Study Stopped
Trial re-design; no safety issues identified
VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis
VELVET
VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate.
3 other identifiers
interventional
300
11 countries
63
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Aug 2011
Shorter than P25 for phase_2 rheumatoid-arthritis
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedApril 13, 2016
March 1, 2016
1.2 years
July 5, 2011
March 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American College of Rheumatology 20 (ACR20) response rate at completion of week 24
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 of disability * Level of acute-phase reactant (CRP)
24 weeks
Secondary Outcomes (3)
ACR50/70 response rate
24 and 48 weeks
ACR20 response rate
48 weeks
Further efficacy analyses (Hybrid ACR response, DAS28-CRP, EULAR response)
24 and 48 weeks
Study Arms (4)
Veltuzumab 80 mg
ACTIVE COMPARATORVeltuzumab 160 mg
ACTIVE COMPARATORVeltuzumab 320 mg
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
administered once weekly (days 1, 8, 15 and 22) by subcutaneous injection
Eligibility Criteria
You may qualify if:
- Active disease defined as:
- Diagnosis of RA using the ACR criteria for the classification of RA for at least 6 months prior to trial entry (Screening, Visit 1)
- Swollen joint count (SJC) ≥ 6 and tender joint count (TJC) ≥ 6 referred to as the 66/68 - joint count system
- High sensitivity C-reactive protein (hs-CRP) ≥ 15 mg/L and/or an erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour
- Positive rheumatoid factor (RF) ≥ 14 IU/mL and/or anti-cyclic citrullinated protein (CCP) ≥ 20 U
- An inadequate response (insufficient initial or loss of response and/or intolerance to at least one administration of these agents) to previous or current treatment with either MTX alone or MTX plus anti-tumour necrosis factor alpha (anti-TNFα) biological treatment. Subjects should not have received more than two different anti-TNFα therapies.
- Receiving MTX 15-25 mg/week (oral or parenteral) for at least 20 weeks, including the last 6 weeks prior to Baseline (Visit 3, Day 1) at a stable dose via the same route of administration and formulation. A stable dose of 12.5 mg of MTX is acceptable if the MTX dose has been reduced for reasons of toxicity, e.g. pulmonary, hepatic or haematological toxicity. MTX co-medication will be continued until the end of the trial (Week 48)
You may not qualify if:
- Primary or secondary immunodeficiency including HIV infection
- Evidence of acute or chronic infection with hepatitis B and C virus (HBV and HCV)
- Significant cardiac disease or history of severe COPD
- Diabetes mellitus type 1 or unstable type 2
- History of cancer within the last 5 years treated with anti-cancer chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (63)
Nycomed Investigational Site
La Mesa, California, United States
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, C1015ABO, Argentina
Nycomed Investigational Site
Caba, Buenos Aires, C1114AAH, Argentina
Nycomed Investigational Site
Caba, Buenos Aires, C1419AHN, Argentina
Nycomed Investigational Site
Caba, Buenos Aires, C1425DQK, Argentina
Nycomed Investigational Site
Caba, Buenos Aires, C1425DTG, Argentina
Nycomed Investigational Site
Caba, Buenos Aires, C1426AAL, Argentina
Nycomed Investigational Site
Córdoba, Córdoba Province, X5016KEH, Argentina
Nycomed Investigational Site
San Juan, San Juan Province, J5402DKL, Argentina
Nycomed Investigational Site
Santa Fe, Santa Fe Province, S3000FWO, Argentina
Nycomed Investigational Site
San Miguel de Tucumán, Tucumán Province, T4000AXL, 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
Hlučín, Czechia
Nycomed Investigational Site
Hostivice, Czechia
Nycomed Investigational Site
Pilsen, Czechia
Nycomed Investigational Site
Prague, Czechia
Nycomed Investigational Site
Uherské Hradiště, Czechia
Nycomed Investigational Site
Zlín, Czechia
Nycomed Investigational Site
Bad Nauheim, Germany
Nycomed Investigational Site
Würzburg, Germany
Nycomed Investigational Site
Debrecen, Hungary
Nycomed Investigational Site
Kecskemét, Hungary
Nycomed Investigational Site
Kiskunhaias, Hungary
Nycomed Investigational Site
Kistarcsa, Hungary
Nycomed Investigational Site
Mezőkövesd, Hungary
Nycomed Investigational Site
Székesfehérvár, Hungary
Nycomed Investigational Site
Szolnok, Hungary
Nycomed Investigational Site
Arenzano (GE), Italy
Nycomed Investigational Site
Jesi (AN), Italy
Nycomed Investigational Site
Massa, Italy
Nycomed Investigational Site
Valeggio S/M (VR), Italy
Nycomed Investigational Site
Guadalajara, Jalisco, 44185, Mexico
Nycomed Investigational Site
Guadalajara, Jalisco, 44620, Mexico
Nycomed Investigational Site
Distrito Federal, Mexico, 06700, Mexico
Nycomed Investigational Site
Distrito Federal, México, 06700, Mexico
Nycomed Investigational Site
Monterrey, Nuevo León, 64460, Mexico
Nycomed Investigational Site
Culiacán, Sinaloa, 80020, Mexico
Nycomed Investigational Site
Mazatlán, Sinaloa, 82126, Mexico
Nycomed Investigational Site
Ciudad Obregón, Sonora, 85000, Mexico
Nycomed Investigational Site
Bialystok, Poland
Nycomed Investigational Site
Bydgoszcz, Poland
Nycomed Investigational Site
Lublin, Poland
Nycomed Investigational Site
Poznan, Poland
Nycomed Investigational Site
Sopot, Poland
Nycomed Investigational Site
Warsaw, Poland
Nycomed Investigational Site
Seville, Andalusia, Spain
Nycomed Investigational Site
Barakaldo, Basque Country, Spain
Nycomed Investigational Site
A Coruña, Galicia, Spain
Nycomed Investigational Site
Ashford, Middlesex, United Kingdom
Nycomed Investigational Site
Barnsley, S. Yorkshire, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2011
First Posted
July 11, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
April 13, 2016
Record last verified: 2016-03