The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis
調査の概要
詳細な説明
In other studies, TNFR:Fc significantly reduced joint pain and swelling in adult patients with rheumatoid arthritis, and the Food and Drug Administration has approved the drug for that use. Because medicines for arthritis often help patients with eye inflammation, this study will examine whether TNFR:Fc can help patients with uveitis.
Patients with uveitis who are not responding well to standard treatment, such as steroids, and patients who have side effects from other medicines used to treat their uveitis or have refused treatment because of possible side effects may be eligible for this study. Candidates will be screened with a medical history, physical examination, and eye examination. The eye exam includes a check of vision and eye pressure, examination of the back of the eye (retina), and front of the eye, including measurements of protein and inflammation. Candidates will also undergo fluorescein angiography-a procedure in which photographs are taken of the retina to see if there is any leakage in the eye's blood vessels. A blood test and joint evaluation will also be done.
Study participants will be given an injection of TNFR:Fc twice a week for up to 12 months and may continue other medicines they may be taking, such as prednisone or methotrexate. They will have follow-up examinations at week two and months one, two, three and four. Those who wish to continue treatment after the fourth month can receive the drug for another eight months and will have follow-up exams at months six, nine and 12, and one month after treatment ends. Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine.
研究の種類
段階
- フェーズ 3
連絡先と場所
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892
- 募集
- National Institutes of Health
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コンタクト:
- Susan H Smith
- 電話番号:391-435-4559
- メール:smithsmith@intra.nei.nih.gov
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主任研究者:
- Janine A Smith, M.D.
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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
説明
Must meet American College of Rheumatology Criteria for JRA.
Must have active anterior uveitis defined as the presence of inflammatory cells (Grade 1+ or higher) in the anterior chamber of at least one eye or the current use of topical corticosteroids to control exacerbation of disease at a frequency of TID or higher.
Age between 2 and 18 years, inclusive.
Ability to undergo slit lamp biomicroscopy for assessment of anterior chamber cells.
Ability to comply with study requirements.
Be up to date on all recommended childhood immunizations.
Using current arthritis regimen for at least 8 weeks prior to enrollment.
No media opacity that precludes assessment of anterior chamber inflammation.
No periocular injection of corticosteroids within 2 months of baseline, or used a systemic experimental therapy within one month of baseline evaluation.
Not currently receiving disease modifying antirheumatic therapy (DMARD), with the exception of prednisone at a dose no greater than 1.0 mg/kg/day, or methotrexate at a dose no greater than 15 mg/m(2)/week.
No active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications.
No females who are pregnant or lactating.
No refusal to use contraception during the study and 6 months after termination of active study therapy, if child-bearing or fathering potential exists.
No use of Latanoprost within two weeks prior to enrollment, or have a current or likely need for Latanoprost during the course of the study.
No hypersensitivity to fluorescein dye.
No active serious infections or history of recurring serious infections.
No evidence of spondyloarthropathy or entheseopathy.
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
- 主な目的:処理
協力者と研究者
研究記録日
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
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。
TNFR:FCの臨床試験
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)完了
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Children's Oncology GroupNational Cancer Institute (NCI)完了若年性骨髄単球性白血病 | 続発性急性骨髄性白血病 | 寛解期の小児急性骨髄性白血病 | 加速期慢性骨髄性白血病 | 寛解期の小児急性リンパ芽球性白血病 | 小児慢性骨髄性白血病 | 小児骨髄異形成症候群 | 慢性期 慢性骨髄性白血病 | 以前に治療された骨髄異形成症候群 | 再発性小児急性リンパ芽球性白血病 | 再発性小児急性骨髄性白血病 | 慢性骨髄性白血病の再発 | 続発性骨髄異形成症候群 | 再発神経芽腫 | 再発小児横紋筋肉腫 | 肺合併症 | 播種性神経芽腫 | 再発性ウィルムス腫瘍およびその他の小児腎腫瘍 | 治療歴のある小児横紋筋肉腫 | 再発小児大細胞型リンパ腫 | 再発小児リンパ芽球性リンパ腫 | 再発小児小非分割細胞性リンパ腫 | 再発/難治性小児ホジキンリンパ腫 | デノボ骨髄異... およびその他の条件アメリカ