Observation of Treatment With Certolizumab Pegol in Daily Practice
FasT
A Multicenter, Observational, Non-interventional Study to Evaluate the Safety and Efficacy of Anti-TNF (Anti-Tumor Necrosis Factor) Alpha Therapy With Certolizumab Pegol Observed in Daily Practice in Adult Rheumatoid Arthritis (RA) Patients
1 other identifier
observational
1,117
1 country
163
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2009
Longer than P75 for all trials
163 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 15, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
September 29, 2015
CompletedOctober 29, 2015
October 1, 2015
4.9 years
February 15, 2010
August 27, 2015
October 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6
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
From Baseline to Visit 9 (around Week 104)
Secondary Outcomes (3)
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)
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)
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)
Study Arms (1)
Cimzia
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
Eligibility Criteria
Male or female ≥ 18 years of age with RA and is eligible for treatment with Cimzia. Recruited in Germany.
You may qualify if:
- Patients eligible for treatment with Cimzia as defined in EU approved SmPC
You may not qualify if:
- Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma GmbHlead
Study Sites (163)
174
Altenburg, Germany
70
Amberg, Germany
122
Attendorn, Germany
153
Augsburg, Germany
3
Bad Aibling, Germany
133
Bad Bramstedt, Germany
167
Bad Buchau, Germany
20
Bad Doberan, Germany
166
Bad Endbach, Germany
8
Bad Iburg, Germany
66
Bad Kissingen, Germany
137
Bad Kreuznach, Germany
119
Bad Liebenwerda, Germany
4
Bad Nauheim, Germany
13
Bad Neuenahr-Ahrweiler, Germany
87
Bad Staffelstein, Germany
173
Baden-Baden, Germany
19
Bamberg, Germany
115
Bautzen, Germany
21
Bayreuth, Germany
58
Bayreuth, Germany
112
Berlin, Germany
12
Berlin, Germany
163
Berlin, Germany
179
Berlin, Germany
1
Berlin, Germany
25
Berlin, Germany
26
Berlin, Germany
43
Berlin, Germany
54
Berlin, Germany
59
Berlin, Germany
61
Berlin, Germany
72
Berlin, Germany
78
Berlin, Germany
91
Berlin, Germany
95
Berlin, Germany
28
Chemnitz, Germany
75
Chemnitz, Germany
16
Cologne, Germany
73
Cologne, Germany
97
Cologne, Germany
134
Darmstadt, Germany
71
Darmstadt, Germany
125
Deggendorf, Germany
131
Dresden, Germany
36
Dresden, Germany
88
Dresden, Germany
98
Dresden, Germany
49
Duisburg, Germany
46
Düsseldorf, Germany
102
Elmshorn, Germany
83
Erfurt, Germany
2
Erlangen, Germany
37
Essen, Germany
84
Essen, Germany
136
Frankenberg-Sachsen, Germany
103
Frankfurt, Germany
53
Frankfurt, Germany
29
Freiberg, Germany
86
Freiburg im Breisgau, Germany
77
Fulda, Germany
15
Goslar, Germany
100
Göttingen, Germany
89
Gräfelfing, Germany
135
Greifswald, Germany
107
Güstrow, Germany
157
Hagen, Germany
150
Haldensleben I, Germany
11
Halle, Germany
116
Hamburg, Germany
128
Hamburg, Germany
139
Hamburg, Germany
175
Hamburg, Germany
50
Hamburg, Germany
55
Hamburg, Germany
67
Hamburg, Germany
6
Hamburg, Germany
129
Hanau, Germany
159
Hanover, Germany
171
Hanover, Germany
17
Hanover, Germany
138
Heidelberg, Germany
146
Heidelberg, Germany
47
Heidelberg, Germany
92
Heilbad Heiligenstadt, Germany
64
Herrsching am Ammersee, Germany
5
Hildesheim, Germany
30
Hofheim, Germany
48
Hoyerswerda, Germany
130
Karlsruhe, Germany
56
Karlsruhe, Germany
96
Karlsruhe, Germany
101
Karlstadt am Main, Germany
121
Kassel, Germany
161
Katzhütte, Germany
158
Kiel, Germany
127
Leipzig, Germany
51
Ludwigsfelde, Germany
140
Ludwigslust, Germany
93
Lübeck, Germany
68
Magdeburg, Germany
145
Mainz, Germany
31
Marktredwitz, Germany
94
Mittelherwigsdorf, Germany
18
Mönchengladbach, Germany
104
Mühlheim An Der Ruhr, Germany
10
München, Germany
164
München, Germany
178
München, Germany
9
München, Germany
113
Münster, Germany
123
Münster, Germany
57
Naunhof, Germany
32
Neubrandenburg, Germany
108
Neuburg am Inn, Germany
149
Neuruppin, Germany
44
Neuss, Germany
7
Nienburg, Germany
141
Norderstedt, Germany
172
Nuremberg, Germany
22
Nuremberg, Germany
99
Oberammergau, Germany
23
Oberhausen, Germany
33
Offenburg, Germany
38
Osnabrück, Germany
154
Paderborn, Germany
34
Pirna, Germany
81
Planegg, Germany
85
Plauen, Germany
27
Potsdam, Germany
35
Potsdam, Germany
24
Ratingen, Germany
82
Rendsburg, Germany
124
Rheine, Germany
109
Rostock, Germany
76
Rostock, Germany
90
Rüdersdorf, Germany
39
Saarbrücken, Germany
69
Salzwedel, Germany
117
Schramberg-Sulgen, Germany
143
Schwerin, Germany
142
Schwerte, Germany
120
Seesen, Germany
105
Stadtbergen, Germany
14
Stuttgart, Germany
40
Stuttgart, Germany
160
Traunstein, Germany
170
Treuenbrietzen, Germany
41
Tübingen, Germany
168
Uffenheim, Germany
111
Ulm, Germany
65
Ulm, Germany
52
Villingen-Schwenningen, Germany
106
Weener, Germany
162
Weiden, Germany
177
Weißenfels, Germany
118
Wiesbaden, Germany
74
Wiesbaden, Germany
60
Winsen, Germany
165
Würselen, Germany
152
Würzburg, Germany
110
Zeven, Germany
45
Zwiesel, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2010
First Posted
February 17, 2010
Study Start
October 1, 2009
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
October 29, 2015
Results First Posted
September 29, 2015
Record last verified: 2015-10