Rheumatoid ArthritisFasTNCT01069419
Observation of Treatment With Certolizumab Pegol in Daily Practice
An observational study of Rheumatoid Arthritis, run by UCB Pharma GmbH at 163 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 1,117 participants
- Where
- 163 sitesGermany
- Study dates
- Oct 2009to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female ≥ 18 years of age with RA and is eligible for treatment with Cimzia. Recruited in Germany.
Who may be able to join
- Patients eligible for treatment with Cimzia as defined in EU approved SmPC
Who cannot join
- Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia
Trial locations and contacts
163 sites in 1 country.
163 sites in 1 country
Germany163 sites
174
Altenburg
70
Amberg
122
Attendorn
153
Augsburg
3
Bad Aibling
133
Bad Bramstedt
167
Bad Buchau
20
Bad Doberan
166
Bad Endbach
8
Bad Iburg
66
Bad Kissingen
137
Bad Kreuznach
119
Bad Liebenwerda
4
Bad Nauheim
13
Bad Neuenahr-Ahrweiler
87
Bad Staffelstein
173
Baden-Baden
19
Bamberg
115
Bautzen
21
Bayreuth
58
Bayreuth
112
Berlin
12
Berlin
163
Berlin
179
Berlin
1
Berlin
25
Berlin
26
Berlin
43
Berlin
54
Berlin
59
Berlin
61
Berlin
72
Berlin
78
Berlin
91
Berlin
95
Berlin
28
Chemnitz
75
Chemnitz
16
Cologne
73
Cologne
97
Cologne
134
Darmstadt
71
Darmstadt
125
Deggendorf
131
Dresden
36
Dresden
88
Dresden
98
Dresden
49
Duisburg
46
Düsseldorf
102
Elmshorn
83
Erfurt
2
Erlangen
37
Essen
84
Essen
136
Frankenberg-Sachsen
103
Frankfurt
53
Frankfurt
29
Freiberg
86
Freiburg im Breisgau
77
Fulda
15
Goslar
100
Göttingen
89
Gräfelfing
135
Greifswald
107
Güstrow
157
Hagen
150
Haldensleben I
11
Halle
116
Hamburg
128
Hamburg
139
Hamburg
175
Hamburg
50
Hamburg
55
Hamburg
67
Hamburg
6
Hamburg
129
Hanau
159
Hanover
171
Hanover
17
Hanover
69
Hansestadt Salzwedel
138
Heidelberg
146
Heidelberg
47
Heidelberg
92
Heilbad Heiligenstadt
64
Herrsching am Ammersee
5
Hildesheim
30
Hofheim
48
Hoyerswerda
130
Karlsruhe
56
Karlsruhe
96
Karlsruhe
101
Karlstadt am Main
121
Kassel
161
Katzhütte
158
Kiel
127
Leipzig
93
Lübeck
51
Ludwigsfelde
140
Ludwigslust
68
Magdeburg
145
Mainz
31
Marktredwitz
94
Mittelherwigsdorf
18
Mönchengladbach
104
Mühlheim An Der Ruhr
10
München
164
München
178
München
9
München
113
Münster
123
Münster
57
Naunhof
32
Neubrandenburg
108
Neuburg am Inn
149
Neuruppin
44
Neuss
7
Nienburg
141
Norderstedt
172
Nuremberg
22
Nuremberg
99
Oberammergau
23
Oberhausen
33
Offenburg
38
Osnabrück
154
Paderborn
34
Pirna
81
Planegg
85
Plauen
27
Potsdam
35
Potsdam
24
Ratingen
82
Rendsburg
124
Rheine
109
Rostock
76
Rostock
90
Rüdersdorf
39
Saarbrücken
117
Schramberg-Sulgen
143
Schwerin
142
Schwerte
120
Seesen
105
Stadtbergen
14
Stuttgart
40
Stuttgart
160
Traunstein
170
Treuenbrietzen
41
Tübingen
168
Uffenheim
111
Ulm
65
Ulm
52
Villingen-Schwenningen
106
Weener
162
Weiden
177
Weißenfels
118
Wiesbaden
74
Wiesbaden
60
Winsen
165
Würselen
152
Würzburg
110
Zeven
45
Zwiesel
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Certolizumab Pegol, Cimzia
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cimzia | All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: From Baseline to Visit 9 (around Week 104)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,117 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069419
- Sponsor's protocol ID
- RA0027
- Acronym
- FasT
- Status last verified
- Oct 2015
- First submitted
- 15 Feb 2010
- Last updated
- 29 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01069419
- Acronym / sponsor ID
- FasT / RA0027
- Conditions
- Rheumatoid Arthritis
- Keywords
- Certolizumab Pegol, Cimzia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,117 participants (actual)
- Lead sponsor
- UCB Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Posted 29 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cimzia | – | –All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female ≥ 18 years of age with RA and is eligible for treatment with Cimzia. Recruited in Germany.
Key inclusion criteria (1 listed)
- Patients eligible for treatment with Cimzia as defined in EU approved SmPC
Key exclusion criteria (1 listed)
- Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6
Time frame: 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
3 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: From Baseline to Visit 9 (around Week 104)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call center study director
+1 877 822 9493 (UCB)
163 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by UCB Pharma GmbH at 163 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 163 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6 (time frame: From Baseline to Visit 9 (around Week 104)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.