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

15. marts 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

210

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with moderate to severe rheumatoid arthritis

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Level of Education Completed
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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 )
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: At Visit 1
At Visit 1
Number of Participants Discontinued the Previous Treatment and Started the Study Treatment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At Visit 1
Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.
At Visit 1
Number of Participants With Reasons for Starting Current Biologic Monotherapy
Tidsramme: 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
Tidsramme: 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
Tidsramme: At Visit 1
At Visit 1
Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

8. august 2012

Først indsendt, der opfyldte QC-kriterier

10. august 2012

Først opslået (Skøn)

14. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML28356
  • ROC-BIO-2011-01 (Anden identifikator: Agencia Española del Medicamento y Productos Sanitarios)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Placeringer

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