Trials Sponsors Conditions Drugs Pricing

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisanti-CD20 antibodysubcutaneous

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 COMPARATOR

Drug: Veltuzumab

Veltuzumab 160 mg

ACTIVE COMPARATOR

Drug: Veltuzumab

Veltuzumab 320 mg

ACTIVE COMPARATOR

Drug: Veltuzumab

Placebo

PLACEBO COMPARATOR

Interventions

VeltuzumabDrug

administered once weekly (days 1, 8, 15 and 22) by subcutaneous injection

PlaceboVeltuzumab 160 mgVeltuzumab 320 mgVeltuzumab 80 mg

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

Takeda
Industrylead

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

veltuzumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

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 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2012

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (4)

Veltuzumab 80 mg

Veltuzumab 160 mg

Veltuzumab 320 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (63)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (4)

Veltuzumab 80 mg

Veltuzumab 160 mg

Veltuzumab 320 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (63)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations