Clinical trial NCT01069419: Observation of Treatment With Certolizumab Pegol in Daily Practice
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Certolizumab Pegol
Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 1117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female ≥ 18 years of age with RA and is eligible for treatment with Cimzia. Recruited in Germany.

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.

Eligibility criteria: Inclusion Criteria:

* Patients eligible for treatment with Cimzia as defined in EU approved SmPC

Exclusion Criteria:

* Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia

Primary outcomes:
measure: Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6
timeFrame: From Baseline to Visit 9 (around Week 104)
Secondary outcomes:
measure: 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)
timeFrame: From Baseline to Visit 9 (around Week 104)
measure: 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)
timeFrame: From Baseline to Visit 9 (around Week 104)
measure: Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI)
timeFrame: From Baseline to Visit 9 (around Week 104)
Other outcomes:
Locations:
city: Altenburg
country: Germany
facility: 174
city: Amberg
country: Germany
facility: 70
city: Attendorn
country: Germany
facility: 122
city: Augsburg
country: Germany
facility: 153
city: Bad Aibling
country: Germany
facility: 3
city: Bad Bramstedt
country: Germany
facility: 133
city: Bad Buchau
country: Germany
facility: 167
city: Bad Doberan
country: Germany
facility: 20
city: Bad Endbach
country: Germany
facility: 166
city: Bad Iburg
country: Germany
facility: 8
city: Bad Kissingen
country: Germany
facility: 66
city: Bad Kreuznach
country: Germany
facility: 137
city: Bad Liebenwerda
country: Germany
facility: 119
city: Bad Nauheim
country: Germany
facility: 4
city: Bad Neuenahr-Ahrweiler
country: Germany
facility: 13
city: Bad Staffelstein
country: Germany
facility: 87
city: Baden Baden
country: Germany
facility: 173
city: Bamberg
country: Germany
facility: 19
city: Bautzen
country: Germany
facility: 115
city: Bayreuth
country: Germany
facility: 21
city: Bayreuth
country: Germany
facility: 58
city: Berlin
country: Germany
facility: 112
city: Berlin
country: Germany
facility: 12
city: Berlin
country: Germany
facility: 163
city: Berlin
country: Germany
facility: 179
city: Berlin
country: Germany
facility: 1
city: Berlin
country: Germany
facility: 25
city: Berlin
country: Germany
facility: 26
city: Berlin
country: Germany
facility: 43
city: Berlin
country: Germany
facility: 54
city: Berlin
country: Germany
facility: 59
city: Berlin
country: Germany
facility: 61
city: Berlin
country: Germany
facility: 72
city: Berlin
country: Germany
facility: 78
city: Berlin
country: Germany
facility: 91
city: Berlin
country: Germany
facility: 95
city: Chemnitz
country: Germany
facility: 28
city: Chemnitz
country: Germany
facility: 75
city: Darmstadt
country: Germany
facility: 134
city: Darmstadt
country: Germany
facility: 71
city: Deggendorf
country: Germany
facility: 125
city: Dresden
country: Germany
facility: 131
city: Dresden
country: Germany
facility: 36
city: Dresden
country: Germany
facility: 88
city: Dresden
country: Germany
facility: 98
city: Duisburg
country: Germany
facility: 49
city: Düsseldorf
country: Germany
facility: 46
city: Elmshorn
country: Germany
facility: 102
city: Erfurt
country: Germany
facility: 83
city: Erlangen
country: Germany
facility: 2
city: Essen
country: Germany
facility: 37
city: Essen
country: Germany
facility: 84
city: Frankenberg-Sachsen
country: Germany
facility: 136
city: Frankfurt
country: Germany
facility: 103
city: Frankfurt
country: Germany
facility: 53
city: Freiberg
country: Germany
facility: 29
city: Freiburg
country: Germany
facility: 86
city: Fulda
country: Germany
facility: 77
city: Goslar
country: Germany
facility: 15
city: Greifswald
country: Germany
facility: 135
city: Gräfelfing
country: Germany
facility: 89
city: Guestrow
country: Germany
facility: 107
city: Göttingen
country: Germany
facility: 100
city: Hagen
country: Germany
facility: 157
city: Haldensleben
country: Germany
facility: 150
city: Halle
country: Germany
facility: 11
city: Hamburg
country: Germany
facility: 116
city: Hamburg
country: Germany
facility: 128
city: Hamburg
country: Germany
facility: 139
city: Hamburg
country: Germany
facility: 175
