Brief Title
Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever
Official Title
An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever
Brief Summary
Establish the safety and efficacy of 3 months treatment with canakinumab in patients with
colchicine resistant Familial Mediterranean Fever.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
To measure the effect of canakinumab on the frequency of FMF attacks defined as percentage of patients with at least 50% reduction in the attack frequency during 3 month treatment period.
Secondary Outcome
To assess the effect of canakinumab with regard to percentage of patients with no attacks in month 3.
Condition
Familial Mediterranean Fever
Intervention
Canakinumab
Study Arms / Comparison Groups
Canakinumab
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
10
Start Date
April 2010
Completion Date
August 2011
Primary Completion Date
August 2011
Eligibility Criteria
Inclusion Criteria:
- Male and female patients between 12 and 75 years of age with active type 1 FMF disease
(according to Tel-Hashomer criteria for diagnosis of FMF) despite colchicine therapy
(1.5 to 2.0 mg/day).
- Patients who are intolerant to effective doses of colchicine (1.5 to 2 mg/day)
- Patients with demonstrated minimum 1 typical acute attack per month and genetic
confirmation of diagnosis (with at least one of the known MEFV gene exon 10
mutations). Patients with manifested amyloidosis are excluded.
- Patients must have a historical data showing a frequency of at least 1 attack/month
within the last 3 months before they can be enter the run-in period.
- Patients must have type 1 disease characterized by recurrent and short episodes of
inflammation and serositis with an average of at least 1 documented acute FMF attack
per month during the previous 6 months and lasting approximately 12 to 72 hours.
- Patients treated with IL-1 therapies must complete washout and have experienced at
least 2 attacks since (e.g. Anakinra: 3 day washout; Rilonacept: 3 week washout)
- Patients treated with anti-TNF drugs must undergo appropriate washout. Prior to
randomization, use of Etanercept must be discontinued for 4 weeks or use of Adalimumab
or Infliximab must be discontinued for 8 weeks.
- Female subjects of childbearing potential must be using two acceptable methods of
contraception
- Patients treated with Interferon therapies must complete 1 month washout period.
Exclusion Criteria:
- Patients with end-organ dysfunction due to amyloidosis (e.g. existing biopsy proven
amyloidosis or proteinuria > 0.5 gram per day)
- Patients taking steroids within 1 month prior to baseline
- Presence or history of any other inflammatory rheumatic disease
- Positive PPD test (according to local guidance) where a latent or active TB infection
cannot be excluded via Quantiferon (T-Spot or radiographic imaging if needed).
- Patients who are pregnant or lactating
- Presence of any active or chronic infection or any major episode of infection
requiring hospitalization or treatment with i.v. antibiotics within 30 days or oral
antibiotics within 14 days prior to screening
- History or a malignancy within the last 5 years, except for successfully excised
squamous or basal cell carcinoma of the skin
Other protocol-defined inclusion/exclusion criteria may apply
Gender
All
Ages
12 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT01088880
Organization ID
CACZ885DTR01
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
April 2012