Lupus Erythematosus, SystemicPhase 3VOYAGERNCT00381810
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
A Phase 3 study testing Rituximab, Methylprednisolone and Acetaminophen in people with Lupus Erythematosus, Systemic, run by Genentech, Inc. at 11 sites in United States.
Trial summary
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Rituximab, Methylprednisolone and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Jun 2006to 29 Feb 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with systemic lupus erythematosus (SLE) who participated and satisfactorily completed their Week 52 evaluation in Study U2971g.
- For partial clinical response (PCR) or nonclinical response (NCR), active disease at screening as defined by one or more domains with a British Isles Lupus Assessment Group (BILAG) A score or 2 or more domains with a BILAG B score.
Who cannot join
- Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.
- Any safety concern potentially attributed to rituximab that in the investigator's opinion would jeopardize subject safety.
- Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.
- Subjects, that in the investigator's opinion, have not demonstrated any clinical improvement by Week 52 in study U2971g and in whom the proposed therapy would represent risk without benefit.
- Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
- Pregnant women or nursing (breastfeeding) mothers.
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- History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 8 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
- Major surgery within 4 weeks prior to screening.
- Intolerance or contraindication to oral or IV corticosteroids.
- Positive hepatitis B surface antigen (BsAg) or hepatitis C serology.
- Receipt of a live vaccine within 28 days prior to treatment.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Intermountain Research Center
Boise, Idaho, 83702
Medical Univ of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, 83814
North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology
Great Neck, New York, 11021
University of Kansas Medical Center
Kansas City, Kansas, 66160
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Arizona Arthritis & Rheumatology Research, Pllc
Paradise Valley, Arizona, 85253
Eden Medical Center San Leandro Hospital
San Leandro, California, 94578
Seattle Rheumatology Assoc; Swedish Rheumatology Research
Seattle, Washington, 98104
Texas Research Center
Sugar Land, Texas, 77479
About this study
Official title: An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Rituximab, Methylprednisolone, Acetaminophen, Diphenhydramine
- Keywords
- Rituxan, SLE, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Rituximab will be supplied as a liquid for intravenous infusion.
AcetaminophenDrug
DiphenhydramineDrug
| Study group | Role | What they receive |
|---|---|---|
| Rituximab 1000 mg | Experimental | Participants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion. Receives: Drug: Rituximab; Drug: Methylprednisolone; Drug: Acetaminophen; Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least 1 Serious Adverse Event
A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.
Measured: Baseline to the end of the study (up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study start22 Jun 2006
- Primary completion31 Jul 2008
- Study completion29 Feb 2012
Why it stopped: During a safety review of studies U2970g and U2971g, the Data Monitoring Committee recommended that enrollment in this extension trial be terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Brunetta, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381810
- Sponsor's protocol ID
- U3389g
- Acronym
- VOYAGER
- Status last verified
- Jun 2017
- First submitted
- 26 Sep 2006
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g
- ClinicalTrials.gov ID
- NCT00381810
- Acronym / sponsor ID
- VOYAGER / U3389g
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Rituxan, SLE, Lupus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: During a safety review of studies U2970g and U2971g, the Data Monitoring Committee recommended that enrollment in this extension trial be terminated.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2006 (actual)
- Primary completion
- 31 Jul 2008 (actual)
- Study completion
- 29 Feb 2012 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Posted 18 Dec 2009
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 Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab 1000 mg | Experimental | Drug: Rituximab, Drug: Methylprednisolone, Drug: Acetaminophen, Drug: DiphenhydramineParticipants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with systemic lupus erythematosus (SLE) who participated and satisfactorily completed their Week 52 evaluation in Study U2971g.
- For partial clinical response (PCR) or nonclinical response (NCR), active disease at screening as defined by one or more domains with a British Isles Lupus Assessment Group (BILAG) A score or 2 or more domains with a BILAG B score.
Key exclusion criteria (13 listed)
- Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.
- Any safety concern potentially attributed to rituximab that in the investigator's opinion would jeopardize subject safety.
- Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.
- Subjects, that in the investigator's opinion, have not demonstrated any clinical improvement by Week 52 in study U2971g and in whom the proposed therapy would represent risk without benefit.
- Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
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 |
|---|---|---|
| RituximabRituximab will be supplied as a liquid for intravenous infusion. | Drug | Rituximab 1000 mg |
| Methylprednisolone | Drug | Rituximab 1000 mg |
| Acetaminophen | Drug | Rituximab 1000 mg |
| Diphenhydramine | Drug | Rituximab 1000 mg |
Primary outcome
Percentage of Participants With at Least 1 Serious Adverse Event
Time frame: Baseline to the end of the study (up to 52 weeks)
A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Brunetta, M.D. study director
Genentech, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab, Methylprednisolone and Acetaminophen in people with Lupus Erythematosus, Systemic, run by Genentech, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With at Least 1 Serious Adverse Event (time frame: Baseline to the end of the study (up to 52 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 1 Aug 2017.