A Phase 2 interventional study of Epratuzumab and Placebo in Systemic Lupus Erythematosus, sponsored by UCB Pharma. Completed at 53 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-12.
Sponsored by UCB Pharma (part of UCB S.A.) · Phase 2, Interventional, and Treatment
The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.
1,222 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 227 is above the median of 50 across 881 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →UCB Pharma is the lead sponsor of 242 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Phosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3.
Other: Placebo
600 mg Epratuzumab infusions at study weeks 0, 1, 2, and 3.
Biological: Epratuzumab
100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Biological: Epratuzumab · Other: Placebo
400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Biological: Epratuzumab · Other: Placebo
1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Biological: Epratuzumab · Other: Placebo
1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
Biological: Epratuzumab · Other: Placebo
Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.
Phosphate-buffered Saline (PBS) infusion.
Response at Week 12 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Time frame: Week 12
Response at Week 4 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Time frame: Week 4
Response at Week 8 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Time frame: Week 8
Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Time frame: Week 4
Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Time frame: Week 8
Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, treatment failure status, and SF-36 response.
Time frame: Week 12
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4
Time frame: Baseline, Week 4
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8
Time frame: Baseline, Week 8
Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12
Time frame: Baseline, Week 12
Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24
Time frame: Baseline, Week 24
Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12
Time frame: Baseline, Week 12
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2
Time frame: Baseline, Week 2
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4
Time frame: Baseline, Week 4
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8
Time frame: Baseline, Week 8
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12
Time frame: Baseline, Week 12
Change from baseline in physician global assessment at Week 12
Time frame: Baseline, Week 12
Change from baseline in patient global assessment at Week 12
Time frame: Baseline, Week 12
Short Form-36 (SF-36) response at Week 2
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores.
Time frame: Baseline, Week 2
Short Form-36 (SF-36) response at Week 4
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores
Time frame: Baseline, Week 4
Short Form-36 (SF-36) response at Week 8
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores
Time frame: Baseline, Week 8
Short Form-36 (SF-36) response at Week 12
SF-36 response is defined as no changes from baseline more negative than -0.8 in PCS or \> -2.5 changes in any of the 8 domain scores
Time frame: Baseline, Week 12
European Quality of Life-5 Dimensions (EQ-5D) score at Week 12
Time frame: Week 12
Time to first sustained British Isles Lupus Assessment Group (BILAG) response
Time frame: From Baseline to Week 12
Time to enhanced British Isles Lupus Assessment Group (BILAG) response
Time frame: From Baseline to Week 12
Treatment failure up to Week 12
Treatment failure is defined as increase in (or addition of a new) immunosuppressive agent over baseline treatment levels, or any increase in corticosteroid baseline treatment level, or any IV, IA, or IM injections of corticosteroids.
Time frame: From Baseline to Week 12
Cumulative steroid dose at Week 12
Time frame: From Baseline to Week 12
Human anti-human antibodies (HAHA) levels at Week 12
Time frame: Week 12
Change from baseline in levels of circulating B cells at Week 12
Time frame: Baseline, Week 12
Change from baseline in levels of circulating T cells at Week 12
Time frame: Baseline, Week 12
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Epratuzumab
Lupus Erythematosus, Systemic →