Indirect treatment comparison of pegloticase in combination with methotrexate versus nanoencapsulated sirolimus plus pegadricase for the treatment of uncontrolled gout (20260129)

Study identification

• EU PAS number:
  EUPAS1000001127
• Study ID:
  1000001127
• Official title and acronym:
  Indirect treatment comparison of pegloticase in combination with methotrexate versus nanoencapsulated sirolimus plus pegadricase for the treatment of uncontrolled gout (20260129)
• DARWIN EU® study:
  No
• Study countries:
  Other
• Study description:
  Secondary evidence synthesis using randomized controlled trial (RCT) data and published aggregate evidence. An Amgen systematic literature review identified four eligible RCTs: C405/C406, MIRROR RCT, COMPARE, and DISSOLVE I/II. Individual participant data (IPD) are available for C405/C406 and MIRROR RCT; aggregate data are available for COMPARE and DISSOLVE I/II. The primary analysis is an anchored matching-adjusted indirect comparison (MAIC) using MIRROR RCT and COMPARE, with treatment response at month 6 as the primary endpoint. Treatment response is defined as maintaining serum uric acid (sUA) <6 mg/dL for ≥80% of the assessment period. Additional supportive treatment-response analyses will evaluate month 3 and months 3 and 6 combined. Analyses follow NICE DSU TSD 18 and EU Joint Clinical Assessment guidance.
• Study status:
  Ongoing

Research institutions and networks

No information provided.

Study timelines

Date when funding contract was signed

Planned:12/03/2026

Actual:12/03/2026

Study start date

Planned:12/10/2026

Actual:12/10/2026

Data analysis start date

Planned:19/10/2026

Actual:19/10/2026

Date of interim report, if expected

Planned:20/11/2026

Date of final study report

Planned:18/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable