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NCT01390545 · ClinicalTrials.gov registry record · Phase 2
VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis
A Phase 2 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT01390545 is a Phase 2 study that was terminated before completion, run by Takeda. The registered enrollment target is 300 participants.
The verdict
NCT01390545, a Phase 2 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study Summary
This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc) injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on continued stable co-medication with methotrexate (MTX).
Interventions
- DRUG Veltuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01390545
The ClinicalTrials.gov registry entry for NCT01390545 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Veltuzumab is the first listed.
NCT01390545 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01390545 about?
NCT01390545 is a clinical study titled "VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis". This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc) injection to subjects with mode...
What is the current status of trial NCT01390545?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2011-08. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01390545?
The interventions under investigation include: Veltuzumab (DRUG).
Who is sponsoring clinical trial NCT01390545?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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