Adalimumab s.c. for the treatment of patients with hidradenitis suppurativa – clinical efficacy, safety and tolerability - SOPHISTICATE - SOPHISTICATE

niversity of Copenhagen, Roskilde, Department of Dermatology0 个研究点开始时间: 2006年11月24日最近更新: 2017年8月21日

研究概览

暂无简介。

•Adult patients (>=18 years) with moderate to severe HS, defined as a Hurley stage II or III, for more than 6 months, and not responding adequately to conventional therapy will be included.
•Female patients of childbearing potential should have a negative pregnancy test (serum HCG) prior to start of study treatment. [Non-childbearing potential is defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)], and further, should use a reliable method of contraception e.g. intra-uterine devices or hormone contraceptives (oral, implantable, or injectable) during the entire study and 150 days after cessation of study medication.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Discharging HS lesions with defined microbial pathogens (Staphylococcus aureus or Streptococcus pyogenes, Group A).
•Use of conventional therapy for HS including but not limited to antibiotics, oestrogens/cyproterone acetate and surgery 4 weeks prior to baseline and during the 12 weeks’ treatment phase and biological therapies 12 weeks prior to baseline and during the 12 weeks’ treatment phase, or during the follow-up period as defined in this protocol, is not allowed.
•Patients with positive serology for hepatitis B or C indicating active infection, immuno-compromised conditions or history of HIV, history of listeriosis, history of histoplasmosis, active or latent TB, persistent chronic or active infections requiring hospitalisation and/or treatment with i.v. antibiotics, i.v. antivirals, or i.v. antifungals within 30 days or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to screening are excluded.
•Patients with a history of malignancy are excluded.

发起方

niversity of Copenhagen, Roskilde, Department of Dermatology