Trial · NCT01663623

Belimumab in Remission of VASculitis

NCT01663623, Phase 3, Completed, Human Genome Sciences Inc., a GSK Company; results first posted 2018-04-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Belimumab in Remission of VASculitis. Trials, record NCT01663623. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01663623

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Belimumab in Remission of VASculitis
NCT number: NCT01663623
Status: Completed
Phases: Phase 3
Enrollment: 106 participants, actual
Lead sponsor: Human Genome Sciences Inc., a GSK Company
Conditions: Vasculitis
Interventions: Placebo, Belimumab 10 mg/kg, Azathioprine
First posted: 2012-08-13
Last updated: 2018-04-17
Results first posted: 2018-04-17
Limitations and caveats: The sample size was small as it was truncated from approximately 300 to 100 participants, largely owing to a change in standard of care.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to First Relapse	Approximately up to 4 years	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.
Secondary	Number of Participants With Major Relapse During the Double-blind Phase of the Study	Approximately up to 4 years	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to First Relapse	Approximately up to 4 years	Intent-to-treat population	Days	MEDIAN
SECONDARY	Number of Participants With Major Relapse During the Double-blind Phase of the Study	Approximately up to 4 years	Intent-to-treat population	Participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time to First Relapse	Placebo	NA	Inter-Quartile Range 789.0 to NA	Days
Time to First Relapse	Belimumab 10 mg/kg	NA	Inter-Quartile Range NA to NA	Days
Number of Participants With Major Relapse During the Double-blind Phase of the Study	Placebo	0		Participants
Number of Participants With Major Relapse During the Double-blind Phase of the Study	Belimumab 10 mg/kg	1		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	52
Overall Study	STARTED	Belimumab 10 mg/kg	53
Overall Study	COMPLETED	Placebo	40
Overall Study	COMPLETED	Belimumab 10 mg/kg	33
Overall Study	NOT COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	Belimumab 10 mg/kg	20

Source ClinicalTrials.gov

Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Placebo	10	52
other	Nasopharyngitis	Infections and infestations	Belimumab 10 mg/kg	6	53
other	Upper respiratory tract infection	Infections and infestations	Placebo	8	52
other	Upper respiratory tract infection	Infections and infestations	Belimumab 10 mg/kg	7	53
other	Urinary tract infection	Infections and infestations	Placebo	4	52
other	Urinary tract infection	Infections and infestations	Belimumab 10 mg/kg	5	53
other	Bronchitis	Infections and infestations	Placebo	6	52
other	Bronchitis	Infections and infestations	Belimumab 10 mg/kg	1	53
other	Influenza	Infections and infestations	Placebo	1	52
other	Influenza	Infections and infestations	Belimumab 10 mg/kg	5	53

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	52
Total, all-cause mortality	Belimumab 10 mg/kg	1	53
Total, other adverse events	Placebo	33	52
Total, other adverse events	Belimumab 10 mg/kg	32	53
Total, serious adverse events	Placebo	16	52
Total, serious adverse events	Belimumab 10 mg/kg	18	53

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30666823	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Belimumab 10 mg/kg vs Placebo: deaths from any cause	Trial comparisons
Belimumab 10 mg/kg vs Placebo: Number of Participants With Major Relapse During the Double-blind Phase of the Study	Trial comparisons
Belimumab 10 mg/kg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01663623

GET https://conductscience.org/api/trials/v1/NCT01663623/events?page=2

API reference For AI assistants