Clinical trial NCT01764321: Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors
Official title: A Multi-center, Noninterventional Study With Certolizumab Pegol in Comparison With Any Other Subcutaneous TNF Inhibitor in Two Parallel Groups in Biologic Naive Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Certolizumab Pegol
Cimzia®
TNF inhibitor
DMARD
Rheumatoid Arthritis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2013-01-09
Enrollment: 1723
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: Adult patients with diagnosed Rheumatoid Arthritis (RA)

Brief summary: This prospective, post marketing, observational, Noninterventional Study (NIS) is designed to compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF) inhibitor.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis (RA)
* Moderate to severe disease activity of RA
* The patient receives Tumor Necrosis Factor (TNF) inhibitor in combination with at least 1 synthetic Disease Modifying Antirheumatic Drug (DMARD)
* The decision to prescribe a TNF inhibitor in combination with DMARD is made by the treating physician, prior to and independently from the decision to include the patient in this Non-Interventional Study (NIS)
* Male or female patients ≥ 18 years of age, considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires)
* The patient personally signed and dated Patient Data Consent Form (PDCF) prior to Visit 2
* Treatment is according to the Summary of Product Characteristics (SmPC)

Exclusion Criteria:

* Known contraindications to Tumor Necrosis Factor (TNF) inhibitors
* Prior use of any TNF inhibitors (including Adalimumab, Etanercept, Infliximab, Certolizumab, or Golimumab), or other biologic DMARDs (including Abatacept, Rituximab, Tocilizumab, or Anakinra)
* Participation in an investigational study

