Systemic Lupus ErythematosusPhase 1NCT00541749
A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus
A Phase 1 study testing rhuMAb IFNalpha in people with Systemic Lupus Erythematosus, run by Genentech, Inc..
Trial summary
This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- rhuMAb IFNalpha
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to not given
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For patients with reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) throughout their participation in the study
- Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria
- Disease duration of ≥ 1 year (after first diagnosis by a physician)
- Current immunity to measles, mumps, rubella, and varicella, as evidenced by positive IgG titers at the time of screening
- Current vaccination against influenza unless contraindicated in the investigator's judgment
- Normal Pap smear within the applicable time interval recommended by current American Cancer Society guidelines
Who cannot join
- Presence of active lupus nephritis
- Presence of active central nervous system (CNS) disease requiring treatment with high-dose corticosteroids or immunosuppressive agents
- Presence of active vasculitis requiring treatment
- History of arterial or venous thromboses within 12 months of screening
- Moderate to severe anemia, thrombocytopenia, or neutropenia
- Any manifestation likely to require, in the investigator's judgment, treatment with high-dose corticosteroids or the addition of an immunosuppressive regimen during the course of the trial
Show all 36Show fewer
- Pregnancy or lactation
- Lack of peripheral venous access
- History of alcohol or substance abuse within 6 months of screening
- History of severe allergic or anaphylactic reactions to antibodies or fusion proteins
- Evidence of significant uncontrolled concomitant diseases
- Significant laboratory or electrocardiogram (ECG) abnormalities
- Evidence of any clinically significant abnormality on a chest X-ray
- Severly impaired renal function
- Impaired hepatic function
- Poorly controlled diabetes
- Conditions other than SLE that could require treatment with corticosteroids
- History of malignancy except completely excised basal cell carcinoma
- Congenital immune deficiency
- Positive tests for antibodies to HIV, hepatitis B (HBS antigen, anti-HBC) or C
- Positive IgM antibody titers in the presence of negative IgG titers to Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
- Frequent recurrence of herpes lesions
- Episode of shingles within one year of screening
- Positive screening test for latent mycobacterium tuberculosis infection
- History of severe systemic bacterial, fungal, viral, or parasitic infections within the year prior to screening
- Any current or recent signs or symptoms of infection
- Received antibiotics orally (PO) during the 30 days prior to screening or IV antibiotics during the 60 days prior to screening
- Received a live vaccine within the 30 days prior to screening
- Has been hospitalized within the 30 days prior to screening
- Received > 20 mg/day prednisone for > 3 days during the 30 days prior to screening
- Received azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, pulse dose corticosteroids, intravenous immunoglobulin (IVIG), or transfusions within 6 months prior to screening
- Received cyclophosphamide within 2 years prior to screening
- Received a monoclonal antibody during the 12 months prior to screening
- Previously received an investigational treatment directed against interferon alpha
- Received B-cell depleting therapy (e.g., anti-CD20, anti-CD22)
- Received investigational treatment during the 30 days prior to screening
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus
This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- rhuMAb IFNalpha
- Keywords
- SLE
- 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.
rhuMAb IFNalphaDrug
Intravenous repeating dose
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and nature of laboratory abnormalities
Measured: Length of study
The incidence, nature, and severity of adverse events
Measured: Length of study
Secondary outcomes (2)
The PK profile of rhuMAb IFNalpha
Measured: Length of study
The incidence of antibodies directed against rhuMAb IFNalpha
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorn Drappa, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541749
- Sponsor's protocol ID
- IFN3958g
- Status last verified
- Sep 2011
- First submitted
- 7 Oct 2007
- Last updated
- 22 Sep 2011
- Results posted
- No
Publications
McBride JM, Jiang J, Abbas AR, Morimoto A, Li J, Maciuca R, Townsend M, Wallace DJ, Kennedy WP, Drappa J. Safety and pharmacodynamics of rontalizumab in patients with systemic lupus erythematosus: results of a phase I, placebo-controlled, double-blind, dose-escalation study. Arthritis Rheum. 2012 Nov;64(11):3666-76. doi: 10.1002/art.34632.
PubMed 22833362
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00541749
- Acronym / sponsor ID
- IFN3958g
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- First posted
- 10 Oct 2007 (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 Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For patients with reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) throughout their participation in the study
- Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria
- Disease duration of ≥ 1 year (after first diagnosis by a physician)
- Current immunity to measles, mumps, rubella, and varicella, as evidenced by positive IgG titers at the time of screening
- Current vaccination against influenza unless contraindicated in the investigator's judgment
Key exclusion criteria (36 listed)
- Presence of active lupus nephritis
- Presence of active central nervous system (CNS) disease requiring treatment with high-dose corticosteroids or immunosuppressive agents
- Presence of active vasculitis requiring treatment
- History of arterial or venous thromboses within 12 months of screening
- Moderate to severe anemia, thrombocytopenia, or neutropenia
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 |
|---|---|---|
| rhuMAb IFNalphaIntravenous repeating dose | Drug | – |
Primary outcome
The incidence and nature of laboratory abnormalities
Time frame: Length of study
The incidence, nature, and severity of adverse events
Time frame: Length of study
2 secondary outcomes
The PK profile of rhuMAb IFNalpha
Time frame: Length of study
The incidence of antibodies directed against rhuMAb IFNalpha
Time frame: Length of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
- Derived from this study: PubMed 22833362McBride JM, Jiang J, Abbas AR, Morimoto A, Li J, Maciuca R, Townsend M, Wallace DJ, Kennedy WP, Drappa J. Safety and pharmacodynamics of rontalizumab in patients with systemic lupus erythematosus: results of a phase I, placebo-controlled, double-blind, dose-escalation study. Arthritis Rheum. 2012 Nov;64(11):3666-76. doi: 10.1002/art.34632.
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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.
Jorn Drappa, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rhuMAb IFNalpha in people with Systemic Lupus Erythematosus, run by Genentech, Inc..
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 6 inclusion and 36 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: finished, as of the sponsor's last update on 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence and nature of laboratory abnormalities (time frame: Length of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00541749, which also lists 1 linked publication.
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 22 Sep 2011.