Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout (MIRROR RCT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03994731 |
Recruitment Status :
Completed
First Posted : June 21, 2019
Results First Posted : May 16, 2022
Last Update Posted : May 16, 2022
|
Sponsor:
Horizon Therapeutics Ireland DAC
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland ( Horizon Therapeutics Ireland DAC )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Gout |
Interventions |
Biological: Pegloticase Drug: methotrexate Drug: placebo Dietary Supplement: folic acid Drug: gout flare prophylaxis regimen Drug: fexofenadine Drug: acetaminophen Drug: methylprednisolone |
Enrollment | 152 |
Participant Flow
Recruitment Details | This record presents results data as of 14 October 2021 (database lock date). |
Pre-assignment Details | This study included a 2-week MTX Tolerability Assessment Period consisting of 2 weeks oral MTX. 159 participants received MTX in this period. The 7 participants who were unable to tolerate MTX in this period or who met other exclusion criteria were not randomized and were classified as screen failures per protocol section 9.4.6.3.2.2. 152 randomized participants were considered enrolled in this trial. |
Arm/Group Title | Pegloticase + MTX | Pegloticase + Placebo |
---|---|---|
![]() |
Participants were randomized to receive blinded oral MTX 15 mg weekly during the Run-in Period. During the Pegloticase + Immunomodulator (IMM) Period, in addition to oral MTX 15 mg, participants received intravenous (IV) pegloticase 8 mg every 2 weeks (Q2W) for a total of 26 infusions from Day 1 through the Week 50 Visit. | Participants were randomized to receive blinded oral placebo weekly during the Run-in Period. During the Pegloticase + IMM Period, in addition to oral placebo for MTX, participants received IV pegloticase 8 mg Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit. |
Period Title: Run-in Period (From Week -4 to Day 1) | ||
Started [1] | 100 | 52 |
Took at Least 1 Dose of MTX or Placebo | 98 | 51 |
Completed | 96 | 49 |
Not Completed | 4 | 3 |
[1]
Randomized
|
||
Period Title: Pegloticase + IMM Period | ||
Started | 96 | 49 |
Discontinued Study Treatment Early | 38 | 33 |
Completed | 76 | 34 |
Not Completed | 20 | 15 |
Reason Not Completed | ||
Death | 2 | 0 |
Lost to Follow-up | 3 | 6 |
Withdrawal by Subject | 15 | 9 |
Baseline Characteristics
Arm/Group Title | Pegloticase + MTX | Pegloticase + Placebo | Total | |
---|---|---|---|---|
![]() |
Participants were randomized to receive blinded oral MTX 15 mg weekly during the Run-in Period. During the Pegloticase + IMM Period, in addition to oral MTX 15 mg, participants received IV pegloticase 8 mg Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit. | Participants were randomized to receive blinded oral placebo weekly during the Run-in Period. During the Pegloticase + IMM Period, in addition to oral placebo for MTX, participants received IV pegloticase 8 mg Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit. | Total of all reporting groups | |
Overall Number of Baseline Participants | 100 | 52 | 152 | |
![]() |
[Not Specified]
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 100 participants | 52 participants | 152 participants | |
55.6 (12.74) | 53.0 (12.12) | 54.7 (12.56) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 100 participants | 52 participants | 152 participants | |
Female |
9 9.0%
|
8 15.4%
|
17 11.2%
|
|
Male |
91 91.0%
|
44 84.6%
|
135 88.8%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 100 participants | 52 participants | 152 participants | |
Hispanic or Latino |
19 19.0%
|
9 17.3%
|
28 18.4%
|
|
Not Hispanic or Latino |
81 81.0%
|
42 80.8%
|
123 80.9%
|
|
Unknown or Not Reported |
0 0.0%
|
1 1.9%
|
1 0.7%
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 100 participants | 52 participants | 152 participants |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
8 8.0%
|
6 11.5%
|
14 9.2%
|
|
Black or African American |
16 16.0%
|
6 11.5%
|
22 14.5%
|
|
Native Hawaiian or Other Pacific Islander |
4 4.0%
|
1 1.9%
|
5 3.3%
|
|
White |
69 69.0%
|
36 69.2%
|
105 69.1%
|
|
Other, Not Specified |
3 3.0%
|
2 3.8%
|
5 3.3%
|
|
Missing |
0 0.0%
|
1 1.9%
|
1 0.7%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Horizon requests that any investigator/institution that plans on presenting/publishing results provide written notification of their request 60 days prior to their presentation/publication. Horizon requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Horizon needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: | Supra Verma, MD |
Organization: | Horizon Therapeutics USA, Inc. |
Phone: | 866-479-6742 |
EMail: | clinicaltrials@horizontherapeutics.com |
Responsible Party: | Horizon Pharma Ireland, Ltd., Dublin Ireland ( Horizon Therapeutics Ireland DAC ) |
ClinicalTrials.gov Identifier: | NCT03994731 |
Other Study ID Numbers: |
HZNP-KRY-202 |
First Submitted: | June 19, 2019 |
First Posted: | June 21, 2019 |
Results First Submitted: | March 4, 2022 |
Results First Posted: | May 16, 2022 |
Last Update Posted: | May 16, 2022 |