Rheumatoid ArthritisPhase 2VELVETNCT01390545
VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis
A Phase 2 study testing Veltuzumab in people with Rheumatoid Arthritis, run by Takeda at 63 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Veltuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 63 sitesin 11 countries
- Study dates
- Aug 2011to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
63 sites in 11 countries.
63 sites in 11 countries
Argentina10 sites
Nycomed Investigational Site
Caba, Buenos Aires, C1015ABO
Nycomed Investigational Site
Caba, Buenos Aires, C1114AAH
Nycomed Investigational Site
Caba, Buenos Aires, C1419AHN
Nycomed Investigational Site
Caba, Buenos Aires, C1425DQK
Nycomed Investigational Site
Caba, Buenos Aires, C1425DTG
Nycomed Investigational Site
Caba, Buenos Aires, C1426AAL
Nycomed Investigational Site
Córdoba, Córdoba Province, X5016KEH
Nycomed Investigational Site
San Juan, San Juan Province, J5402DKL
Nycomed Investigational Site
San Miguel de Tucumán, Tucumán Province, T4000AXL
Nycomed Investigational Site
Santa Fe, Santa Fe Province, S3000FWO
United States8 sites
Nycomed Investigational Site
Aventura, Florida
Nycomed Investigational Site
Charleston, South Carolina
Nycomed Investigational Site
La Mesa, California
Nycomed Investigational Site
Las Vegas, Nevada
Nycomed Investigational Site
Los Angeles, California
Nycomed Investigational Site
Nashville, Tennessee
Nycomed Investigational Site
San Antonio, Texas
Nycomed Investigational Site
Upland, California
Mexico8 sites
Nycomed Investigational Site
Ciudad Obregón, Sonora, 85000
Nycomed Investigational Site
Culiacán, Sinaloa, 80020
Nycomed Investigational Site
Distrito Federal, Mexico, 06700
Nycomed Investigational Site
Distrito Federal, México, 06700
Nycomed Investigational Site
Guadalajara, Jalisco, 44185
Nycomed Investigational Site
Guadalajara, Jalisco, 44620
Nycomed Investigational Site
Mazatlán, Sinaloa, 82126
Nycomed Investigational Site
Monterrey, Nuevo León, 64460
Canada7 sites
Nycomed Investigational Site
Calgary, Alberta
Nycomed Investigational Site
Kitchener, Ontario
Nycomed Investigational Site
Ottawa, Ontario
Nycomed Investigational Site
Saskatoon, Saskatchewan
Nycomed Investigational Site
St. Catharines, Ontario
Nycomed Investigational Site
Toronto, Ontario
Nycomed Investigational Site
Windsor, Ontario
Hungary7 sites
Nycomed Investigational Site
Debrecen
Nycomed Investigational Site
Kecskemét
Nycomed Investigational Site
Kiskunhaias
Nycomed Investigational Site
Kistarcsa
Nycomed Investigational Site
Mezőkövesd
Nycomed Investigational Site
Székesfehérvár
Nycomed Investigational Site
Szolnok
Czechia6 sites
Nycomed Investigational Site
Hlučín
Nycomed Investigational Site
Hostivice
Nycomed Investigational Site
Pilsen
Nycomed Investigational Site
Prague
Nycomed Investigational Site
Uherské Hradiště
Nycomed Investigational Site
Zlín
Poland6 sites
Nycomed Investigational Site
Bialystok
Nycomed Investigational Site
Bydgoszcz
Nycomed Investigational Site
Lublin
Nycomed Investigational Site
Poznan
Nycomed Investigational Site
Sopot
Nycomed Investigational Site
Warsaw
Italy4 sites
Nycomed Investigational Site
Arenzano (GE)
Nycomed Investigational Site
Jesi (AN)
Nycomed Investigational Site
Massa
Nycomed Investigational Site
Valeggio S/M (VR)
Spain3 sites
Nycomed Investigational Site
A Coruña, Galicia
Nycomed Investigational Site
Barakaldo, Basque Country
Nycomed Investigational Site
Seville, Andalusia
Germany2 sites
Nycomed Investigational Site
Bad Nauheim
Nycomed Investigational Site
Würzburg
United Kingdom2 sites
Nycomed Investigational Site
Ashford, Middlesex
Nycomed Investigational Site
Barnsley, S. Yorkshire
About this study
Official 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.
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).
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Veltuzumab
- Keywords
- Rheumatoid arthritis, anti-CD20 antibody, subcutaneous
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeltuzumabDrug
administered once weekly (days 1, 8, 15 and 22) by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Veltuzumab 80 mg | Active comparator | Not described Receives: Drug: Veltuzumab |
| Veltuzumab 160 mg | Active comparator | Not described Receives: Drug: Veltuzumab |
| Veltuzumab 320 mg | Active comparator | Not described Receives: Drug: Veltuzumab |
| Placebo | Placebo comparator | Not described Receives: Drug: Veltuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 weeks
Secondary outcomes (3)
ACR50/70 response rate
ACR50/70 response rate is defined as improvement from baseline to endpoint fulfilling the following criteria:
- 50/70 percent reduction in the TJC (66/68 joint count system)
- 50/70 percent reduction in the SJC (66/68 joint count system)
- 50/70 percent 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)
Measured: 24 and 48 weeks
ACR20 response rate
ACR20 response rate is defined as improvement from baseline to endpoint fulfilling the following criteria:
- 20 percent reduction in the TJC (66/68 joint count system)
- 20 percent reduction in the 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)
Measured: 48 weeks
Further efficacy analyses (Hybrid ACR response, DAS28-CRP, EULAR response)
To further demonstrate efficacy of veltuzumab
Measured: 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Trial re-design; no safety issues identified
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390545
- Sponsor's protocol ID
- VT-4001-001-SP
- Other IDs
- 2010-022378-15, U1111-1136-3415
- Acronym
- VELVET
- Status last verified
- Mar 2016
- First submitted
- 5 Jul 2011
- Last updated
- 13 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01390545
- Acronym / sponsor ID
- VELVET / VT-4001-001-SP
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, anti-CD20 antibody, subcutaneous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial re-design; no safety issues identified
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Veltuzumab 80 mg | Active comparator | Drug: Veltuzumab |
| Veltuzumab 160 mg | Active comparator | Drug: Veltuzumab |
| Veltuzumab 320 mg | Active comparator | Drug: Veltuzumab |
| Placebo | Placebo comparator | Drug: Veltuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veltuzumabadministered once weekly (days 1, 8, 15 and 22) by subcutaneous injection | Drug | Placebo, Veltuzumab 160 mg, Veltuzumab 320 mg, Veltuzumab 80 mg |
Primary outcome
American College of Rheumatology 20 (ACR20) response rate at completion of week 24
Time frame: 24 weeks
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)
3 secondary outcomes
ACR50/70 response rate
Time frame: 24 and 48 weeks
ACR20 response rate
Time frame: 48 weeks
Further efficacy analyses (Hybrid ACR response, DAS28-CRP, EULAR response)
Time frame: 24 and 48 weeks
Results and safety
The study was stopped early (reason given: Trial re-design; no safety issues identified). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Veltuzumab in people with Rheumatoid Arthritis, run by Takeda at 63 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in Argentina, United States, Mexico, Canada, Hungary and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Trial re-design; no safety issues identified). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology 20 (ACR20) response rate at completion of week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.