CompletedPhase 3

Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis

United States86 participantsStarted 2019-01-07

Plain-language summary

The primary objective of this study was to assess the efficacy of rilonacept treatment in participants with recurrent pericarditis.

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female aged 12 or older
✓. Has a diagnosis of recurrent pericarditis
✓. Must provide Informed Consent
✓. Presents with at least the third episode of pericarditis during screening.
✓. Has received nonsteroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids (in any combination), if used, at stable dose levels (or at least not increased) for at least 3 days prior to first study drug administration
✓. Female subjects must be postmenopausal, or incapable of pregnancy or permanently sterile, or if of childbearing potential must agree to use highly-effective method of contraception.
✓. Must be up-to-date with all immunizations, in agreement with current local immunization guidelines for immunosuppressed subjects, before first study drug administration.
✓. Is able to adequately maintain a daily subject diary according to protocol.

✕. Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.
✕. Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
✕. Has a history of myeloproliferative disorder.
✕. Has a history of demyelinating disease or symptoms suggestive of multiple sclerosis.
✕. Has a history of active or latent tuberculosis (TB) prior to screening
✕. Has chest x-ray at screening or within 12 weeks before receiving first administration of study drug, with evidence of malignancy or abnormality consistent with prior or active TB infection.
✕. Has a history of positive or intermediate results for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening.
✕. Has a history of malignancy of any organ system within the past 5 years before screening (other than a successfully treated non metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).

Time to Pericarditis Recurrence in the RW Period

Timeframe: RW Period (mean 24.8 weeks)

NCT IDNCT03737110

SponsorKiniksa Pharmaceuticals (UK), Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-29

Results submitted2021-05-25

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female aged 12 or older
✓. Has a diagnosis of recurrent pericarditis
✓. Must provide Informed Consent
✓. Presents with at least the third episode of pericarditis during screening.
✓. Has received nonsteroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids (in any combination), if used, at stable dose levels (or at least not increased) for at least 3 days prior to first study drug administration
✓. Female subjects must be postmenopausal, or incapable of pregnancy or permanently sterile, or if of childbearing potential must agree to use highly-effective method of contraception.
✓. Must be up-to-date with all immunizations, in agreement with current local immunization guidelines for immunosuppressed subjects, before first study drug administration.
✓. Is able to adequately maintain a daily subject diary according to protocol.

✕. Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.
✕. Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
✕. Has a history of myeloproliferative disorder.
✕. Has a history of demyelinating disease or symptoms suggestive of multiple sclerosis.
✕. Has a history of active or latent tuberculosis (TB) prior to screening
✕. Has chest x-ray at screening or within 12 weeks before receiving first administration of study drug, with evidence of malignancy or abnormality consistent with prior or active TB infection.
✕. Has a history of positive or intermediate results for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening.
✕. Has a history of malignancy of any organ system within the past 5 years before screening (other than a successfully treated non metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).