A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis (Protocol No. P07642, Also Known as MK-8259-006-02).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 主要终点
- Percentage of Participants Who Experienced at Least One Adverse Event (AE)
研究概览
简要总结
This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2, the participants were to be told they were receiving active study drug. The primary hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to placebo as measured by the proportion of participants achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active axial spondyloarthritis with disease duration ≤5 years, and chronic back pain of ≥3 month duration
- •Have either an inadequate response to 30 days of optimal daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a full 30 day maximal NSAID therapy because of intolerance, toxicity or contraindications to NSAIDs
- •Females of child-bearing potential must use contraception
- •No history of untreated latent or active tuberculosis
排除标准
- •Fulfillment of modified New York criteria for ankylosing spondylitis
- •Has ever received tumor necrosis factor (TNF)-α targeted therapy or any biological agents
- •Any systemic inflammatory condition other than spondyloarthritis
- •Serious infection within 2 months
- •Any known malignancy or a history of malignancy within the previous 5 years
- •Has or had a substance abuse (drug or alcohol) problem within the previous 2 years
研究组 & 干预措施
Placebo→Golimumab
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
干预措施: Placebo (Biological)
Golimumab→Golimumab
In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
干预措施: Golimumab (Biological)
Placebo→Golimumab
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
干预措施: Golimumab (Biological)
结局指标
主要结局
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
时间窗: Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.
Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16
时间窗: Week 16
The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of \>=20% from Baseline and an absolute improvement from Baseline of \>=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a \>=20% worsening and an absolute worsening of \>=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.
Percentage of Participants Who Discontinued Study Drug Due to an AE
时间窗: Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.
次要结局
- Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16(Week 16)
- Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16(Week 16)
- Percentage of Participants Achieving ASAS Partial Remission at Week 16(Week 16)
- Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16(Baseline and Week 16)