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
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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)
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
|Nycomed Investigational Site||La Mesa, California|
|Nycomed Investigational Site||Aventura, Florida|
|Nycomed Investigational Site||Las Vegas, Nevada|
|Nycomed Investigational Site||Charleston, South Carolina|
|Nycomed Investigational Site||Nashville, Tennessee|
|Nycomed Investigational Site||San Antonio, Texas|