Clinical Trial: Takayasu Arteritis Clinical Trial in China

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparison of the Efficacy and Safety of Leflunomide Versus Placebo Combine With the Basic Prednisone Therapy in Patients With Active Phase of Takayasu's Arteritis: a Rand

Brief Summary: The purpose of this study is to investigate the efficacy and Safety of Leflunomide in Patients With Active Phase of Takayasu's Arteritis

Detailed Summary:
Sponsor: Jiang lindi

Current Primary Outcome: Number of participants achieving clinical remission [ Time Frame: From the date of randomization until the end of induced remission therapy, assessed up to 24 weeks ]

Clinical remission is defined as follows:

  1. No systemic symptoms such as fever, fatigue and weight loss;
  2. without new onset of ischemic symptoms and ischemic signs;
  3. Serum Erythrocyte sedimentation rate(ESR）levels in normal range (if not, retest after 1 week, take the lower one into analyse);

Subject achieving clinical remission should meet all these criteria above.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to achieve clinical remission [ Time Frame: From the date of randomization until the date of first documented clinical remission, assessed up to 24 weeks ]
  • Mean dose of prednisone in each group at the end of induced remission therapy [ Time Frame: At the end of induced remission therapy, assessed up to 24 weeks ]
  • Recurrence rate during leflunomide maintenance therapy [ Time Frame: From the beginning of maintenance therapy to the end of follow up, assessed up to 32 weeks(from the end of the 24th week till the end of the 56th week) ]

    Recurrence is determined as follows:Kerr score>= 2 or do not meet two or more than two criteria of the clinical remission standard,and the results need to be reconfirm 28 days later.

    Kerr score:

    1) presence of systemic symptoms as fever, fatigue and weight loss (1');

    2）presence of ischemic symptoms or signs (1');

    3) abnormal serum ESR levels (1');

    4) progression or new site of vascular lesions on MRA or CTA compared to baseline(1').

  • Time to recurrence during leflunomide maintenance therapy [ Time Frame: From the beginning of maintenance therapy (the 25th week) to the date of first documented recurrence, assessed up to 32 weeks ]
  • Number of participants with adverse events related to leflunomide treatments [ Time Frame: From the date of randomization until the end of this trial, assessed up to 56 weeks ]
    Adverse events include neutropenia, elevated serum level of liver enzymes(> 2 fold of normal upper limit), reproductive toxicity and infection
  • The changes of Doctor General Visual Analogue Scale at the end of 24 weeks and 56 weeks compared to baseline [ Time Frame: From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks) ]
  • The changes of participant self-reports at the end of 24 weeks and 56 weeks compared to baseline [ Time Frame: From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks) ]
    Participant self-reports include Patients General Visual Analogue Scale, SF-36 quality of life questionnaire, and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale
  • The changes of biomarkers related to Takayasu's disease at the end of 24 weeks and 56 weeks compared to the baseline, including the whole blood cell RNA transcripts, and gene epigenetics. [ Time Frame: From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks) ]
  • Radiological changes including Magnetic Resonance Angiography or Computed Tomography Angiography at the end of 24 weeks and 56 weeks compared to the baseline [ Time Frame: From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks) ]


Original Secondary Outcome: Same as current

Information By: Shanghai Zhongshan Hospital

Dates:
Date Received: November 22, 2016
Date Started: December 2016
Date Completion: December 2019
Last Updated: December 1, 2016
Last Verified: December 2016