Clinical trial NCT01664117: An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy
Official title: Study of the Profile and Clinical Management of Patients With Rheumatoid Arthritis Treated With Biologic Therapy Alone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe rheumatoid arthritis

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Level of Education Completed
timeFrame: At Visit 1 (Single visit study)
measure: Number of Participants With Smoking Habits
timeFrame: At Visit 1
measure: Smoking-habit for Smokers or Ex-smokers (Packs in Years)
timeFrame: At Visit 1
measure: Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )
timeFrame: At Visit 1
measure: Mean Time of Onset of Rheumatoid Arthritis
timeFrame: At Visit 1
measure: Number of Participants With Family History of Rheumatoid Arthritis
timeFrame: At Visit 1
measure: Number of Participants With Co-morbidities
timeFrame: At Visit 1
measure: Number of Participants With Extra-articular Manifestations at Visit 1
timeFrame: At Visit 1
measure: Mean Number of Painful and Swollen Joints at Visit 1
timeFrame: At Visit 1
measure: Physician's Global Assessment of Disease Activity at Visit 1
timeFrame: At Visit 1
measure: Patient's Global Assessment of Disease Activity at Visit 1
timeFrame: At Visit 1
measure: Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1
timeFrame: At Visit 1
measure: Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1
timeFrame: At Visit 1
measure: Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies
timeFrame: At Visit 1
measure: Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1
timeFrame: At Visit 1
measure: Patient Pain Visual Analog Scale Score at Visit 1
timeFrame: At Visit 1
measure: Number of Participants With Joint Damage at Visit 1
timeFrame: At Visit 1
measure: Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1
timeFrame: At Visit 1
measure: Number of Participants With Disease Activity Score by Categorization at Visit 1
timeFrame: At Visit 1
measure: Mean Score on Clinical Disease Activity Index at Visit 1
timeFrame: At Visit 1
measure: Number of Participants With Clinical Disease Activity by Categorization at Visit 1
timeFrame: At Visit 1
measure: Mean Score on Simple Disease Activity Index at Visit 1
timeFrame: At Visit 1
measure: Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1
timeFrame: At Visit 1
Secondary outcomes:
measure: Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study
timeFrame: At Visit 1
measure: Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug
timeFrame: At Visit 1
measure: Number of Participants Who Received Each sDMARD Before The Study
timeFrame: At Visit 1
measure: Number of Participants Who Received Last sDMARD Prescribed Before the Study
timeFrame: At Visit 1
measure: Number of Participants Prescribed First bDMARD Before the Study
timeFrame: At Visit 1
measure: Number of Participants Who Received Each bDMARD Before the Study
timeFrame: At Visit 1
measure: Mean Time Between the Last sDMARD and bDMARD Received at Visit 1
timeFrame: At Visit 1
measure: Number of Participants With Changing the Previous sDMARD/ bDMARD
timeFrame: At Visit 1
measure: Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)
timeFrame: At Visit 1
measure: Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment
timeFrame: At Visit 1
measure: Number of Participants Discontinued the Previous Treatment and Started the Study Treatment
timeFrame: At Visit 1
measure: Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment
timeFrame: At Visit 1
measure: Number of Participants Treated With Concomitant Medications Before the Study
timeFrame: At Visit 1
measure: Number of Participants Received Current bDMARD Treatment at the Time of the Study
timeFrame: At Visit 1
measure: Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy
timeFrame: At Visit 1
measure: Number of Participants With Reasons for Starting Current Biologic Monotherapy
timeFrame: At Visit 1
measure: Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study
timeFrame: At Visit 1
measure: Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA
timeFrame: At Visit 1
measure: Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)
timeFrame: At Visit 1
measure: 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
timeFrame: At Visit 1
measure: Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score
timeFrame: At Visit 1
measure: Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study
timeFrame: At Visit 1
measure: 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
timeFrame: At Visit 1
measure: Number of Participants With Adverse Events Leading to a Change of Treatment
timeFrame: At the time of change of treatment
measure: Number of Participants With Any Adverse Events and Any Serious Adverse Events
timeFrame: At the time of change of treatment (to the current treatment)
Other outcomes:
Locations:
city: Vitoria
country: Spain
state: Alava
city: Elche
country: Spain
state: Alicante
city: Oviedo
country: Spain
state: Asturias
city: Zafra
country: Spain
state: Badajoz
city: Sabadell
country: Spain
state: Barcelona
city: Viladecans
country: Spain
state: Barcelona
city: Jerez de la Frontera
country: Spain
state: Cadiz
city: Vinaroz
country: Spain
state: Castellon
city: Cenes de la vega
country: Spain
state: Granada
city: Granda
country: Spain
state: Granada
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Ibiza
country: Spain
state: Islas Baleares
city: Inca
country: Spain
state: Islas Baleares
city: Manacor (Islas Baleares)
country: Spain
state: Islas Baleares
city: Jaén
country: Spain
state: Jaen
city: La Coruna
country: Spain
state: La Coruña
city: Alcala de Henares
country: Spain
state: Madrid
city: Benalmadena
country: Spain
state: Malaga
city: Vigo
country: Spain
state: Pontevedra
city: Gandia
country: Spain
state: Valencia
city: Alicante
country: Spain
city: Burgos
country: Spain
city: Caceres
country: Spain
city: Cordoba
country: Spain
city: Girona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Murcia
country: Spain
city: Palencia
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Tenerife
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Zamora
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: