AzTrials
AzTrials

Rheumatoid ArthritisNexTNCT01764321

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

An observational study of Rheumatoid Arthritis, run by UCB Pharma SA at 122 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
Type of treatment
Injection or infusion
How many people
1,723 participants
Where
122 sitesGermany
Study dates
Dec 2012to 16 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with diagnosed Rheumatoid Arthritis (RA)

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

122 sites in 1 country.

122 sites in 1 country

Germany122 sites

  • 039

    Aachen

  • 079

    Aachen

  • 017

    Altenburg

  • 044

    Altenholz

  • 082

    Amberg

  • 030

    Bad Bramstedt

  • 073

    Bad Doberan

  • 134

    Bad Homburg

  • 010

    Bad Kreuznach

  • 153

    Bad Kreuznach

  • 023

    Bad Nauheim

  • 132

    Bad Neuenahr-Ahrweiler

  • 196

    Bad Pyrmont

  • 046

    Bautzen

  • 125

    Bautzen

  • 031

    Bayreuth

  • 033

    Bayreuth

  • 018

    Berlin

  • 019

    Berlin

  • 036

    Berlin

  • 040

    Berlin

  • 058

    Berlin

  • 072

    Berlin

  • 087

    Berlin

  • 099

    Berlin

  • 100

    Berlin

  • 101

    Berlin

  • 005

    Bochum

  • 194

    Braunschweig

  • 021

    Burghausen

  • 179

    Chemnitz

  • 075

    Cottbus

  • 027

    Darmstadt

  • 062

    Donaueschingen

  • 089

    Dresden

  • 110

    Dresden

  • 063

    Düsseldorf

  • 014

    Elmshorn

  • 080

    Erfurt

  • 142

    Erlangen

  • 176

    Essen

  • 008

    Frankenberg

  • 016

    Frankfurt

  • 098

    Frankfurt

  • 054

    Freiberg

  • 041

    Freiburg im Breisgau

  • 147

    Freiburg im Breisgau

  • 188

    Friedrichroda

  • 140

    Geilenkirchen

  • 164

    Geislingen an der Steige

  • 133

    Giessen

  • 191

    Giessen

  • 143

    Goslar

  • 032

    Göttingen

  • 025

    Greifswald

  • 029

    Halle

  • 186

    Halle

  • 002

    Hamburg

  • 006

    Hamburg

  • 052

    Hamburg

  • 056

    Hamburg

  • 070

    Hamburg

  • 107

    Hanover

  • 136

    Hanover

  • 048

    Heidelberg

  • 057

    Heidelberg

  • 124

    Herne

  • 043

    Hildesheim

  • 053

    Hofheim

  • 092

    Hoyerswerda

  • 096

    Jena

  • 180

    Karlsruhe

  • 184

    Kronach

  • 004

    Leipzig

  • 068

    Leipzig

  • 114

    Lübeck

  • 013

    Ludwigsfelde

  • 034

    Magdeburg

  • 177

    Mainz

  • 195

    Mansfeld

  • 028

    Marktredwitz

  • 049

    Mittelherwigsdorf

  • 055

    Mönchengladbach

  • 015

    München

  • 020

    München

  • 093

    München

  • 111

    München

  • 175

    München

  • 037

    Naunhof

  • 047

    Neubrandenburg

  • 078

    Neuss

  • 090

    Neuss

  • 109

    Nienburg

  • 076

    Offenburg

  • 035

    Planegg

  • 097

    Plauen

  • 051

    Potsdam

  • 187

    Potsdam

  • 061

    Püttlingen

  • 185

    Radebeul

  • 123

    Rendsburg

  • 118

    Rostock

  • 112

    Saarbrücken

  • 121

    Schwerin

  • 122

    Schwerin

  • 144

    Schwerin

  • 193

    Seesen

  • 115

    Stadtbergen

  • 171

    Stolberg

  • 074

    Stuttgart

  • 146

    Stuttgart

  • 085

    Traunstein

  • 152

    Treuenbrietzen

  • 009

    Tübingen

  • 059

    Tübingen

  • 077

    Weener

  • 113

    Winsen

  • 065

    Wuppertal

  • 106

    Würselen

  • 042

    Würzburg

  • 182

    Zwickau

  • 001

    Zwiesel

Other trials in Germany

About this study

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

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.

Keywords
Certolizumab Pegol, Cimzia®, TNF inhibitor, DMARD, Rheumatoid Arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01764321
Study groupRoleWhat they receive
Certolizumab Pegol treatmentCertolizumab Pegol in combination with at least one Disease Modifying Antirheumatic Drug (DMARD)
Other Tumor Necrosis Factor TNF inhibitor treatmentOther subcutaneous (sc) Tumor Necrosis Factor (TNF) inhibitor (Adalimumab, Golimumab, Etanercept) in combination with at least one Disease Modifying Antirheumatic Drug (DMARD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to Week 104

Secondary outcomes (13)

  1. 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

    Measured: From Baseline up to Week 12

  2. 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

    • LDA is defined as DAS28 ≤ 3.2
    • DAS28 is defined as Disease Activity Score 28

    Measured: From Baseline up to Week 12 and to Week 104

  3. 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

    • LDA is defined as DAS28 ≤ 3.2
    • DAS28 is defined as Disease Activity Score 28

    Measured: From Baseline up to Week 12 and to Week 104

  4. Proportion of patients achieving early clinical response to treatment based on Disease Activity Score 28 (DAS28) reduction of ≥ 1.2 up to Week 12

    Measured: From Baseline up to Week 12

  5. 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

    Measured: From Baseline up to Week 12 and to Week 104

  6. 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

    Measured: From Baseline up to Week 12 and to Week 104

  7. 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)

    Measured: From Baseline up to Week 104

  8. 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)

    Measured: From Baseline up to Week 104

  9. 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)

    Measured: From Baseline up to Week 104

  10. 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

    Measured: From Baseline up to Week 104

  11. 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)

    Measured: From Baseline up to Week 104

  12. 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)

    Measured: From Baseline up to Week 104

  13. 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)

    Measured: From Baseline up to Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2013 (estimated)
  2. Study startDec 2012
  3. Primary completion16 Jun 2020
  4. Study completion16 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,723 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01764321
Sponsor's protocol ID
RA0097
Acronym
NexT
Status last verified
Dec 2020
First submitted
7 Jan 2013
Last updated
22 Dec 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by UCB Pharma SA at 122 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01764321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in