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Trial record 3 of 5 for:    "Unicentric Castleman Disease" | "Antibodies"

A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease

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ClinicalTrials.gov Identifier: NCT01400503
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : March 29, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multicentric Castleman's Disease
Intervention Drug: Siltuximab
Enrollment 60
Recruitment Details  
Pre-assignment Details Participants enrolled in this study CNTO328MCD2002 included participants who were previously enrolled in study C0328T03 (NCT00412321) or CNTO328MCD2001 (NCT01024036) (either placebo or siltuximab treatment arm). A total of 60 participants from previous MCD studies C0328T03 and CNTO328MCD2001 were found eligible to be enrolled in this study.
Arm/Group Title Siltuximab
Hide Arm/Group Description Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
Period Title: Overall Study
Started 60
Completed 0
Not Completed 60
Reason Not Completed
Withdrawal by Subject             1
Study Terminated by Sponsor             58
Other             1
Arm/Group Title Siltuximab
Hide Arm/Group Description Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
45.1  (14.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
20
  33.3%
Male
40
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Hispanic or Latino
5
   8.3%
Not Hispanic or Latino
55
  91.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
American Indian or Alaska Native
1
   1.7%
Asian
23
  38.3%
Native Hawaiian or Other Pacific Islander
2
   3.3%
Black or African American
3
   5.0%
White
31
  51.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Asian
23
  38.3%
Black or African American
3
   5.0%
Hispanic or Latino
5
   8.3%
Other
3
   5.0%
White Non-Hispanic
26
  43.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Belgium
1
   1.7%
Brazil
1
   1.7%
Canada
1
   1.7%
China
6
  10.0%
Egypt
1
   1.7%
France
3
   5.0%
Germany
1
   1.7%
Hong Kong
3
   5.0%
New Zealand
2
   3.3%
Norway
2
   3.3%
Singapore
3
   5.0%
Korea, Republic Of
4
   6.7%
Spain
2
   3.3%
Taiwan, Province Of China
1
   1.7%
United Kingdom
2
   3.3%
United States
27
  45.0%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants in this study.
Arm/Group Title Siltuximab
Hide Arm/Group Description:
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
60
 100.0%
2.Secondary Outcome
Title Percentage of Previously Responding Participants Who Maintained Disease Control
Hide Description Percentage of participants maintaining disease control (defined as stable or better response) was defined as the percentage of previously responding participants who had not progressed during the long-term safety extension based on investigator assessment. A worsening in any of the measures will be considered as a progression of the disease.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Population included subset of safety analysis set who previously responded to siltuximab treatment ie, did not report disease progression while receiving siltuximab in study C0328T03 or CNTO328MCD2001.
Arm/Group Title Siltuximab
Hide Arm/Group Description:
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: percentage of participants
96.5
3.Secondary Outcome
Title Percentage of Siltuximab-naive Participants Who Experienced Disease Control
Hide Description Percentage of participants experiencing disease control was defined as the percentage of siltuximab-naïve participants who had stable or better response during the long-term safety extension based on investigator’s judgment. Disease control was defined as stable or better response assessed by the investigators.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Population included subset of safety analysis set who were previously Siltuximab-naive i.e., received placebo in study CNTO328MCD2001 and never received siltuximab prior to enrollment in this study.
Arm/Group Title Siltuximab
Hide Arm/Group Description:
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percentage of participants
100
4.Secondary Outcome
Title Duration of Disease Control
Hide Description Duration of disease control (DODC) was defined as the time from the first siltuximab administration in this study to disease progression as assessed by the investigator. Disease control was defined as stable or better response assessed by the investigators. Kaplan-Meier method was used to estimate the duration of disease control.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants in this study.
Arm/Group Title Siltuximab
Hide Arm/Group Description:
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(NA to NA)
[1]
Median and confidence interval (CI) were not estimable due to insufficient number of participants with loss of response or disease control (due to high censorship rate).
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time between the first study siltuximab administration and death due to any cause. Kaplan-Meier method was used to estimate the overall survival.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants in this study.
Arm/Group Title Siltuximab
Hide Arm/Group Description:
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(NA to NA)
[1]
Median and CI were not estimable due to insufficient number of participants with death.
