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An Open-label, Multicenter, Efficacy and Safety Study of 4-month Canakinumab Treatment With 5-month Follow-up and Long-term Treatment Period in Patients With Active Recurrent or Chronic (Tumor Necrosis Factor)TNF-receptor Associated Periodic Syndrome (TRAPS)

Phase 2
4 Years
Open (Enrolling)
TNF-receptor Associated Periodic Syndromes (TRAPS)

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Trial Information

An Open-label, Multicenter, Efficacy and Safety Study of 4-month Canakinumab Treatment With 5-month Follow-up and Long-term Treatment Period in Patients With Active Recurrent or Chronic (Tumor Necrosis Factor)TNF-receptor Associated Periodic Syndrome (TRAPS)

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 mg/L) and/or SAA > 10 mg/L (Normal SAA range 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 use a reliable
contraception throughout the study and for 3 months after study drug

- Women are considered post-menopausal and not of child bearing potential if they
have had 12 months of natural (spontaneous) amenorrhea with an appropriate
clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six
months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had
surgical bilateral oophorectomy (with or without hysterectomy) at least six
weeks ago. In the case of oophorectomy alone, only when the reproductive status
of the woman has been confirmed by follow up hormone level assessment is she
considered not of child bearing potential.

3. History of being immunocompromised, including a positive HIV at screening (ELISA and
Western blot) test result.

4. 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.

5. Live vaccinations within 3 months prior to the start of the trial, during the trial,
and up to 3 months following the last dose.

6. History of significant other medical conditions, which in the Investigator's opinion
would exclude the patient from participating in this trial.

7. History of recurrent and/or evidence of active bacterial, fungal, or viral

8. 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

9. History of known hypersensitivity to canakinumab.

10. History of malignancy of any organ system (other than localized basal cell carcinoma
of the skin), treated or untreated, within the past 5 years, regardless of whether
there is evidence of local recurrence or metastases

Other protocol defined inclusion/exclusion criteria may apply.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete/almost complete response in patients with active TRAPS determined by results of The Physician's Global Assessment, C-reactive protein (CRP) and serum amyloid A (SAA) results

Outcome Time Frame:

Day 15 and throughout 4-month and long-term treatment period

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Ireland: The Food Safety Authority of Ireland

Study ID:




Start Date:

October 2010

Completion Date:

January 2014

Related Keywords:

  • TNF-receptor Associated Periodic Syndromes (TRAPS)
  • TNF-receptor associated periodic syndrome
  • fevers
  • rashes
  • musculoskeletal and abdominal pain
  • periorbital edema
  • TNFR1
  • Hereditary Autoinflammatory Diseases