Systemic Lupus ErythematosusPhase 2NCT02124798
A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector
A Phase 2 study testing Belimumab autoinjector in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 27 sites in United States.
Trial summary
The primary objective of this study is to assess the suitability of the autoinjector for self-administration of belimumab by subjects with SLE in real-life conditions. The study will assess the use of the autoinjector inside the clinic setting and outside the clinic setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Belimumab autoinjector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 27 sitesUnited States
- Study dates
- 20 May 2014to 13 Apr 2015
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged at least 18 years at the time of signing the informed consent.
- Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) criteria.
- Active, autoantibody positive SLE, defined as the presence of anti nuclear antibody (ANA) or anti-double strand deoxyribonucleic acid (dsDNA) antibodies (at screening or historically).
- Are on a SLE treatment regimen including intravenous (IV) belimumab every 28 days for at least three 28-day cycles. Day 0 (i.e., day of first dose of study agent) should be scheduled about 2 weeks after the last dose IV dose of belimumab but may be scheduled 1 week and up to 4 weeks after the last IV dose.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy (for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records); or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] >40 milli international unit/milliliter [MIU/mL] and estradiol <40 picogram/mL [<147 picomoles/Liter] is confirmatory). (Females on hormone replacement therapy [HRT] and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.); Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at screening and urine hCG test prior to dosing; Agrees to use one of the contraception methods for 2 weeks prior to the day of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until Day 112; OR has only same-sex partners, when this is her preferred and usual lifestyle
- Alanine aminotransferase (ALT) <2x upper limit of normal (ULN), alkaline phosphatase and bilirubin <=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Have previously participated in a study of SC belimumab.
- Have received a live vaccine within 30 days of Day 0 or anticipate receipt of a live vaccine during the study or within 120 days after the last injection of study drug.
- Have received a non-biologic investigational agent within 60 days of Day 0.
- Have severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), cerebritis or CNS vasculitis requiring therapeutic intervention within 60 days of Day 0.
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.
- Have a planned surgical procedure
Show all 17Show fewer
- History of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, that, in the opinion of the investigator, makes the subject unsuitable for the study.
- Have required management of acute or chronic infections, as follows: Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria); Hospitalization for treatment of infection within 60 days of Day 0; Use of parenteral (IV or intramascular [IM]) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of Day 0.
- History of or a positive test for human immuno virus (HIV) at Screening.
- A positive Hepatitis B surface antigen or Hepatitis B core antibody, or positive Hepatitis C antibody result within 3 months of Screening or positive at Screening.
- Have an Immunoglobulin A (IgA) deficiency (IgA level <10 milligrams/deciliter).
- Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity Grading except for the following that are allowed: Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment; Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy; Stable Grade 3/4 proteinuria (<=6 grams/24 hour equivalent by spot urine protein to creatinine ratio allowed); Stable Grade 3 hypoalbuminemia due to lupus nephritis, and not related to liver disease or malnutrition; Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis, and not related to alcoholic liver disease, uncontrolled diabetes, or viral hepatitis. If present, any abnormalities in the ALT and/or aspartate aminotransferase (AST) must be<= Grade 2; Stable Grade 3 neutropenia or stable Grade 3 white blood cell count. Note: All Grade 3 or greater laboratory abnormalities will be flagged in the laboratory report. Therefore the above exceptions will be determined by the Investigator and Medical Monitor.
- Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies
- Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months, or who in the investigator's opinion, pose a significant suicide risk
- Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0
- Are unable to administer study agent by SC injection.
- In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a patient diary.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
GSK Investigational Site
Beckley, West Virginia, 25801
GSK Investigational Site
Birmingham, Alabama, 35249
GSK Investigational Site
Brooklyn, New York, 11203
GSK Investigational Site
Chapel Hill, North Carolina, 27514
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Charlotte, North Carolina, 28210
GSK Investigational Site
Duncansville, Pennsylvania, 16635
GSK Investigational Site
Flowood, Mississippi, 39232
GSK Investigational Site
Gilbert, Arizona, 85234
GSK Investigational Site
Greenville, North Carolina, 27834
GSK Investigational Site
Greenville, South Carolina, 29601
GSK Investigational Site
Houston, Texas, 77034
GSK Investigational Site
Houston, Texas, 77084
GSK Investigational Site
Lansing, Michigan, 48917
GSK Investigational Site
Lawrenceville, Georgia, 30045
GSK Investigational Site
Mesa, Arizona, 85202
GSK Investigational Site
Oklahoma City, Oklahoma, 73103
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Phoenix, Arizona, 85037
GSK Investigational Site
Raleigh, North Carolina, 27617
GSK Investigational Site
San Leandro, California, 94578
GSK Investigational Site
Smithtown, New York, 11787
GSK Investigational Site
Tuscaloosa, Alabama, 35406
GSK Investigational Site
Tustin, California, 92780
GSK Investigational Site
Webster, Texas, 77598
GSK Investigational Site
Wyomissing, Pennsylvania, 19610
About this study
Official title: An Open-Label Single-Arm Study to Evaluate the Reliability of an Autoinjector That Administers Belimumab Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
The primary objective of this study is to assess the suitability of the autoinjector for self-administration of belimumab by subjects with SLE in real-life conditions. The study will assess the use of the autoinjector inside the clinic setting and outside the clinic setting. The study will also assess the safety and tolerability of belimumab administered subcutaneously (SC) via the autoinjector. Subjects will self-administer belimumab SC into the thigh or abdomen using the autoinjector device for 8 weekly doses. Subjects will return for a follow-up visit 4 weeks after the last SC dose of belimumab. All injections will be assessed by the investigators for success based on direct observation and/or the subject diary. A total of 118 subjects (treated with at least one dose of study drug) are planned to be enrolled in this study.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Belimumab autoinjector
- Keywords
- Subcutaneous, Autoinjector, Belimumab, Real-Life Use Study, Reliability
- 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.
