Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase
There are very few data on the safety of Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs), especially abatacept which compared to Tumor Necrosis Factor α (TNFα) inhibitors has distinct mechanism of action. Abatacept is a recombinant fusion protein of human Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) and the Fc region of human immunoglobulin gamma-1 (IgG1). This CTLA4-fusion protein blocks the signal of T cell activation by binding to CD80 and CD86.
Recently, the investigator's study found in a US cohort of 64,000 patients with Rheumatoid Arthritis (RA) a potential signal for a higher risk of cancer overall and particularly non-melanoma skin cancer with abatacept compared to other bDMARDs (article in press). These results were in accordance with another prospective cohort study of the public health care system in Sweden, showing an increased risk of NMSC in abatacept users compared with TNFα inhibitors. As these results warrant replication, the present study will assess whether abatacept is associated with an increased risk of reporting overall cancer and specific cancer, including breast, lung, lymphoma, cervical, melanoma and NMSC, compared to other bDMARDs.
調査の概要
詳細な説明
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Toulouse、フランス、31059
- 募集
- UHToulouse
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コンタクト：
- François MD MONTASTRUC, PhD
- 電話番号：+33 5 61 14 59 60
- メール：francois.montastruc@univ-tlse3.fr
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コンタクト：
- Isabelle OLIVIER, PhD
- 電話番号：+33 561777051
- メール：olivier.i@chu-toulouse.fr
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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:
- case reported in the World Health Organization (WHO) database of individual safety case report to 11/20/2018
- Patient treated with at least one bDMARD prescriptions
- adverse events reported were including the MedDRA terms
Exclusion Criteria:
- Chronology not compatible
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
- 観測モデル：コホート
- 時間の展望：回顧
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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abatacept
patients with abatacept prescription
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Case report of cancer overall
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others bDMARDs
patients with at least one bDMARD prescriptions
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Case report of cancer overall
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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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Risk of reporting cancer overall specific cancers
時間枠：Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
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Estimate statistically the risk of reporting cancer overall and specific cancers (including breast, lung, lymphoma, cervical, melanoma and NMSC) compared with all other adverse drug reactions (ADR) for abatacept compared to all ADRs for other bDMARDs performing a disproportionality analysis
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Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
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Risk of reporting specific cancers
時間枠：Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
|
Estimate statistically the risk of specific cancers (including breast, lung, lymphoma, cervical, melanoma and NMSC) compared with all other adverse drug reactions (ADR) for abatacept compared to all ADRs for other bDMARDs performing a disproportionality analysis
|
Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
|
協力者と研究者
捜査官
- スタディディレクター：François MONTASTRUC, PhD MD、University Hospital, Toulouse
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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。