Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).
CompletedPhase 2NCT01242813
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This trial will assess the safety and efficacy of ACZ885 in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS).
Study details
- Official title
- An Open-label, Multicenter, Efficacy and Safety Study of 4-month Canakinumab Treatment With 6-month Follow-up in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).
- Conditions
- TNF-receptor Associated Periodic Syndromes (TRAPS)
- Interventions
- Drug: ACZ885
- Sponsor
- Novartis Pharmaceuticals
- Organization
- Novartis
- Start date
- 2010-10
- Primary completion
- 2014-06
- Sex
- All
- Age range
- from 4 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Ireland, Italy, United Kingdom
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Patient's written informed consent for \>or= 18 years of age before any assessment is performed. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients \< 18 years of age. 2. Male and female patients at least 4 years of age at the time of the screening visit. 3. Patients with a clinical diagnosis of TRAPS and a mutation of TNFRSF1A gene. Patients with low penetrance mutations, such as R92Q or P46L, can be included with mutual agreement between the investigator and Novartis. 4. Patients with a diagnosis of recurrent TRAPS must experience more than 6 episodes/year prior to receiving an effective biologic therapy and the duration of each episode lasted at least 8 days. For patients receiving biologic therapy, this criterion applies to prior to receiving the biologic therapy. 5. Patients who have been treated with anakinra must have demonstrated a partial or complete clinical response with an associated decrease in their inflammation markers (CRP and SAA). 6. Active TRAPS as evidenced by clinical signs and symptoms of active TRAPS (Physician's Global Assessment \>or= 2) and an elevated CRP \> 10mg/L (Normal CRP range \<or= 10 mg/L) and/or SAA \> 10 mg/L (Normal SAA range \<or= 10 mg/L) at time of first canakinumab treatment. Exclusion Criteria: 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL). 2. Women of child-bearing potential, defined as pre-menarche females aged 8 years and above or all women physiologically capable of becoming pregnant, UNLESS they are * women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner * women whose partners have been sterilized by vasectomy or other means * using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices \[IUDs\]; periodic abstinence \[e.g. calendar, ovulation, symptothermal, post-ovulation methods\] is not acceptable) or total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. * Women of child-bearing potential should be willing to us…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01242813