EUCTR2013-003413-18-GB
进行中（未招募）
1 期
Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRA
适应症The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPArheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis.MedDRA version: 20.0 Level: PT Classification code 10003239 Term: Arthralgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA
- 发起方
- King’s College London
- 入组人数
- 206
- 状态
- 进行中（未招募）
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Male or female subjects, aged \= 18 years.
- •\- Arthralgia that is considered to be inflammatory in nature.
- •\- ACPA and RF positive, or high titre ACPA.
- •\- Able and willing to give written informed consent and comply with the requirements of the study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 206
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 206
排除标准
- •\- Clinically apparent arthritis, as assessed by a rheumatologist.
- •\- A history of inflammatory arthritis, as assessed by a rheumatologist.
- •\- History or current use of DMARDs or biologics.
- •\- History of oral or parenteral use of corticosteroids within the last 12 weeks.
- •\- Co\-morbidities requiring treatment with immunosuppressive or immune modulating therapy.
- •\- Chronic illnesses that would, in the opinion of the investigator, put the subject at risk.
- •\- Recipients of a live vaccine within 3 months of inclusion.
- •\- Pregnant or breastfeeding
- •\- Unable to give informed consent
结局指标
主要结局
未指定
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Arthritis prevention with abataceptThe target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPArheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis.MedDRA version: 20.0Level: PTClassification code 10003239Term: ArthralgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]EUCTR2013-003413-18-NLeiden University Medical Center206
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