Belimumab autoinjectorDevice
Single use, disposable autoinjector assembled with the prefilled syringe containing the drug product belimumab with unit dose strength of 200mg/mL and 1 mL will be given as a once weekly SC dose
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Subjects will self-administer belimumab SC into thigh or abdomen using the autoinjector device for 8 weekly doses; 4 of the doses will be administered under observation in the clinic and 4 of the doses will be administered outside the clinic and without observation Receives: Device: Belimumab autoinjector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic)
The primary objective was to assess the suitability of the auto injector for self-administration of belimumab. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.
Measured: Weeks 1 and 2 (Inside clinic)
Secondary outcomes (2)
Number of Participants Successfully Able to Self-administer Their Observed Doses in Weeks 4 and 8 (Inside Clinic)
The main objective was to assess the suitability of the auto injector for self-administration of belimumab by participants with SLE. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.
Measured: Weeks 4 and 8 (Inside clinic)
Number of Participants Who Reported They Were Successfully Able to Self-administer Their Doses Outside the Clinic Setting in Weeks 3, 5, 6, and 7 (Outside Clinic)
Assessment was performed for suitability of the auto injector for self-administration of belimumab by participant with SLE outside the clinic setting. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections outside of the clinic without assistance were included.
Measured: Weeks 3, 5, 6, and 7 (Outside clinic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study start20 May 2014
- Primary completion13 Apr 2015
- Study completion13 Apr 2015
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 Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124798
- Sponsor's protocol ID
- 200339
- Status last verified
- Mar 2018
- First submitted
- 24 Apr 2014
- Last updated
- 11 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Single-Arm Study to Evaluate the Reliability of an Autoinjector That Administers Belimumab Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT02124798
- Acronym / sponsor ID
- 200339
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Subcutaneous, Autoinjector, Belimumab, Real-Life Use Study, Reliability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 May 2014 (actual)
- Primary completion
- 13 Apr 2015 (actual)
- Study completion
- 13 Apr 2015 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the suitability of the autoinjector for self-administration of belimumab by subjects with SLE in real-life conditions. The study will assess the use of the autoinjector inside the clinic setting and outside the clinic setting. The study will also assess the safety and tolerability of belimumab administered subcutaneously (SC) via the autoinjector. Subjects will self-administer belimumab SC into the thigh or abdomen using the autoinjector device for 8 weekly doses. Subjects will return for a follow-up visit 4 weeks after the last SC dose of belimumab. All injections will be assessed by the investigators for success based on direct observation and/or the subject diary. A total of 118 subjects (treated with at least one dose of study drug) are planned to be enrolled in this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Belimumab autoinjectorSubjects will self-administer belimumab SC into thigh or abdomen using the autoinjector device for 8 weekly doses; 4 of the doses will be administered under observation in the clinic and 4 of the doses will be administered outside the clinic and without observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged at least 18 years at the time of signing the informed consent.
- Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) criteria.
- Active, autoantibody positive SLE, defined as the presence of anti nuclear antibody (ANA) or anti-double strand deoxyribonucleic acid (dsDNA) antibodies (at screening or historically).
- Are on a SLE treatment regimen including intravenous (IV) belimumab every 28 days for at least three 28-day cycles. Day 0 (i.e., day of first dose of study agent) should be scheduled about 2 weeks after the last dose IV dose of belimumab but may be scheduled 1 week and up to 4 weeks after the last IV dose.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy (for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records); or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] >40 milli international unit/milliliter [MIU/mL] and estradiol <40 picogram/mL [<147 picomoles/Liter] is confirmatory). (Females on hormone replacement therapy [HRT] and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.); Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at screening and urine hCG test prior to dosing; Agrees to use one of the contraception methods for 2 weeks prior to the day of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until Day 112; OR has only same-sex partners, when this is her preferred and usual lifestyle
Key exclusion criteria (17 listed)
- Have previously participated in a study of SC belimumab.
- Have received a live vaccine within 30 days of Day 0 or anticipate receipt of a live vaccine during the study or within 120 days after the last injection of study drug.
- Have received a non-biologic investigational agent within 60 days of Day 0.
- Have severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), cerebritis or CNS vasculitis requiring therapeutic intervention within 60 days of Day 0.
- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.
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 |
|---|---|---|
| Belimumab autoinjectorSingle use, disposable autoinjector assembled with the prefilled syringe containing the drug product belimumab with unit dose strength of 200mg/mL and 1 mL will be given as a once weekly SC dose | Device | Single arm |
Primary outcome
Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic)
Time frame: Weeks 1 and 2 (Inside clinic)
The primary objective was to assess the suitability of the auto injector for self-administration of belimumab. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.
2 secondary outcomes
Number of Participants Successfully Able to Self-administer Their Observed Doses in Weeks 4 and 8 (Inside Clinic)
Time frame: Weeks 4 and 8 (Inside clinic)
Number of Participants Who Reported They Were Successfully Able to Self-administer Their Doses Outside the Clinic Setting in Weeks 3, 5, 6, and 7 (Outside Clinic)
Time frame: Weeks 3, 5, 6, and 7 (Outside clinic)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belimumab autoinjector in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 27 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 7 inclusion and 17 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 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 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?
Yes. Results are posted in the registry (first posted 30 May 2017). 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?
Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic) (time frame: Weeks 1 and 2 (Inside clinic)). 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 11 Apr 2018.