Efficacy and Tolerance of Tocilizumab In Takayasu Arteritis

NCT02101333 | Completed Phase 3 DMC

• 1 other identifier: P130404
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

First-line tocilizumab treatment during 6 months could permit rapid steroid-tapering and induction of remission in Takayasu arteritis (TA).

Conditions

TAKAYASU ARTERITIS

Keywords

TAKAYASU ARTERITIS; STEROID SPARING; TOCILIZUMAB; EFFICACY; SAFETY

Outcome Measures

Primary Outcomes (1)

• number of good responders without prednisone after 6-months tocilizumab treatment

  6 months

Secondary Outcomes (7)

• Number of good and partial responders at 3 , 6, 12 months

  one year

• Total dose steroids during 6 months

  6 months

• TA global activity associated with tocilizumab treatment, by the questionnaires: BVAS, PGO, Dei-Tak;

  18 months

• Clinical response evaluation

  18 months

• Biological response evaluation

  18 months

Study Arms (1)

TOCILIZUMAB MONTHLY DURING 6

EXPERIMENTAL

intravenous injection, 8 mg/kg, monthly during 6 months

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

intravenous injection 8 mg/kg, monthly during 6 months

Also known as: humanized anti-IL6 receptor antibody

TOCILIZUMAB MONTHLY DURING 6

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of TA : ACR and /or Ishikawa modified Sharma criteria of TA
• Age of 18 years or older
• Willing to use an effective means of birth control throughout the study

You may not qualify if:

• Patients immunosuppressive treatment or biologics other than steroids 4 months before
• Evidence of active infection (including chronic infection)
• HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen
• History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years
• Inability to provide informed consent
• Cytopenia, as defined by platelet count \< 100 × 109/L (100,000/mm3), hemoglobin \< 85 g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count \< 2.0 × 109/L (2000/mm3), absolute lymphocyte count \< 0.5 × 109/L (500/mm3)
• Insufficient liver function
• Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
• Positive tuberculin skin test and/or positive Quantiferon
• Radiographic evidence suggestive of tuberculosis
• Contraindication to and precaution in use of Tocilizumab according to the summary product description
• Pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Chugai Pharmaceutical: collaborator

Study Sites (1)

Department of internal medicine

Saint-Antoine, Paris, 75012, France

Location

Related Publications (6)

• Mekinian A, Neel A, Sibilia J, Cohen P, Connault J, Lambert M, Federici L, Berthier S, Fiessinger JN, Godeau B, Marie I, Guillevin L, Hamidou M, Fain O; Club Rhumatismes et Inflammation, French Vasculitis Study Group and Societe Nationale Francaise de Medecine Interne. Efficacy and tolerance of infliximab in refractory Takayasu arteritis: French multicentre study. Rheumatology (Oxford). 2012 May;51(5):882-6. doi: 10.1093/rheumatology/ker380. Epub 2012 Jan 5.

  PMID: 22223706 BACKGROUND

• Abisror N, Mekinian A, Lavigne C, Vandenhende MA, Soussan M, Fain O; Club Rhumatismes et Inflammation, and SNFMI. Tocilizumab in refractory Takayasu arteritis: a case series and updated literature review. Autoimmun Rev. 2013 Oct;12(12):1143-9. doi: 10.1016/j.autrev.2013.06.019. Epub 2013 Jun 29.

  PMID: 23820042 BACKGROUND

• Nishimoto N, Nakahara H, Yoshio-Hoshino N, Mima T. Successful treatment of a patient with Takayasu arteritis using a humanized anti-interleukin-6 receptor antibody. Arthritis Rheum. 2008 Apr;58(4):1197-200. doi: 10.1002/art.23373.

  PMID: 18383395 BACKGROUND

• Unizony S, Arias-Urdaneta L, Miloslavsky E, Arvikar S, Khosroshahi A, Keroack B, Stone JR, Stone JH. Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatica. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1720-9. doi: 10.1002/acr.21750.

  PMID: 22674883 BACKGROUND

• Salvarani C, Magnani L, Catanoso MG, Pipitone N, Versari A, Dardani L, Pulsatelli L, Meliconi R, Boiardi L. Rescue treatment with tocilizumab for Takayasu arteritis resistant to TNF-alpha blockers. Clin Exp Rheumatol. 2012 Jan-Feb;30(1 Suppl 70):S90-3. Epub 2012 May 11.

  PMID: 22410150 BACKGROUND

• Mekinian A, Saadoun D, Vicaut E, Thietart S, Lioger B, Jego P, Bleibtreu A, Limal N, Connault J, Gottenberg JE, Lhorte P, Bertola JP, Delforge J, Ferreira-Maldent N, Perlat A, Talib Z, Vautier M, Savey L, Quiere I, Cacoub P, Fain O; French Takayasu network. Tocilizumab in treatment-naive patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial. Arthritis Res Ther. 2020 Sep 17;22(1):218. doi: 10.1186/s13075-020-02311-y.

  PMID: 32943098 DERIVED

MeSH Terms

Conditions

Takayasu Arteritis

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Olivier FAIN

  médecine interne - St Antoine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: April 2, 2014
• Study Start: June 10, 2014
• Primary Completion: December 10, 2018
• Study Completion: February 1, 2019
• Last Updated: August 19, 2020

Record last verified: 2020-07

Locations

FR (1)