- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04944524
Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA
July 5, 2021 updated by: Shanghai Zhongshan Hospital
Randomized Trial of Tofacitinib Versus Methotrexate for Maintenance Therapy in Granulomatosis With Polyangiitis
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
66
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lindi Jiang, PhD
- Phone Number: 2471 +8602164041990
- Email: zsh-rheum@hotmail.com
Study Contact Backup
- Name: Yun Liu, PhD
- Phone Number: 2471 +8602164041990
- Email: chenry825@hotmail.com
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200032
- Recruiting
- Department of Rheumatology in Zhongshan hospital, Fudan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with newly diagnosed or relapsing Granulomatosis with polyangiitis met the criteria of 1990 ACR and 2012 Chapel Hill criteria
- Patients in disease flare have achieved remission using a treatment combining corticosteroids and IV cyclophosphamide
- 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
- Age 18 to 75 years
- Written informed consent obtained before taking part in the study
Exclusion Criteria:
- 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.)
- Serum creatinine>120umol/L or proteinuria>1.0g/d
- Failure to response after treatment with methotrexate or cyclophosphamide previously
- Receipt of a JAKi therapy previously
- Co-existence of another systemic autoimmune disease
- Secondary vasculitis (following neoplastic disease, an infection or antithyroid drugs)
- Malignancy or history of malignancy
- Infection by HIV, HCV, HBV or tuberculosis
- Severe uncontrolled cardiovascular, pulmonary, liver, gastrointestinal, endocrine, hematological, neurological, or psychiatric diseases that are not related to systemic vasculitis
- Allergic to any of the medication (cyclophosphamide, corticosteroids, tofacitinib, methotrexate)
- 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
- 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.
- Incapacity or refusal to understand or sign the informed consent form.
- Pregnancy, breastfeeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tofactitinib
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.
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Other Names:
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ACTIVE_COMPARATOR: Methotrexate
partcipants would be given tablets of methotrexate (2.5mg per tablet) from the initial dose of 15mg (6 tablets) and add to the maximal and optimal dose of 20mg (8 tablets), once per week, the treatment duration will last 12 months during the whole follow-up period.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse rate (major or minor) at 12 months
Time Frame: From the enrollment to the the end of 12 month.
|
The major or minor relapse rate equals to the patients with relapse/ total participants ( A major relapse should be defined as the re-occurrence or new onset of potentially organ- or life-threatening disease activity that cannot be treated with an increase of GC alone and requires further escalation of treatment.
All other relapses should be classified as minor.)
|
From the enrollment to the the end of 12 month.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first relapse.
Time Frame: From the enrollment to the the end of 12 month.
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The time period from the baseline to the time when the first relapse occurred.
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From the enrollment to the the end of 12 month.
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Number of relapse
Time Frame: From the enrollment to the the end of 12 month.
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Total times of relapse during the whole period of 12-month follow-up.
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From the enrollment to the the end of 12 month.
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Cumulative dosage of corticosteroids
Time Frame: From the enrollment to the the end of 12 month.
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The cumulative dosage of corticosteroids during the whole period of 12-month follow-up.
The cumulative dosage = Sum of different dose of prednisone every day.
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From the enrollment to the the end of 12 month.
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Adverse events
Time Frame: From the enrollment to the the end of 12 month.
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All the kinds of adverse event related to the treatment and the disease itself will be recorded.
|
From the enrollment to the the end of 12 month.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2021
Primary Completion (ANTICIPATED)
July 1, 2024
Study Completion (ANTICIPATED)
July 1, 2024
Study Registration Dates
First Submitted
June 22, 2021
First Submitted That Met QC Criteria
June 22, 2021
First Posted (ACTUAL)
June 29, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 9, 2021
Last Update Submitted That Met QC Criteria
July 5, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Autoimmune Diseases
- Lung Diseases
- Vasculitis
- Lung Diseases, Interstitial
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Granulomatosis with Polyangiitis
- Systemic Vasculitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Protein Kinase Inhibitors
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Tofacitinib
Other Study ID Numbers
- TofMTX-GPA maintain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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