A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial SpondyloarthritisMedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2018-003933-14-CZ
- Lead Sponsor
- Galapagos NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 109
- 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:
a) RA:
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
b) PsA
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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method