CompletedPhase 2

Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).

Ireland, Italy20 participantsStarted 2010-10

Plain-language summary

This trial will assess the safety and efficacy of ACZ885 in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS).

Who can participate

Age range4 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Male and female patients at least 4 years of age at the time of the screening visit.
✓. 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.
✓. 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.
✓. 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).
✓. 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

✕. 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).
✕. 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
✕. History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) test result.
✕. Positive QuantiFERON (QFT-TB G In-Tube) test or positive Purified Protein Derivative (PPD) test (\>or= 5 mm induration) at screening or within 2 month prior to the screening visit, according to the national guidelines. Patients with a positive PPD test (\>or= 5 mm induration) at screening may be enrolled only if they have either a negative chest x-ray or a negative QuantiFERON test.
✕. Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.
✕. History of significant other medical conditions, which in the Investigator's opinion would exclude the patient from participating in this trial.
✕. History of recurrent and/or evidence of active bacterial, fungal, or viral infection(s).
✕. Use of prohibited therapies, any other investigational biologics within 8 weeks prior to the Baseline visit, any other investigational drugs, other than investigational biologic treatment, within 30 days (or 3 months for investigational monoclonal antibodies) or 5 half-lives prior to the Baseline visit, whichever is longer

What they're measuring

Percentage of Participants With Complete or Almost Complete Response at Day 15

Timeframe: Day 15

Trial details

NCT IDNCT01242813

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-06

Results submitted2015-11-02

View on ClinicalTrials.gov More TNF-receptor Associated Periodic Syndromes (TRAPS) trials