A Prospective Study of Tocilizumab in the Treatment of Idiopathic Retroperitoneal Fibrosis
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
Drug: Tocilizumab
Tocilizumab treatment: Tocilizumab infusion 8mg/Kg,Once per month for 3 months.
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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. |
Drug: 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.
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Outcome Measures
Primary Outcome Measures
- remission [5 years]
Remission is achieved when symptoms are alleviated and laboratory tests return to normal levels or radiologic improvement is observed.
Secondary Outcome Measures
- relapse [5 years]
Participants have recurrence of symptoms and laboratory abnormalities.
Other Outcome Measures
- adverse events [5 years]
Participants suffer from adverse events due to the drug treatment
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100032 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Summaries for patients. Tamoxifen for the treatment of retroperitoneal fibrosis. Ann Intern Med. 2006 Jan 17;144(2):I51.
- 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.
- Vaglio A, Greco P, Buzio C. Tamoxifen therapy for retroperitoneal fibrosis. Ann Intern Med. 2006 Apr 18;144(8):619; author reply 619-20.
- 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.
- Vaglio A, Salvarani C, Buzio C. Retroperitoneal fibrosis. Lancet. 2006 Jan 21;367(9506):241-51. Review.
- 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.
- tocilizumab treatment for IRPF