Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors (NexT)

December 21, 2020 updated by: UCB Pharma SA

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1723

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • 039
      • Aachen, Germany
        • 079
      • Altenburg, Germany
        • 017
      • Altenholz, Germany
        • 044
      • Amberg, Germany
        • 082
      • Bad Bramstedt, Germany
        • 030
      • Bad Doberan, Germany
        • 073
      • Bad Homburg, Germany
        • 134
      • Bad Kreuznach, Germany
        • 010
      • Bad Kreuznach, Germany
        • 153
      • Bad Nauheim, Germany
        • 023
      • Bad Neuenahr-Ahrweiler, Germany
        • 132
      • Bad Pyrmont, Germany
        • 196
      • Bautzen, Germany
        • 046
      • Bautzen, Germany
        • 125
      • Bayreuth, Germany
        • 031
      • Bayreuth, Germany
        • 033
      • Berlin, 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
      • Bochum, Germany
        • 005
      • Braunschweig, Germany
        • 194
      • Burghausen, Germany
        • 021
      • Chemnitz, Germany
        • 179
      • Cottbus, Germany
        • 075
      • Darmstadt, Germany
        • 027
      • Donaueschingen, Germany
        • 062
      • Dresden, Germany
        • 089
      • Dresden, Germany
        • 110
      • Düsseldorf, Germany
        • 063
      • Elmshorn, Germany
        • 014
      • Erfurt, Germany
        • 080
      • Erlangen, Germany
        • 142
      • Essen, Germany
        • 176
      • Frankenberg/Sa., Germany
        • 008
      • Frankfurt, Germany
        • 016
      • Frankfurt, Germany
        • 098
      • Freiberg, Germany
        • 054
      • Freiburg, Germany
        • 041
      • Freiburg, Germany
        • 147
      • Friedrichroda, Germany
        • 188
      • Geilenkirchen, Germany
        • 140
      • Geislingen an der Steige, Germany
        • 164
      • Giessen, Germany
        • 133
      • Giessen, Germany
        • 191
      • Goslar, Germany
        • 143
      • Greifswald, Germany
        • 025
      • Göttingen, Germany
        • 032
      • Halle, Germany
        • 029
      • Halle, Germany
        • 186
      • Hamburg, Germany
        • 002
      • Hamburg, Germany
        • 006
      • Hamburg, Germany
        • 052
      • Hamburg, Germany
        • 056
      • Hamburg, Germany
        • 070
      • Hannover, Germany
        • 107
      • Hannover, Germany
        • 136
      • Heidelberg, Germany
        • 048
      • Heidelberg, Germany
        • 057
      • Herne, Germany
        • 124
      • Hildesheim, Germany
        • 043
      • Hofheim, Germany
        • 053
      • Hoyerswerda, Germany
        • 092
      • Jena, Germany
        • 096
      • Karlsruhe, Germany
        • 180
      • Kronach, Germany
        • 184
      • Leipzig, Germany
        • 004
      • Leipzig, Germany
        • 068
      • Ludwigsfelde, Germany
        • 013
      • Luebeck, Germany
        • 114
      • Magdeburg, Germany
        • 034
      • Mainz, Germany
        • 177
      • Mansfeld, Germany
        • 195
      • Marktredwitz, Germany
        • 028
      • Mittelherwigsdorf, Germany
        • 049
      • Moenchengladbach, Germany
        • 055
      • Muenchen, Germany
        • 111
      • München, Germany
        • 015
      • München, Germany
        • 020
      • München, Germany
        • 093
      • München, Germany
        • 175
      • Naunhof, Germany
        • 037
      • Neubrandenburg, Germany
        • 047
      • Neuss, Germany
        • 078
      • Neuss, Germany
        • 090
      • Nienburg, Germany
        • 109
      • Offenburg, Germany
        • 076
      • Planegg, Germany
        • 035
      • Plauen, Germany
        • 097
      • Potsdam, Germany
        • 051
      • Potsdam, Germany
        • 187
      • Püttlingen, Germany
        • 061
      • Radebeul, Germany
        • 185
      • Rendsburg, Germany
        • 123
      • Rostock, Germany
        • 118
      • Saarbrücken, Germany
        • 112
      • Schwerin, Germany
        • 121
      • Schwerin, Germany
        • 122
      • Schwerin, Germany
        • 144
      • Seesen, Germany
        • 193
      • Stadtbergen, Germany
        • 115
      • Stolberg, Germany
        • 171
      • Stuttgart, Germany
        • 146
      • Stuttgart, Germany
        • 074
      • Traunstein, Germany
        • 085
      • Treuenbrietzen, Germany
        • 152
      • Tuebingen, Germany
        • 009
      • Tübingen, Germany
        • 059
      • Weener, Germany
        • 077
      • Winsen, Germany
        • 113
      • Wuppertal, Germany
        • 065
      • Würselen, Germany
        • 106
      • Würzburg, Germany
        • 042
      • Zwickau, Germany
        • 182
      • Zwiesel, Germany
        • 001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with diagnosed Rheumatoid Arthritis (RA)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients demonstrating persistence to the initially prescribed Tumor Necrosis Factor (TNF) inhibitor after 24 months of treatment
Time Frame: 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.
up to Week 104

Secondary Outcome Measures

Outcome Measure
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
Time Frame: From Baseline 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
Time Frame: From Baseline up to Week 12 and to Week 104
  • LDA is defined as DAS28 ≤ 3.2
  • DAS28 is defined as Disease Activity Score 28
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
Time Frame: From Baseline up to Week 12 and to Week 104
  • LDA is defined as DAS28 ≤ 3.2
  • DAS28 is defined as Disease Activity Score 28
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
Time Frame: From Baseline 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
Time Frame: From Baseline up to Week 12 and to 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
Time Frame: From Baseline up to Week 12 and to 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)
Time Frame: From Baseline 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)
Time Frame: From Baseline 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)
Time Frame: From Baseline 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
Time Frame: From Baseline 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)
Time Frame: From Baseline 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)
Time Frame: From Baseline 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)
Time Frame: From Baseline up to Week 104
From Baseline up to Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2012

Primary Completion (ACTUAL)

June 16, 2020

Study Completion (ACTUAL)

June 16, 2020

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (ESTIMATE)

January 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA0097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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