EUCTR2016-003828-23-DE
Active, not recruiting
Phase 1
A pilot open-label study to assess the efficacy and safety of tocilizumab (TCZ) in patients with active Schnitzler’s syndrome (SchS)
Charité - Universitätsmedizin Berlin; Dpt. of Dermatology and Allergy0 sites12 target enrollmentJanuary 31, 2017
ConditionsSchnitzler’s syndrome (SchS)MedDRA version: 19.1 Level: PT Classification code 10062908 Term: Schnitzler's syndrome System Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsRoActemra
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Schnitzler’s syndrome (SchS)
- Sponsor
- Charité - Universitätsmedizin Berlin; Dpt. of Dermatology and Allergy
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (18 years or older)
- •SchS diagnosis based on Strasbourg clinical criteria
- •Active SchS, refractory to treatment with antihistamines, NSAIDS or colchicine, hydroxychloroquine or dapsone
- •Patients who have a symptom score (PGA) of at least 8 (0\-20\) at baseline
- •If necessary, concurrent/ongoing treatment with a stable dose of systemic corticosteroids not greater than 10mg/d for 14 days prior to screening
- •If necessary, concurrent/ongoing treatment with a stable dose of antihistamines and NSAIDs for 7 days prior to screening
- •Able to read, understand and willing to sign the informed consent form and abide with study procedures
- •Willing, committed and able to return for all clinic visits and complete all study\-related procedures, including willingness to have SC injections administered by a qualified person
- •In females of childbearing potential: Negative pregnancy test within 28 days of randomization; males and females willing to use highly effective contraception (Pearl\-Index \< 1\) during study treatment and for a minimum of 3 months after last dose of TCZ. Pregnancies occurring up to 90 days after the completion of the study medication must be reported to the investigator. A woman will be considered not of childbearing potential if she is post\-menopausal for greater than two years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
- •Subjects are considered eligible, if they meet the following tuberculosis (TB) screening criteria: no history of latent or active TB prior to screening, no signs or symptoms suggestive of active TB, no recent close contacts with a person with active TB, and negative QuantiFERON\-TB test at screening (if QuantiFERON\-TB test is positive, the patient can only be included if active TB is ruled out with appropriate measurements according to standard of care, e.g. the patient is pre\-treated with isoniazide for 4 weeks).
Exclusion Criteria
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
- •Concurrent/ongoing treatment with biologics or recent treatment (less than 5 half lives)
- •o With Anakinra within 7 days prior to screening, with canakinumab within 100 days prior to screening
- •o with oral/parental corticosteriods greater than 10 mg/d within 2 weeks prior to screening
- •o with Cyclosporin A Methotrexate, Dapsone, Chloroquine, Hydroxychloroquine, Azathioprine, Cyclophosphamide within 4 weeks prior to screening
- •o other immunosuppressives within 4 weeks or 5 half lives prior to screening, whichever is longer
- •o Previous treatment within six months of randomization with any cell\-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti\-CD4, anti\-CD5, anti\-CD3, anti\-CD19 and anti\-CD20\.
- •o Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.
- •Treatment with a live (attenuated) virus vaccine within 4 weeks prior to Baseline visit
- •Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
Outcomes
Primary Outcomes
Not specified
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