Infliximab Biosimilar in Takayasu’s Arteritis

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Brief Title

Infliximab Biosimilar in Takayasu's Arteritis

Official Title

A Prospective Observational Study of Infliximab Biosimilar in the Treatment of Takayasu's Arteritis Resistant to Corticosteroids and Conventional Immune-suppressive Treatments

Brief Summary

      Takayasu arteritis (TA) is a chronic inflammatory disease affecting large and medium caliber
      arteries, particularly the aortic arch and its main branches. Clinical manifestations are
      caused by the marked thickening of the wall of the involved vessels, resulting in lumen
      narrowing and ischemia of the tributary districts. Therapy is based on the use of
      corticosteroids, immunosuppressants, and biologic drugs including infliximab, a monoclonal
      antibody blocking tissue necrosis factor (TNF)-alpha. Biosimilar infliximab is commercially
      available and used in the treatment of various immune-mediated conditions. There are
      currently no data on the efficacy and safety of biosimilar infliximab in the treatment of TA.

      The investigators propose this monocentric, observational, prospective, open label study to
      evaluate the efficacy and safety of biosimilar infliximab in the treatment of 30 patients
      with TA. Specifically, the study will include: I) TA patients refractory to treatment with
      corticosteroid and/or immmunosuppressive therapy, not previously treated with infliximab; II)
      TA patients already receiving treatment with originator infliximab.

      Biosimilar infliximab will be administered at dosages usually employed in the treatment of
      TA. Specifically, patients not previously treated with the originator drug will receive
      biosimilar infliximab intravenously at a dose of 5 mg/Kg at time 0, at week 2, at week 4;
      thereafter, treatment will be administered every 4-6 weeks at a dose of 5-10 mg/kg based on
      clinical judgement. In patients previously treated with the originator drug, biosimilar
      infliximab will be administered at the same dosages.

      To evaluate the efficacy of therapy, changes in clinical manifestations, laboratory
      examinations, and imaging findings including angio-magnetic resonance imaging (MRI) of
      thoracic and abdominal vessels and total body PET/CT scan will be evaluate at time 0 as well
      as 6 and 12 months following treatment initiation. In order to evaluate the safety of the
      study treatment, the investigators will stringently evaluate possible side effects of
      treatment, including infusion reactions, changes in laboratory tests, infection, cancer,
      autoimmune manifestations, neurological and cardiovascular symptoms.

      The total duration of follow up for each patient will be 52 weeks from enrolment.
    



Study Type

Observational


Primary Outcome

Number of patients with active disease at month 6

Secondary Outcome

 Number of patients with active disease at month 12

Condition

Takayasu Arteritis

Intervention

Infliximab

Study Arms / Comparison Groups

 Naive patients
Description:  Patients with corticosteroid- and/or traditional immunosuppressive drug-resistant Takayasu's arteritis with indication of initiating therapy with anti-TNF-alpha

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

30

Start Date

March 1, 2017

Completion Date

July 2019

Primary Completion Date

February 2019

Eligibility Criteria

        Inclusion Criteria:

          -  age> 18 years;

          -  negative pregnancy test;

          -  use of a reliable contraceptive method by all potentially fertile patients during the
             study and for the six months following the end of therapy;

          -  diagnosis of TA according to the Classification criteria of the American College of
             Rheumatology 1990;

          -  Multifocal vascular aortic and arterial involvement as evaluated by imaging
             examinations (angiography / angio-MRI / vascular ecocolordoppler / PET);

          -  failure to respond to corticosteroid therapy after 6-8 weeks of prednisone therapy at
             a dose of 1 mg / Kg per day, or impossibility to reduce the dose of prednisone to 0.5
             mg / Kg within 3 months of initiation of therapy and to less than 0.2 mg / kg per day
             within 6 months of initiation of therapy (may also include patients who, despite
             receiving combination therapy with prednisone and cyclophosphamide, azathioprine,
             methotrexate, cyclosporin A, mycophenolate mofetil, leflunomide and rapamycin for at
             least 3 months, could not reduce the prednisone dose to 0.5 mg / Kg per day within 3
             months of initiation of therapy, or to less than 0.2 mg / kg per day within 6 months
             of initiation of therapy);

          -  ongoing anti-TNF-alpha treatment with originator infliximab (inclusion criterion for
             the switch arm).

        Exclusion Criteria:

          -  history of lymphoproliferative disease or solid neoplasm in the last 5 years, with the
             exception of successfully treated and completely resolved squamous cell skin
             carcinoma;

          -  history of uncontrolled diabetes, unstable cardiac ischaemia, congestive heart failure
             (NYHA class III and IV), active intestinal inflammatory disease, active peptic ulcer,
             recent stroke (within 3 months) and any other pathological conditions that, according
             to the treating physician, could expose the subject to the risk of adverse events;

          -  serological tests for hepatitis B or C indicating an active infection;

          -  history of HIV infection;

          -  chronic infection, or severe infections requiring hospitalization or intravenous
             antibiotic treatment within 30 days prior to inclusion in the study, or requiring
             treatment with oral antibiotics within 14 days prior to enrollment;

          -  ongoing pregnancy or lactation;

          -  history of drug or alcohol abuse;

          -  Previous diagnosis or signs of demyelinating disease of the central nervous system;

          -  history of active tuberculosis, histoplasmosis or listeriosis;

          -  previous infection with M. tuberculosis (as documented by chest x-rays and / or
             positive quantiferon test), in which case patients will only be enrolled after
             initiating prophylactic therapy according to current guidelines.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lorenzo Dagna, MD, +39022643, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT03192878

Organization ID

TakaSim


Responsible Party

Principal Investigator

Study Sponsor

Ospedale San Raffaele


Study Sponsor

Lorenzo Dagna, MD, Principal Investigator, IRCCS H San Raffaele


Verification Date

June 2017