Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients

NCT04299971 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: TACTIC-MM
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. Here we tried to classify TAK patients in 3 levels, including mild, moderate, and severe, and prescribe methotrexate and tofacitinib randomly in mild and moderate patients, to observe the relatively better treatment strategy, facilitating better intervention strategy in TAK patients.

Conditions

Takayasu Arteritis; Methotrexate; Inhibition; Treatment

Keywords

Takayasu arteritis; methotrexate; tofacitinib; treatment

Outcome Measures

Primary Outcomes (1)

• Disease remission at 24 weeks.

  comparison of clinical remission rate between tofacitinib and methotrexate groups at the end of 24th week follow-up;

  24 weeks

Secondary Outcomes (7)

• Disease remission at 48 weeks.

  48 weeks

• Prednisone dose reduction at endpoint

  24 weeks and 48 weeks.

• disease relapse in the follow-up

  At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.

• Vascular progression in angiographic examination at 6 months and 12 months.

  24 weeks and 48 weeks.

• Change of the quality of life with questionnaire SF-36

  At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.

Study Arms (2)

methotrexate

ACTIVE COMPARATOR

This group of 38 TAK cases are prescribed with methotrexate tablets (Dose: 15.0 mg. qw. p.o.) for 24 weeks.

Drug: Methotrexate Tablets

Tofacitinib

EXPERIMENTAL

This group of 38 TAK cases are prescribed with tofacitinib tablets (Dose: 5.0 mg. bid. p.o.) for 24 weeks.

Drug: Tofacitinib tablet

Interventions

Methotrexate Tablets DRUG

The methotrexate group is prescribed with methotrexate Tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated, then the usage of methotrexate is maintained for another 24 weeks, otherwise (resistant), patients would be given tofacitinib (5.0mg.bid.p.o.) for 24 weeks instead.

Also known as: methotrexate pills

methotrexate

Tofacitinib tablet DRUG

The tofacitinib group is prescribed with tofacitinib tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated, then the usage of tofacitinib is maintained for another 24 weeks, otherwise (resistant), patients would be given methotrexate (15.0mg.qw.p.o.) for 24 weeks instead.

Also known as: Xeljanz

Tofacitinib

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age≥14 years;
• active status: Kerr score≥ 2;
• mild and moderate:
• Blood pressure (maximum) \< 180/110mmHg;
• branches with the stenotic rate \< 70% involved;
• mildly ischemic manifestation relative to activity but relieve after rest;
• no or low degree of organ insufficiency: NYHF I\~II; eGFR (MRDR) ≥ 60ml/min;

You may not qualify if:

• Severe organ insufficiency;
• Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;
• Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;
• malignant tumors;
• history of severe drug allergy;
• successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Lindi Jiang

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Takayasu Arteritis; Inhibition, Psychological

Interventions

Methotrexate; tofacitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lindi Jiang, PhD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Rongyi Chen, PhD

CONTACT

+86-15221160538; chenry825@hotmail.com

Lili Ma, PhD

CONTACT

+86-15221160538; ma.lili1@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomized but open-label.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mild and moderate TAK patients were divided into two groups, with 38 cases for each group at the randomized ratio 1:1, prescribed with methotrexate (15mg.qw.po) and tofacitinib (5mg.bid.po) respectively, in the presence of prednisone. After the 24 weeks of treatment, the disease remission is evaluated (primary endpoint). If the disease activity is alleviated, the strategy would be maintained for another 24weeks, otherwise, the treatment strategy would be shifted to the opposite for 24weeks. After 48 weeks, the disease remission would be evaluated once again (secondary endpoint)

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 12, 2020

Record last verified: 2020-03

Locations

CN (1)