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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664117
First received: August 8, 2012
Last updated: March 15, 2016
Last verified: March 2016
  Purpose
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.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of the Profile and Clinical Management of Patients With Rheumatoid Arthritis Treated With Biologic Therapy Alone

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants With Level of Education Completed [ Time Frame: At Visit 1 (Single visit study) ] [ Designated as safety issue: No ]
    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)

  • Number of Participants With Smoking Habits [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.

  • Smoking-habit for Smokers or Ex-smokers (Packs in Years) [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Smoking-habit included number of pack per years is reported.

  • Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking ) [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Smoking-habit included years of smoking/quit smoking is reported for participants.

  • Mean Time of Onset of Rheumatoid Arthritis [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Onset of rheumatoid arthritis is a component of clinical characteristics.

  • Number of Participants With Family History of Rheumatoid Arthritis [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Co-morbidities [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Extra-articular Manifestations at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Mean Number of Painful and Swollen Joints at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Physician's Global Assessment of Disease Activity at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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).

  • Patient's Global Assessment of Disease Activity at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Patient Pain Visual Analog Scale Score at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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"

  • Number of Participants With Joint Damage at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Number of participants with joint damage is recorded as yes and no.

  • Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Disease Activity Score by Categorization at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Mean Score on Clinical Disease Activity Index at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Clinical Disease Activity by Categorization at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    CDAI is divided into 4 categories as: remission <2.8, low activity 2.8-10, moderate 10-22 and high>22.

  • Mean Score on Simple Disease Activity Index at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    SDAI is divided into 4 categories as: remission (<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (>26).


Secondary Outcome Measures:
  • Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.

  • Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.

  • Number of Participants Who Received Each sDMARD Before The Study [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Received Last sDMARD Prescribed Before the Study [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Prescribed First bDMARD Before the Study [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Number of participants prescribed first bDMARD before the study was presented.

  • Number of Participants Who Received Each bDMARD Before the Study [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.

  • Mean Time Between the Last sDMARD and bDMARD Received at Visit 1 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.

  • Number of Participants With Changing the Previous sDMARD/ bDMARD [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy) [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Number of sDMARD and bDMARDs received by Participants before the study was presented

  • Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
  • Number of Participants Discontinued the Previous Treatment and Started the Study Treatment [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Median time in months taking the Biologic Agent in monotherapy before the study was presented.

  • Number of Participants Treated With Concomitant Medications Before the Study [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.

  • Number of Participants Received Current bDMARD Treatment at the Time of the Study [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.

  • Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.

  • Number of Participants With Reasons for Starting Current Biologic Monotherapy [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.

  • Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.

  • Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
  • Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent) [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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 .

  • Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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).

  • 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 [ Time Frame: At Visit 1 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Adverse Events Leading to a Change of Treatment [ Time Frame: At the time of change of treatment ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Any Adverse Events and Any Serious Adverse Events [ Time Frame: At the time of change of treatment (to the current treatment) ] [ Designated as safety issue: No ]
    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.


Enrollment: 210
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with moderate to severe rheumatoid arthritis
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664117

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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01664117     History of Changes
Other Study ID Numbers: ML28356  ROC-BIO-2011-01 
Study First Received: August 8, 2012
Results First Received: February 1, 2016
Last Updated: March 15, 2016
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios (AEMPS)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 21, 2016