Objectives: • To provide continuing treatment to subjects with SLE who complete HGS1006-C1056 or HGS1006-C1057.• To evaluate the long-term safety and tolerability of belimumab in subjects with SLE.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As this is a follow-up study studying the long-term safety aspects of the use
of the study medication, the only study variable is the number of adverse
events.
Secondary outcome
As this is a follow-up study studying the long-term safety aspects of the use
of the study medication, there are no other study variables than the number of
adverse events.
Background summary
This trial provides subjects who complete either the HGS1006-C1056 or
HGS1006-C1057 trial the option of continuing treatment with belimumab, as an
add-on to their standard of care SLE therapy. Subjects in HGS1006-C1056 or
HGS1006-1057 who have tolerated study drug, and wish to continue to receive
belimumab may do so, under the conditions of this protocol. Those subjects
randomized to placebo plus SOC in HGS1006-C1056 or HGS1006-1057 will receive
belimumab (10mg.kg) plus SOC in the continuation trial. This is an optional
trial in which eligible subjects will be enrolled at the discretion of the
investigator and consent of the subject. The trial will also provide data on
long-term safety of belimumab.
Study objective
Objectives:
• To provide continuing treatment to subjects with SLE who complete
HGS1006-C1056 or HGS1006-C1057.
• To evaluate the long-term safety and tolerability of belimumab in subjects
with SLE.
Study design
This is a multi-center, continuation trial of belimumab plus standard of care
(SOC) in SLE subjects who completed the Phase 3 HGS1006-C1056 or HGS1006-C1057
protocol. Subjects participating in this protocol will continue to be monitored
for safety. The frequency of safety laboratory evaluations has been reduced in
this protocol compared with HGS1006-C1056 or HGS1006-C1057 based on the safety
profile of belimumab studies to date and is not anticipated to compromise the
well being and safety of subjects. In the Phase 2 and the Phase 2 continuation
trials, the incidence rates of adverse events (AEs) in general and by SOC
(including infections), serious AEs, and malignancies were comparable to
placebo per 100 subject years of exposure. The overall incidence rate of
adverse events remained stable or decreased over 2.5 years of exposure to
belimumab. HGS will remain blinded to subjects* treatment until all data from
the Phase 3 study in which they participated, HGS1006-C1056 or HGS1006-C1057,
are locked and unblinded. Clinical sites will remain blinded until after the
results of HGS1006-C1056 and HGS1006-C1057 are publicly disclosed.
Intervention
Subjects on active drug will continue to receive belimumab at their present
dose every 28 days intravenously (IV) over 1 hour. Subjects on placebo will
receive belimumab at a dose of 10mg/kg every 28 days IV over 1 hour. The 1st
dose on the continuation trial must be given 4 weeks (minimum of 2 weeks,
maximum of 8 weeks) after the last dose in HGS1006-C1056 or HGS1006-C1057.
Study burden and risks
Subjects who complete the study will have a total of 6 blood and urine samples
in the first year and 2 samples every next year. At the exit-visit and
follow-up post last infusion visit there will also be taken blood and urine
samples (females will have a urine pregnancy test at every visit). Subjects
will be asked for adverse events at every visit. Study agent is administered at
every visit except at the Exit visit, unscheduled visits and at the 8-week
follow-up visit.
The main side effects from the study drug that have been reported in clinical
trials were arthralgia, headache, skin rash, diarrhea, nausea, tiredness,
infections in the upper respiratory tract, arthritis, back pain, urinary tract
infections, peripheral edema, sinusitis and myalgia.
A possible safety risk of belimumab is weakening of the immune system, with the
possible consequence of reduction of the amount of antibodies, which will cause
an increased recovery time for infections. Increase of infections and more
severe infections is also a possibility.
Shady Grove Road 14200
Rockville, Maryland 20850
US
Shady Grove Road 14200
Rockville, Maryland 20850
US
Listed location countries
Age
Inclusion criteria
1. Have completed the HGS1006-C1056 or HGS1006-C1057 Protocol through the week 72 or week 48 visits, respectively.
2. Be able to receive the 1st dose of belimumab for HGS1006-C1074 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in HGS1006-C1056 or HGS1006 C1057.
Exclusion criteria
1. Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (ie, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk.;2. Have developed any other medical diseases (eg, cardiopulmonary), laboratory abnormalities, or conditions (eg, poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-007648-85-NL |
| ClinicalTrials.gov | NCT00712933 |
| CCMO | NL26234.101.08 |