Last updated: 07/17/2024 16:44:30
Belimumab treatment holiday and treatment re-start study in lupus patients
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Open-label, Non-randomized, 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment With Belimumab 10 mg/kg in Systemic Lupus Erythematosus Subjects
Trial description: This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
SELENA SLEDAI
Timeframe: Over 52 weeks
SLE Flare Index
Timeframe: Over 52 weeks
Secondary outcomes:
Safety
Timeframe: Over 52 weeks
Interventions:
Enrollment:
80
Primary completion date:
2018-14-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Sang-Cheol Bae, Damon L Bass, Myron Chu, Paula Curtis, Richard Dimelow, Laurence Harvey, Beulah Ji, Regina Kurrasch, Saima Muzaffar, Raj Punwaney, David A Roth, Yeong-Wook Song, Wendy Xie, Fengchun Zhang. The effect of 24-week belimumab treatment withdrawal followed by treatment restart in patients with SLE: an open-label, non-randomized 52-week study. Arthritis Res Ther. 2022;24
DOI: https://doi.org/10.1186/s13075-022-02723-y
PMID: NULL
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
May 2014 to December 2018
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study.
- Be 18 years of age at the Day 0 visit.
- Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk.
- Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study.
- Be 18 years of age at the Day 0 visit.
- Non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol.
- Able to provide written informed consent to participate.
- Subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a SELENA SLEDAI score of 3 or less after the minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable SLE treatment regimen during the 30 day screening period prior to Day 0.
- Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies.
Exclusion criteria:
- Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk.
- Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study.
Trial location(s)
Showing 1 - 6 of 18 Results
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2018-14-12
Actual study completion date
2018-14-12
Plain language summaries
Summary of results in plain language
Available language(s): English, Japanese, Korean, Chinese (China)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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