VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01390545
• Date of registration: 05/07/2011
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis VELVET
• Scientific title: 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.
• Date of first enrolment: August 2011
• Target sample size: 300
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01390545
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Argentina, Canada, Czech Republic, Germany, Hungary, Italy, Mexico, Poland, Spain, United Kingdom, United States

Key inclusion & exclusion criteria

Main Inclusion Criteria:

- 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-TNFa) biological
treatment. Subjects should not have received more than two different anti-TNFa
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)

Main Exclusion Criteria:

- Primary or secondary immunodeficiency including HIV infection

- Evidence of acute or chronic infection with hepatitis B and C virus (HBV and HCV)

- Evidence (e.g. chest X-ray [posterior-anterior view], tuberculin/ PPD skin test,
etc., according local guidelines) and/or history of active tuberculosis (TB), prior
to successfully completing an anti-TB treatment. X-rays performed prior to inclusion
(Screening, Visit 1) into the trial are accepted provided they were done within 3
months prior to Screening (Visit 1). Subjects with latent TB infection (LTBI) can be
included

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Veltuzumab

Primary Outcome(s)

American College of Rheumatology 20 (ACR20) response rate at completion of week 24 [Time Frame: 24 weeks]

Secondary Outcome(s)

Further efficacy analyses (Hybrid ACR response, DAS28-CRP, EULAR response) [Time Frame: 24 and 48 weeks]

ACR20 response rate [Time Frame: 48 weeks]

ACR50/70 response rate [Time Frame: 24 and 48 weeks]

Secondary ID(s)

VT-4001-001-SP

2010-022378-15

U1111-1136-3415

Source(s) of Monetary Support

Please refer to primary and secondary sponsors