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A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers (CRADLE)

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ClinicalTrials.gov Identifier: NCT02154425
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : February 6, 2017
Last Update Posted : April 3, 2018
Sponsor:
Collaborators:
PPD
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Axial Spondyloarthritis (AxSpA)
Non-radiographic Evidence-AxSpA
Ankylosing Spondylitis
Crohn's Disease
Psoriatic Arthritis
Rheumatoid Arthritis
Interventions Procedure: Breast milk sampling
Biological: Certolizumab Pegol
Enrollment 17
Recruitment Details The study started to enroll patients in September 2014 and concluded in December 2015.
Pre-assignment Details The Participant Flow refers to the Safety Set which consisted of 18 mothers, who were screened and had received at least one dose of Certolizumab Pegol (CZP), but only 17 mothers entered the study (Enrollment number), as one subject was a screen failure.
Arm/Group Title Mothers (SS)
Hide Arm/Group Description This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
Period Title: Screening Period
Started 18
Completed 17
Not Completed 1
Reason Not Completed
Adverse Event             1
Period Title: Sampling Period
Started 17
Completed 17
Not Completed 0
Arm/Group Title Mothers (SS)
Hide Arm/Group Description This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
The Safety Set consisted of all participating mothers who had received at least 1 dose of CZP.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
arithmetic mean (standard deviation) Number Analyzed 18 participants
33.7  (4.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
18
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0
Hide Description Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title Mothers CZP (PK-PPS) Q2W Mothers CZP (PK-PPS) Q4W
Hide Arm/Group Description:
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
Overall Number of Participants Analyzed 16 1
Median (Full Range)
Unit of Measure: µg/mL
NA [1] 
(NA to 0.0571)
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
2.Primary Outcome
Title The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2
Hide Description Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.
Time Frame Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title Mothers CZP (PK-PPS) Q2W Mothers CZP (PK-PPS) Q4W
Hide Arm/Group Description:
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
Overall Number of Participants Analyzed 16 1
Median (Full Range)
Unit of Measure: µg/mL
NA [1] 
(NA to 0.0686)
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
3.Primary Outcome
Title The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4
Hide Description Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title Mothers CZP (PK-PPS) Q2W Mothers CZP (PK-PPS) Q4W
Hide Arm/Group Description:
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
Overall Number of Participants Analyzed 16 1
Median (Full Range)
Unit of Measure: µg/mL
0.03578 [1] 
(NA to 0.0742)
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
4.Primary Outcome
Title The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6
Hide Description Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title Mothers CZP (PK-PPS) Q2W Mothers CZP (PK-PPS) Q4W
Hide Arm/Group Description:
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
Overall Number of Participants Analyzed 16 1
Median (Full Range)
Unit of Measure: µg/mL
0.03739 [1] 
(NA to 0.0758)
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
5.Primary Outcome
Title The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8
Hide Description Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title Mothers CZP (PK-PPS) Q2W Mothers CZP (PK-PPS) Q4W
Hide Arm/Group Description:
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
Overall Number of Participants Analyzed 16 1
Median (Full Range)
Unit of Measure: µg/mL
0.03899 [1] 
(NA to 0.0755)
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
6.Primary Outcome
Title The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10
Hide Description Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title Mothers CZP (PK-PPS) Q2W Mothers CZP (PK-PPS) Q4W
Hide Arm/Group Description:
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
Overall Number of Participants Analyzed 16 1
Median (Full Range)
Unit of Measure: µg/mL
NA [1] 
(NA to 0.0685)
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
7.Primary Outcome
Title The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12
Hide Description Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.
Time Frame Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title Mothers CZP (PK-PPS) Q2W Mothers CZP (PK-PPS) Q4W
Hide Arm/Group Description:
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
Overall Number of Participants Analyzed 16 1
Median (Full Range)
Unit of Measure: µg/mL
NA [1] 
(NA to 0.0694)
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
8.Primary Outcome
Title The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14
Hide Description Mature breast milk samples were collected (predose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title Mothers CZP (PK-PPS) Q2W Mothers CZP (PK-PPS) Q4W
Hide Arm/Group Description:
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
Overall Number of Participants Analyzed 16 1
Mean (Full Range)
Unit of Measure: µg/mL
NA [1] 
(NA to 0.0603)
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
9.Primary Outcome
Title The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28
Hide Description In subjects receiving CZP 400 mg Q4W, a mature breast milk sample were collected on or about Day 28, prior to the next scheduled administration of CZP.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title Mothers CZP (PK-PPS) Q4W
Hide Arm/Group Description:
This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
Overall Number of Participants Analyzed 1
Median (Full Range)
Unit of Measure: µg/mL
NA [1] 
(NA to NA)
[1]
NA = below limit of quantification.
10.Primary Outcome
Title The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2
Hide Description Mature breast milk samples was collected on Day 2 of the Sampling Period for all subjects.
Time Frame Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title All Mothers (PK-PPS)
Hide Arm/Group Description:
This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: mg/kg/day
0
(0 to 0.0103)
11.Primary Outcome
Title The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4
Hide Description Mature breast milk samples was collected on Day 4 of the Sampling Period for all subjects.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title All Mothers (PK-PPS)
Hide Arm/Group Description:
This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: mg/kg/day
0.005306
(0 to 0.0111)
12.Primary Outcome
Title The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6
Hide Description Mature breast milk samples was collected on Day 6 of the Sampling Period for all subjects.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title All Mothers (PK-PPS)
Hide Arm/Group Description:
This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: mg/kg/day
0.005604
(0 to 0.0114)
13.Primary Outcome
Title The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8
Hide Description Mature breast milk samples was collected on Day 8 of the Sampling Period for all subjects.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title All Mothers (PK-PPS)
Hide Arm/Group Description:
This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: mg/kg/day
0.005606
(0 to 0.0113)
14.Primary Outcome
Title The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10
Hide Description Mature breast milk samples was collected on Day 10 of the Sampling Period for all subjects.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title All Mothers (PK-PPS)
Hide Arm/Group Description:
This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: mg/kg/day
0
(0 to 0.0103)
15.Primary Outcome
Title The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12
Hide Description Mature breast milk samples was collected on Day 12 of the Sampling Period for all subjects.
Time Frame Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title All Mothers (PK-PPS)
Hide Arm/Group Description:
This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: mg/kg/day
0
(0 to 0.0104)
16.Primary Outcome
Title The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14
Hide Description Mature breast milk samples was collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title All Mothers (PK-PPS)
Hide Arm/Group Description:
This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: mg/kg/day
0
(0 to 0.00904)
17.Primary Outcome
Title The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28
Hide Description In subjects receiving CZP 400 mg Q4W, a mature breast milk sample was collected on or about Day 28, prior to the next scheduled administration of CZP.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable. Measurement on day 28 applies to subjects on a CZP 400mg Q4W dosing regimen only.
Arm/Group Title All Mothers (PK-PPS)
Hide Arm/Group Description:
This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Overall Number of Participants Analyzed 1
Median (Full Range)
Unit of Measure: mg/kg/day
0
(0 to 0)
18.Primary Outcome
Title The Average Daily Infant Dose of Certolizumab Pegol (CZP) Over the Dosing Interval (14 or 28 Days)
Hide Description Mature breast milk samples will be collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 or on Day 28 of the Sampling Period for all subjects.
Time Frame From Day 0 to Day 14 or 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Arm/Group Title All Mothers (PK-PPS)
Hide Arm/Group Description:
This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: mg/kg/day
0.003503
(0 to 0.0104)
Time Frame Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SS-M SS-I
Hide Arm/Group Description This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP). This arm consisted of all infants of mothers in the SS-M.
All-Cause Mortality
SS-M SS-I
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SS-M SS-I
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      0/17 (0.00%)    
Infections and infestations     
Breast abscess * 1  1/18 (5.56%)  1 0/17 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SS-M SS-I
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/18 (50.00%)      8/17 (47.06%)    
Gastrointestinal disorders     
Exacerbation of Crohn's disease * 1  1/18 (5.56%)  1 0/17 (0.00%)  0
Gastrooesophageal reflux disease * 1  0/18 (0.00%)  0 1/17 (5.88%)  1
Vomiting * 1  0/18 (0.00%)  0 1/17 (5.88%)  1
Infections and infestations     
Upper respiratory tract infection * 1  2/18 (11.11%)  2 3/17 (17.65%)  3
Candida infection * 1  1/18 (5.56%)  1 1/17 (5.88%)  1
Herpes zoster * 1  1/18 (5.56%)  1 0/17 (0.00%)  0
Pneumonia * 1  1/18 (5.56%)  1 0/17 (0.00%)  0
Viral upper respiratory tract infection * 1  1/18 (5.56%)  1 0/17 (0.00%)  0
Nasopharyngitis * 1  0/18 (0.00%)  0 4/17 (23.53%)  4
Musculoskeletal and connective tissue disorders     
Psoriatic arthropathy * 1  1/18 (5.56%)  1 0/17 (0.00%)  0
Nervous system disorders     
Headache * 1  2/18 (11.11%)  2 0/17 (0.00%)  0
Reproductive system and breast disorders     
Galactostasis * 1  1/18 (5.56%)  1 0/17 (0.00%)  0
Nipple disorder * 1  1/18 (5.56%)  1 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash * 1  1/18 (5.56%)  1 0/17 (0.00%)  0
Lichen striatus * 1  0/18 (0.00%)  0 1/17 (5.88%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1877 822 ext 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT02154425     History of Changes
Other Study ID Numbers: UP0016
2013-004126-28 ( EudraCT Number )
First Submitted: May 30, 2014
First Posted: June 3, 2014
Results First Submitted: December 8, 2016
Results First Posted: February 6, 2017
Last Update Posted: April 3, 2018