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An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy

15 marzo 2016 aggiornato da: Hoffmann-La Roche

Study of the Profile and Clinical Management of Patients With Rheumatoid Arthritis Treated With Biologic Therapy Alone

This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.

Panoramica dello studio

Stato

Completato

Condizioni

Artrite reumatoide

Tipo di studio

Osservativo

Iscrizione (Effettivo)

210

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Spagna
- - Alicante, Spagna, 03010
  - Burgos, Spagna, 06006
  - Caceres, Spagna, 10310
  - Cordoba, Spagna, 14001
  - Girona, Spagna, 17007
  - Madrid, Spagna, 28006
  - Madrid, Spagna, 28034
  - Madrid, Spagna, 28905
  - Madrid, Spagna, 28007
  - Madrid, Spagna, 28222
  - Malaga, Spagna, 29005
  - Murcia, Spagna, 30008
  - Palencia, Spagna, 34005
  - Sevilla, Spagna, 41013
  - Sevilla, Spagna, 41018
  - Tenerife, Spagna, 38010
  - Toledo, Spagna, 45004
  - Valencia, Spagna, 46015
  - Valladolid, Spagna, 47005
  - Zamora, Spagna, 49022
  - Zaragoza, Spagna, 50009
- Alava
  - Vitoria, Alava, Spagna, 01009
- Alicante
  - Elche, Alicante, Spagna, 03203
- Asturias
  - Oviedo, Asturias, Spagna, 33006
- Badajoz
  - Zafra, Badajoz, Spagna, 06300
- Barcelona
  - Sabadell, Barcelona, Spagna, 08208
  - Viladecans, Barcelona, Spagna, 08840
- Cadiz
  - Jerez de la Frontera, Cadiz, Spagna, 11407
- Castellon
  - Vinaroz, Castellon, Spagna, 12500
- Granada
  - Cenes de la vega, Granada, Spagna, 18190
  - Granda, Granada, Spagna, 18190
- Guipuzcoa
  - San Sebastian, Guipuzcoa, Spagna, 20080
- Islas Baleares
  - Ibiza, Islas Baleares, Spagna, 07800
  - Inca, Islas Baleares, Spagna, 07300
  - Manacor (Islas Baleares), Islas Baleares, Spagna, 07500
- Jaen
  - Jaén, Jaen, Spagna, 23007
- La Coruña
  - La Coruna, La Coruña, Spagna, 15006
- Madrid
  - Alcala de Henares, Madrid, Spagna, 28805
- Malaga
  - Benalmadena, Malaga, Spagna, 29630
- Pontevedra
  - Vigo, Pontevedra, Spagna, 36214
- Valencia
  - Gandia, Valencia, Spagna, 46700

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Patients with moderate to severe rheumatoid arthritis

Descrizione

Inclusion Criteria:

Adult patients, >/=18 years of age
Patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) or other biological drugs
Patients treated with biologic DMARDs alone for at least 6 months

Exclusion Criteria:

Patients not willing or unable to give written informed consent for participation in this study
Patients who are participating in any clinical trial at the time of this study

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Modelli osservazionali: Coorte
Prospettive temporali: Trasversale

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
bDMARD Monotherapy Patients with moderate to severe rheumatoid arthritis (RA) will be treated with bDMARD (biologic disease-modifying antirheumatic drug) monotherapy under routine clinical practice conditions at rheumatology clinics

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Number of Participants With Level of Education Completed Lasso di tempo: At Visit 1 (Single visit study)	Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)	At Visit 1 (Single visit study)
Number of Participants With Smoking Habits Lasso di tempo: At Visit 1	Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.	At Visit 1
Smoking-habit for Smokers or Ex-smokers (Packs in Years) Lasso di tempo: At Visit 1	Smoking-habit included number of pack per years is reported.	At Visit 1
Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking ) Lasso di tempo: At Visit 1	Smoking-habit included years of smoking/quit smoking is reported for participants.	At Visit 1
Mean Time of Onset of Rheumatoid Arthritis Lasso di tempo: At Visit 1	Onset of rheumatoid arthritis is a component of clinical characteristics.	At Visit 1
Number of Participants With Family History of Rheumatoid Arthritis Lasso di tempo: At Visit 1	Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.	At Visit 1
Number of Participants With Co-morbidities Lasso di tempo: At Visit 1	Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.	At Visit 1
Number of Participants With Extra-articular Manifestations at Visit 1 Lasso di tempo: At Visit 1	Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.	At Visit 1
Mean Number of Painful and Swollen Joints at Visit 1 Lasso di tempo: At Visit 1	Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.	At Visit 1
Physician's Global Assessment of Disease Activity at Visit 1 Lasso di tempo: At Visit 1	The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).	At Visit 1
Patient's Global Assessment of Disease Activity at Visit 1 Lasso di tempo: At Visit 1	Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).	At Visit 1
Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 Lasso di tempo: At Visit 1	Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.	At Visit 1
Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 Lasso di tempo: At Visit 1	Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.	At Visit 1
Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies Lasso di tempo: At Visit 1	Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.	At Visit 1
Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1 Lasso di tempo: At Visit 1	The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.	At Visit 1
Patient Pain Visual Analog Scale Score at Visit 1 Lasso di tempo: At Visit 1	Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as "no pain" and the right-hand extreme equals 10 as "unbearable pain"	At Visit 1
Number of Participants With Joint Damage at Visit 1 Lasso di tempo: At Visit 1	Number of participants with joint damage is recorded as yes and no.	At Visit 1
Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1 Lasso di tempo: At Visit 1	Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.	At Visit 1
Number of Participants With Disease Activity Score by Categorization at Visit 1 Lasso di tempo: At Visit 1	DAS28 is divided into 4 categories as: remission <2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high >5.1.	At Visit 1
Mean Score on Clinical Disease Activity Index at Visit 1 Lasso di tempo: At Visit 1	Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.	At Visit 1
Number of Participants With Clinical Disease Activity by Categorization at Visit 1 Lasso di tempo: At Visit 1	CDAI is divided into 4 categories as: remission <2.8, low activity 2.8-10, moderate 10-22 and high>22.	At Visit 1
Mean Score on Simple Disease Activity Index at Visit 1 Lasso di tempo: At Visit 1	Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.	At Visit 1
Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1 Lasso di tempo: At Visit 1	SDAI is divided into 4 categories as: remission (<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (>26).	At Visit 1

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study Lasso di tempo: At Visit 1	Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.	At Visit 1
Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug Lasso di tempo: At Visit 1	Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.	At Visit 1
Number of Participants Who Received Each sDMARD Before The Study Lasso di tempo: At Visit 1	Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.	At Visit 1
Number of Participants Who Received Last sDMARD Prescribed Before the Study Lasso di tempo: At Visit 1	Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.	At Visit 1
Number of Participants Prescribed First bDMARD Before the Study Lasso di tempo: At Visit 1	Number of participants prescribed first bDMARD before the study was presented.	At Visit 1
Number of Participants Who Received Each bDMARD Before the Study Lasso di tempo: At Visit 1	Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.	At Visit 1
Mean Time Between the Last sDMARD and bDMARD Received at Visit 1 Lasso di tempo: At Visit 1	Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.	At Visit 1
Number of Participants With Changing the Previous sDMARD/ bDMARD Lasso di tempo: At Visit 1	Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.	At Visit 1
Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy) Lasso di tempo: At Visit 1	Number of sDMARD and bDMARDs received by Participants before the study was presented	At Visit 1
Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment Lasso di tempo: At Visit 1		At Visit 1
Number of Participants Discontinued the Previous Treatment and Started the Study Treatment Lasso di tempo: At Visit 1	The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.	At Visit 1
Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment Lasso di tempo: At Visit 1	Median time in months taking the Biologic Agent in monotherapy before the study was presented.	At Visit 1
Number of Participants Treated With Concomitant Medications Before the Study Lasso di tempo: At Visit 1	Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.	At Visit 1
Number of Participants Received Current bDMARD Treatment at the Time of the Study Lasso di tempo: At Visit 1	Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.	At Visit 1
Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy Lasso di tempo: At Visit 1	Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.	At Visit 1
Number of Participants With Reasons for Starting Current Biologic Monotherapy Lasso di tempo: At Visit 1	The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.	At Visit 1
Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study Lasso di tempo: At Visit 1	Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.	At Visit 1
Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA Lasso di tempo: At Visit 1		At Visit 1
Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent) Lasso di tempo: At Visit 1		At Visit 1
Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study Lasso di tempo: At Visit 1	Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.	At Visit 1
Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score Lasso di tempo: At Visit 1	Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .	At Visit 1
Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study Lasso di tempo: At Visit 1	Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).	At Visit 1
Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study Lasso di tempo: At Visit 1	Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).	At Visit 1
Number of Participants With Adverse Events Leading to a Change of Treatment Lasso di tempo: At the time of change of treatment	An Adverse Event was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Adverse events were collected as a reason for the change to monotherapy.	At the time of change of treatment
Number of Participants With Any Adverse Events and Any Serious Adverse Events Lasso di tempo: At the time of change of treatment (to the current treatment)	An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.	At the time of change of treatment (to the current treatment)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2012

Completamento primario (Effettivo)

1 giugno 2013

Completamento dello studio (Effettivo)

1 giugno 2013

Date di iscrizione allo studio

Primo inviato

8 agosto 2012

Primo inviato che soddisfa i criteri di controllo qualità

10 agosto 2012

Primo Inserito (Stima)

14 agosto 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 aprile 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 marzo 2016

Ultimo verificato

1 marzo 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

ML28356
ROC-BIO-2011-01 (Altro identificatore: Agencia Española del Medicamento y Productos Sanitarios)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy

Study of the Profile and Clinical Management of Patients With Rheumatoid Arthritis Treated With Biologic Therapy Alone

Panoramica dello studio

Stato

Condizioni

Tipo di studio

Iscrizione (Effettivo)

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Metodo di campionamento

Popolazione di studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Studiare le date dei record

Studia le date principali

Inizio studio

Completamento primario (Effettivo)

Completamento dello studio (Effettivo)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Stima)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in France

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi