Clinical Trials Register

Summary
EudraCT Number:	2016-003129-40
Sponsor's Protocol Code Number:	FARM125FKN
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-09-10
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-003129-40

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Remission after suspension of TNF alpha therapies in RA

Remissione dopo terapia con farmaci Anti TNF in pazienti affetti da Artrite Reumatoide

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

FARM125FKN

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AIFA - Italian Medicines Agency
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	U.O. Reumatologia - AOUP
B.5.2	Functional name of contact point	U.O. Reumatologia
B.5.3	Address:
B.5.3.1	Street Address	Via Roma 67
B.5.3.2	Town/ city	PISA
B.5.3.3	Post code	56126
B.5.3.4	Country	Italy
B.5.4	Telephone number	050992074
B.5.5	Fax number	0502218292
B.5.6	E-mail	l.bazzichi@ao-pisa.toscana.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 2 SIRINGHE PRERIEMPITE 0.8 ML + 2 TAMPONI IMBEVUTI DI ALCOL IN 1 BLISTER
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBVIE LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	HUMIRA (ADALIMUMAB)
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ADALIMUMAB
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI ALCOOL
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB PHARMA S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	CIMZIA (Certolizumab Pegol)
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CERTOLIZUMAB PEGOL
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZ
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	ENBREL (Etanercept)
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ETANERCEPT
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	REMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EV
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN BIOLOGICS B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	REMICADE (INFLIXIMAB)
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLIXIMAB
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	SIMPONI - 50 MG-SOLUZIONE PER INIEZIONE IN PENNA PRERIEMPITA-USO SOTTOCUTANEO-PENNA PRERIEMPITA(VETRO) -0.5 ML 3 (3X1) PENNE PRERIEMPITE
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN BIOLOGICS B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	SIMPONI (GOLIMUMAB)
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GOLIMUMAB
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

RHEUMATOID ARTHRITIS (RA) PATIENTS

PAZIENTI AFFETTI DA ARTRITE REUMATOIDE (AR)

E.1.1.1

Medical condition in easily understood language

RHEUMATOID ARTHRITIS (RA) PATIENTS

PAZIENTI AFFETTI DA ARTRITE REUMATOIDE (AR)

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10003268
E.1.2	Term	Arthritis rheumatoid
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

L'obiettivo primario del progetto è quello di valutare il mantenimento della remissione clinica di malattia dopo 6, 12, 18 e 24 mesi dalla sospensione della terapia con farmaco anti-TNF-alfa (i.e. infliximab, adalimumab, etanercept, certolizumab pegol, golimumab) in pazienti affetti da AR.

E.2.2

Secondary objectives of the trial

• 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

- Valutare le differenze tra il gruppo di pazienti che sospendono l’Anti TNF mediante Tapering (braccio A) e il gruppo di pazienti che sospendono il trattamento senza tapering (braccio B)
- valutare la massima latenza del mantenimento dell’efficacia tra le somministrazioni (braccio A)
- valutare la correlazione tra il mantenimento della remissione dopo sospensione dell’Anti TNF e l’associazione con DMARDs classici
- valutare da un punto di vista ecografico le articolazioni dopo al baseline e dopo 3, 6, 12, 18 e 24 mesi dalla sospensione dell’Anti TNF
- valutare radiograficamente le articolazioni di mani e polsi al baseline e dopo 12 e 24 mesi dopo la sospensione del farmaco Anti TNF
- valutare la correlazione tra dati clinici e strumentali nella valutazione dell’attività di malattia

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Able to comply and give informed consent;
2. Age > 18 and < 70 years;
3. diagnosis of RA according to ACR Criteria
4. clinical remission since at least 12 months (DAS 28 = 2.6, ACR remission criteria)
5. current therapy with anti TNF-alpha (adalimumab, etanercept o infliximab, certolizumab pegol, golimumab) from at least 15 months
6. = 6 mg/die of 6-methylprednisolone at stable dose for at least 3 months.
7. if the patient takes stable DMARDs (Methotrexate or Leflunomide or Hydroxicloroquine) therapy they must be at a stable dose for at least 3 months.

- diagnosi di AR in accordo con i criteri ACR;
- remissione clinica da almeno 12 mesi;
-trattamento in atto con farmaco anti TNF-alfa (adalimumab, etanercept o infliximab, certolizumab pegol, golimumab) da almeno 15 mesi
- consenso informato scritto;
- età > 18 e < di 70 anni;
- dose di steroidi < 6 mg/die 6-metil-prednisolone/die da almeno tre mesi.
- se il paziente è in terapia con DMARDs (come ad esempio Metotrexato, Leflunomide o Idrossiclorochina), il dosaggio deve essere stabile da almeno 3 mesi

E.4

Principal 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.

- criteri di esclusione previsti per l'accesso al trattamento con farmaci anti TNF alfa (come ad esempio Tubercolosi, epatite sostenuta da visus B o C, immunodeficienza da HIV)
- precedenti trattamenti con farmaci biologici (e.g. rituximab, Tocilizumab, Abatacept)
- concomitanza di altre malattie autoimmuni sistemiche
- pazienti in classe funzionale IV ACR
- gravidanza o allattamento

E.5 End points

E.5.1

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)

Valutazione del numero di pazienti affetti da AR che mantengono la remissione clinica dopo 6, 12, 18 e 24 mesi dalla sospensione della terapia anti TNF-alfa (cioè infliximab, adalimumab, etanercept, certolizumab pegol, golimumab)

E.5.1.1

Timepoint(s) of evaluation of this end point

24 months

24 mesi

E.5.2

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

- Numero di pazienti che mantengono la remissione dopo la sospensione della terapia con TNF-alfa (cioè infliximab, adalimumab, etanercept, certolizumab pegol, golimumab) sia con un programma di tapering che senza alcun programma di tapering
- Remissione clinica (DAS 28, CDAI, SDAI, ACR criteri di remissione) al basale e, 6, 12, 18 e 24 mesi)
- Valutazione ecografica (punteggio 0-4) a 3, 6, 12, 18 e 24 mesi.
- Valutazione radiografica articolare (al basale, dopo 12 e dopo 24 mesi)
- Qualità della vita misurata dal SF-36 e questionari HAQ (versione italiana) al basale e dopo 6, 12, 18 e 24 mesi
; - Numero di pazienti che mantengono la remissione dopo la sospensione della terapia con TNF-alfa (cioè infliximab, adalimumab, etanercept, certolizumab pegol, golimumab) sia con un programma di tapering che senza alcun programma di tapering
- Remissione clinica (DAS 28, CDAI, SDAI, ACR criteri di remissione) al basale e, 6, 12, 18 e 24 mesi)
- Valutazione ecografica (punteggio 0-4) a 3, 6, 12, 18 e 24 mesi.
- Valutazione radiografica articolare (al basale, dopo 12 e dopo 24 mesi)
- Qualità della vita misurata dal SF-36 e questionari HAQ (versione italiana) al basale e dopo 6, 12, 18 e 24 mesi

E.5.2.1

Timepoint(s) of evaluation of this end point

24 months ; 24 months

24 mesi; 24 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Trattamento con csDMARD

Treatment with csDMARD

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will continue with standard of care

I pazienti proseguiranno con i programmi assistenziali previsti dalla routine clinica

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-01-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-10-27

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
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