Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA

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Wegener’s Granulomatosis
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Brief Title

Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA

Official Title

Randomized Trial of Tofacitinib Versus Methotrexate for Maintenance Therapy in Granulomatosis With Polyangiitis

Brief Summary

      The aim of this study is to identify the optimal maintenance therapy for granulomatosis with
      polyangiitis (GPA) by comparing the MTX (standard regimen) with Tofacitinib in terms of
      efficacy, i.e. in preventing relapses.

Detailed Description

      Granulomatosis with polyangiitis (GPA), a systemic small-vessel vasculitis, could involve
      multiple tissues and organs. Remission of GPA can be obtained in approximately 80% of the
      patients with a combination of corticosteroids and cyclophosphamide. However, relapses are
      frequent and remain a challenge. The optimal drug for maintenance treatment is not
      determined. Tofacitinib is a Jak inhibitor which has been proved to be effective in multiple
      inflammatory diseases such as rheumatoid arthritis. But the efficiency and safety of
      tofacitinib in treating GPA remains unclear yet. In the present randomized trial, the
      comparison of MTX (standard regimen) with Tofacitinib in terms of efficacy, i.e. in
      preventing relapses will be conducted.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Relapse rate (major or minor) at 12 months

Secondary Outcome

 Time to first relapse.

Condition

Granulomatosis With Polyangiitis

Intervention

Tofacitinib

Study Arms / Comparison Groups

 Tofactitinib
Description:  partcipants would be given one tablet of tofacitinib (5mg per tablet), twice per day, the treatment duration will last 12 months during the whole follow-up period.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

66

Start Date

July 1, 2021

Completion Date

July 1, 2024

Primary Completion Date

July 1, 2024

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with newly diagnosed or relapsing Granulomatosis with polyangiitis met the
             criteria of 1990 ACR and 2012 Chapel Hill criteria

          2. Patients in disease flare have achieved remission using a treatment combining
             corticosteroids and IV cyclophosphamide

          3. Remission is defined as a Birmingham Vasculitis Activity/ Wegener's granulomatosis
             (BVAS/WG) score of 0 and receiving 10 mg/day of oral prednisone (or equivalent) at
             least 2 weeks

          4. Age 18 to 75 years

          5. Written informed consent obtained before taking part in the study

        Exclusion Criteria:

          1. Severe GPA defined as potentially organ- or life-threatening disease (i.e. alveolar
             haemorrhage, heart failure caused by myocarditis or pericarditis, progressive
             neurological symptoms, deaf, blindness, et al.)

          2. Serum creatinine>120umol/L or proteinuria>1.0g/d

          3. Failure to response after treatment with methotrexate or cyclophosphamide previously

          4. Receipt of a JAKi therapy previously

          5. Co-existence of another systemic autoimmune disease

          6. Secondary vasculitis (following neoplastic disease, an infection or antithyroid drugs)

          7. Malignancy or history of malignancy

          8. Infection by HIV, HCV, HBV or tuberculosis

          9. Severe uncontrolled cardiovascular, pulmonary, liver, gastrointestinal, endocrine,
             hematological, neurological, or psychiatric diseases that are not related to systemic
             vasculitis

         10. Allergic to any of the medication (cyclophosphamide, corticosteroids, tofacitinib,
             methotrexate)

         11. Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White
             blood cell count <3.0 x 109/L; Absolute neutrophil count <1.5 x 109/L; Platelet count
             <100 x 109/L; Alanine transaminase or aspartate aminotransferase or total
             bilirubin>1.5 upper normal limit; Estimated glomerular filtration rate<60ml/min/1.73m2

         12. Any medical or psychiatric disorder which, in the investigator's opinion, may prevent
             the administration of treatment and patient follow-up according to the protocol,
             and/or which may expose the patient to a too greater risk of an adverse effect.

         13. Incapacity or refusal to understand or sign the informed consent form.

         14. Pregnancy, breastfeeding.

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Lindi Jiang, PhD, +8602164041990, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04944524

Organization ID

TofMTX-GPA maintain

Responsible Party

Sponsor

Study Sponsor

Shanghai Zhongshan Hospital

Study Sponsor

Lindi Jiang, PhD, Study Chair, Fudan University

Verification Date

June 2021