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Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT01925768
Recruitment Status : Completed
First Posted : August 20, 2013
Results First Posted : June 13, 2016
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: Apremilast 30 mg
Drug: Placebo
Enrollment 219
Recruitment Details This is an ongoing study consisting of a 24-week randomized, double-blind, placebo-controlled treatment phase, followed by a 28-week active treatment phase and a 52-week open-label extension phase, for an overall study duration of 113 weeks.
Pre-assignment Details Randomized participants were stratified by their baseline prednisone use (yes or no) and by their previous disease modifying antirheumatic drug (DMARD) use (excluding biologics). Participants were allowed to take non-steroidal anti-inflammatory agents and/or low dose corticosteroids during the study.
Arm/Group Title Placebo (PBO) Apremilast (APR) 30 mg
Hide Arm/Group Description Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion. Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
Period Title: Overall Study
Started 109 110
Received Treatment 109 109
Safety Population 109 [1] 109 [1]
Completed Week 16 101 91
Escaped Early (EE) 35 [2] 13 [2]
Completed 98 [3] 87 [3]
Not Completed 11 23
Reason Not Completed
Lost to Follow-up             1             0
Protocol Violation             1             2
Adverse Event             5             10
Lack of Efficacy             3             6
Withdrawal by Subject             1             4
Non-compliance with study drug             0             1
[1]
Safety population = participants who were randomized and received at least one dose of study drug.
[2]
EE= investigator’s discretion plus <10% improvement in both swollen & tender joint counts at Week16
[3]
Completed = participants who completed week 24
Arm/Group Title Placebo (PBO) Apremilast (APR) 30 mg Total
Hide Arm/Group Description Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion. Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion. Total of all reporting groups
Overall Number of Baseline Participants 109 110 219
Hide Baseline Analysis Population Description
Full analysis set consisting of all participants who were randomized as specified in the protocol.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 110 participants 219 participants
48.0  (13.75) 50.7  (12.22) 49.3  (13.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 110 participants 219 participants
Female
65
  59.6%
58
  52.7%
123
  56.2%
Male
44
  40.4%
52
  47.3%
96
  43.8%
Duration of Psoriatic Arthritis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 110 participants 219 participants
3.59  (5.497) 4.04  (4.482) 3.82  (5.007)
[1]
Measure Description: Duration of Psoriatic Arthritis is reported as the time since diagnosis
1.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
Hide Description Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)
Time Frame Baseline and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population consisting of all participants randomized as specified in the protocol; Those who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders. Non-responder imputation (NRI)
Arm/Group Title Placebo (PBO) Apremilast (APR) 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
Overall Number of Participants Analyzed 109 110
Measure Type: Number
Unit of Measure: percentage of participants
20.2 38.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (PBO), Apremilast (APR) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0040
Comments The 2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for previous DMARD use and baseline oral corticosteroids (prednisone or equivalent) use
Method Cochran-Mantel-Haenszel
Comments Two-sided 95% CI is based on a normal approximation to the weighted average
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 17.7
Confidence Interval (2-Sided) 95%
6.2 to 29.3
Estimation Comments Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata (determined by 2 stratification factors: previous DMARD use and baseline oral corticosteroids use using CMH weights;
2.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24
Hide Description HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.
Time Frame Baseline and Week 24
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Percentage of Participants Who Achieve an ACR 20 Response at Week 24
Hide Description Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)
Time Frame Baseline and Week 24
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change From Baseline in the 28-joint Disease Activity Score Using C-reactive Protein as the Acute-phase Reactant (DAS28 [CRP]) at Week 24
Hide Description

The DAS28 measures the severity of disease at a specific time and is derived from the following variables:

  • 28 tender joint count
  • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
  • C-reactive protein (CRP)
  • Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement
Time Frame Baseline and Week 24
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score Change at Week 24
Hide Description The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.
Time Frame Baseline and Week 24
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change From Baseline in the SF-36V2 Physical Component Summary Score at Week 24
Hide Description The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.
Time Frame Baseline and Week 24
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change From Baseline in the Duration of Morning Stiffness at Week 24
Hide Description Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.
Time Frame Baseline and Week 24
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Participants Whose Severity of Morning Stiffness at Week 24 Improved From Baseline
Hide Description Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.
Time Frame Baseline and Week 24
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
Hide Description HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.
Time Frame Baseline and Week 16
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16
Hide Description

The DAS28 measures the severity of disease at a specific time and is derived from the following variables:

  • 28 tender joint count
  • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
  • C-reactive protein (CRP)
  • Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement
Time Frame Baseline and Week 16
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2.0 Physical Functioning Domain at Week 16
Hide Description The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.
Time Frame Baseline and Week 16
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Change From Baseline in the Duration of Morning Stiffness at Week 16
Hide Description Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.
Time Frame Baseline and Week 16
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline
Hide Description Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.
Time Frame Baseline and Week 16
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Percentage of Participants Who Achieve an ACR 20 Response at Weeks 2, 4, 6, 8, 12 and 20
Hide Description Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)
Time Frame Baseline and at Weeks 2, 4, 6, 8, 12 and 20
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104
Hide Description Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)
Time Frame Baseline and Weeks 52 and 104
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Weeks 52 and 104
Hide Description HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.
Time Frame Baseline and Weeks 52 and 104
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104
Hide Description

The DAS28 measures the severity of disease at a specific time and is derived from the following variables:

  • 28 tender joint count
  • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
  • C-reactive protein (CRP)
  • Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement
Time Frame Baseline and Weeks 52 and 104
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Component Scores and Summary Score at Weeks 52 and 104
Hide Description The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.
Time Frame Baseline and Weeks 52 and 104
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104
Hide Description Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.
Time Frame Baseline and Weeks 52 and 104
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Change From Baseline in the Severity of Morning Stiffness at Weeks 52 and 104
Hide Description Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.
Time Frame Baseline and Weeks 52 and 104
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase
Hide Description A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Time Frame Start of the lst dose of IP to the end of the PBO controlled phase; Weeks 0-24 for those randomized to APR 30 mg; Weeks 0-24 for those randomized to PBO who did not enter EE at Week 16; Weeks 0-16 for those randomized to PBO who entered EE at Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who were randomized and received at least one dose of IP
Arm/Group Title Placebo (PBO) Apremilast (APR) 30 mg
Hide Arm/Group Description:
Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
Overall Number of Participants Analyzed 109 109
Measure Type: Number
Unit of Measure: Participants
Any TEAE 69 73
Any drug-related TEAE 18 30
Any severe TEAE 4 2
Any serious TEAE 5 3
Any serious drug-related TEAE 0 0
Any TEAE leading to study drug withdrawal 5 10
Any TEAE leading to study dose interruption 7 10
Any TEAE leading to death 0 0
Time Frame Adverse events are reported for the placebo-controlled period and collected through week 24.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Week 24: Placebo Week 24: Apremilast 30 mg
Hide Arm/Group Description Participants randomized to receive placebo tablets twice daily (BID) during the placebo-controlled phase. Includes data through week 16 for participants who early escaped and through week 24 for all other participants. Participants randomized to receive 30 mg apremilast BID during the 24 week placebo controlled period.
All-Cause Mortality
Week 24: Placebo Week 24: Apremilast 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Week 24: Placebo Week 24: Apremilast 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   5/109 (4.59%)   3/109 (2.75%) 
Blood and lymphatic system disorders     
Iron Deficiency Anemia  1  1/109 (0.92%)  0/109 (0.00%) 
Cardiac disorders     
Angina Pectoris  1  1/109 (0.92%)  0/109 (0.00%) 
General disorders     
Chest Pain  1  1/109 (0.92%)  0/109 (0.00%) 
Hepatobiliary disorders     
Biliary Colic  1  0/109 (0.00%)  1/109 (0.92%) 
Injury, poisoning and procedural complications     
Head Injury  1  0/109 (0.00%)  1/109 (0.92%) 
Joint Dislocation  1  0/109 (0.00%)  1/109 (0.92%) 
Cervical vertebral fracture  1  1/109 (0.92%)  0/109 (0.00%) 
Spinal Column Injury  1  1/109 (0.92%)  0/109 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/109 (0.92%)  0/109 (0.00%) 
Respiratory papilloma  1  1/109 (0.92%)  0/109 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Week 24: Placebo Week 24: Apremilast 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   36/109 (33.03%)   40/109 (36.70%) 
Gastrointestinal disorders     
Diarrhoea  1  12/109 (11.01%)  16/109 (14.68%) 
Nausea  1  2/109 (1.83%)  9/109 (8.26%) 
Infections and infestations     
Nasopharyngitis  1  7/109 (6.42%)  9/109 (8.26%) 
Upper respiratory tract infection  1  11/109 (10.09%)  5/109 (4.59%) 
Nervous system disorders     
Headache  1  4/109 (3.67%)  8/109 (7.34%) 
Vascular disorders     
Hypertension  1  7/109 (6.42%)  7/109 (6.42%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 14.0
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 from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications
Results Point of Contact
Name/Title: Anne McClain, Senior Manager
Organization: Celgene Corporation
Phone: 888-260-1599
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01925768     History of Changes
Other Study ID Numbers: CC-10004-PSA-006
First Submitted: August 15, 2013
First Posted: August 20, 2013
Results First Submitted: February 25, 2016
Results First Posted: June 13, 2016
Last Update Posted: April 6, 2017