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

2016年3月15日更新者：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.

調査の概要

状態

完了

条件

関節リウマチ

研究の種類

観察的

入学 (実際)

210

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

Patients with moderate to severe rheumatoid arthritis

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

観測モデル：コホート
時間の展望：断面図

グループ/コホートの数

コホートと介入

グループ/コホート
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

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Number of Participants With Level of Education Completed 時間枠：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 時間枠：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) 時間枠：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 ) 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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) 時間枠：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 時間枠：At Visit 1		At Visit 1
Number of Participants Discontinued the Previous Treatment and Started the Study Treatment 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：At Visit 1	Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.	At Visit 1
Number of Participants With Reasons for Starting Current Biologic Monotherapy 時間枠：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 時間枠：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 時間枠：At Visit 1		At Visit 1
Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent) 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hoffmann-La Roche

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年6月1日

一次修了 (実際)

2013年6月1日

研究の完了 (実際)

2013年6月1日

試験登録日

最初に提出

2012年8月8日

QC基準を満たした最初の提出物

2012年8月10日

最初の投稿 (見積もり)

2012年8月14日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年4月4日

QC基準を満たした最後の更新が送信されました

2016年3月15日

最終確認日

2016年3月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

ML28356
ROC-BIO-2011-01 (その他の識別子：Agencia Española del Medicamento y Productos Sanitarios)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。