city: Hamburg
country: Germany
facility: 50
city: Hamburg
country: Germany
facility: 55
city: Hamburg
country: Germany
facility: 67
city: Hamburg
country: Germany
facility: 6
city: Hanau
country: Germany
facility: 129
city: Hannover
country: Germany
facility: 159
city: Hannover
country: Germany
facility: 171
city: Hannover
country: Germany
facility: 17
city: Heidelberg
country: Germany
facility: 138
city: Heidelberg
country: Germany
facility: 146
city: Heidelberg
country: Germany
facility: 47
city: Heilbad Heiligenstadt
country: Germany
facility: 92
city: Herrsching
country: Germany
facility: 64
city: Hildesheim
country: Germany
facility: 5
city: Hofheim
country: Germany
facility: 30
city: Hoyerswerda
country: Germany
facility: 48
city: Karlsruhe
country: Germany
facility: 130
city: Karlsruhe
country: Germany
facility: 56
city: Karlsruhe
country: Germany
facility: 96
city: Karlstadt
country: Germany
facility: 101
city: Kassel
country: Germany
facility: 121
city: Katzhuette
country: Germany
facility: 161
city: Kiel
country: Germany
facility: 158
city: Köln
country: Germany
facility: 16
city: Köln
country: Germany
facility: 73
city: Köln
country: Germany
facility: 97
city: Leipzig
country: Germany
facility: 127
city: Ludwigsfelde
country: Germany
facility: 51
city: Ludwigslust
country: Germany
facility: 140
city: Lübeck
country: Germany
facility: 93
city: Magdeburg
country: Germany
facility: 68
city: Mainz
country: Germany
facility: 145
city: Marktredwitz
country: Germany
facility: 31
city: Mittelherwigsdorf
country: Germany
facility: 94
city: Mönchengladbach
country: Germany
facility: 18
city: Mühlheim an der Ruhr
country: Germany
facility: 104
city: München
country: Germany
facility: 10
city: München
country: Germany
facility: 164
city: München
country: Germany
facility: 178
city: München
country: Germany
facility: 9
city: Münster
country: Germany
facility: 113
city: Münster
country: Germany
facility: 123
city: Naunhof
country: Germany
facility: 57
city: Neubrandenburg
country: Germany
facility: 32
city: Neuburg
country: Germany
facility: 108
city: Neuruppin
country: Germany
facility: 149
city: Neuss
country: Germany
facility: 44
city: Nienburg
country: Germany
facility: 7
city: Norderstedt
country: Germany
facility: 141
city: Nürnberg
country: Germany
facility: 172
city: Nürnberg
country: Germany
facility: 22
city: Oberammergau
country: Germany
facility: 99
city: Oberhausen
country: Germany
facility: 23
city: Offenburg
country: Germany
facility: 33
city: Osnabrück
country: Germany
facility: 38
city: Paderborn
country: Germany
facility: 154
city: Pirna
country: Germany
facility: 34
city: Planegg
country: Germany
facility: 81
city: Plauen
country: Germany
facility: 85
city: Potsdam
country: Germany
facility: 27
city: Potsdam
country: Germany
facility: 35
city: Ratingen
country: Germany
facility: 24
city: Rendsburg
country: Germany
facility: 82
city: Rheine
country: Germany
facility: 124
city: Rostock
country: Germany
facility: 109
city: Rostock
country: Germany
facility: 76
city: Rüdersdorf
country: Germany
facility: 90
city: Saarbrücken
country: Germany
facility: 39
city: Salzwedel
country: Germany
facility: 69
city: Schramberg-Sulgen
country: Germany
facility: 117
city: Schwerin
country: Germany
facility: 143
city: Schwerte
country: Germany
facility: 142
city: Seesen
country: Germany
facility: 120
city: Stadtbergen
country: Germany
facility: 105
city: Stuttgart
country: Germany
facility: 14
city: Stuttgart
country: Germany
facility: 40
city: Traunstein
country: Germany
facility: 160
city: Treuenbrietzen
country: Germany
facility: 170
city: Tübingen
country: Germany
facility: 41
city: Uffenheim
country: Germany
facility: 168
city: Ulm
country: Germany
facility: 111
city: Ulm
country: Germany
facility: 65
city: Villingen-Schwenningen
country: Germany
facility: 52
city: Weener
country: Germany
facility: 106
city: Weiden
country: Germany
facility: 162
city: Weißenfels
country: Germany
facility: 177
city: Wiesbaden
country: Germany
facility: 118
city: Wiesbaden
country: Germany
facility: 74
city: Winsen
country: Germany
facility: 60
city: Würselen
country: Germany
facility: 165
city: Würzburg
country: Germany
facility: 152
city: Zeven
country: Germany
facility: 110
city: Zwiesel
country: Germany
facility: 45
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call center
role: STUDY_DIRECTOR
References: