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CompletedNCT01408576EMBODY4Updated Oct 3, 2018Results posted

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

A Phase 3 interventional study of Epratuzumab and Epratuzumab in Systemic Lupus Erythematosus, sponsored by UCB Pharma. Completed at 228 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-03.

Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Read the detailed description

Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • Lupus
  • Monoclonal antibody
  • B-Cell immunotherapy
  • Epratuzumab
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 1,250 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
  • Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
  • Women of childbearing potential must agree to use an acceptable method of birth control

Exclusion criteria

Exclusion Criteria:

  • Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
  • Subjects with active, severe SLE disease activity which involves the renal system
  • Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
  • Substance abuse or dependence
  • History of malignant cancer
  • Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,250 participants (actual)

Study arms

  • Experimental
    Epratuzumab 600 mg per week

    600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles

    Drug: Epratuzumab

  • Experimental
    Epratuzumab 1200 mg every other week

    1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles

    Drug: Epratuzumab

Interventions

  • DrugEpratuzumab

    600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles

  • DrugEpratuzumab

    1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles

06

What researchers measure

Primary outcomes

  1. Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)

    A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

    Time frame: During the treatment period (through Week 96)

  2. Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)

    A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

    Time frame: During the treatment period (through Week 96)

  3. Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)

    A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization

    Time frame: During the treatment period (through Week 96)

  4. Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)

    A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization

    Time frame: During the treatment period (through Week 96)

Secondary outcomes

  1. Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

    Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

    Time frame: At Week 48

  2. Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

    Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

    Time frame: Week 48

  3. Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

    Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

    Time frame: Week 96

  4. The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

    Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

    Time frame: Week 96

07

Results

Posted Oct 3, 2018

Participant flow

The study started to enroll patients in July 2011 and concluded in February 2016.

Participant flow — Overall Study
MilestoneEnrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)
Started244498508
Completed5600
Not completed188498508
Withdrew: Lack of efficacy173048
Withdrew: Protocol violation122
Withdrew: Lost to follow-up10917
Withdrew: Withdrawal by subject346066
Withdrew: Sponsor terminated study89333330
Withdrew: Ae, serious fatal441
Withdrew: Sae, non-fatal112314
Withdrew: Ae, non-serious non-fatal121911
Withdrew: Sae, non-fatal+ae, non-serious non-fatal011
Withdrew: Ae, unknown type010
Withdrew: Other101618

Outcome measures

PrimaryNumber of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)

A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

Time frame:
During the treatment period (through Week 96)
Reported as:
Count of participants · Participants
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
ParticipantsEnrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)All Epratuzumab 600 mg Per WeekAll Subjects
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)2645255196
PrimaryPercentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)

A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

Time frame:
During the treatment period (through Week 96)
Reported as:
Number · percentage of participants
Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
percentage of participantsEnrollment Cohort 1 Epratuzumab 600 mg Per WeekEnrollment Cohort 2 Epratuzumab 1200 mg Q2WEnrollment Cohort 2 Epratuzumab 600 mg Per WeekAll Epratuzumab 600 mg Per WeekAll Subjects
Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)10.79.14.96.87.7
PrimaryNumber of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)

A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization

Time frame:
During the treatment period (through Week 96)
Reported as:
Count of participants · Participants
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
ParticipantsEnrollment Cohort 1 Epratuzumab 600 mg Per WeekEnrollment Cohort 2 Epratuzumab 1200 mg Q2WEnrollment Cohort 2 Epratuzumab 600 mg Per WeekAll Epratuzumab 600 mg Per WeekAll Subjects
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)81119104185304
PrimaryPercentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)

A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization

Time frame:
During the treatment period (through Week 96)
Reported as:
Number · percentage of participants
Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
percentage of participantsEnrollment Cohort 1 Epratuzumab 600 mg Per WeekEnrollment Cohort 2 Epratuzumab 1200 mg Q2WEnrollment Cohort 2 Epratuzumab 600 mg Per WeekAll Epratuzumab 600 mg Per WeekAll Subjects
Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)33.223.920.524.624.4
SecondaryNumber of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

Time frame:
At Week 48
Reported as:
Count of participants · Participants
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
ParticipantsEnrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1)Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1)Enrollment Cohort 2 Epratuzumab 600 mg Per Week (FASS1)All Epratuzumab 600 mg Per Week (FASS1)All Subjects (FASS1)
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index82146134216362
SecondaryPercentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

Time frame:
Week 48
Reported as:
Number · percentage of participants
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
percentage of participantsEnrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1)Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1)Enrollment Cohort 2 Epratuzumab 600 mg Per Week (FASS1)All Epratuzumab 600 mg Per Week (FASS1)All Subjects (FASS1)
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index35.729.927.129.829.9
SecondaryNumber of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

Time frame:
Week 96
Reported as:
Count of participants · Participants
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
ParticipantsEnrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1)Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1)Enrollment Cohort 2 Epratuzumab 600 mg Per Week (FASS1)All Epratuzumab 600 mg Per Week (FASS1)All Subjects (FASS1)
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index746678152218
SecondaryThe Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index

Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

Time frame:
Week 96
Reported as:
Number · percentage of participants
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
percentage of participantsEnrollment Cohort 1 Epratuzumab 600 mg Per Week (FASS1)Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (FASS1)Enrollment Cohort 2 Epratuzumab 600 mg Per Week (FASS1)All Epratuzumab 600 mg Per Week (FASS1)All Subjects (FASS1)
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index39.821.626.231.427.6

Adverse events

Collected over Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enrollment Cohort 1 Epratuzumab 600 mg Per Week4/244 (1.6%)81/244 (33.2%)177/244 (72.5%)
Enrollment Cohort 2 Epratuzumab 1200 mg Q2W4/497 (0.8%)119/497 (23.9%)296/497 (59.6%)
Enrollment Cohort 2 Epratuzumab 600 mg Per Week1/507 (0.2%)104/507 (20.5%)306/507 (60.4%)
All Epratuzumab 600 mg Per Week5/751 (0.7%)185/751 (24.6%)483/751 (64.3%)
All Subjects9/1,248 (0.7%)304/1,248 (24.4%)779/1,248 (62.4%)
Most frequent serious events
Showing 10 of 306
Most frequent serious events
EventEnrollment Cohort 1 Epratuzumab 600 mg Per WeekEnrollment Cohort 2 Epratuzumab 1200 mg Q2WEnrollment Cohort 2 Epratuzumab 600 mg Per WeekAll Epratuzumab 600 mg Per WeekAll Subjects
Systemic lupus erythematosusMusculoskeletal and connective tissue disorders7/24413/49712/50719/75132/1248
PneumoniaInfections and infestations6/2447/4979/50715/75122/1248
Chest painGeneral disorders1/2444/4978/5079/75113/1248
SepsisInfections and infestations3/2443/4974/5077/75110/1248
Meniscus injuryInjury, poisoning and procedural complications3/2440/4970/5073/7513/1248
Transient ischaemic attackNervous system disorders3/2440/4973/5076/7516/1248
Abortion spontaneousPregnancy, puerperium and perinatal conditions3/2440/4971/5074/7514/1248
Deep vein thrombosisVascular disorders3/2440/4972/5075/7515/1248
Myocardial infarctionCardiac disorders2/2441/4970/5072/7513/1248
NauseaGastrointestinal disorders2/2441/4971/5073/7514/1248
Most frequent other events
Showing 10 of 26
Most frequent other events
EventEnrollment Cohort 1 Epratuzumab 600 mg Per WeekEnrollment Cohort 2 Epratuzumab 1200 mg Q2WEnrollment Cohort 2 Epratuzumab 600 mg Per WeekAll Epratuzumab 600 mg Per WeekAll Subjects
Upper respiratory tract infectionInfections and infestations66/24476/49782/507148/751224/1248
Urinary tract infectionInfections and infestations56/24461/49762/507118/751179/1248
HeadacheNervous system disorders46/24467/49757/507103/751170/1248
NauseaGastrointestinal disorders39/24459/49762/507101/751160/1248
NasopharyngitisInfections and infestations38/24442/49745/50783/751125/1248
BronchitisInfections and infestations34/24435/49735/50769/751104/1248
Back painMusculoskeletal and connective tissue disorders34/24431/49732/50766/75197/1248
DiarrhoeaGastrointestinal disorders27/24447/49734/50761/751108/1248
SinusitisInfections and infestations25/24441/49738/50763/751104/1248
ArthralgiaMusculoskeletal and connective tissue disorders24/24436/49730/50754/75190/1248

Baseline characteristics

Baseline Characteristics refers to the Enrolled Set, that consisted of all subjects who gave informed consent.

Age, Categorical
Age, Categorical(Participants)Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)Total Title
<=18 years0000
Between 18 and 65 years2394894901218
>=65 years591832
Age, Continuous
Age, Continuous(years)Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)Total Title
Mean41.0 ± 12.041.9 ± 11.542.5 ± 11.942.0 ± 11.7
Sex: Female, Male
Sex: Female, Male(Participants)Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES)Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES)Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES)Total Title
Female2264674781171
Male18313079
08

Study locations

228 sites
  • 539
    Birmingham, Alabama, United States
  • 557
    Little Rock, Arkansas, United States
  • 515
    Hemet, California, United States
  • 544
    Huntington Beach, California, United States
  • 550
    La Jolla, California, United States
  • 031
    Los Angeles, California, United States
  • 051
    Los Angeles, California, United States
  • 089
    Los Angeles, California, United States
  • 531
    San Leandro, California, United States
  • 594
    Thousand Oaks, California, United States
  • 558
    Torrance, California, United States
  • 048
    Aurora, Colorado, United States
  • 037
    Colorado Springs, Colorado, United States
  • 532
    Denver, Colorado, United States
  • 511
    Bridgeport, Connecticut, United States
  • 039
    Farmington, Connecticut, United States
  • 042
    Aventura, Florida, United States
  • 514
    Brandon, Florida, United States
  • 090
    Clearwater, Florida, United States
  • 092
    DeBary, Florida, United States
  • 533
    Fort Lauderdale, Florida, United States
  • 064
    Jupiter, Florida, United States
  • 070
    Ormond Beach, Florida, United States
  • 084
    Palm Harbor, Florida, United States
  • 518
    Plantation, Florida, United States
  • 585
    Port Orange, Florida, United States
  • 050
    Tampa, Florida, United States
  • 538
    Tampa, Florida, United States
  • 087
    Vero Beach, Florida, United States
  • 537
    Atlanta, Georgia, United States
  • 044
    Duluth, Georgia, United States
  • 590
    Idaho Falls, Idaho, United States
  • 052
    Chicago, Illinois, United States
  • 096
    Indianapolis, Indiana, United States
  • 060
    Shreveport, Louisiana, United States
  • 513
    Lansing, Michigan, United States
  • 599
    Lansing, Michigan, United States
  • 047
    Saint Clair Shores, Michigan, United States
  • 575
    Florissant, Missouri, United States
  • 549
    Saint Louis, Missouri, United States
  • 596
    Nashua, New Hampshire, United States
  • 568
    Freehold, New Jersey, United States
  • 593
    Trenton, New Jersey, United States
  • 067
    Las Cruces, New Mexico, United States
  • 551
    Brooklyn, New York, United States
  • 553
    Great Neck, New York, United States
  • 545
    Manhasset, New York, United States
  • 053
    New York, New York, United States
  • 577
    Roslyn, New York, United States
  • 077
    Charlotte, North Carolina, United States
  • 559
    Charlotte, North Carolina, United States
  • 058
    Durham, North Carolina, United States
  • 075
    Wilmington, North Carolina, United States
  • 061
    Columbus, Ohio, United States
  • 071
    Middleburg Heights, Ohio, United States
  • 041
    Oklahoma City, Oklahoma, United States
  • 076
    Oklahoma City, Oklahoma, United States
  • 097
    Oklahoma City, Oklahoma, United States
  • 547
    Tulsa, Oklahoma, United States
  • 032
    Duncansville, Pennsylvania, United States
  • 093
    Philadelphia, Pennsylvania, United States
  • 073
    Pittsburgh, Pennsylvania, United States
  • 094
    Pittsburgh, Pennsylvania, United States
  • 535
    Charleston, South Carolina, United States
  • 598
    Myrtle Beach, South Carolina, United States
  • 571
    Jackson, Tennessee, United States
  • 057
    Memphis, Tennessee, United States
  • 574
    Amarillo, Texas, United States
  • 078
    Austin, Texas, United States
  • 098
    Austin, Texas, United States
  • 570
    Austin, Texas, United States
  • 079
    Dallas, Texas, United States
  • 541
    Houston, Texas, United States
  • 563
    Houston, Texas, United States
  • 036
    Mesquite, Texas, United States
  • 066
    San Antonio, Texas, United States
  • 562
    San Antonio, Texas, United States
  • 534
    Seattle, Washington, United States
  • 429
    Camperdown, Australia
  • 427
    Clayton, Australia
  • 430
    Liverpool, Australia
  • 425
    Malvern, Australia
  • 426
    Maroochydore, Australia
  • 106
    Brussels, Belgium
  • 107
    Brussels, Belgium
  • 105
    Leuven, Belgium
  • 104
    Liege, Belgium
  • 954
    Belo Horizonte, Brazil
  • 956
    Campinas, Brazil
  • 955
    Goiânia, Brazil
  • 950
    Juiz de Fora, Brazil
  • 453
    Porto Alegre, Brazil
  • 451
    Recife, Brazil
  • 450
    Rio de Janeiro, Brazil
  • 952
    Rio de Janeiro, Brazil
  • 452
    Salvador, Brazil
  • 454
    Sao Paulo, Brazil
  • 200
    Sofia, Bulgaria
  • 202
    Sofia, Bulgaria
  • 203
    Sofia, Bulgaria

Showing the first 100 of 228 sites across 25 countries.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01408576
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Aug 3, 2011
Start date
Jul 2011
Primary completion
Feb 2016
Completion
Feb 2016
Results posted
Oct 3, 2018
Last update
Oct 3, 2018

Study contacts

UCB Clinical Trial Call Center
study director · UCB Pharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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