Health TrialsbyHealthPanel

Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis

ConditionTakayasu Arteritis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Zhongshan Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: TofacitinibExperimental treatment 1 intervention
Group B: MethotrexateActive comparator 1 intervention

Trial outcomes

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.

Time frame
From the enrollment to the end of 6 months

Secondary outcomes

1

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

Ratio of patients who achieved remission with GCs 7.5mg qd at the end of 12 months. The remission is defined as satisfying three of the following 1)-4) 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. It is required that GCs 7.5mg qd should be maintained at least for four weeks.

Time frame
From the enrollment to the the end of 12 months
2

Relapse free survival rate

Ratio of patients without relapse after achieving remission during the 12 months follow-up

Time frame
From the enrollment to the the end of 12 month
3

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

The cumulative dosage = Sum of doses of prednisone （or equivalents） each day

Time frame
From the enrollment to the the end of 12 months
4

Side effects rate

Ratio of patients with side effects. All the kinds of adverse event related to the treatment and the disease itself will be recorded.

Time frame
From the enrollment to the the end of 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now