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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03192878
Date of registration: 09/05/2017
Prospective Registration: Yes
Primary sponsor: Ospedale San Raffaele
Public title: Infliximab Biosimilar in Takayasu's Arteritis TAKASIM
Scientific title: A Prospective Observational Study of Infliximab Biosimilar in the Treatment of Takayasu's Arteritis Resistant to Corticosteroids and Conventional Immune-suppressive Treatments
Date of first enrolment: March 1, 2017
Target sample size: 30
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03192878
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Italy
Contacts
Name:     Elena M Baldissera, MD
Address: 
Telephone: +39022643
Email: baldissera.elena@hsr.it
Affiliation: 
Name:     Elena M Baldissera, MD
Address: 
Telephone: +39022643
Email: baldissera.elena@hsr.it
Affiliation: 
Name:     Lorenzo Dagna, MD
Address: 
Telephone:
Email:
Affiliation:  IRCCS H San Raffaele
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Takayasu Arteritis
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time Frame: 12 months of treatment]
Number of patients with active disease at month 6 [Time Frame: 6 months of treatment]
Secondary Outcome(s)
Changes in the serum levels of TNF-alpha and anti-infliximab antibodies before and upon treatment with biosimilar infliximab. [Time Frame: 12 months of treatment]
Changes in the serum levels of TNF-alpha and anti-infliximab antibodies before and upon treatment with biosimilar infliximab. [Time Frame: 6 months of treatment]
Impact of the treatment on quality of life as assessed by the HAQ questionnaire [Time Frame: 12 months of treatment]
Impact of the treatment on quality of life as assessed by the HAQ questionnaire [Time Frame: 6 months of treatment]
Impact of the treatment on quality of life as assessed by the SF36 questionnaire [Time Frame: 12 months of treatment]
Impact of the treatment on quality of life as assessed by the SF36 questionnaire [Time Frame: 6 months of treatment]
Number of patients with active disease at month 12 [Time Frame: 12 months of treatment]
Secondary ID(s)
TakaSim
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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