Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors
NexT
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
1 other identifier
observational
1,723
1 country
122
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Longer than P75 for all trials
122 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
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 7, 2013
CompletedFirst Posted
Study publicly available on registry
January 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2020
CompletedDecember 22, 2020
December 1, 2020
7.5 years
January 7, 2013
December 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients demonstrating persistence to the initially prescribed Tumor Necrosis Factor (TNF) inhibitor after 24 months of treatment
For a patient to be classified as persistent he or she must be classified as an early responder up to Week 12 and be continuously treated up to Week 104 with the initially prescribed Tumor Necrosis Factor (TNF) inhibitor at a dose not greater than that initially prescribed according to the Summary of Product Characteristics (SmPC). For the definition of persistence rate for the primary variable, patients will be classified as early responders if their Disease Activity Score 28 (DAS28) shows a reduction of \>=1.2 from Baseline or decreases to \<=3.2 (Low Disease Activity (LDA) or remission) up to Week 12. Non responders up to Week 12 will be counted as non persistent to the initially prescribed TNF inhibitor treatment. Patients who stop the initially prescribed TNF inhibitor treatment will not be counted as persistent, except if treatment with TNF inhibitor is stopped because the patient is in clinical remission.
up to Week 104
Secondary Outcomes (13)
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
From Baseline up to Week 12
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
From Baseline up to Week 12 and to Week 104
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
From Baseline up to Week 12 and to Week 104
Proportion of patients achieving early clinical response to treatment based on Disease Activity Score 28 (DAS28) reduction of ≥ 1.2 up to Week 12
From Baseline up to Week 12
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
From Baseline up to Week 12 and to Week 104
- +8 more secondary outcomes
Study Arms (2)
Certolizumab Pegol treatment
Certolizumab Pegol in combination with at least one Disease Modifying Antirheumatic Drug (DMARD)
Other Tumor Necrosis Factor TNF inhibitor treatment
Other subcutaneous (sc) Tumor Necrosis Factor (TNF) inhibitor (Adalimumab, Golimumab, Etanercept) in combination with at least one Disease Modifying Antirheumatic Drug (DMARD)
Eligibility Criteria
Adult patients with diagnosed Rheumatoid Arthritis (RA)
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma SAlead
Study Sites (122)
039
Aachen, Germany
079
Aachen, Germany
017
Altenburg, Germany
044
Altenholz, Germany
082
Amberg, Germany
030
Bad Bramstedt, Germany
073
Bad Doberan, Germany
134
Bad Homburg, Germany
010
Bad Kreuznach, Germany
153
Bad Kreuznach, Germany
023
Bad Nauheim, Germany
132
Bad Neuenahr-Ahrweiler, Germany
196
Bad Pyrmont, Germany
046
Bautzen, Germany
125
Bautzen, Germany
031
Bayreuth, Germany
033
Bayreuth, Germany
018
Berlin, Germany
019
Berlin, Germany
036
Berlin, Germany
040
Berlin, Germany
058
Berlin, Germany
072
Berlin, Germany
087
Berlin, Germany
099
Berlin, Germany
100
Berlin, Germany
101
Berlin, Germany
005
Bochum, Germany
194
Braunschweig, Germany
021
Burghausen, Germany
179
Chemnitz, Germany
075
Cottbus, Germany
027
Darmstadt, Germany
062
Donaueschingen, Germany
089
Dresden, Germany
110
Dresden, Germany
063
Düsseldorf, Germany
014
Elmshorn, Germany
080
Erfurt, Germany
142
Erlangen, Germany
176
Essen, Germany
008
Frankenberg, Germany
016
Frankfurt, Germany
098
Frankfurt, Germany
054
Freiberg, Germany
041
Freiburg im Breisgau, Germany
147
Freiburg im Breisgau, Germany
188
Friedrichroda, Germany
140
Geilenkirchen, Germany
164
Geislingen an der Steige, Germany
133
Giessen, Germany
191
Giessen, Germany
143
Goslar, Germany
032
Göttingen, Germany
025
Greifswald, Germany
029
Halle, Germany
186
Halle, Germany
002
Hamburg, Germany
006
Hamburg, Germany
052
Hamburg, Germany
056
Hamburg, Germany
070
Hamburg, Germany
107
Hanover, Germany
136
Hanover, Germany
048
Heidelberg, Germany
057
Heidelberg, Germany
124
Herne, Germany
043
Hildesheim, Germany
053
Hofheim, Germany
092
Hoyerswerda, Germany
096
Jena, Germany
180
Karlsruhe, Germany
184
Kronach, Germany
004
Leipzig, Germany
068
Leipzig, Germany
013
Ludwigsfelde, Germany
114
Lübeck, Germany
034
Magdeburg, Germany
177
Mainz, Germany
195
Mansfeld, Germany
028
Marktredwitz, Germany
049
Mittelherwigsdorf, Germany
055
Mönchengladbach, Germany
015
München, Germany
020
München, Germany
093
München, Germany
111
München, Germany
175
München, Germany
037
Naunhof, Germany
047
Neubrandenburg, Germany
078
Neuss, Germany
090
Neuss, Germany
109
Nienburg, Germany
076
Offenburg, Germany
035
Planegg, Germany
097
Plauen, Germany
051
Potsdam, Germany
187
Potsdam, Germany
061
Püttlingen, Germany
185
Radebeul, Germany
123
Rendsburg, Germany
118
Rostock, Germany
112
Saarbrücken, Germany
121
Schwerin, Germany
122
Schwerin, Germany
144
Schwerin, Germany
193
Seesen, Germany
115
Stadtbergen, Germany
171
Stolberg, Germany
074
Stuttgart, Germany
146
Stuttgart, Germany
085
Traunstein, Germany
152
Treuenbrietzen, Germany
009
Tübingen, Germany
059
Tübingen, Germany
077
Weener, Germany
113
Winsen, Germany
065
Wuppertal, Germany
106
Würselen, Germany
042
Würzburg, Germany
182
Zwickau, Germany
001
Zwiesel, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273 (UCB)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2013
First Posted
January 9, 2013
Study Start
December 1, 2012
Primary Completion
June 16, 2020
Study Completion
June 16, 2020
Last Updated
December 22, 2020
Record last verified: 2020-12