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An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With Rituximab

2016年1月3日更新者：Hoffmann-La Roche

An Observational, Prospective, Multicenter, Local, to Assess the Quality of Life Through the Use of Questionnaires in a Cohort of Patients With Rheumatoid Arthritis Treated With Anti-CD20 Therapy

This multicenter prospective observational study will evaluate the quality of life in participants with rheumatoid arthritis (RA) who are initiated with rituximab (MabThera/Rituxan). Participants will be followed for 6 months from initiation of treatment.

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)

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

ブラジル
- BA
  - Salvador、BA、ブラジル、40050-410
  - Salvador、BA、ブラジル、41810-570
- MG
  - Juiz de Fora、MG、ブラジル、36036-330
  - Uberlandia、MG、ブラジル、38405-320
- MS
  - Cuiaba、MS、ブラジル、78020-450
- PE
  - Recife、PE、ブラジル、50000-000
  - Recife、PE、ブラジル、50100-130
- PR
  - Curtiba、PR、ブラジル、80030-110
- RJ
  - Rio De Janeiro、RJ、ブラジル、22640102
- RS
  - Porto Alegre、RS、ブラジル、90610-000
- SP
  - Campinas、SP、ブラジル、13015-001
  - Campinas、SP、ブラジル、13073-350
  - Osasco、SP、ブラジル、06010-080
  - Santo Andre、SP、ブラジル、09060-650
  - Sao Jose do Rio Preto、SP、ブラジル、15090-000
  - Sao Paulo、SP、ブラジル、05403-010
  - Sao Paulo、SP、ブラジル、04026-000
  - Sao Paulo、SP、ブラジル、03533-000
  - Sao Paulo、SP、ブラジル、04041-000
  - Sao Paulo、SP、ブラジル、1228200

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

Participants with RA initiating rituximab

説明

Inclusion Criteria:

Adult participants of both genders who are 18 years or older
Diagnosis of RA for at least 6 months according to the criteria of the American College of Rheumatology (ACR) of 1987 for the RA classification
Participants with medically prescribed or being administered with unique rituximab infusion in the least 3 days, according to the approved label
Ability to meet the program's requirements and to voluntarily sign the Informed Consent Term.

Exclusion Criteria:

Participants who have received any investigational medication within less than or equal to (<=) 1 year before the first dose of the currently indicated treatment
Participants with an active infection
Participants with conditions that may interfere in the ability to understand the requests of data collection and to obey to the study's requirements
Functional Class IV defined based on the ACR functionality criteria for RA
Participants who can not or who do not want, for any reason, to answer the questionnaires.

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：見込みのある

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
Rituximab Participants who are receiving 1000 milligrams (mg) intravenous (IV) infusion of rituximab on Day 1 and Day 15 as part of standard of care of the treating site will be included in this observational study.

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
Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24 時間枠：Week 24	The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.	Week 24
Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24 時間枠：Baseline and Week 24	SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.	Baseline and Week 24

二次結果の測定

結果測定	メジャーの説明	時間枠
Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment. 時間枠：Up to 24 Weeks	An infusion reaction is defined as an adverse event that occurs during infusion or within 24 hours after infusion of Rituximab. All infectious events, whether considered related or not to Rituximab, were collected for the safety analysis of the study. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 24 Weeks
Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) 時間枠：Baseline, Week 12, Week 24	Erythrocyte Sedimentation Rate is an acute phase reactant and a measure of inflammation.	Baseline, Week 12, Week 24
Mean Change From Baseline in C-reactive Protein (CRP). 時間枠：Baseline, Week 12, Week 24	CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis.	Baseline, Week 12, Week 24
Mean Change From Baseline in Swollen Joint Count (SJC) 時間枠：Baseline, Week 12, Week 24	A swollen joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It reflects the amount of inflamed synovial tissue.	Baseline, Week 12, Week 24
Mean Change From Baseline in Tender Joint Count (TJC) 時間枠：Baseline, Week 12, Week 24	A tender joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It is associated more with the level of pain.	Baseline, Week 12, Week 24
Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score 時間枠：Baseline, Week 12, Week 24	DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.	Baseline, Week 12, Week 24
Mean Change From Baseline in Patient Global Assessment (100 mm VAS) 時間枠：Baseline, Week 12, Week 24	The Physician's Global Assessment of disease activity was assessed using a 0 to 100 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).Change from Baseline = scores at observation minus score at Baseline. An increase in score from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.	Baseline, Week 12, Week 24
Change in HAQ Score From Screening to Weeks 12 and 24 時間枠：Baseline, Week 12, Week 24	The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The number of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.	Baseline, Week 12, Week 24
Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24 時間枠：Baseline, Week 12, Week 24	Visual Analogue Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from Screening=scores at observation minus score at Screening. An increase in score from Screening represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. The change in pain scale was analyzed for the set of observed cases (OC) at each assessment time.	Baseline, Week 12, Week 24
Change in SF-36 Physical and Mental Component Scores From Screening to Week 12 時間枠：Baseline, Week 12	SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.	Baseline, Week 12
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 時間枠：Baseline, Week 12, Week 24	SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.	Baseline, Week 12, Week 24
Percentage of Participants Achieving a Clinically Important Reduction of >= 0.22 Point in HAQ Score at Week 12. 時間枠：Week 12	The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.	Week 12
Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 24. 時間枠：Week 12 and 24	SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.	Week 12 and 24

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

2009年7月1日

一次修了 (実際)

2012年6月1日

研究の完了 (実際)

2012年6月1日

試験登録日

最初に提出

2015年7月23日

QC基準を満たした最初の提出物

2015年7月23日

最初の投稿 (見積もり)

2015年7月24日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年2月2日

QC基準を満たした最後の更新が送信されました

2016年1月3日

最終確認日

2016年1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

ML22064

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