Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03635957
Study type Interventional
Source Horizon Pharma Ireland, Ltd., Dublin Ireland
Contact
Status Completed
Phase Phase 4
Start date September 26, 2018
Completion date October 26, 2020

See also
  Status Clinical Trial Phase
Completed NCT04060173 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Phase 1
Completed NCT04966325 - Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects Early Phase 1
Completed NCT03015948 - A Single Dose Study of SHR4640 in Healthy Male Volunteers Phase 1
Completed NCT02855437 - Novel Methods for Ascertainment of Gout Flares -A Pilot Study N/A
Active, not recruiting NCT02702375 - Meta-analyses of Impotrant Food Sources of Sugars and Incident Cardiometabolic Diseases N/A
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT00995618 - Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia Phase 2
Completed NCT00985127 - Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout Phase 2
Terminated NCT04987294 - Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease Phase 2
Completed NCT03291782 - D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers Phase 1
Recruiting NCT03388515 - A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects. Phase 1
Completed NCT06189404 - Effect of Tigulixostat on the Pharmacokinetics of Theophylline Phase 1
Enrolling by invitation NCT03336203 - The Impact of Urate-lowering Therapy on Kidney Function (IMPULsKF) Phase 4
Recruiting NCT05586958 - Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients Phase 3
Recruiting NCT04047394 - A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers Phase 1
Recruiting NCT06056570 - Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia Phase 1/Phase 2
Completed NCT02557126 - Study of URC102 to Assess the Safety and Efficacy in Gout Patients Phase 2
Completed NCT02246673 - RDEA3170 and Febuxostat Combination Study in Gout Subjects Phase 2
Completed NCT01472692 - Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure Phase 4
Active, not recruiting NCT01021241 - Safety and Efficacy Study of Intravenous Uricase-PEG 20 Phase 1