Baden Baden, Germany
58
🇩🇪Bayreuth, Germany
43
🇩🇪Berlin, Germany
59
🇩🇪Berlin, Germany
75
🇩🇪Chemnitz, Germany
134
🇩🇪Darmstadt, Germany
71
🇩🇪Darmstadt, Germany
61
🇩🇪Berlin, Germany
131
🇩🇪Dresden, Germany
49
🇩🇪Duisburg, Germany
46
🇩🇪Düsseldorf, Germany
100
🇩🇪Göttingen, Germany
103
🇩🇪Frankfurt, Germany
102
🇩🇪Elmshorn, Germany
83
🇩🇪Erfurt, Germany
84
🇩🇪Essen, Germany
77
🇩🇪Fulda, Germany
29
🇩🇪Freiberg, Germany
15
🇩🇪Goslar, Germany
135
🇩🇪Greifswald, Germany
107
🇩🇪Guestrow, Germany
89
🇩🇪Gräfelfing, Germany
150
🇩🇪Haldensleben, Germany
157
🇩🇪Hagen, Germany
128
🇩🇪Hamburg, Germany
50
🇩🇪Hamburg, Germany
55
🇩🇪Hamburg, Germany
67
🇩🇪Hamburg, Germany
6
🇩🇪Hamburg, Germany
129
🇩🇪Hanau, Germany
146
🇩🇪Heidelberg, Germany
47
🇩🇪Heidelberg, Germany
159
🇩🇪Hannover, Germany
138
🇩🇪Heidelberg, Germany
171
🇩🇪Hannover, Germany
92
🇩🇪Heilbad Heiligenstadt, Germany
64
🇩🇪Herrsching, Germany
48
🇩🇪Hoyerswerda, Germany
130
🇩🇪Karlsruhe, Germany
161
🇩🇪Katzhuette, Germany
56
🇩🇪Karlsruhe, Germany
96
🇩🇪Karlsruhe, Germany
158
🇩🇪Kiel, Germany
68
🇩🇪Magdeburg, Germany
97
🇩🇪Köln, Germany
16
🇩🇪Köln, Germany
73
🇩🇪Köln, Germany
145
🇩🇪Mainz, Germany
93
🇩🇪Lübeck, Germany
31
🇩🇪Marktredwitz, Germany
104
🇩🇪Mühlheim an der Ruhr, Germany
94
🇩🇪Mittelherwigsdorf, Germany
18
🇩🇪Mönchengladbach, Germany
10
🇩🇪München, Germany
164
🇩🇪München, Germany
178
🇩🇪München, Germany
9
🇩🇪München, Germany
113
🇩🇪Münster, Germany
123
🇩🇪Münster, Germany
108
🇩🇪Neuburg, Germany
99
🇩🇪Oberammergau, Germany
33
🇩🇪Offenburg, Germany
154
🇩🇪Paderborn, Germany
38
🇩🇪Osnabrück, Germany
34
🇩🇪Pirna, Germany
81
🇩🇪Planegg, Germany
85
🇩🇪Plauen, Germany
82
🇩🇪Rendsburg, Germany
27
🇩🇪Potsdam, Germany
35
🇩🇪Potsdam, Germany
124
🇩🇪Rheine, Germany
109
🇩🇪Rostock, Germany
90
🇩🇪Rüdersdorf, Germany
117
🇩🇪Schramberg-Sulgen, Germany
76
🇩🇪Rostock, Germany
120
🇩🇪Seesen, Germany
143
🇩🇪Schwerin, Germany
105
🇩🇪Stadtbergen, Germany
14
🇩🇪Stuttgart, Germany
142
🇩🇪Schwerte, Germany
160
🇩🇪Traunstein, Germany
170
🇩🇪Treuenbrietzen, Germany
41
🇩🇪Tübingen, Germany
162
🇩🇪Weiden, Germany
52
🇩🇪Villingen-Schwenningen, Germany
118
🇩🇪Wiesbaden, Germany
60
🇩🇪Winsen, Germany
110
🇩🇪Zeven, Germany
45
🇩🇪Zwiesel, Germany
3
🇩🇪Bad Aibling, Germany
112
🇩🇪Berlin, Germany
95
🇩🇪Berlin, Germany
86
🇩🇪Freiburg, Germany
11
🇩🇪Halle, Germany
5
🇩🇪Hildesheim, Germany
30
🇩🇪Hofheim, Germany
101
🇩🇪Karlstadt, Germany
121
🇩🇪Kassel, Germany
51
🇩🇪Ludwigsfelde, Germany
57
🇩🇪Naunhof, Germany
32
🇩🇪Neubrandenburg, Germany
149
🇩🇪Neuruppin, Germany
44
🇩🇪Neuss, Germany
7
🇩🇪Nienburg, Germany
141
🇩🇪Norderstedt, Germany
22
🇩🇪Nürnberg, Germany
40
🇩🇪Stuttgart, Germany
17
🇩🇪Hannover, Germany
72
🇩🇪Berlin, Germany
78
🇩🇪Berlin, Germany
91
🇩🇪Berlin, Germany
36
🇩🇪Dresden, Germany
175
🇩🇪Hamburg, Germany
88
🇩🇪Dresden, Germany
24
🇩🇪Ratingen, Germany
39
🇩🇪Saarbrücken, Germany
69
🇩🇪Salzwedel, Germany
168
🇩🇪Uffenheim, Germany