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NCT03112603 · ClinicalTrials.gov registry record · Phase 3
A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)
A Phase 3 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
NCT03112603: Completed Phase 3 study, sponsored by Incyte Corporation.
NCT03112603 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 330 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03112603, a Phase 3 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
Primary Outcome
ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluab
Interventions
- DRUG Ruxolitinib
- DRUG Mycophenolate mofetil (MMF)
- DRUG Extracorporeal photopheresis (ECP)
- DRUG Low-dose methotrexate (MTX)
- DRUG mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2017-06-29 |
| Est. Completion | 2022-12-15 |
| Phase | Phase 3 |
What the finished NCT03112603 record still lists
NCT03112603 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 5 interventions - of which Ruxolitinib is the first listed.
NCT03112603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03112603 about?
NCT03112603 is a clinical study titled "A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)". The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
What is the current status of trial NCT03112603?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2017-06-29. Estimated completion is 2022-12-15.
What interventions are being tested in trial NCT03112603?
The interventions under investigation include: Ruxolitinib (DRUG), Mycophenolate mofetil (MMF) (DRUG), Extracorporeal photopheresis (ECP) (DRUG), Low-dose methotrexate (MTX) (DRUG), mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus) (DRUG).
Who is sponsoring clinical trial NCT03112603?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03112603's enrollment target sits among peer trials
330 1066th of 2000 higher than 927 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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