deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04677543

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex (ARISE)

A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

Sponsor: Insmed Incorporated

Conditions Mycobacterium Infections, Nontuberculous
Interventions ALIS Azithromycin ELC Ethambutol
Updated 23 times since 2021 Last updated: Jun 26, 2024 Started: Dec 22, 2020 Primary completion: May 9, 2023 Completion: May 9, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Mycobacterium Infections, Nontuberculous and is currently completed. Insmed Incorporated leads this study, which shows 23 recorded versions since 2020 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~May 2022 · 5 months · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jul 2023 · 2 months · monthly snapshot~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

23 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jul 2023 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. May 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE3

▶ Show 18 earlier versions

  1. Apr 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE3

  2. Mar 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE3

  3. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  4. Jan 2023 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  5. Dec 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  6. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  7. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  8. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  9. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  10. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  11. Dec 2021 — May 2022 [monthly]

    Recruiting PHASE3

  12. Oct 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  13. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  14. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  15. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE3

  16. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  17. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE3

  18. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE3

    First recorded

Dec 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Insmed Incorporated
Data source: Insmed Incorporated

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aalborg, Denmark , Aarhus, Denmark , Adelaide, Australia , Anderson, United States , Ashkelon, Israel , Augusta, United States , Baltimore, United States , Barcelona, Spain , Bayside, United States , Birmingham, United States and 49 more locations