Amgen
The overall objective of the study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of the concomitant use of pegloticase with methotrexate (MTX) to enhance the response rate seen with pegloticase alone in adults with uncontrolled gout.
Gout
Pegloticase
Methotrexate (MTX)
Standard Gout Flare Prophylaxis
Infusion Reaction (IR) Prophylaxis
Folic Acid
PHASE4
The study design will include: 1) up to a 2-week Screening Period (screening should be complete within 2 weeks prior to Week -4), 2) a 4-week MTX Run in Period (Week - 4 through Day 1); 3) a 52-week Pegloticase + IMM (immunomodulator), (Pegloticase + MTX) Period 4) a Safety Follow-up (Phone/Email/Site Visit) and 5) a 3 and 6 month Post Treatment Follow-up. Study acquired from Horizon in 2024.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 14 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | A Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Open-Label [OL]) |
Actual Study Start Date : | 2018-09-26 |
Estimated Primary Completion Date : | 2019-10-23 |
Estimated Study Completion Date : | 2020-10-26 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Orthopedic Physicians Alaska
Anchorage, alaska, United States, 99508
Not yet recruiting
Arizona Arthritis & Rheumatology -West Valley
Glendale, arizona, United States, 85306
Not yet recruiting
Arizona Arthritis & Rheumatology -East Valley
Mesa, arizona, United States, 85210
Not yet recruiting
Avail Clinical Research
DeLand, florida, United States, 32720
Not yet recruiting
Western Washington Arthritis Clinic
Bothell, Washington, United States, 98021
Not yet recruiting
Arthritis Northwest PLLC
Spokane, Washington, United States, 99204