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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

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Trial Information

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.


The trial comprises a screening phase (4 to 12 weeks prior to first administration of
veltuzumab), a 4-week treatment phase (weeks 1 to 4), a core phase from week 4 to week 24,
and a follow-up phase from week 24 to week 48. The primary end-point, the American College
of Rheumatology 20 (ACR 20) response rate, will be evaluated at week 24.

The objectives of this trial are:

- To investigate the efficacy, safety and tolerability at week 24 of three different sc
dose levels of the humanized anti-CD20 antibody veltuzumab as an add-on treatment to
MTX compared to MTX alone in subjects with moderate to severe RA

- To evaluate the durability of the clinical response and safety of veltuzumab over 48
weeks

- To identify the dosage(s) of veltuzumab with the most favourable benefit-risk profile
to be further evaluated in the subsequent phase II/III clinical program in subjects
with moderate to severe RA.

Current status of the trial: Following the voluntary temporary halt of the VELVET dose range
finding trial, the sponsor has decided to redesign the protocol and start a new trial as
soon as possible.

All patients treated prior to the voluntary halt have completed their safety assessments. It
was decided to terminate the VELVET trial and consequently not to recommence enrollment.

In the VELVET trial, a total of 11 patients received trial medication prior to the voluntary
temporary halt. No efficacy conclusions according to protocol can be drawn from the 11
patients treated. Based on the collected clinical data from this trial, there is no clinical
safety signal and no increased clinical safety risk observed to date that precludes
continued clinical investigation of veltuzumab.


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-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)

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

American College of Rheumatology 20 (ACR20) response rate at completion of week 24

Outcome Description:

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)

Outcome Time Frame:

24 weeks

Safety Issue:

No

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

VT-4001-001-SP

NCT ID:

NCT01390545

Start Date:

August 2011

Completion Date:

October 2012

Related Keywords:

  • Rheumatoid Arthritis
  • Rheumatoid arthritis
  • anti-CD20 antibody
  • subcutaneous
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Nycomed Investigational SiteLa Mesa, California  
Nycomed Investigational SiteAventura, Florida  
Nycomed Investigational SiteLas Vegas, Nevada  
Nycomed Investigational SiteCharleston, South Carolina  
Nycomed Investigational SiteNashville, Tennessee  
Nycomed Investigational SiteSan Antonio, Texas