VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
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).
Key facts
- Study ID
- NCT01390545
- Run by
- Takeda
- People needed
- 300
- Starts
- 2011-08-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2016-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Nycomed Investigational Site — Los Angeles, California, United States
- Nycomed Investigational Site — Upland, California, United States
- Nycomed Investigational Site — Aventura, Florida, United States
- Nycomed Investigational Site — Las Vegas, Nevada, United States
- Nycomed Investigational Site — Charleston, South Carolina, United States
- Nycomed Investigational Site — Nashville, Tennessee, United States
- Nycomed Investigational Site — San Antonio, Texas, United States
- Nycomed Investigational Site — Caba, Buenos Aires, Argentina
- Nycomed Investigational Site — Caba, Buenos Aires, Argentina
- Nycomed Investigational Site — Caba, Buenos Aires, Argentina
- Nycomed Investigational Site — Caba, Buenos Aires, Argentina
- Nycomed Investigational Site — Caba, Buenos Aires, Argentina
- Nycomed Investigational Site — Caba, Buenos Aires, Argentina
- Nycomed Investigational Site — Córdoba, Córdoba Province, Argentina
- Nycomed Investigational Site — San Juan, San Juan Province, Argentina
- Nycomed Investigational Site — Santa Fe, Santa Fe Province, Argentina
- Nycomed Investigational Site — San Miguel de Tucumán, Tucumán Province, Argentina
- Nycomed Investigational Site — Calgary, Alberta, Canada
- Nycomed Investigational Site — Kitchener, Ontario, Canada
- Nycomed Investigational Site — Ottawa, Ontario, Canada
- Nycomed Investigational Site — St. Catharines, Ontario, Canada
- Nycomed Investigational Site — Toronto, Ontario, Canada
- Nycomed Investigational Site — Windsor, Ontario, Canada
- Nycomed Investigational Site — Saskatoon, Saskatchewan, Canada
- Nycomed Investigational Site — La Mesa, California, United States
Full record on ClinicalTrials.gov
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