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NCT03221257 · ClinicalTrials.gov registry record · Phase 2
Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate
A Phase 2 study of Interstitial Lung Disease and Scleroderma, Systemic, sponsored by Michael Roth.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 16
- Study locations
NCT03221257: Completed Phase 2 study of Interstitial Lung Disease and Scleroderma, Systemic, sponsored by Michael Roth.
NCT03221257 is a Phase 2 study of Interstitial Lung Disease and Scleroderma, Systemic that has completed, run by Michael Roth. The registered enrollment target is 51 participants, below the 565-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (91% lower). The trial reports 16 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03221257, a Phase 2 study of Interstitial Lung Disease and Scleroderma, Systemic, has completed, sponsored by Michael Roth.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 16
- Study locations
Study Summary
A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD).
Primary Outcome
Change from baseline to month 18 in the mean forced vital capacity (represented as the percentage of the age-; height-; gender-; and race-adjusted predicted value, i.e. FVC-%).
Conditions Studied
Interventions
- DRUG Mycophenolate Mofetil (MMF)
- DRUG Pirfenidone (PFD)
- DRUG Placebo (Plac)
Study Locations (16)
Massachusetts
- Harvard Medical School, Brigham & Women's Hospital - Boston
- Boston University, School of Medicine - Boston
California
- University of California Los Angeles - Los Angeles
Colorado
- University of Colorado - Aurora
District of Columbia
- Georgetown University - Washington D.C.
Illinois
- Northwestern University - Chicago
Indiana
- Indiana University Health - Indianapolis
Maryland
- Johns Hopkins University - Baltimore
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2022-06-13 |
| Phase | Phase 2 |
What the finished NCT03221257 record still lists
NCT03221257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 565-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Interstitial Lung Disease appearing as the primary indexed condition, and to 3 interventions - of which Mycophenolate Mofetil (MMF) is the first listed.
NCT03221257 lists 16 locations in 15 states (Massachusetts, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT03221257 about?
NCT03221257 is a clinical study titled "Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate". A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD).
What is the current status of trial NCT03221257?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2017-11-28. Estimated completion is 2022-06-13.
What conditions does trial NCT03221257 study?
This clinical trial studies the following conditions: Interstitial Lung Disease, Scleroderma, Systemic.
What interventions are being tested in trial NCT03221257?
The interventions under investigation include: Mycophenolate Mofetil (MMF) (DRUG), Pirfenidone (PFD) (DRUG), Placebo (Plac) (DRUG).
Who is sponsoring clinical trial NCT03221257?
This trial is sponsored by Michael Roth, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03221257 being conducted?
This trial has 16 study locations across California, Colorado, District of Columbia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03221257's enrollment target sits among peer trials
51 23rd of 36 higher than 14 of 36 other Interstitial Lung Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Interstitial Lung Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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