A Phase 3 interventional study of Placebo and Belimumab 10 mg/kg in Vasculitis, sponsored by Human Genome Sciences Inc., a GSK Company. Completed at 89 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Human Genome Sciences Inc., a GSK Company (part of GlaxoSmithKline) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.
170 studies on the registry are indexed under Vasculitis; 46 are open to participants now.
This study's enrollment of 106 is above the median of 58 across 87 interventional studies indexed under Vasculitis.
Browse Vasculitis studies →Human Genome Sciences Inc., a GSK Company is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted after Human Genome Sciences Inc. became part of GlaxoSmithKline.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo IV plus oral azathioprine 2 mg/kg/day; placebo administered on Days 0, 14, 28, and then every 28 days until the end of the study. If the results in the double-blind period show that belimumab is safe and effective, then participants have the option to receive treatment with belimumab in a 6-month open-label extension phase. Placebo patients who opt to participate in the extension will receive belimumab 10 mg/kg IV every 28 days plus oral azathioprine 2 mg/kg/day for an additional 6 months.
Biological: Placebo · Drug: Azathioprine
Belimumab 10 mg/kg IV plus oral azathioprine 2 mg/kg/day; belimumab administered on Days 0, 14, 28, and then every 28 days until the end of the study. If the results in the double-blind period show that belimumab is safe and effective, then participants have the option to continue treatment with belimumab in a 6-month open-label extension phase. Patients who opt to participate in the extension will continue to receive belimumab 10 mg/kg IV every 28 plus oral azathioprine 2 mg/kg/day days for an additional 6 months.
Biological: Belimumab 10 mg/kg · Drug: Azathioprine
Placebo
Drug page: Belimumab
Belimumab 10 mg/kg
Also known as: BENLYSTA™
Azathioprine
Time to First Relapse
Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date - treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates.
Time frame: Approximately up to 4 years
Number of Participants With Major Relapse During the Double-blind Phase of the Study
Data for number of participants with major relapse \[defined as experiencing at least 1 major Birmingham Vasculitis Activity Score (BVAS) item\] during the double-bind phase of the study was reported. Analysis was performed using a Cox proportional hazard model.
Time frame: Approximately up to 4 years
Participants with diagnosis of Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) were randomized in this study. The study was conducted at 37 centers in 15 countries in North America, Central America, South America, Western Europe, Eastern Europe, and Australia during 20 March 2013 - 06 February 2017.
| Milestone | Placebo | Belimumab 10 mg/kg |
|---|---|---|
| Started | 52 | 53 |
| Completed | 40 | 33 |
| Not completed | 12 | 20 |
| Withdrew: Adverse event | 3 | 7 |
| Withdrew: Lack of efficacy | 5 | 6 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Other-study closed/terminated | 1 | 1 |
| Withdrew: Physician decision | 1 | 4 |
| Withdrew: Withdrawal by subject | 2 | 1 |
Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date - treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates.
| Days | Placebo | Belimumab 10 mg/kg |
|---|---|---|
| Time to First Relapse | NA (789.0 to NA) | NA (NA to NA) |
Data for number of participants with major relapse \[defined as experiencing at least 1 major Birmingham Vasculitis Activity Score (BVAS) item\] during the double-bind phase of the study was reported. Analysis was performed using a Cox proportional hazard model.
| Participants | Placebo | Belimumab 10 mg/kg |
|---|---|---|
| Number of Participants With Major Relapse During the Double-blind Phase of the Study | 0 | 1 |
Collected over Adverse events (AE) were collected from the start of study agent administration (Day 0) through 8 weeks following administration of the last dose of study agent (approximately up to 4 years).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/52 (0%) | 16/52 (30.8%) | 33/52 (63.5%) |
| Belimumab 10 mg/kg | 1/53 (1.9%) | 18/53 (34%) | 32/53 (60.4%) |
| Event | Placebo | Belimumab 10 mg/kg |
|---|---|---|
| PyrexiaGeneral disorders | 2/52 | 0/53 |
| HypersensitivityImmune system disorders | 0/52 | 2/53 |
| BronchitisInfections and infestations | 1/52 | 0/53 |
| Pyelonephritis acuteInfections and infestations | 1/52 | 0/53 |
| SalmonellosisInfections and infestations | 1/52 | 0/53 |
| TuberculosisInfections and infestations | 1/52 | 0/53 |
| Tendon ruptureInjury, poisoning and procedural complications | 1/52 | 0/53 |
| AnaemiaBlood and lymphatic system disorders | 1/52 | 0/53 |
| PancytopeniaBlood and lymphatic system disorders | 1/52 | 0/53 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/52 | 0/53 |
| Event | Placebo | Belimumab 10 mg/kg |
|---|---|---|
| NasopharyngitisInfections and infestations | 10/52 | 6/53 |
| CoughRespiratory, thoracic and mediastinal disorders | 8/52 | 10/53 |
| Upper respiratory tract infectionInfections and infestations | 8/52 | 7/53 |
| FatigueGeneral disorders | 7/52 | 7/53 |
| HeadacheNervous system disorders | 7/52 | 5/53 |
| NauseaGastrointestinal disorders | 2/52 | 7/53 |
| BronchitisInfections and infestations | 6/52 | 1/53 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 6/52 | 6/53 |
| PyrexiaGeneral disorders | 2/52 | 6/53 |
| Urinary tract infectionInfections and infestations | 4/52 | 5/53 |
| Age, Continuous(Years) | Placebo | Belimumab 10 mg/kg | Total |
|---|---|---|---|
| Mean | 53.5 ± 13.56 | 56.2 ± 13.59 | 54.8 ± 13.58 |
| Sex: Female, Male(Participants) | Placebo | Belimumab 10 mg/kg | Total |
|---|---|---|---|
| Female | 25 | 26 | 51 |
| Male | 27 | 27 | 54 |
| Race/Ethnicity, Customized(Participants) | Placebo | Belimumab 10 mg/kg | Total |
|---|---|---|---|
| African American/African Heritage | 1 | 1 | 2 |
| American Indian or Alaskan Native | 5 | 6 | 11 |
| Central/South Asian Heritage | 2 | 0 | 2 |
| White | 44 | 46 | 90 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Belimumab
Human Genome Sciences Inc., a GSK Company →