Clinical Outcomes, Compliance and Effectiveness of Switching From Infliximab or Etanercept to Adalimumab in Patients With Active Rheumatoid Arthritis (RA). A Multicenter Post-Marketing Observational Study in Routine Clinical Use (FALLA)
Clinical Outcomes,Compliance and Effectiveness of Switching From Infliximab or Etanercept to Adalimumab. A Multicenter Post-Marketing Observational Study in Routine Clinical Use
This is a prospective, single-arm, post marketing observational study in adult patients with active rheumatoid arthritis (RA) who are discontinuing treatment due to lack of efficacy, intolerance or to an incomplete response with either infliximab or etanercept.
The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.
調査の概要
状態
条件
詳細な説明
This is a prospective, single-arm, post marketing observational study in adult patients with active RA who are discontinuing treatment due to lack of efficacy, intolerance or to an incomplete response with either infliximab or etanercept.
The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to Adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.
Study Objectives:
Primary objective:
To assess the effectiveness of the treatment with adalimumab in patients with rheumatoid arthritis (RA) that have failed or presented an incomplete response to current treatment with either infliximab or etanercept.
Secondary objective:
To evaluate the compliance and clinical tolerability with adalimumab
Investigational Plan and Selection of Study Population:
All patients belonging to any of the centres participating in the study that meet all the inclusion criteria and none of the exclusion criteria will be considered eligible.
Patients considered eligible for the study will have to give their consent for the use and/or disclose of the patient's personal and/or health data. Patient's consent will be obtained before his/her participation in the study and will be documented in an Informed Consent Form approved by an Ethics Committee.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Chihuahua、メキシコ、31000
- Site Reference ID/Investigator# 27882
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Chihuahua、メキシコ、31200
- Site Reference ID/Investigator# 27883
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Culiacán Sin.、メキシコ、80000
- Site Reference ID/Investigator# 27884
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Guadalajara, Jal.、メキシコ、44320
- Site Reference ID/Investigator# 27888
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Guadalajara, Jal.、メキシコ、44650
- Site Reference ID/Investigator# 27886
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Guadalajara, Jal.、メキシコ、44670
- Site Reference ID/Investigator# 27887
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Leon, Gto.、メキシコ、37000
- Site Reference ID/Investigator# 25943
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Mexico City、メキシコ、03100
- Site Reference ID/Investigator# 28059
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Mexico City,、メキシコ、06700
- Site Reference ID/Investigator# 27885
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Puebla, Pue.、メキシコ、72000
- Site Reference ID/Investigator# 27890
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Puebla, Pue.、メキシコ、72570
- Site Reference ID/Investigator# 27889
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Tuxtla Gutierrez、メキシコ、29000
- Site Reference ID/Investigator# 28057
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients ≥18 and <75 years of age that meet the American College of Rheumatology (ACR) criteria for RA.
Patients with active RA defined as:
- ≥3 tender joints and ≥3 swollen joints, or
- DAS 28 score >3.1
Patients who are discontinuing treatment with either infliximab or etanercept due to:
- Lack of efficacy, or
- Incomplete response.
- Patients that, in the opinion of the physician could result beneficiated with the locally approved treatment scheme of adalimumab
- Those patients who switch from infliximab or etanercept to adalimumab has been done in the last 60 days could be included in the study.
Exclusion Criteria:
The following patients will not be included in the study:
- Patients who have active infections.
- Patients with latent TB. For this protocol, evidence of latent TB infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement. Any suggested data on the clinical history or chest x-ray.
- Patients participating into another study or clinical trial
- Any condition that according to the criteria of the participating physician represents an obstacle for study conduct and/or represents a potential unacceptable risk for patients.
研究計画
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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Non responders to other anti-TNF
Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers.
A 40 mg dose was administered every other week for 24 weeks.
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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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DAS28 (Disease Activity Score in 28 Joints)
時間枠：Baseline and Weeks 8,16 and 24
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The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad").
Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1).
The mean change in DAS 28 score from baseline to each visit is presented.
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Baseline and Weeks 8,16 and 24
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Tender Joint Count and Swollen Joint Count
時間枠：Baseline and Weeks 8,16 and 24
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The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints.
The mean number of painful or swollen joints for participants evaluated at each time point are presented.
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Baseline and Weeks 8,16 and 24
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Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)
時間枠：Baseline and Weeks 8,16 and 24
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Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS).
The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm).
Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit.
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Baseline and Weeks 8,16 and 24
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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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Evaluate the Compliance and Clinical Tolerability With Adalimumab
時間枠：Baseline to Week 24
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To assess compliance, participants were asked at the Week 8 and Week 16 visits how many doses they had missed since their previous visit.
Adverse events were collected throughout the study, from the time the participant signed the informed consent form until 30 days or 5 half-lives after the last dose of study drug.
For additional information see the Reported Adverse Event section.
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Baseline to Week 24
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Juan Pozos, MD、Abbott
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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