Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01764321
- Lead Sponsor
- UCB Pharma SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1723
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients demonstrating persistence to the initially prescribed Tumor Necrosis Factor (TNF) inhibitor after 24 months of treatment up to Week 104 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.
- Secondary Outcome Measures
Name Time Method 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 * LDA is defined as DAS28 ≤ 3.2
* DAS28 is defined as Disease Activity Score 28Proportion 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 Low Disease Activity (LDA) is defined as DAS28 ≤ 3.2
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) From Baseline up to Week 104 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) From Baseline up 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 * LDA is defined as DAS28 ≤ 3.2
* DAS28 is defined as Disease Activity Score 28Proportion 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 From Baseline up to Week 12 and to Week 104 Low Disease Activity (LDA) is defined as DAS28 ≤ 3.2
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 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) From Baseline up to Week 104 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) From Baseline up to Week 104 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) From Baseline up to Week 104 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) From Baseline up to Week 104 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 From Baseline up to Week 104
Trial Locations
- Locations (122)
039
🇩🇪Aachen, Germany
017
🇩🇪Altenburg, Germany
079
🇩🇪Aachen, 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
196
🇩🇪Bad Pyrmont, Germany
125
🇩🇪Bautzen, Germany
132
🇩🇪Bad Neuenahr-Ahrweiler, Germany
023
🇩🇪Bad Nauheim, Germany
046
🇩🇪Bautzen, Germany
031
🇩🇪Bayreuth, Germany
033
🇩🇪Bayreuth, Germany
018
🇩🇪Berlin, Germany
036
🇩🇪Berlin, Germany
019
🇩🇪Berlin, Germany
040
🇩🇪Berlin, Germany
058
🇩🇪Berlin, Germany
072
🇩🇪Berlin, Germany
087
🇩🇪Berlin, Germany
099
🇩🇪Berlin, Germany
005
🇩🇪Bochum, Germany
100
🇩🇪Berlin, Germany
101
🇩🇪Berlin, Germany
194
🇩🇪Braunschweig, 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
098
🇩🇪Frankfurt, Germany
176
🇩🇪Essen, Germany
054
🇩🇪Freiberg, Germany
016
🇩🇪Frankfurt, Germany
041
🇩🇪Freiburg, Germany
147
🇩🇪Freiburg, Germany
008
🇩🇪Frankenberg/Sa., Germany
140
🇩🇪Geilenkirchen, Germany
191
🇩🇪Giessen, Germany
133
🇩🇪Giessen, Germany
025
🇩🇪Greifswald, Germany
143
🇩🇪Goslar, Germany
029
🇩🇪Halle, Germany
032
🇩🇪Göttingen, Germany
186
🇩🇪Halle, Germany
002
🇩🇪Hamburg, Germany
056
🇩🇪Hamburg, Germany
052
🇩🇪Hamburg, Germany
006
🇩🇪Hamburg, Germany
070
🇩🇪Hamburg, Germany
107
🇩🇪Hannover, Germany
057
🇩🇪Heidelberg, Germany
048
🇩🇪Heidelberg, Germany
043
🇩🇪Hildesheim, Germany
124
🇩🇪Herne, Germany
136
🇩🇪Hannover, Germany
053
🇩🇪Hofheim, Germany
092
🇩🇪Hoyerswerda, Germany
096
🇩🇪Jena, Germany
180
🇩🇪Karlsruhe, Germany
184
🇩🇪Kronach, Germany
013
🇩🇪Ludwigsfelde, Germany
114
🇩🇪Luebeck, Germany
004
🇩🇪Leipzig, Germany
177
🇩🇪Mainz, Germany
028
🇩🇪Marktredwitz, Germany
068
🇩🇪Leipzig, Germany
034
🇩🇪Magdeburg, Germany
195
🇩🇪Mansfeld, Germany
049
🇩🇪Mittelherwigsdorf, Germany
055
🇩🇪Moenchengladbach, Germany
047
🇩🇪Neubrandenburg, Germany
020
🇩🇪München, Germany
111
🇩🇪Muenchen, Germany
015
🇩🇪München, Germany
093
🇩🇪München, Germany
175
🇩🇪München, Germany
037
🇩🇪Naunhof, Germany
090
🇩🇪Neuss, Germany
109
🇩🇪Nienburg, Germany
076
🇩🇪Offenburg, Germany
035
🇩🇪Planegg, Germany
051
🇩🇪Potsdam, Germany
097
🇩🇪Plauen, Germany
187
🇩🇪Potsdam, Germany
061
🇩🇪Püttlingen, Germany
185
🇩🇪Radebeul, Germany
123
🇩🇪Rendsburg, Germany
118
🇩🇪Rostock, Germany
121
🇩🇪Schwerin, Germany
112
🇩🇪Saarbrücken, Germany
122
🇩🇪Schwerin, Germany
144
🇩🇪Schwerin, Germany
193
🇩🇪Seesen, Germany
115
🇩🇪Stadtbergen, Germany
171
🇩🇪Stolberg, Germany
146
🇩🇪Stuttgart, Germany
074
🇩🇪Stuttgart, Germany
085
🇩🇪Traunstein, Germany
009
🇩🇪Tuebingen, Germany
059
🇩🇪Tübingen, Germany
077
🇩🇪Weener, Germany
113
🇩🇪Winsen, Germany
106
🇩🇪Würselen, Germany
182
🇩🇪Zwickau, Germany
078
🇩🇪Neuss, Germany
065
🇩🇪Wuppertal, Germany
042
🇩🇪Würzburg, Germany
001
🇩🇪Zwiesel, Germany
021
🇩🇪Burghausen, Germany
188
🇩🇪Friedrichroda, Germany
164
🇩🇪Geislingen an der Steige, Germany
152
🇩🇪Treuenbrietzen, Germany