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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: Clinical Trial Phase 2 study, sponsored by Takeda.
NCT01390545 is a Phase 2 study that was terminated before completion, run by Takeda. The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
ACR20 response rate is defined as improvement from baseline to endpoint fulfilling the following criteria: * ≥ 20 percent reduction in the Tender joint count (TJC) (66/68 joint count system) * ≥ 20 percent reduction in the Swollen joint count (SJC) (66/68 joint count system) * ≥ 20 percent reduction in three of the following additional measures: * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Degree
Interventions
- DRUG Veltuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
Why NCT01390545 stopped before completion
NCT01390545 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 1 intervention - of which Veltuzumab is the first listed.
NCT01390545 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01390545's enrollment target sits among peer trials
300 167th of 2000 higher than 1,813 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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