TOCIlizumab for difficult-to-treat RETroperitoneal fibrosis. TOCIRET Trial”

Phase 1

• Conditions: idiopathic retroperitoneal fibrosis; MedDRA version: 20.1Level: LLTClassification code 10021244Term: Idiopathic retroperitoneal fibrosisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-001429-41-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-01
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

- Written signed Informed consent
- patients with clinically active IRF, who have refractory disease: disease unresponsive to standard glucocorticoid therapy (initial dose 1 mg/kg/d) +/- conventional immunosuppressants (MTX, MMF).
- patients with clinically active IRF who previously reported serious adverse events related to the use of standard-dose glucocorticoids with or without common immunosuppressive drugs
-age 18-80 years
- Men and women of reproductive potential must agree to use a highly efficient means of contraception during the study. Such means include: a) intrauterine device (IUD) b) hormonal methods (such methods were used for at least three months prior to study entry and that they are used with a condom in the male partner); c) Essure micro-insert system ; d)complete abstinence from intercourse of reproductive potential; e) for male patients with female partners of childbearing potential, use of condoms is required. Female partners of male study subjects are asked to select one of the above methods.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

-Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrolment.
-secondary forms of retroperitoneal fibrosis
-Treatment-naïve patients
-Treatment with the investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening.
-Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20.
-Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.
-Immunization with a live/attenuated vaccine within 4 weeks prior to baseline.
-Previous treatment with TCZ (an exception to this criterion may be granted for single dose exposure).
-Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn’s disease.)
- Any history of recent serious bacterial, viral, fungal, or other opportunistic infections.
-Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.
-Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial.
- History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer.
- Pregnant women or nursing (breast feeding) mothers.
- Patients with reproductive potential not willing to use an effective method of contraception.
- History of alcohol, drug or chemical abuse within 1 year prior to screening.
- Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation.
- Patients with lack of peripheral venous access.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified