A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Krystexxa (pegloticase)(MIRROR Randomized Controlled Trial [RCT])

This Study is
No Longer Enrolling

Details
Age

Adult

Eligibility

18 years of age or older Uncontrolled gout- Serum Uric Acid 7mg/dL or higher Failure to maintain normalization of serum uric acid with xanthine oxidease inhibitor at the maximum medically appropriate dose or contraindication to xanthine oxidase inhibitors. Symptoms of gout- 1. Presence of at lease one tophus 2. Recurrent flares defined as 2 or more flares in the past 12 months 3. Presence of chronic gouty arthritis

Phase

IV - Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.

Type of Study

Treatment

Locations

Barbara Davis Center
University of Colorado Hospital

Study ID

Protocol Number: 19-1717

More information available at ClinicalTrials.gov: NCT03994731

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