- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04762784
A Prospective Study of Tocilizumab in the Treatment of Idiopathic Retroperitoneal Fibrosis
A Prospective, Controlled, Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab in the Treatment of Idiopathic Retroperitoneal Fibrosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100032
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Yunyun Fei
- Phone Number: +8613681125226
- Email: feiyunyun2013@sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tocilizumab treatment
Tocilizumab is a recombinant humanized monoclonal antibody against human interleukin-6 (IL-6) receptor.
Tocilizumab acts by inhibiting the activity of IL-6 receptor.
IL-6 is a pro-inflammatory cytokine whose release can trigger a series of downstream pro-inflammatory responses.
Tocilizumab inhibits IL-6 signal transduction by blocking the binding of IL-6 to soluble and membrane-bound IL-6 receptors, thereby reducing pathological inflammatory responses.
|
Tocilizumab treatment: Tocilizumab infusion 8mg/Kg,Once per month for 3 months.
|
Active Comparator: Glucocorticoids monotherapy
Glucocorticoids has fast onset of action and multiple anti-inflammatory effects.The conventional protocol is oral prednisone, followed by a slow tapering over 4 weeks.
Besides, precautionary measures need to be taken against possible complications brought by the application of corticosteroids such as infections, diabetes mellitus, hypertension, Cushing's syndrome and osteoporosis, etc.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
remission
Time Frame: 5 years
|
Remission is achieved when symptoms are alleviated and laboratory tests return to normal levels or radiologic improvement is observed.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relapse
Time Frame: 5 years
|
Participants have recurrence of symptoms and laboratory abnormalities.
|
5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse events
Time Frame: 5 years
|
Participants suffer from adverse events due to the drug treatment
|
5 years
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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. doi: 10.7326/0003-4819-144-2-200601170-00007.
- Vaglio A, Salvarani C, Buzio C. Retroperitoneal fibrosis. Lancet. 2006 Jan 21;367(9506):241-51. doi: 10.1016/S0140-6736(06)68035-5.
- 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. doi: 10.1136/ard.60.4.427.
- 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.
- 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. No abstract available.
- 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.
- 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.
- 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. No abstract available.
- 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. doi: 10.1136/ard.62.5.486. No abstract available.
- Summaries for patients. Tamoxifen for the treatment of retroperitoneal fibrosis. Ann Intern Med. 2006 Jan 17;144(2):I51. doi: 10.7326/0003-4819-144-2-200601170-00002. No abstract available.
- Vaglio A, Greco P, Buzio C. Tamoxifen therapy for retroperitoneal fibrosis. Ann Intern Med. 2006 Apr 18;144(8):619; author reply 619-20. doi: 10.7326/0003-4819-144-8-200604180-00017. No abstract available.
- 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. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- tocilizumab treatment for IRPF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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