EUCTR2016-002569-68-GB进行中（未招募）1 期
Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease: A feasibility study - APRI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Aged 18 years or over (for patients aged 65 and over, additional caution should be taken to assess their health status prior to inclusion)
- •Agree to use 2 acceptable forms of effective contraception for the duration of the study trial and a further 14 weeks after completion
- •Meet a diagnosis of RA by 2010 EULAR/ACR criteria
- •Have interstitial lung disease associated with RA, with supportive findings on their PFTs and CT Chest scans. Participants will be included if their ILD has not responded to conventional immunosuppressive therapy, or has progressed over 24 weeks, regardless of the severity of the ILD at the time of inclusion to the trial. Progression will be defined as EITHER a decrease in either FVC or DLCOc by at least 5% over 6 months or 10% over 12 months (or by (0.83 x m)%, where m =number of months’ interval between a pair of lung function tests done within the last 18 months) OR progression of lung fibrosis on a high-resolution CT chest, as reported by a chest radiologist.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •The presence of any of the following will preclude patient participant inclusion:
- •Unable to provide written informed consent
- •Participants who are taking other immunosuppressants, e.g. mycophenolate mofetil (MMF), unless this has been discontinued with an adequate washout period. The exceptions to this exclusion criterion are methotrexate (MTX) and hydroxychloroquine, which are allowed provided the dose has been stable for 6 weeks prior to baseline (visit 2).
- •Participants who have been taking > 10mg Prednisolone daily within the last 6 weeks prior to baseline (visit 2)
- •Participants who have had rituximab, within the 24 weeks prior to baseline (Visit 2)
- •Any participant with active signs or symptoms of infection at the time of recruitment baseline (visit 2) or requiring antibiotic treatment within the preceding 4 weeks
- •Any participant with significant co-existing lung disease, such as asthma, bronchiectasis, emphysema, Chronic Obstructive Pulmonary Disease (COPD) or if their pre-bronchodilator FEV1/FVC ratio is < 70%.
- •Significant other co-morbidity (e.g. active malignancy/liver disease/renal disease) within the last 5 years
- •Prior use of abatacept at any time
- •Participation in any other clinical trial within 8 weeks or 5 half-lives of IMP, whichever is longer, prior to baseline (visit 2) (participation in ‘observational’ studies is allowed)
- •Hypersensitivity to any excipients of abatacept
- •Any participant who has had live vaccines within 6 weeks prior to baseline (Visit 2)
- •Participant is pregnant or breastfeeding
研究者
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