Remission after suspension of TNF alpha therapies in RA

PHASE 4, MULTICENTER RANDOMISED STUDY, AIMED AT EVALUATING THE MAINTENANCE OF REMISSION AFTER 6, 12, 18 AND 24 MONTHS FROM SUSPENSION OF TNF-ALPHA THERAPIES (ADALIMUMAB, ETANERCEPT, INFLIXIMAB, CERTOLIZUMAB PEGOL, GOLIMUMAB) IN RHEUMATOID ARTHRITIS (RA) PATIENTS - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003129-40-IT

Enrollment

Registered

2021-09-10

Start date

2017-01-05

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RHEUMATOID ARTHRITIS (RA) PATIENTS MedDRA version: 23.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859

Interventions

Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 2 SIRINGHE PRERIEMPITE 0.8 ML + 2 TAMPONI IMBEVUTI DI ALCOL IN 1 BLISTER Product Name: HUMIRA (ADALIMUMAB) Product Code: [NA] Pharmace

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Able to comply and give informed consent; 2. Age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria already provided for anti TNF alpha therapy (such as Tubercolosis, Hepatitis B or C and HIV infection) 2. Previous treatment with biological drugs (i.e. Rituximab, Tocilizumab, Abatacept) 3. Concomitant other systemic autoimmune diseases. 4. Functional status class IV classified according to the American College of Rheumatology 1991 revised criteria 5. Pregnant women or nursing (breast feeding) mothers.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is the evaluation of sustained remission of disease activity after 6, 12,18 and 24 months from anti-TNF suspension in AR patients.;Secondary Objective: •to evaluate the differences between the group of patients that suspending the anti TNF by the tapering and the patients without tapering. •to evaluate the maximum latency of administration efficacy, only in the arm A •to evaluate the correlation between sustained remission after anti-TNF suspension and combined therapy with classical DMARDs •to evaluate the ultrasound echography at baseline and after 3, 6, 12 18 and 24 months from anti-TNF suspension •radiographic articular evaluation at baseline and after 12 and 24 months from anti-TNF suspension •to evaluate correlation between clinical and instrumental evaluation and disease activity ;Primary end point(s): Evaluation of number of RA patients that maintain clinical remission after 6, 12, 18 and 24 months from suspension of anti TNF-alpha therapy (i.e. infliximab, adalimumab, etanercept, certolizumab pegol, golimumab) ;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Main Objective: The primary objective is the evaluation of sustained remission of disease activity after 6, 12,18 and 24 months from anti-TNF suspension in AR patients.;Secondary Objective: •to evaluate the differences between the group of patients that suspending the anti TNF by the tapering and the patients without tapering. •to evaluate the maximum latency of administration efficacy, only in the arm A •to evaluate the correlation between sustained remission after anti-TNF suspension and combined therapy with classical DMARDs •to evaluate the ultrasound echography at baseline and after 3, 6, 12 18 and 24 months from anti-TNF suspension •radiographic articular evaluation at baseline and after 12 and 24 months from anti-TNF suspension •to evaluate correlation between clinical and instrumental evaluation and disease activity ;Primary end point(s): Evaluation of number of RA patients that maintain clinical remission after 6, 12, 18 and 24 months from suspension of anti TNF-alpha therapy (i.e. infliximab, adalimumab, etanercept, certolizumab pegol, golimumab) ;Timepoint(s) of evaluation of this end point: 24 months

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Secondary

Measure	Time frame
Secondary end point(s): - Number of patients that maintain remission after suspension of TNF-alpha therapy (i.e. infliximab, adalimumab, etanercept, certolizumab pegol, golimumab) either with a tapering schedule and without any tapering schedule - clinical remission (DAS 28, CDAI, SDAI, ACR remission criteria) at baseline and 6, 12, 18 and 24 months) - ultrasound evaluation (score 0-4) at 3, 6, 12, 18 and 24 months. - radiographic articular evaluation (at baseline and after 12 and 24 months) - Quality-of-life measured by the SF-36 and HAQ questionnaires (Italian version) at baseline and after , 6, 12, 18 and 24 months ; - Number of patients that maintain remission after suspension of TNF-alpha therapy (i.e. infliximab, adalimumab, etanercept, certolizumab pegol, golimumab) either with a tapering schedule and without any tapering schedule - clinical remission (DAS 28, CDAI, SDAI, ACR remission criteria) at baseline and 6, 12, 18 and 24 months) - ultrasound evaluation (score 0-4) at 3, 6, 12, 18 and 24 months. - radiographic articular evaluation (at baseline and after 12 and 24 months) - Quality-of-life measured by the SF-36 and HAQ questionnaires (Italian version) at baseline and after , 6, 12, 18 and 24 months ;Timepoint(s) of evaluation of this end point: 24 months ; 24 months	—

Measure

Time frame

Secondary end point(s): - Number of patients that maintain remission after suspension of TNF-alpha therapy (i.e. infliximab, adalimumab, etanercept, certolizumab pegol, golimumab) either with a tapering schedule and without any tapering schedule - clinical remission (DAS 28, CDAI, SDAI, ACR remission criteria) at baseline and 6, 12, 18 and 24 months) - ultrasound evaluation (score 0-4) at 3, 6, 12, 18 and 24 months. - radiographic articular evaluation (at baseline and after 12 and 24 months) - Quality-of-life measured by the SF-36 and HAQ questionnaires (Italian version) at baseline and after , 6, 12, 18 and 24 months ; - Number of patients that maintain remission after suspension of TNF-alpha therapy (i.e. infliximab, adalimumab, etanercept, certolizumab pegol, golimumab) either with a tapering schedule and without any tapering schedule - clinical remission (DAS 28, CDAI, SDAI, ACR remission criteria) at baseline and 6, 12, 18 and 24 months) - ultrasound evaluation (score 0-4) at 3, 6, 12, 18 and 24 months. - radiographic articular evaluation (at baseline and after 12 and 24 months) - Quality-of-life measured by the SF-36 and HAQ questionnaires (Italian version) at baseline and after , 6, 12, 18 and 24 months ;Timepoint(s) of evaluation of this end point: 24 months ; 24 months

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Countries

Italy

Contacts

Public ContactU.O. Reumatologia

U.O. Reumatologia - AOUP

l.bazzichi@ao-pisa.toscana.it050992074

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026