Clinical Trial: AnakInRa for Treatment of Recurrent Idiopathic Pericarditis (AIRTRIP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: AnakInRa for Treatment of Recurrent Idiopathic Pericarditis

Brief Summary: Recent findings suggest that recurrent pericarditis (RP) may be a previously unrecognized autoinflammatory disease. The pivotal pathogenic role of interleukin (IL)-1 in RP has been shown by the achievement of complete responses after treatment with the recombinant IL-1-receptor antagonist, anakinra. Anakinra is the recombinant form of IL-1Ra. The proposed study is designed to demonstarate the efficacy of anakinra in RP.

Detailed Summary: This is a 8-month, multicenter (3 Italian centers), randomized, double-blind, placebo-controlled, multicenter, medication-withdrawal study to evaluate the efficacy, tolerability, and safety of anakinra in adults and children with idiopathic recurrent pericarditis (RP).
Sponsor: Massimo Imazio

Current Primary Outcome: Recurrence rate [ Time Frame: 8 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 1. responder status in the open label phase [ Time Frame: 60 days ]

  To assess the responder status in the open label phase at Day 8 and 60 and at the end of the study with the following three criteria all to be met:

  1. no or mild pericardial pain (a score ≤2.5 on a 21 circle VAS), AND
  2. normal CRP levels (CRP ≤0.5 mg/dL), AND
  3. absent or mild (≤10 mm) echocardiographic effusion. Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 2. change over time of the 3 outcome criteria, i.e. pericardial pain, CRP levels, and echocardiographic effusion; [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 3. time to response in the open label phase [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 4. percentage of patients who relapse in the withdrawal part in the two arms; [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 5. change over time in patient's/parent's global assessment of overall well being on a 21 circle VAS; [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 6. change over time in the global evaluation of disease activity by physicians on a 21 circle VAS [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 8. percentage off CS and any other concurrent medication at 6weeks [ Time Frame: 6 weeks ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 9. tolerability and safety of the treatment [ Time Frame: 8 months ]
  To assess the tolerability and safety of the treatment, i.e. monitoring and recording all adverse events (AEs), with attention to local tolerability to s.c. injection, and serious adverse events (SAEs), and the regularly scheduled monitoring of hematology, blood chemistry, physical examinations, and vital signs including blood pressure over 8 months. Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.

Original Secondary Outcome:

• 1. responder status in the open label phase [ Time Frame: 60 days ]

  To assess the responder status in the open label phase at Day 8 and 60 and at the end of the study with the following three criteria all to be met:

  1. no or mild pericardial pain (a score ≤2.5 on a 21 circle VAS), AND
  2. normal CRP levels (CRP ≤0.5 mg/dL), AND
  3. absent or mild (≤10 mm) echocardiographic effusion. Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 2. change over time of the 3 outcome criteria, i.e. pericardial pain, CRP levels, and echocardiographic effusion; [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 3. time to response in the open label phase [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 4. percentage of patients who relapse in the withdrawal part in the two arms; [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 5. change over time in patient's/parent's global assessment of overall well being on a 21 circle VAS; [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 6. change over time in the global evaluation of disease activity by physicians on a 21 circle VAS [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 7. change over time in quality of life as assessed by the SF-36 scale in adults and by the CHQ in children [ Time Frame: 8 months ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 8. percentage off CS and any other concurrent medication at 6weeks [ Time Frame: 6 weeks ]
  Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
• 9. tolerability and safety of the treatment [ Time Frame: 8 months ]
  To assess the tolerability and safety of the treatment, i.e. monitoring and recording all adverse events (AEs), with attention to local tolerability to s.c. injection, and serious adverse events (SAEs), and the regularly scheduled monitoring of hematology, blood chemistry, physical examinations, and vital signs including blood pressure over 8 months. Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.

Dates:
Date Received: August 14, 2014
Date Started: June 2014
Date Completion:
Last Updated: December 17, 2015
Last Verified: December 2015