6.Secondary Outcome
Title Number of Participants Positive for Antibodies to Siltuximab
Hide Description Serum samples were screened for antibodies binding to siltuximab and number of participants positive for antibodies to siltuximab was reported.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants in this study.
Arm/Group Title Siltuximab
Hide Arm/Group Description:
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
3
   5.0%
Time Frame Up to 6 years
Adverse Event Reporting Description Safety analysis set included all enrolled participants in this study.
 
Arm/Group Title Siltuximab
Hide Arm/Group Description Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1-hour intravenous infusion every 3 weeks until disease progression, withdrew, experienced unacceptable toxicity,or until the 6-year data cutoff, whichever occurred first.
All-Cause Mortality
Siltuximab
Affected / at Risk (%)
Total   0/60 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Siltuximab
Affected / at Risk (%)
Total   25/60 (41.67%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/60 (1.67%) 
Lymphadenopathy * 1  1/60 (1.67%) 
Polycythaemia * 1  1/60 (1.67%) 
Endocrine disorders   
Hyperthyroidism * 1  1/60 (1.67%) 
Eye disorders   
Vitreous Haemorrhage * 1  1/60 (1.67%) 
Gastrointestinal disorders   
Food Poisoning * 1  1/60 (1.67%) 
Nausea * 1  2/60 (3.33%) 
Umbilical Hernia * 1  1/60 (1.67%) 
Vomiting * 1  1/60 (1.67%) 
General disorders   
Chest Pain * 1  1/60 (1.67%) 
Hepatobiliary disorders   
Cholelithiasis * 1  1/60 (1.67%) 
Infections and infestations   
Abscess Limb * 1  1/60 (1.67%) 
Anal Abscess * 1  1/60 (1.67%) 
Cellulitis * 1  1/60 (1.67%) 
Cystitis * 1  1/60 (1.67%) 
Device Related Infection * 1  1/60 (1.67%) 
Infection * 1  2/60 (3.33%) 
Lower Respiratory Tract Infection * 1  1/60 (1.67%) 
Parotitis * 1  1/60 (1.67%) 
Peritonitis * 1  1/60 (1.67%) 
Pneumonia * 1  2/60 (3.33%) 
Pyelonephritis * 1  1/60 (1.67%) 
Vulval Abscess * 1  1/60 (1.67%) 
Wound Infection Staphylococcal * 1  1/60 (1.67%) 
Injury, poisoning and procedural complications   
Ankle Fracture * 1  1/60 (1.67%) 
Avulsion Fracture * 1  1/60 (1.67%) 
Chest Injury * 1  1/60 (1.67%) 
Contusion * 1  1/60 (1.67%) 
Fractured Sacrum * 1  1/60 (1.67%) 
Ilium Fracture * 1  1/60 (1.67%) 
Pubis Fracture * 1  1/60 (1.67%) 
Rib Fracture * 1  2/60 (3.33%) 
Tibia Fracture * 1  2/60 (3.33%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/60 (1.67%) 
Musculoskeletal and connective tissue disorders   
Back Pain * 1  1/60 (1.67%) 
Spinal Column Stenosis * 1  1/60 (1.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign Neoplasm of Testis * 1  1/60 (1.67%) 
Uterine Leiomyoma * 1  1/60 (1.67%) 
Nervous system disorders   
Cerebrospinal Fluid Leakage * 1  1/60 (1.67%) 
Syncope * 1  1/60 (1.67%) 
Renal and urinary disorders   
