A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Synovial Biopsy Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 主要终点
- Assessment of rheumatoid arthritis (RA) biomarkers
研究概览
简要总结
The purpose of this study is to assess the impact of JNJ-38518168 on rheumatoid arthritis (RA) disease-related biomarkers in synovial biopsy tissue and blood in participants with active RA despite methotrexate (MTX) therapy and to assess the safety and tolerability of JNJ-38518168 over one year.
详细描述
This is a randomized (participants assigned to treatment by chance), double-blind (participants and study personnel will not know what treatment is being given), placebo-controlled (a placebo appears identical to a study drug, but contains no active ingredients), parallel-group (treatments will be given to groups of participants at the same time) study. Participants will be randomly assigned in a 3:1 ratio to receive either JNJ-38518168 for 52 weeks or receive matching placebo for 12 weeks, followed by JNJ-38518168 for 40 weeks. The total duration of participation will be approximately 60 weeks for all participants, including a screening visit and follow-up visits. Safety and tolerability of JNJ-38518168 will be evaluated by monitoring adverse events reported by participants throughout the study . In addition, results from clinical laboratory tests, electrocardiograms, vital signs measurements, and physical examinations performed during the study will be monitored.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had rheumatoid arthritis (RA) for at least 6 months prior to the date of signing the informed consent at screening
- •Be positive for either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum at screening
- •Have active RA defined for the purpose of this study as persistent disease activity with both of the following criteria: At least 4 swollen and 4 tender joints using a 66/68 joint count. At the time of screening, one of the tender or swollen joints or both must include the non-prosthetic knee to be biopsied; and serum C-reactive protein (CRP_ ≥ 0.60 mg/dL at screening
- •Have been treated with and tolerated oral methotrexate (MTX) treatment at doses from 10 mg/week to 25 mg/week inclusive, for a minimum of 3 months prior to the date of signing the informed consent at screening and must have a stable MTX dose for a minimum of 8 weeks prior to the date of signing the informed consent at screening and continue to receive the same MTX dose at Week 0
- •If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (pain relievers) regularly for RA, the participant must have been on a stable dose for at least 2 weeks prior to the first administration of study agent. If not using NSAIDs or other analgesics for RA at Week 0, the participant must have not received NSAIDs or other analgesics for RA for at least 2 weeks prior to the first administration of study agent
排除标准
- •Has inflammatory diseases other than RA
- •Has a history of juvenile idiopathic arthritis (JIA)
- •Has current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled
研究组 & 干预措施
JNJ-38518168
JNJ-38518168 30 mg once daily for 52 weeks.
干预措施: JNJ-38518168 (Drug)
JNJ-38518168
JNJ-38518168 30 mg once daily for 52 weeks.
干预措施: Methotrexate (Drug)
Placebo/JNJ-38518168
Matching placebo once daily for 12 weeks followed by JNJ-38518168 30 mg once daily for 40 weeks.
干预措施: JNJ-38518168 (Drug)
Placebo/JNJ-38518168
Matching placebo once daily for 12 weeks followed by JNJ-38518168 30 mg once daily for 40 weeks.
干预措施: Placebo (Drug)
Placebo/JNJ-38518168
Matching placebo once daily for 12 weeks followed by JNJ-38518168 30 mg once daily for 40 weeks.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Assessment of rheumatoid arthritis (RA) biomarkers
时间窗: Up to Week 52
Biomarkers may include, but are not limited to, inflammatory markers and cytokines; synovium/cartilage/bone markers; and gene expression profiles.
次要结局
- Number of participants reporting adverse events as a measure of safety and tolerability(Up to Week 56)