NCT03253796已完成4 期
A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH 900259]) After Treatment Withdrawal, Compared With Continued Treatment (Either Full- or Reduced-Treatment Regimen), In Subjects With Non-Radiographic Axial Spondyloarthritis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 142
- 主要终点
- Percentage of Participants Without a Disease Activity Flare During Period 2
研究概览
简要总结
The purpose of this study is to evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.
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
- •Is not of reproductive potential, or is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner while receiving trial medication or within 6 months after the last dose of trial medication
- •Has chronic back pain of ≥3 months duration by history
- •Has physician-diagnosed active non-radiographic axial spondyloarthritis (nr-axSpA) with disease duration <= 5 years
- •Meets one of the following criteria:
- •Has active inflammation on magnetic resonance imaging (MRI) highly suggestive of sacroiliitis associated with spondyloarthropathy and 1 or more of the following spondyloarthritis (SpA) characteristics:
- •Inflammatory back pain
- •Arthritis (physician-diagnosed)
- •Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the Achilles tendon or plantar fascia)
- •Dactylitis (physician-diagnosed)
- •Psoriasis (physician-diagnosed)
- •History of physician-diagnosed inflammatory bowel disease (IBD)
- •History of uveitis confirmed by an ophthalmologist
- •Good response to nonsteroidal anti-inflammatory drugs (NSAID)
- •Family history of SpA (presence of ankylosing spondylitis, psoriasis, acute uveitis, reactive arthritis, or IBD)
- •Elevated C-reactive protein (CRP)
- •Human leukocyte antigen B27 (HLA-B27)+ gene OR
- •Has a HLA-B27+ gene and 2 or more of the following SpA characteristics:
- •Inflammatory back pain
- •Arthritis (physician-diagnosed)
- •Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the Achilles tendon or plantar fascia)
- •Dactylitis (physician-diagnosed)
- •Psoriasis (physician-diagnosed)
- •History of physician-diagnosed inflammatory bowel disease (IBD)
- •History of uveitis confirmed by an ophthalmologist
- •Good response to nonsteroidal anti-inflammatory drugs (NSAID)
- •Family history of SpA (presence of ankylosing spondylitis, psoriasis, acute uveitis, reactive arthritis, or IBD)
- •Elevated C-reactive protein (CRP)
- •Has elevated CRP at Screening or evidence of active inflammation in the sacroiliac joints on MRI
- •Has an Ankylosing Spondylitis Disease Activity Score (ASDAS) >= 2.1 at Screening
- •Shows high disease activity at Screening and Baseline of both a Total Back Pain score of ≥4 and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of >= 4
- •Has an acceptable history of NSAID use
- •Has no history of untreated latent or active tuberculosis (TB) prior to Screening
- •Has had no recent close contact with a person with active TB or, if there has been such contact, will undergo additional evaluations and receive appropriate treatment for latent TB
- •Agrees to undergo screening for hepatitis B virus (HBV) and demonstrates negative results for hepatitis B surface antigen (HBsAg) and HBV deoxyribonucleic acid (DNA)
排除标准
- •Has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional x-rays
- •Is a nursing or pregnant female, or intends to become pregnant within 6 months after receiving trial medication
- •Intends to donate eggs (female participants) or sperm (male participants) while receiving trial medication or within 6 months after trial medication
- •Has any clinically significant condition or situation that would interfere with the trial evaluations or participation in the trial
- •Has ever received any cytotoxic drugs, including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents
- •Has received any treatment listed below more recently than the indicated off-drug period prior to Screening
- •• Disease-modifying anti-rheumatic drugs (30 days off drug)
- •• Live vaccinations (3 months off drug)
- •• Investigational medications (30 days or 5 half-lives off drug, whichever is longer)
- •• Bacille Calmette-Guerin (BCG) vaccination (12 months off drug)
- •Has any systemic inflammatory condition, including psoriatic arthritis, active Lyme disease, systemic lupus erythematosus, infectious arthritis, vasculitis, parvovirus infection, rheumatoid arthritis, active uveitis, or active IBD
- •Has a history of latent or active granulomatous infection prior to Screening
- •Had a nontuberculous mycobacterial infection or opportunistic infection within 6 months prior to Screening
- •Has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
- •Had a serious infection, has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 2 months prior to Baseline
- •Had a history of, or ongoing, chronic or recurrent infectious disease
- •Is known to be infected with human immunodeficiency virus (HIV) or seropositive for hepatitis C virus (HCV)
- •Has had a chest x-ray within 2 months prior to Screening that shows an abnormality suggestive of a current active infection or malignancy
- •Has a history of lymphoproliferative disease
- •Has had a malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of cervix that has been surgically cured)
- •Has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis
- •Has a history of or concurrent congestive heart failure of any grade
- •Has a transplanted organ (with the exception of a corneal transplant performed >= 3 months prior to baseline)
- •Has current signs or symptoms of significant medical illness which could interfere with the trial, or require treatment that might interfere with the trial
- •Is a user of recreational or illicit drugs or has or had a substance abuse (drug or alcohol) problem within the previous 2 years
结局指标
主要结局
Percentage of Participants Without a Disease Activity Flare During Period 2
时间窗: Up to 12 months
Disease flare is defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) at two consecutive visits that both show either absolute score ≥2.1 or a post-withdrawal increase of ≥1.1 relative to baseline prior to the first dose of double-blind treatment in Period 2. The ASDAS is a composite index assessing disease activity in axial spondyloarthropathies that consists of 4 self-assessed parameters and 1 laboratory parameter. The self-assessed parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are individually scored on a numeric scale of 0 to 10, with 0 being low activity/impact and 10 being high activity/impact. The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which has a lower limit of 0.6 and no defined upper limit. A higher score indicates greater disease activity.
次要结局
- Time to First Disease Flare(Month 3, Month 6, Month 9, and Month 12)
- Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment)(Up to 12 months)
- Percentage of Participants Achieving ASAS Partial Remission (Double-blind Treatment)(Up to 12 months)
- Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment)(Up to 12 months)
- Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment(Up to 3 months following start of retreatment)
- Percentage of Participants Achieving ASAS40 Response (Open-label Retreatment)(Up to 12 months)
- Percentage of Participants Achieving ASAS Partial Remission (Open-label Retreatment)(Up to 12 months)
- Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment)(Up to 12 months)
- Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment)(Up to 12 months)
- Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2(Up to approximately 15 months)
- Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment)(Up to 12 months)
- Percentage of Participants Achieving Inactive Disease Status (Open-label Retreatment)(Up to 12 months)
- Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2(Up to approximately 12 months)
- Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment)(Up to 12 months)
研究者
研究点 (142)
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