Bladder Pain * 1  1/60 (1.67%) 
Bladder Spasm * 1  1/60 (1.67%) 
Dysuria * 1  1/60 (1.67%) 
Micturition Disorder * 1  1/60 (1.67%) 
Renal Colic * 1  1/60 (1.67%) 
Ureteral Disorder * 1  1/60 (1.67%) 
Urinary Retention * 1  2/60 (3.33%) 
Reproductive system and breast disorders   
Haemorrhagic Ovarian Cyst * 1  1/60 (1.67%) 
Uterine Haemorrhage * 1  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/60 (1.67%) 
Pleural Effusion * 1  1/60 (1.67%) 
Pneumothorax * 1  1/60 (1.67%) 
Skin and subcutaneous tissue disorders   
Henoch-Schonlein Purpura * 1  1/60 (1.67%) 
Surgical and medical procedures   
Mastectomy * 1  1/60 (1.67%) 
Vascular disorders   
Hypertension * 1  1/60 (1.67%) 
Hypertensive Crisis * 1  1/60 (1.67%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Siltuximab
Affected / at Risk (%)
Total   60/60 (100.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  7/60 (11.67%) 
Leukopenia * 1  5/60 (8.33%) 
Lymphadenopathy * 1  3/60 (5.00%) 
Lymphopenia * 1  3/60 (5.00%) 
Neutropenia * 1  9/60 (15.00%) 
Thrombocytopenia * 1  7/60 (11.67%) 
Cardiac disorders   
Atrioventricular Block First Degree * 1  2/60 (3.33%) 
Cardiac Disorder * 1  2/60 (3.33%) 
Palpitations * 1  2/60 (3.33%) 
Ear and labyrinth disorders   
Ear Pain * 1  6/60 (10.00%) 
Tinnitus * 1  5/60 (8.33%) 
Tympanic Membrane Perforation * 1  2/60 (3.33%) 
Vertigo * 1  6/60 (10.00%) 
Eye disorders   
Cataract * 1  4/60 (6.67%) 
Dry Eye * 1  2/60 (3.33%) 
Eye Irritation * 1  2/60 (3.33%) 
Periorbital Oedema * 1  2/60 (3.33%) 
Vision Blurred * 1  7/60 (11.67%) 
Gastrointestinal disorders   
Abdominal Discomfort * 1  2/60 (3.33%) 
Abdominal Distension * 1  2/60 (3.33%) 
Abdominal Pain * 1  14/60 (23.33%) 
Abdominal Pain Lower * 1  2/60 (3.33%) 
Abdominal Pain Upper * 1  10/60 (16.67%) 
Anal Fistula * 1  2/60 (3.33%) 
Aphthous Ulcer * 1  5/60 (8.33%) 
Chronic Gastritis * 1  2/60 (3.33%) 
Constipation * 1  17/60 (28.33%) 
Dental Caries * 1  2/60 (3.33%) 
Diarrhoea * 1  23/60 (38.33%) 
Dry Mouth * 1  2/60 (3.33%) 
Dyspepsia * 1  8/60 (13.33%) 
Dysphagia * 1  3/60 (5.00%) 
Flatulence * 1  2/60 (3.33%) 
Gastrooesophageal Reflux Disease * 1  9/60 (15.00%) 
Gingival Pain * 1  2/60 (3.33%) 
Haematochezia * 1  3/60 (5.00%) 
Haemorrhoids * 1  2/60 (3.33%) 
Hiatus Hernia * 1  3/60 (5.00%) 
Mouth Ulceration * 1  2/60 (3.33%) 
Nausea * 1  22/60 (36.67%) 
Oral Pain * 1  3/60 (5.00%) 
Stomatitis * 1  3/60 (5.00%) 
Tongue Ulceration * 1  2/60 (3.33%) 
Toothache * 1  4/60 (6.67%) 
Vomiting * 1  16/60 (26.67%) 
General disorders   
Asthenia * 1  3/60 (5.00%) 
Catheter Site Pain * 1  2/60 (3.33%) 
Chest Discomfort * 1  2/60 (3.33%) 
Chest Pain * 1  3/60 (5.00%) 
Cyst * 1  2/60 (3.33%) 
Fatigue * 1  31/60 (51.67%) 
Generalised Oedema * 1  4/60 (6.67%) 
Influenza Like Illness * 1  2/60 (3.33%) 
