ISRCTN46017566已完成未知
Arthritis Prevention In the Pre-clinical Phase of Rheumatoid Arthritis with Abatacept: a randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 213
研究概览
简要总结
2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31307535/ protocol (added 05/06/2020) 2024 Results article in https://doi.org/10.1016/S0140-6736(23)02649-1 (added 19/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects, aged 18 years or over
- •2. Arthralgia, defined as non-traumatic joint pain localised to synovial joints including, but not necessarily confined to, hands, wrists or feet, and in the opinion of the supervising rheumatologist considered to be inflammatory in nature
- •3. Positive for serum rheumatoid factor (RF) and antibodies to citrullinated protein antigens (ACPA) as defined by local clinical laboratory testing. Subjects who are RF negative, but who carry high levels of serum ACPA (defined as being = 3 x upper limit of normal [ULN] for the assay) may be included
- •4. Able and willing to give written informed consent and comply with the requirements of the study protocol
排除标准
- •1. Previous diagnosis of RA or other form of inflammatory arthritis including, but not limited to, SLE, psoriatic arthritis, ankylosing spondylitis, gout or pyrophosphate arthopathy, and including current treatment with DMARDs or biological therapy
- •2. Arthralgia that, in the opinion of the supervising physician, is poorly localised, e.g., pelvic or shoulder girdle pain that is confined to the axial skeleton or entheses, or pain which the physician considers to be due to osteoarthritis or fibromyalgia, or related to other autoimmune conditions such as type I diabetes, coeliac or autoimmune thyroid disease
- •3. Clinically apparent arthritis, as assessed by a rheumatologist, characterised by soft tissue swelling of one or more synovial joints. Subclinical synovitis, as detected by imaging modalities such as ultrasonography or MRI, is NOT an exclusion criterion
- •4. A history of oral or parenteral use of corticosteroids within the last 12 weeks used to treat the current episode of musculoskeletal symptoms
- •5. Co-morbidities requiring chronic treatment with immunosuppressive or immune-modulating therapy
- •6. Subjects who have at any time received treatment with any investigational drug within 28 days
- •7. A history of acute allergic reactions to biological therapy or immunoglobulins
- •8. Subjects who are incapable of completing study-related assessments or give informed consent
- •9. Subjects with current symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic or cerebral disease, whether or not related to RA and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study
- •10. Subjects with a cancer history within the last 5 years
- •11. Subjects with tuberculosis (including those at high risk of tuberculosis), chronic viral infections, recent serious bacterial infections, or subjects receiving live vaccinations within 3 months of the anticipated first dose of study medication, or those with chronic illnesses that would, in the opinion of the investigator, put the patient at risk
- •12. Subjects who currently abuse drugs or alcohol
- •13. Subjects who are pregnant or who are breastfeeding
- •14. Male subjects or women of childbearing potential not willing to use adequate contraception during the period of IMP dosing and for up to 10 weeks after the last dose of study drug
- •15. Subjects with abnormal laboratory tests, as defined in the study protocol
研究者
相似试验
进行中（未招募）
1 期
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 disordersEUCTR2013-003413-18-NLeiden University Medical Center206
已完成
2 期
Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept.gewrichsaandoeningenArthralgiaReumatoid Arthritis10003816NL-OMON47610eids Universitair Medisch Centrum20
进行中（未招募）
1 期
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: 20.0 Level: PT Classification code 10003239 Term: Arthralgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2013-003413-18-GBKing’s College London206
已完成
不适用
Rheumatoid arthritis prevention with abatacept - long-term outcome studyMusculoskeletal DiseasesRheumatoid arthritis, unspecifiedRheumatoid arthritisISRCTN12680338Kings College London and Guy's and St Thomas' NHS Foundation Trust143
已完成
不适用
Osteoarthritis preoperative package for care of orthotics, rehabilitation, topical and oral agent usage and nutrition to improve outcomes at a yearOsteoarthritisISRCTN96684272HS Lothian60