EUCTR2018-003933-14-CZ进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galapagos NV
- 入组人数
- 109
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Male between the ages of 21 and 65 (inclusive) on the day of signing informed consent.
- •- Diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nrAxSpA) for at least 12 weeks prior to screening, meeting the corresponding specific classification criteria:
- •a) RA, American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010
- •b) PsA, Classification criteria for Psoriatic Arthritis (CASPAR) criteria
- •c) AS or nrAxSpA, Assessment of Spondyloarthritis International Society (ASAS) criteria for axial spondyloarthritis
- •- For RA, PsA, AS, or nrAxSpA, meets the following criteria:
- •i) Inadequate response or intolerant to an =12-week course of csDMARD or biological DMARD (bDMARD) therapy for RA
- •ii) Have a Clinical Disease Activity Index (CDAI) >10 at screening
- •i) Inadequate response or intolerant =12-weeks’ course of csDMARD or bDMARD therapy for PsA
- •ii) Have a Disease Activity in Psoriatric Arthritis (DAPSA) score >14 at screening
- •c) Axial Spondyloarthritis (applicable to those with diagnosis of AS or nrAxSpA)
- •i) Inadequate response or intolerant to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), which may include cyclooxygenase-2 (COX-2 inhibitors) prescribed for a total period of =4 weeks OR to an at least 12 weeks’ course of csDMARD or bDMARD therapy for spondyloarthritis
- •ii) Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) =4 at screening
- •iii) At screening, subjects should have a C-reactive protein (CRP) >0.3 mg/dL OR sacroiliitis according to the modified New York (NY) criteria OR a history of active inflammation on magnetic resonance imaging (MRI) consistent with sacroiliitis within two year of screening
- •- If using csDMARD therapy, subjects are permitted to use one of the
- •following drugs, alone or in combination and must have been on a stable
- •dose of the drug for at least 4 weeks prior to Screening and remain on a
- •stable dose during the Double-blind treatment phase of the study (stable
- •dose in all cases is defined as no change in prescription):
- •a) MTX oral or parenteral up to 25 mg/week (with concomitant use of folic or folinic acid supplementation as per local standard of care)
- •b) Leflunomide (LEF) up to 20 mg/day orally
- •c) Hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day orally
- •d) Apremilast orally up to 30 mg twice daily orally
- •Note that sulfasalazine is not permitted at any time, beginning 26 weeks prior to Screening until the end of the study, and cannot be included in the standard of care arthritis regimen, due to its potential impact on semen parameters
- •- The mean of 2 separate semen samples collected at Screening must meet the following minimum criteria: semen volume = 1.5 mL, total sperm per ejaculate = 39 million, sperm concentration = 15 million per mL, sperm total motility = 40% and normal sperm morphology = 30%
- •- LH, FSH, inhibin B, and total testosterone values within 20% of laboratory reference ranges at Screening
- •This list only contains the key inclusion criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previously documented problems with male reproductive health
- •including, but not limited to, known hypothalamic-pituitary disorders
- •(eg, pituitary macroadenomas, pituitary infarction, hyperprolactinemia,
- •panhypopituitarism), primary hypogonadism (eg, cryptorchidism,
- •Klinefelter's syndrome)
- •- Prior diagnosis of male infertility (including reduced fertility), or
- •history of anti-sperm antibodies
- •- Clinically significant (per judgment of investigator) varicocele or
- •spermatocele
- •- History of radiation to the testicles
- •- History of clinically significant trauma to, or surgery on, the testicles,
- •including vasectomy
- •- Current treatment with antiandrogen therapy (including but not limited
- •to spirinolactone, oral ketoconazole, or cyproterone acetate), or
- •treatment within 4 weeks of Screening
- •- Presence of disorders of sperm transport, including but not limited to
- •retrograde ejaculation and immotile cilia syndrome.
- •- Clinically significant urinary tract infection, prostatitis, epididymitis,
- •including sexually transmitted infection within 4 weeks of Screening
- •- Any sexual dysfunction of a nature that would prevent sperm collection
- •in accordance with protocol guidance (phosphodiesterase inhibitors,
- •however, are permitted during the study)
- •This list only contains the key exclusion criteria.
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