Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever

Related Clinical Trial
Study of Colchicine Resistance in Familial Mediterranean Fever Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever Central Sensitization in Familial Mediterranean Fever (FMF) Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever Characterization of a Functional Test for Mediterranean Family Fever Screening – 2 Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis Heat Intolerance in the Group of FMF Patients Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission Tocilizumab for the Treatment of Familial Mediterranean Fever Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever. A Diagnostic Test for Familial Mediterranean Fever Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever Rilonacept for Treatment of Familial Mediterranean Fever (FMF)

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