A Prospective Study of Tocilizumab in the Treatment of Idiopathic Retroperitoneal Fibrosis

Idiopathic Retroperitoneal Fibrosis Clinical Trial

Official title:

A Prospective, Controlled, Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab in the Treatment of Idiopathic Retroperitoneal Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04762784
• Other study ID #: tocilizumab treatment for IRPF
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: February 10, 2023

Study information

• Verified date: March 2021
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective study to investigate the treatment response of Tocilizumab on patients with idiopathic retroperitoneal fibrosis（IRPF）. Methods: All the patients fulfilling diagnostic criteria of IRPF would be enrolled. The IRPF patients will accept Tocilizumab or Glucocorticoid monotherapy for 3 months. Endpoints: The primary endpoint is to investigate the response of Tocilizumab on IRPF patients; the secondary endpoints include the decrease of inflammatory markers, side effect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 18-75 diagnosed as IRPF: The diagnosis of idiopathic retroperitoneal fibrosis is based on the following aspects :(1) the swelling of retroperitoneal tissue , which seems neoplastic; (2) A large number of lymphocytes proliferated and infiltrated in the affected tissues and organs, and tissues showed inflammation, fibrosis and sclerosis, in which IgG4-positive cells accounted for less than 50% of plasma cells; (3) Increased inflammatory markers, such as ESR and CRP; (4) Good response to glucocorticoid therapy.

Exclusion Criteria:

• malignancy retroperitoneal fibrosis secondary to other diseases or drug treatment or abdominal surgeries.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Retroperitoneal Fibrosis
• Retroperitoneal Fibrosis

Intervention

Drug:
• Tocilizumab
Tocilizumab treatment: Tocilizumab infusion 8mg/Kg,Once per month for 3 months.
• Glucocorticoids
Prednisone/prednisolone: started at 0.6-0. 8mg/kg.d for 2 to 4 weeks, tapered at 5mg per 1-2 weeks to equal to or less than 15mg per day in 3 months.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

Binder M, Uhl M, Wiech T, Kollert F, Thiel J, Sass JO, Walker UA, Peter HH, Warnatz K. Cyclophosphamide is a highly effective and safe induction therapy in chronic periaortitis: a long-term follow-up of 35 patients with chronic periaortitis. Ann Rheum Dis. 2012 Feb;71(2):311-2. doi: 10.1136/annrheumdis-2011-200148. Epub 2011 Aug 22. — View Citation

Jagadesham VP, Scott DJ, Carding SR. Abdominal aortic aneurysms: an autoimmune disease? Trends Mol Med. 2008 Dec;14(12):522-9. doi: 10.1016/j.molmed.2008.09.008. Epub 2008 Nov 6. Review. — View Citation

Marzano A, Trapani A, Leone N, Actis GC, Rizzetto M. Treatment of idiopathic retroperitoneal fibrosis using cyclosporin. Ann Rheum Dis. 2001 Apr;60(4):427-8. — View Citation

Qian Q, Kashani KB, Miller DV. Ruptured abdominal aortic aneurysm related to IgG4 periaortitis. N Engl J Med. 2009 Sep 10;361(11):1121-3. doi: 10.1056/NEJMc0905265. — View Citation

Scheel PJ Jr, Feeley N, Sozio SM. Combined prednisone and mycophenolate mofetil treatment for retroperitoneal fibrosis: a case series. Ann Intern Med. 2011 Jan 4;154(1):31-6. doi: 10.7326/0003-4819-154-1-201101040-00005. — View Citation

Schultz O, Schuchmann S, Burmester GR, Buttgereit F. Case number 26: systemic idiopathic fibrosis associated with aortitis. Ann Rheum Dis. 2003 May;62(5):486. — View Citation

Summaries for patients. Tamoxifen for the treatment of retroperitoneal fibrosis. Ann Intern Med. 2006 Jan 17;144(2):I51. — View Citation

Swartz R, Scheel P. Retroperitoneal fibrosis: gaining traction on an enigma. Lancet. 2011 Jul 23;378(9788):294-6. doi: 10.1016/S0140-6736(11)60880-5. Epub 2011 Jul 4. — View Citation

Vaglio A, Greco P, Buzio C. Tamoxifen therapy for retroperitoneal fibrosis. Ann Intern Med. 2006 Apr 18;144(8):619; author reply 619-20. — View Citation

Vaglio A, Palmisano A, Alberici F, Maggiore U, Ferretti S, Cobelli R, Ferrozzi F, Corradi D, Salvarani C, Buzio C. Prednisone versus tamoxifen in patients with idiopathic retroperitoneal fibrosis: an open-label randomised controlled trial. Lancet. 2011 Jul 23;378(9788):338-46. doi: 10.1016/S0140-6736(11)60934-3. Epub 2011 Jul 4. — View Citation

Vaglio A, Salvarani C, Buzio C. Retroperitoneal fibrosis. Lancet. 2006 Jan 21;367(9506):241-51. Review. — View Citation

van Bommel EF, Hendriksz TR, Huiskes AW, Zeegers AG. Brief communication: tamoxifen therapy for nonmalignant retroperitoneal fibrosis. Ann Intern Med. 2006 Jan 17;144(2):101-6. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events	Participants suffer from adverse events due to the drug treatment	5 years
Primary	remission	Remission is achieved when symptoms are alleviated and laboratory tests return to normal levels or radiologic improvement is observed.	5 years
Secondary	relapse	Participants have recurrence of symptoms and laboratory abnormalities.	5 years