Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000922279
Ethics application status
Approved
Date submitted
17/03/2018
Date registered
31/05/2018
Date last updated
31/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Tocilizumab for the treatment of retroperitoneal fibrosis
Scientific title
Tocilizumab treatment for induction of remission in patients with idiopathic retroperitoneal fibrosis (TOCIRET)
Secondary ID [1] 294373 0
EUDRACT No. 2017-001429-41
Universal Trial Number (UTN)
Trial acronym
TOCIRET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
retroperitoneal fibrosis 307106 0
Condition category
Condition code
Inflammatory and Immune System 306214 306214 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment with the monoclonal antibody Tocilizumab, given intravenously at a dose of 8 mk/kg every month for 6 consecutive months. This therapeutic regimen will apply to all enrolled patients. The drug will be administered in a hospital setting (day hospital), which will allow evaluation of patient's adherence.
Intervention code [1] 300677 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305230 0
Remission is a composite endpoint, defined as absence of disease-related symptoms and hydronephrosis, in the presence of normal acute-phase reactants, and a prednisone dose max 5 mg/day.
This outcome will be assessed on the basis of: i) patient-reported symptoms; 2)measurement of acute-phase reactants (Erythrocyte sedimentation rate and C-reactive protein level); 3)imaging evaluation of hydronephrosis, assessed by ultrasound, computed tomography or magnetic resonance.
Timepoint [1] 305230 0
6 months (end of treatment)
Secondary outcome [1] 344543 0
Percentage of patients in remission. This will be assessed on the basis of patient reported symptoms and medical records reporting the results of laboratory tests (Erythrocyte sedimentation rate and C reactive protein) and imaging studies (ultrasound of the kidney and urinary tract, abdominal computed tomography or magnetic resonance)
Timepoint [1] 344543 0
Month 12 (6 months after the end of treatment)
Secondary outcome [2] 344544 0
Change in retroperitoneal fibrosis thickness (assessed by CT or MRI)
Timepoint [2] 344544 0
Months 6 and 12 after the start of treatment
Secondary outcome [3] 347507 0
Change in FDG uptake (assessed by PET) versus baseline
Timepoint [3] 347507 0
Months 6 and 12 after the start of treatment
Secondary outcome [4] 347528 0
Treatment-related toxicity (frequency, type and severity of adverse events)
Timepoint [4] 347528 0
This will be monitored monthly during treatment (months 1,2,3,4,5,6 after the start of treatment) and bi-monthly during the post-treatment follow-up (months 8, 10, 12 after the start of treatment)

Eligibility
Key inclusion criteria
- Clinically active idiopathic retroperitoneal fibrosis
- Absence of potential causes of retroperitoneal fibrosis
- Written informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Secondary forms of retroperitoneal fibrosis (infectious, neoplastic, post-radiation therapy, drug-related)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
None
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be presented as median (range) or mean (SD), where appropriate.
Survival will be analyzed using the Kaplan-Meier method
Paired t-tests or the corresponding non-parametric tests will be used to analyze changes in measurable parameters such as mass thickness, FDG uptake, ESR or CRP levels. P values <0.05 will be considered statistically significant.
All patients will be analyzed following an intention-to-treat analysis provided that they received at least 2 months of therapy

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 10226 0
Italy
State/province [1] 10226 0
Parma, Firenze, Reggio Emilia

Funding & Sponsors
Funding source category [1] 299014 0
Commercial sector/Industry
Name [1] 299014 0
Roche
Country [1] 299014 0
Italy
Primary sponsor type
Hospital
Name
Azienda Ospedaliero Universitaria di Parma
Address
Via Gramsci 14, 43126 Parma
Country
Italy
Secondary sponsor category [1] 298240 0
None
Name [1] 298240 0
None
Address [1] 298240 0
None
Country [1] 298240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299952 0
Comitato Etico per Parma
Ethics committee address [1] 299952 0
Ethics committee country [1] 299952 0
Italy
Date submitted for ethics approval [1] 299952 0
18/12/2017
Approval date [1] 299952 0
22/12/2017
Ethics approval number [1] 299952 0
Protocol number 46706

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82062 0
Dr Augusto Vaglio
Address 82062 0
Azienda Ospedaliero-Universitaria di Parma,
Nephrology Unit,
Via Gramsci 14
43126 Parma
Country 82062 0
Italy
Phone 82062 0
+39 0521 702013
Fax 82062 0
+39 0521 704701
Email 82062 0
augusto.vaglio@virgilio.it
Contact person for public queries
Name 82063 0
Augusto Vaglio
Address 82063 0
Azienda Ospedaliero-Universitaria di Parma,
Nephrology Unit,
Via Gramsci 14
43126 Parma
Country 82063 0
Italy
Phone 82063 0
+39 0521 702013
Fax 82063 0
+39 0521 704701
Email 82063 0
augusto.vaglio@virgilio.it
Contact person for scientific queries
Name 82064 0
Augusto Vaglio
Address 82064 0
Azienda Ospedaliero-Universitaria di Parma,
Nephrology Unit,
Via Gramsci 14
43126 Parma
Country 82064 0
Italy
Phone 82064 0
+39 0521 702013
Fax 82064 0
+39 0521 704701
Email 82064 0
augusto.vaglio@virgilio.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.