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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with diagnosed Rheumatoid Arthritis (RA)
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 039 | Aachen | Germany | ||||
| 079 |
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| 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 | Low Disease Activity (LDA) is defined as DAS28 ≤ 3.2 | 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, and being in DAS28 remission (DAS28<2.6) or LDA (DAS28<=3.2) at Week 104 | Low Disease Activity (LDA) is defined as DAS28 ≤ 3.2 | From Baseline up to Week 12 and to Week 104 |
| 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 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 at the dose recommended according to the Summary of Product Characteristics (SmPC) during the duration of the study | 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 |
| 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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