Primary outcomes:
measure: Proportion of patients demonstrating persistence to the initially prescribed Tumor Necrosis Factor (TNF) inhibitor after 24 months of treatment
timeFrame: up to Week 104
Secondary outcomes:
measure: Proportion of patients achieving early clinical response to treatment based on Disease Activity Score 28 (DAS28) reduction of ≥ 1.2 or DAS28 decrease to ≤ 3.2 up to Week 12
timeFrame: From Baseline up to Week 12
measure: Proportion of patients achieving early clinical response to treatment based on DAS28 reduction of ≥ 1.2 or DAS28 decrease to ≤ 3.2, and being in DAS28 remission (DAS28<2.6) or ([LDA] DAS28<=3.2) at Week 104
timeFrame: From Baseline up to Week 12 and to Week 104
measure: Proportion of patients not achieving early clinical response to treatment based on DAS28 reduction of >=1.2 or DAS28 decrease to <=3.2, and being in DAS28 remission (DAS28<2.6) or LDA (DAS28<=3.2) at Week 104
timeFrame: From Baseline up to Week 12 and to Week 104
measure: Proportion of patients achieving early clinical response to treatment based on Disease Activity Score 28 (DAS28) reduction of ≥ 1.2 up to Week 12
timeFrame: From Baseline up to Week 12
measure: Proportion of patients achieving early clinical response to treatment based on Disease Activity Score 28 (DAS28) reduction of ≥ 1.2, and being in DAS28 remission (DAS28<2.6) or LDA (DAS28<=3.2) at Week 104
timeFrame: From Baseline up to Week 12 and to Week 104
measure: Proportion of patients not achieving early clinical response to treatment based on DAS28 reduction of >=1.2, and being in DAS28 remission (DAS28<2.6) or LDA (DAS28<=3.2) at Week 104
timeFrame: From Baseline up to Week 12 and to Week 104
measure: Proportion of patients who discontinued the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to lack/loss of efficacy during the duration of the study (up to Week 104)
timeFrame: From Baseline up to Week 104
measure: Proportion of patients who discontinued the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to Adverse Events (AEs) during the duration of the study (up to Week 104)
timeFrame: From Baseline up to Week 104
measure: Proportion of patients who discontinued the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to any other reasons during the duration of the study (up to Week 104)
timeFrame: From Baseline up to Week 104
measure: Time to discontinuation of the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment at the dose recommended according to the Summary of Product Characteristics (SmPC) during the duration of the study
timeFrame: From Baseline up to Week 104
measure: Time to discontinuation of the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to lack/loss of efficacy during the duration of the study (up to Week 104)
timeFrame: From Baseline up to Week 104
measure: Time to discontinuation of the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to Adverse Events (AEs) during the duration of the study (up to Week 104)
timeFrame: From Baseline up to Week 104
measure: Time to discontinuation of the initially prescribed Tumor Necrosis Factor (TNF) inhibitor treatment due to any other reasons during the duration of the study (up to Week 104)
timeFrame: From Baseline up to Week 104
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: 039
city: Aachen
country: Germany
facility: 079
city: Altenburg
country: Germany
facility: 017
city: Altenholz
country: Germany
facility: 044
city: Amberg
country: Germany
facility: 082
city: Bad Bramstedt
country: Germany
facility: 030
city: Bad Doberan
country: Germany
facility: 073
city: Bad Homburg
country: Germany
facility: 134
city: Bad Kreuznach
country: Germany
facility: 010
city: Bad Kreuznach
country: Germany
facility: 153
city: Bad Nauheim
country: Germany
facility: 023
city: Bad Neuenahr-Ahrweiler
country: Germany
facility: 132
city: Bad Pyrmont
country: Germany
facility: 196
city: Bautzen
country: Germany
facility: 046
city: Bautzen
country: Germany
facility: 125
city: Bayreuth
country: Germany
facility: 031
city: Bayreuth
country: Germany
facility: 033
city: Berlin
country: Germany
facility: 018
city: Berlin
country: Germany
facility: 019
city: Berlin
country: Germany
facility: 036
city: Berlin
country: Germany
facility: 040
city: Berlin
country: Germany
facility: 058
city: Berlin
country: Germany
facility: 072
city: Berlin
country: Germany
facility: 087
city: Berlin
country: Germany
facility: 099
city: Berlin
country: Germany
facility: 100
city: Berlin
country: Germany
facility: 101
city: Bochum
country: Germany
facility: 005
city: Braunschweig
country: Germany
facility: 194
city: Burghausen
country: Germany
facility: 021
city: Chemnitz
country: Germany
facility: 179
city: Cottbus
country: Germany
facility: 075
city: Darmstadt
country: Germany
facility: 027
city: Donaueschingen
country: Germany
facility: 062
city: Dresden
country: Germany
facility: 089
city: Dresden
country: Germany
facility: 110
city: Düsseldorf
country: Germany
facility: 063
city: Elmshorn
country: Germany
facility: 014
city: Erfurt
country: Germany
facility: 080
city: Erlangen
country: Germany
facility: 142
city: Essen
country: Germany
facility: 176
city: Frankenberg/Sa.
country: Germany
facility: 008
city: Frankfurt
country: Germany
facility: 016
city: Frankfurt
country: Germany
facility: 098
city: Freiberg
country: Germany
facility: 054
city: Freiburg
country: Germany
facility: 041
city: Freiburg
country: Germany
facility: 147
city: Friedrichroda
country: Germany
facility: 188
city: Geilenkirchen
country: Germany
facility: 140
city: Geislingen an der Steige
country: Germany
facility: 164
city: Giessen
country: Germany
facility: 133
city: Giessen
country: Germany
facility: 191
city: Goslar
country: Germany
facility: 143
city: Greifswald
country: Germany
facility: 025
city: Göttingen
country: Germany
facility: 032
city: Halle
country: Germany
facility: 029
city: Halle
country: Germany
facility: 186
city: Hamburg
country: Germany
facility: 002
city: Hamburg
country: Germany
facility: 006
city: Hamburg
country: Germany
facility: 052
city: Hamburg
country: Germany
facility: 056
city: Hamburg
country: Germany
facility: 070
city: Hannover
country: Germany
facility: 107
city: Hannover
country: Germany
facility: 136
city: Heidelberg
country: Germany
facility: 048
city: Heidelberg
country: Germany
facility: 057
city: Herne
country: Germany
facility: 124
city: Hildesheim
country: Germany
facility: 043
city: Hofheim
country: Germany
facility: 053
city: Hoyerswerda
country: Germany
facility: 092
city: Jena
country: Germany
facility: 096
city: Karlsruhe
country: Germany
facility: 180
city: Kronach
country: Germany
facility: 184
city: Leipzig
country: Germany
facility: 004
city: Leipzig
country: Germany
facility: 068
city: Ludwigsfelde
country: Germany
facility: 013
city: Luebeck
country: Germany
facility: 114
city: Magdeburg
country: Germany
facility: 034
city: Mainz
country: Germany
facility: 177
city: Mansfeld
country: Germany
facility: 195
city: Marktredwitz
country: Germany
facility: 028
city: Mittelherwigsdorf
country: Germany
facility: 049
city: Moenchengladbach
country: Germany
facility: 055
city: Muenchen
country: Germany
facility: 111
city: München
country: Germany
facility: 015
city: München
country: Germany
facility: 020
city: München
country: Germany
facility: 093
city: München
country: Germany
facility: 175
city: Naunhof
country: Germany
facility: 037
city: Neubrandenburg
country: Germany
facility: 047
city: Neuss
country: Germany
facility: 078
city: Neuss
country: Germany
facility: 090
city: Nienburg
country: Germany
facility: 109
city: Offenburg
country: Germany
facility: 076
city: Planegg
country: Germany
facility: 035
city: Plauen
country: Germany
facility: 097
city: Potsdam
country: Germany
facility: 051
city: Potsdam
country: Germany
facility: 187
city: Püttlingen
country: Germany
facility: 061
city: Radebeul
country: Germany
facility: 185
city: Rendsburg
country: Germany
facility: 123
city: Rostock
country: Germany
facility: 118
city: Saarbrücken
country: Germany
facility: 112
city: Schwerin
country: Germany
facility: 121
city: Schwerin
country: Germany
facility: 122
city: Schwerin
country: Germany
facility: 144
city: Seesen
country: Germany
facility: 193
city: Stadtbergen
country: Germany
facility: 115
city: Stolberg
country: Germany
facility: 171
city: Stuttgart
country: Germany
facility: 074
city: Stuttgart
country: Germany
facility: 146
city: Traunstein
country: Germany
facility: 085
city: Treuenbrietzen
country: Germany
facility: 152
city: Tuebingen
country: Germany
facility: 009
city: Tübingen
country: Germany
facility: 059
city: Weener
country: Germany
facility: 077
city: Winsen
country: Germany
facility: 113
city: Wuppertal
country: Germany
facility: 065
city: Würselen
country: Germany
facility: 106
city: Würzburg
country: Germany
facility: 042
city: Zwickau
country: Germany
facility: 182
city: Zwiesel
country: Germany
facility: 001
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: