Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in Patients With Active Rheumatoid Arthritis (BACH)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Treatment satisfaction at week 24
研究概览
简要总结
Despite their efficacy in the treatment of Rheumatoid Arthritis and their partial advantage over traditional bDMARDs ( biological Disease Modifying antirheumatic drugs), JAK inhibitors (JAKi or tsDMARDs) have not gained preference over Tumor Necrosis Factor inhibitors (TNFi) in guidelines or clinical practice. The biggest influence on recent guidelines has been the "Treat To Target" principle (T2T), in which Shared Decision Making (SDM) plays a key part. Patient preference has proven to be a large barrier in treatment adjustments (14- 37%) while patients showed better adherence and higher treatment satisfaction when engaged in Shared Decision Making. From survey studies it is suggested that patient preference and satisfaction will be in favour of oral JAK inhibitors over parenteral biologics.The investigators want to establish the treatment preference of patients with active RA and compare the treatment satisfaction of patients who are given the opportunity to choose between the JAKi filgotinib and TNFi, to the treatment satisfaction of patients who are randomized to the same treatment options.
In addition to higher treatment satisfaction and better adherence, the investigators expect to find an improvement in DAS28-, HAQ-, SQUASH- and WPAI-scores and also an improved activity and work productivity.
详细描述
Rationale: Despite their efficacy in the treatment of Rheumatoid Arthritis and their partial advantage over traditional bDMARDs, JAK inhibitors (JAKi or tsDMARDs) have not gained preference over Tumor Necrosis Factor inhibitors (TNFi) in guidelines or clinical practice. The biggest influence on recent guidelines has been the "Treat To Target" principle (T2T), in which Shared Decision Making (SDM) plays a key part. Patient preference has proven to be a large barrier in treatment adjustments (14- 37%) while patients showed better adherence and higher treatment satisfaction when engaged in Shared Decision Making. From survey studies it is suggested that patient preference and satisfaction will be in favour of oral JAK inhibitors over parenteral biologics. The investigators want to establish the treatment preference of patients with active RA and compare the treatment satisfaction of patients who are given the opportunity to choose between the JAKi filgotinib and TNFi, to the treatment satisfaction of patients who are randomized to the same treatment options.
In addition to higher treatment satisfaction and better adherence, the investigators expect to find an improvement in DAS28-, HAQ-, SQUASH- and WPAI-scores and also an improved activity and work productivity.
Objective:
- To evaluate the actual preference of patients when they decide themselves which mode of action they want to use for treatment of rheumatoid arthritis.
- To evaluate differences in treatment satisfaction between patients who can choose their therapy and those patients that are randomized for the same treatment options.
- To evaluate if adherence to therapy is increased when patients decide their own therapy.
- To evaluate the difference in improvement of disease activity by the Disease Activity Score (DAS28) and physical activity as measured by SQUASH questionnaire and fitness trackers.
Study design: This study is a multicenter, randomized, 24-week, open label trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 101 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Demographic and general characteristics:
- •Adult male or female patients, at least 18 years of age.
- •Able and willing to give written informed consent.
- •Have sufficient knowledge of the Dutch language to be able to comply with the requirements of the study protocol.
- •Inclusion criteria:
- •Diagnosis of adult-onset RA as defined by the 2010 ACR/ EULAR Rheumatoid arthritis classification criteria;
- •Diagnosis of RA for ≥ three months;
- •Are being treated ≥ three months with ≥ 1 csDMARD therapy;
- •Have had an inadequate response or intolerance to at least 1 csDMARD;
- •Have moderately to severely active RA to the discretion of the rheumatologist or defined as a DAS28 ≥ 3.2 at screening and baseline visits;
- •Subjects must have been on a stable dose of csDMARD therapy (restricted to methotrexate, chloroquine, hydroxychloroquine, sulfasalazine, or leflunomide) for ≥ 4 weeks prior to the baseline visit.
排除标准
- •Previous treatment with any biological DMARD or targeted synthetic DMARD/JAKi;
- •Inflammatory rheumatic disease other than RA, except for secondary Sjögren's syndrome.
- •Having a contraindication for either TNFi or filgotinib;
- •Latent or active tuberculosis;
- •Active or recurrent infections;
- •History of any malignancy within 5 years except for successfully treated NMSC or localized carcinoma in situ of the cervix;
- •≥ 3x upper limit of normal ALT, AST;
- •eGFR ≤ 30 ml/min;
- •planned or actual pregnancy or planning to father a child.
研究组 & 干预措施
Choice group
50 patients will be randomized to the choice group, they will view a neutral information video on anti TNF and Filgotinib and will be given the opportunity to choose between these two treatments
干预措施: Filgotinib (Drug)
Choice group
50 patients will be randomized to the choice group, they will view a neutral information video on anti TNF and Filgotinib and will be given the opportunity to choose between these two treatments
干预措施: Anti-Tumor Necrosis Factor Alpha Drug (Product) (Drug)
Choice group
50 patients will be randomized to the choice group, they will view a neutral information video on anti TNF and Filgotinib and will be given the opportunity to choose between these two treatments
干预措施: 50 patients will have a Free Choice between Filgotinib and anti TNF (Behavioral)
Randomization group anti TNF
A total of 50 patients will be randomized to the randomization group: 25 of those will start treatment with antiTNF
干预措施: Anti-Tumor Necrosis Factor Alpha Drug (Product) (Drug)
Randomization group Filgotinib
A total of 50 patients will be randomized to the randomization group: 25 of those will start treatment with Filgotinib
干预措施: Filgotinib (Drug)
结局指标
主要结局
Treatment satisfaction at week 24
时间窗: 24 weeks
Treatment satisfaction of both subgroups at week 24 at a 5-point Likert scale for current medical treatment: Ranging from 1: very dissatisfied, 2: dissatisfied, 3: neither dissatisfied nor satisfied, 4: satisfied, 5: very satisfied.
The proportion of subjects in the first subgroup choosing filgotinib therapy at baseline
时间窗: Baseline data
The proportion of subjects in the first subgroup choosing filgotinib therapy at baseline
次要结局
- How do patients in the treatment Choice group I rate being in control for their treatment decision.(week 6 and week 24)
- How patients rate being informed by the neutral information video(week 6 and week 24)
- Proportion of subjects who would choose filgotinib (again or otherwise) at 24-weeks if they were allowed to choose again.(week 24)
- Proportion of patients who were not able to make a treatment decision.(baseline data)
研究者
R.Bos
principal (coordinating) investigator
Rheumatology Research Center Northern Netherlands