Assessment of efficacy and safety of Rilonacept treatment in subjects with recurrent pericarditis
- Conditions
- Recurrent pericarditisMedDRA version: 20.0Level: LLTClassification code 10000996Term: Acute pericarditisSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-002719-87-IT
- Lead Sponsor
- Kiniksa Pharmaceuticals, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
1. Is capable of understanding the written informed consent form (ICF) or assent form (for pediatric subjects =12 and <18 years old), has provided signed and witnessed written informed consent or assent (as applicable), and agrees to comply with protocol requirements.
2. Is male or female 12 years of age or older with body weight of at least 23.6 kg (52 Lbs).
3. Has a diagnosis of recurrent pericarditis.
4. At least 1 of the pericarditis episodes experienced prior to screening has met at least 2 of the following 4 criteria, in the opinion of the investigator and based on the documented available data, according to the 2015 ESC Guidelines for the Diagnosis and Management of Pericardial Diseases :
a. Pericarditic chest pain
b. Pericardial rub
c. New widespread ST-segment elevation or PR-segment depression according to ECG findings
d. Pericardial effusion (new or worsening)
5. Presents with at least the third episode of pericarditis during screening (i.e., at least the second pericarditis recurrence following the first pericarditis episode), and within 7 days* prior to and including RI baseline (first administration of study drug) has: a. At least 1 day with pericarditis pain =4 on the 11-point NRS, AND b. CRP level =1.0 mg/dL
*Pericarditis pain =4 and CRP =1 mg/dL are not required to be present on the same day.
6. Has received NSAIDs and/or colchicine and/or CS (in any combination), if used, at stable dose levels (or at least not increased) for at least 3 days prior to and including RI baseline (first administration of study drug), and changes in medications made within this time period (e.g., 1-time use of NSAIDs) are not anticipated, in the opinion of the
investigator, to significantly alter assessments of baseline disease activity.
7. If using NSAIDs and/or colchicine and/or CS at the time of RI baseline (first administration of study drug), is willing and able, in the opinion of the investigator, to taper and discontinue those medications within the 9-week weaning time in the RI period of the study while continuing rilonacept treatment.
8. Female subjects must be:
a. Postmenopausal, defined as at least 12 months after the cessation of menses (without an alternative medical cause) OR
b. Incapable of pregnancy OR
c. Permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal ligation or having a male partner with vasectomy as affirmed by the subject OR d. If of childbearing potential, must agree to use a highly effective method of contraception during the study and for 3 months after the last study drug administration (i.e., hormonal contraceptives associated with inhibition of ovulation, intrauterine device [IUD], intrauterine hormonereleasing
system [IUS], or sexual abstinence)
9. If male and sexually active, must have documented vasectomy or must practice birth control and not donate sperm during the study and for 3 months after the last study drug administration.
10. Must be up-to-date with all immunizations, in agreement with current local immunization guidelines for immunosuppressed subjects, before RI baseline (first administration of study drug).
11. Is able to adequately maintain a daily subject diary according to protocol.
12. Must be able to adhere to the study visit schedule and understand and comply with the other protocol requirements.
13. Agrees to refrain from making any new, major lifestyle changes that may affect pericarditis symptoms (e.g., changing exerc
1. Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including TB; neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma; myocarditis; or systemic autoimmune diseases with exception of Still's disease. 2. Is pregnant, breastfeeding, or planning a pregnancy or fathering a child during the study or within 3M after the last study drug administration. 3. Has a history of immunosuppr, including positive HIV test results. 4. Is currently receiving CS at a dose of >60 mg/day prednis(or equiv) for adult subjects, or >0.5 mg/kg/day (or >60 mg/day, whichever is lower) prednis(or equiv) in pediatric subjects. 5. Has ever received cytotoxic drugs, including cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents. 6. Has ever received agents that deplete B or T cells. 7. Has received systemic immunomodulatory agents (with exception of CS) within the following time frames prior to RI baseline (first administration of study drug): a. Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine within 24W. b. TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors within 12W. c. Anakinumab within 12W. Canakinumab could not have been discontinued due to safety unless it was discontinued due to local injection site reactions. d. Rilonacept within 6W. Rilonacept could not have been discontinued due to lack of efficacy or due to safety. e. Methotrexate within 2W. f. Anakinra within 5D. Anakinra could not have been discontinued due to lack of efficacy or due to safety unless it was discontinued due to local injection site reactions. 8. Has a history of myeloproliferative disorder.
9. Has a history of demyelinating disease or symptoms suggestive of multiple sclerosis.
10. Meets the following TB criteria: a. History of active TB prior to screening OR b. History of latent TB that was not adequately treated prior to screening OR c. Signs or symptoms suggestive of active TB (e.g., new cough of >14D in duration or a change in chronic cough, persistent fever, unintentional weight loss, or night sweats) upon review of medical history and/or physical examination at screening OR d. Recent close contact with a person with active TB OR e. Positive or indeterminate IGRA test results or results from another positive TB test at screening based on acceptable clinical practice for the country in which the subject is enrolling. 11. Has chest x-ray at screening (or history of results within 12W before receiving study drug), with evidence of malignancy or abnormality consistent with prior or active TB infection. 12. Has received immunization with a live (attenuated) vaccine within 12W before screening or is expected to receive live (attenuated) vaccine during the study or within 12W after the last study drug administration. 13. Has a history of positive or intermediate results for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening. 14. Has an eGFR <30 ml/min. 15. Has a history of malignancy of any organ system within the past 5Y before screening.16. Has a known or suspected current active infection or a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, or an open, draining infected skin wound. 17. Has had a serious infection, has been admitted to the hospital for an infection, has been tr
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method