NCT02778906已完成3 期
Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia (ARIAA)
University of Erlangen-Nürnberg Medical School9 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 9
- 主要终点
- Proportion of patients with an improvement of acute inflammation characterised as improvement of synovitis (synovialitis or tenosynovitis) or osteitis in the MRI of the dominant hand after 6 months of treatment with abatacept or placebo
研究概览
简要总结
This is a randomised double-blinded placebo-controlled multi centre study in 98 patients with ACPA positive arthralgia. The study is composed of 2 arms with a 1:1 randomisation at baseline: Treatment phase will be 6 months. Group 1: Abatacept s.c. 125 mg weekly for 6 months vs. Group 2: Placebo s.c. for 6 months. After 6 months both groups will run into the follow up period for another 12 months up to month 18. Patients developing arthritis will be treated according to local guidelines.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females and males aged ≥ 18 years at time of consent
- •ACPA (with or without RF)
- •Joint pain (hand, feet, knee, shoulder or elbow) present for at least 6 weeks prior to inclusion or in past history
- •Presence of synovitis (synovialitis or tenosynovitis) or osteitis in MRI of the dominant hand at baseline
- •Women of childbearing potential or men capable of fathering children must be using effective contraception during treatment with abatacept and up to 14 weeks after the last dose of abatacept treatment.
- •Must understand and voluntarily sign an informed consent form including written consent for data protection
- •Must be able to adhere to the study visit schedule and other protocol requirements
排除标准
- •Presence of arthritis in hand, feet, knee, shoulder or elbow joints defined as swelling
- •Current treatment with glucocorticoids conventional or biologic DMARDs
- •Previous treatment with abatacept
- •Investigational study drug within 4 weeks (or 5 half lives, whichever is longer) prior to randomization
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- •Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis.
- •Any malignancy in the last 5 years
- •Chronic infection such as latent TB (TB not adequately treated according to guidelines) or hepatitis B or C infection
- •Immunocompromised or HIV-positive patients
- •Uncontrolled severe concomitant disease
- •Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG).
- •Pregnant or lactating females
- •Patients who possibly are dependent on the Principal Investigator or Investigator (e.g. family members).
研究组 & 干预措施
Abatacept
Active Comparator
Abatacept 125 mg s.c. weekly
干预措施: Abatacept (Drug)
Placebo
Placebo Comparator
Placebo (NaCl 0,9%) s.c. weekly
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients with an improvement of acute inflammation characterised as improvement of synovitis (synovialitis or tenosynovitis) or osteitis in the MRI of the dominant hand after 6 months of treatment with abatacept or placebo
时间窗: 6 months
次要结局
- Time to disappearance of arthralgia.(6 months)
- RAMRIS osteitis score in the dominant hand 12 and 18 months.(6,12,18 months)
- Swollen Joint Count 68(3,6,9,12,15 and 18 months)
- Visual analogue scale (VAS) patient global(3,6,9,12,15 and 18 months)
- Visual analogue scale (VAS) physician global(3,6,9,12,15 and 18 months)
- Proportion of patients with new or persistent arthralgia.(6,12,18 months)
- Proportion of patients with clinical arthritis defined by joint swelling(6,12,18 months)
- Proportion of patients with RA (ACR/EULAR 2010 criteria)(6,12,18 months)
- Tenosynovitis score in the dominant hand.(6,12,18 months)
- RAMRIS synovitis score in the dominant hand 12 and 18 months.(6,12,18 months)
- Proportion of patients with radiological progress in HR-pQCT analysis comparing baseline image with end of study image.(18 months)
- Tender Joint Count 68(3,6,9,12,15 and 18 months)
- Disease activity score (DAS) 28(3,6,9,12,15 and 18 months)
- Visual analogue scale (VAS) pain(3,6,9,12,15 and 18 months)
- Duration of joint stiffness(3,6,9,12,15 and 18 months)
- Health assessment Questionnaire (HAQ-DI)(6,12 and 18 months)
- Rheumatoid Arthritis Impact of Disease (RAID)(6,12 and 18 months)
- Short Form 36 (SF-36)(6,12 and 18 months)
- Bone mineral density (BMD)(18 months)
- Bone volume per tissue volume (BV/TV)(18 months)
- Cortical width in the micro-CT of the distal radius(18 months)
- Cortical porosity in the micro-CT of the distal radius(18 months)
- RAMRIS erosion score in the dominant hand 12 and 18 months.(6. 12. 18 months)
- Cortical width in the micro-CT of the metacarpal heads(18 months)
- Cortical porosity in the micro-CT of the metacarpal heads(18 months)
研究者
研究点 (9)
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