Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis

NCT05102448 | Recruiting Phase 4

• 1 other identifier: TACTIC-TM
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate and compare the efficacy and safety of tofacitinib and methotrexate based on prednisone therapy in patients with Takayasu arteritis

Conditions

Takayasu Arteritis

Outcome Measures

Primary Outcomes (1)

• The effectiveness rate after 6 months' treatment

  The effectiveness rate equals to patients who achieved this goal /patients at the end of 6 months. The effectiveness was defined as satisfying three of the following 1)-4) criteria and the 5) criteria: 1) no systemic symptoms such as weakness, weight loss, etc; 2) no new ischemic symptoms or signs; 3) normal erythrocyte sedimentation rate (ESR); 4) no new vascular progression or new lesions upon imaging; 5) GCs is tapered to 10mg qd and this dosage is maintained for 4 weeks.

  From the enrollment to the end of 6 months

Secondary Outcomes (4)

• The remission rate with GCs 7.5mg qd at the end of 12 months

  From the enrollment to the the end of 12 months

• Relapse free survival rate

  From the enrollment to the the end of 12 month

• The cumulative dosage of GCs during the whole period of 12-months follow-up

  From the enrollment to the the end of 12 months

• Side effects rate

  From the enrollment to the the end of 12 months

Study Arms (2)

Tofacitinib

EXPERIMENTAL

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.

Drug: Tofacitinib

Methotrexate

ACTIVE COMPARATOR

Participates would be given tablets of methotrexate (2.5mg per tablet) 15mg each week, the treatment duration will last 12 months during the whole follow-up period.

Drug: Methotrexate

Interventions

Tofacitinib DRUG

1. Tofacitinib 5mg twice a day for 12 months; 2. Basic treatment with prednisone: (1) the initial dose of prednisone (or equivalent): 0.8mg/kg/day (maximum 60mg/day). (2) Glucocorticoids tapering: glucocorticoids is tapered after two weeks treatment and is tapered 5mg each 2 weeks to 10mg qd in the first 6 months if patients were in inactive status based on the NIH disease activity criteria. During the 6th to 12th month, glucocorticoids is tapered 2.5mg each 4 weeks until 7.5mg qd if patients were in inactive status based on the NIH disease activity criteria.

Also known as: TOF

Tofacitinib

Methotrexate DRUG

1. Methotrexate (15mg each week) for 12 months 2. Basic treatment with prednisone: (1) the initial dose of prednisone (or equivalent): 0.8mg/kg/day (maximum 60mg/day). (2) Glucocorticoids tapering: glucocorticoids is tapered after two weeks treatment and is tapered 5mg each 2 weeks to 10mg qd in the first 6 months if patients were in inactive status based on the NIH disease activity criteria. During the 6th to 12th month, glucocorticoids is tapered 2.5mg each 4 weeks until 7.5mg qd if patients were in inactive status based on the NIH disease activity criteria.

Also known as: MTX

Methotrexate

Eligibility Criteria

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

You may qualify if:

• Patients met 1990 American College of Rheumatology (ACR) classification criteria or 2018 ACR classification criteria (draft) of TAK
• Women or men aged 18-65
• All patients agreed that there is no fertility plan during clinical trials, and the results of female serum or urinary pregnancy tests must be negative
• Active TAK patients according to NIH disease activity criteria
• All patients agreed to sign the informed consent

You may not qualify if:

• Patients with organ failure who accord to one or more of the following conditions:
• I.Heart function New York class 4 II.Glomerular filtration rate ≤ 60ml/min III.Liver function Child grade 2 and above IV.High-frequency melanoma (attacks for 3 consecutive days) V.Acute cerebral infarction or cerebral hemorrhage VI.Blood pressure \> 160/100mmHg
• Patients who received revascularization surgery related to the treatment of TAK within 3 months (except balloon dilatation); balloon dilatation or surgery unrelated to TAK within 1 month
• Patients who have other autoimmune diseases (e.g. ANCA-associated vasculitis, systemic lupus erythematosus, Behcet's disease, etc.)
• Patients with severe, progressive or uncontrolled comorbidities of kidney, liver, blood system, gastrointestinal, lung, heart, etc or other coexisting medical conditions that may exert unexpected risks
• Patients with concomitant diseases, such as asthma, that may require additional medium to high doses of glucocorticoids (prednisone ≥ 10mg/ days or equivalent dose) during the study period
• Patients with active infections with HBV, HCV, tuberculosis or other serious acute or chronic infections
• Patients with malignancies
• Patients with one or more of the following abnormal laboratory examinations I.Serum ALT or AST ≥ 1.5 times the normal upper limit; II.White blood cell count ≤ 4 × 109/L III.Platelet count ≤ 100x109/L IV.Hemoglobin \< 85g/L V.Other abnormal laboratory tests that may cause unacceptable risks
• Patients allergic to the experimental drug
• Patients who have ever failed to tofacitinib or methotrexate after 3 months' treatment in previous medical history

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Lindi Jiang

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Takayasu Arteritis

Interventions

tofacitinib; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lindi Jiang, Ph.D., M.D.

  Department of Rheumatology in Zhongshan hospital, Fudan University

  STUDY CHAIR

Central Study Contacts

Lindi Jiang, Ph.D., M.D.

CONTACT

021-64041990; zsh-rheum@hotmail.com

Xiufang Kong, Ph.D., M.D.

CONTACT

021-64041990; kongxiufang2007@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, M.D.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 1, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)