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

Rheumatoid Arthritis Clinical Trial

— NexT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764321
• Other study ID #: RA0097
• Status: Completed
• Start date: December 2012
• Est. completion date: June 16, 2020

Study information

• Verified date: December 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1723
• Est. completion date: June 16, 2020
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Germany	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/Sa.
Germany	016	Frankfurt
Germany	098	Frankfurt
Germany	054	Freiberg
Germany	041	Freiburg
Germany	147	Freiburg
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	Hannover
Germany	136	Hannover
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	Luebeck
Germany	034	Magdeburg
Germany	177	Mainz
Germany	195	Mansfeld
Germany	028	Marktredwitz
Germany	049	Mittelherwigsdorf
Germany	055	Moenchengladbach
Germany	111	Muenchen
Germany	015	München
Germany	020	München
Germany	093	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	059	Tübingen
Germany	009	Tuebingen
Germany	077	Weener
Germany	113	Winsen
Germany	065	Wuppertal
Germany	106	Würselen
Germany	042	Würzburg
Germany	182	Zwickau
Germany	001	Zwiesel

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	From Baseline up to Week 12 and to Week 104
Secondary	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	From Baseline up to Week 12 and to Week 104
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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