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Idiopathic Retroperitoneal FibrosisPhase 4NCT04762784

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

A Phase 4 study testing Tocilizumab and Glucocorticoids in people with Idiopathic Retroperitoneal Fibrosis, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Idiopathic Retroperitoneal Fibrosis
What is being tested?
Tocilizumab and Glucocorticoids
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Jul 2020to 10 Feb 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

    Yunyun Fei, +8613681125226, feiyunyun2013@sina.com

    Wen Zhang, zhangwen91@sina.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Tocilizumab, Glucocorticoids
Keywords
idiopathic retroperitoneal fibrosis, Tocilizumab, Response
Medical subject headings
Retroperitoneal Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Tocilizumab treatment: Tocilizumab infusion 8mg/Kg，Once per month for 3 months.

  • GlucocorticoidsDrug

    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.

Study groups in NCT04762784
Study groupRoleWhat they receive
Tocilizumab treatmentExperimentalTocilizumab 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.
Receives: Drug: Tocilizumab
Glucocorticoids monotherapyActive comparatorGlucocorticoids 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.
Receives: Drug: Glucocorticoids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. remission

    Remission is achieved when symptoms are alleviated and laboratory tests return to normal levels or radiologic improvement is observed.

    Measured: 5 years

Secondary outcomes (1)

  1. relapse

    Participants have recurrence of symptoms and laboratory abnormalities.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start1 Jul 2020
  3. Primary completion10 Feb 2023 (estimated)
  4. Study completion10 Feb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04762784
Sponsor's protocol ID
tocilizumab treatment for IRPF
Status last verified
Mar 2021
First submitted
17 Feb 2021
Last updated
22 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11247880

  • 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.

    PubMed 12695167

  • 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.

    PubMed 16418405

  • 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.

    PubMed 16418409

  • Vaglio A, Salvarani C, Buzio C. Retroperitoneal fibrosis. Lancet. 2006 Jan 21;367(9506):241-51. doi: 10.1016/S0140-6736(06)68035-5.

    PubMed 16427494

  • 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.

    PubMed 16618960

  • 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.

    PubMed 18980864

  • 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.

    PubMed 19741239

  • 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.

    PubMed 21200036

  • 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.

    PubMed 21733569

  • 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.

    PubMed 21733570

  • 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.

    PubMed 21859695

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tocilizumab and Glucocorticoids in people with Idiopathic Retroperitoneal Fibrosis, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

remission (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04762784, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.

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