Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab
2014年2月25日 更新者：AbbVie (prior sponsor, Abbott)
The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics.
Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.
調査の概要
詳細な説明
This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
The assignment of the patient to a Humira-containing regimen has to be decided in advance and has to be current practice.
The prescription of Humira is clearly separated from the decision to include the participant in this study.
研究の種類
観察的
入学 (実際)
155
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
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Bludenz、オーストリア、6700
- Site Reference ID/Investigator# 52144
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Fuerstenfeld、オーストリア、8280
- Site Reference ID/Investigator# 44915
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Gloggnitz、オーストリア、A-2640
- Site Reference ID/Investigator# 44910
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Graz、オーストリア、A-8020
- Site Reference ID/Investigator# 44914
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Innsbruck、オーストリア、6020
- Site Reference ID/Investigator# 52143
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Klagenfurt、オーストリア、A-9020
- Site Reference ID/Investigator# 44916
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Linz、オーストリア、4030
- Site Reference ID/Investigator# 44911
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Linz、オーストリア、A-4020
- Site Reference ID/Investigator# 44912
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Linz、オーストリア、A-4020
- Site Reference ID/Investigator# 44913
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Neudorf、オーストリア、A-2351
- Site Reference ID/Investigator# 44906
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Spitz、オーストリア、3620
- Site Reference ID/Investigator# 52145
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St. Poelten、オーストリア、3100
- Site Reference ID/Investigator# 44909
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Stockerau、オーストリア、2000
- Site Reference ID/Investigator# 44908
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Vienna、オーストリア、1040
- Site Reference ID/Investigator# 67062
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Voecklabruck、オーストリア、A-4840
- Site Reference ID/Investigator# 57304
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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
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
primary care clinic and medical practice specialized in rheumatology
説明
Inclusion Criteria:
- Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled:
- unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis
- unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis
Exclusion Criteria:
- Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics
- Patients participating in another study program or clinical trial
- Patients who have been treated with Humira before
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
コホートと介入
グループ/コホート |
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RA, PsA, AS
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
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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 |
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Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12
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Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
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Baseline, Months 3, 6, 9, 12
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Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12
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Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
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Baseline, Months 3, 6, 9, 12
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Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12
時間枠：Baseline, Month 12
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Participants measured their present pain intensity by specifying their level of pain in response to the question "How intensive is your pain at present?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.
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Baseline, Month 12
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Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12
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Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
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Baseline, Months 3, 6, 9, 12
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Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12
時間枠：Baseline, Month 12
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Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question "How intensive was your pain on average in the past 3 months?"
on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.
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Baseline, Month 12
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Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12
時間枠：Baseline, Month 12
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Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).
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Baseline, Month 12
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Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12
時間枠：Baseline, Month 12
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Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.
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Baseline, Month 12
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Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12
時間枠：Baseline, Month 12
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Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.
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Baseline, Month 12
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Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12
時間枠：Baseline, Month 12
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Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.
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Baseline, Month 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12
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The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.
Items 1 to 4 primarily contribute to the physical component summary score (PCS) of the SF-36.
Items 5 to 8 primarily contribute to the mental component summary score (MCS) of the SF-36.
Scores on each item are summed and averaged (range = 0 [worst] to 100 [best ]).
The standard recall period is 4 weeks.
Increases from Baseline indicate improvement.
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Baseline, Months 3, 6, 9, 12
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Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12
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The HAQ-DI is a participant-reported questionnaire.
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities.
Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
The minimal clinically important difference defined for the HAQ-DI is ≥0.22.
HAQ remission, indicating normal physical function, is defined as HAQ-DI < 0.5.
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Baseline, Months 3, 6, 9, 12
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Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12
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The RADAI is a questionnaire for patients used for measuring disease activity.
The index consists of 6 questions.
The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list.
The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes.
The first 4 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity.
The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10.
The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.
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Baseline, Months 3, 6, 9, 12
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Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12
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The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS.
The 10 questions were chosen with a major input from patients with AS.
The first 8 questions consider activities related to functional anatomy.
The final 2 questions assess the participants' ability to cope with everyday life.
A visual analogue scale (with 0 being "easy" and 10 "impossible") is used to answer the questions on the test.
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Baseline, Months 3, 6, 9, 12
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Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12
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The BASDAI is used for measuring and evaluating disease activity in AS.
This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness.
A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions.
The final BASDAI score averages the individual assessments for a final score range of 0-10 (0 being no problem and 10 being the worst problem).
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Baseline, Months 3, 6, 9, 12
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Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12
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The ESR is a practicable and sensitive but not specific parameter for measuring disease progression.
By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease.
The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women.
The higher the ESR value out of the normal range, the higher is the disease activity.
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Baseline, Months 3, 6, 9, 12
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Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12
時間枠：Baseline, Months 3, 6, 9, 12
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The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation.
The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.
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Baseline, Months 3, 6, 9, 12
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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。
協力者
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
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
2011年1月1日
一次修了 (実際)
2013年1月1日
研究の完了 (実際)
2013年1月1日
試験登録日
最初に提出
2011年1月7日
QC基準を満たした最初の提出物
2011年1月7日
最初の投稿 (見積もり)
2011年1月10日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年3月26日
QC基準を満たした最後の更新が送信されました
2014年2月25日
最終確認日
2014年2月1日
詳しくは
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。