Localised Oedema * 1  3/60 (5.00%) 
Malaise * 1  8/60 (13.33%) 
Oedema * 1  2/60 (3.33%) 
Oedema Peripheral * 1  13/60 (21.67%) 
Pain * 1  7/60 (11.67%) 
Peripheral Swelling * 1  5/60 (8.33%) 
Pyrexia * 1  6/60 (10.00%) 
Hepatobiliary disorders   
Cholelithiasis * 1  2/60 (3.33%) 
Gallbladder Polyp * 1  2/60 (3.33%) 
Hepatic Function Abnormal * 1  11/60 (18.33%) 
Hyperbilirubinaemia * 1  7/60 (11.67%) 
Immune system disorders   
Seasonal Allergy * 1  5/60 (8.33%) 
Infections and infestations   
Acute Sinusitis * 1  2/60 (3.33%) 
Bronchitis * 1  2/60 (3.33%) 
Cellulitis * 1  3/60 (5.00%) 
Conjunctivitis * 1  3/60 (5.00%) 
Cystitis * 1  4/60 (6.67%) 
Ear Infection * 1  6/60 (10.00%) 
Fungal Infection * 1  3/60 (5.00%) 
Furuncle * 1  2/60 (3.33%) 
Gastroenteritis * 1  8/60 (13.33%) 
Herpes Simplex * 1  2/60 (3.33%) 
Herpes Zoster * 1  5/60 (8.33%) 
Influenza * 1  6/60 (10.00%) 
Laryngitis * 1  3/60 (5.00%) 
Localised Infection * 1  2/60 (3.33%) 
Lower Respiratory Tract Infection * 1  3/60 (5.00%) 
Nasopharyngitis * 1  11/60 (18.33%) 
Onychomycosis * 1  2/60 (3.33%) 
Oral Candidiasis * 1  2/60 (3.33%) 
Oral Herpes * 1  2/60 (3.33%) 
Otitis Media * 1  4/60 (6.67%) 
Pharyngitis * 1  3/60 (5.00%) 
Pneumonia * 1  4/60 (6.67%) 
Rash Pustular * 1  5/60 (8.33%) 
Respiratory Tract Infection * 1  4/60 (6.67%) 
Rhinitis * 1  3/60 (5.00%) 
Sinusitis * 1  10/60 (16.67%) 
Skin Infection * 1  3/60 (5.00%) 
Tinea Infection * 1  2/60 (3.33%) 
Tooth Abscess * 1  3/60 (5.00%) 
Tooth Infection * 1  2/60 (3.33%) 
Upper Respiratory Tract Infection * 1  40/60 (66.67%) 
Urinary Tract Infection * 1  11/60 (18.33%) 
Viral Infection * 1  2/60 (3.33%) 
Injury, poisoning and procedural complications   
Ankle Fracture * 1  2/60 (3.33%) 
Arthropod Bite * 1  3/60 (5.00%) 
Contusion * 1  5/60 (8.33%) 
Hand Fracture * 1  2/60 (3.33%) 
Laceration * 1  2/60 (3.33%) 
Ligament Sprain * 1  5/60 (8.33%) 
Procedural Pain * 1  4/60 (6.67%) 
Skin Abrasion * 1  5/60 (8.33%) 
Tibia Fracture * 1  2/60 (3.33%) 
Tooth Fracture * 1  3/60 (5.00%) 
Investigations   
Alanine Aminotransferase Increased * 1  4/60 (6.67%) 
Aspartate Aminotransferase Increased * 1  4/60 (6.67%) 
Blood Creatinine Increased * 1  4/60 (6.67%) 
Blood Fibrinogen Decreased * 1  3/60 (5.00%) 
Blood Phosphorus Increased * 1  2/60 (3.33%) 
Haemoglobin Increased * 1  4/60 (6.67%) 
Protein Total Decreased * 1  3/60 (5.00%) 
Serum Ferritin Decreased * 1  4/60 (6.67%) 
Weight Decreased * 1  4/60 (6.67%) 
Weight Increased * 1  11/60 (18.33%) 
Metabolism and nutrition disorders   
Decreased Appetite * 1  13/60 (21.67%) 
Enzyme Abnormality * 1  5/60 (8.33%) 
Gout * 1  6/60 (10.00%) 
Hypercholesterolaemia * 1  13/60 (21.67%) 
Hyperglycaemia * 1  4/60 (6.67%) 
Hyperkalaemia * 1  4/60 (6.67%) 
Hypertriglyceridaemia * 1  17/60 (28.33%) 
Hyperuricaemia * 1  10/60 (16.67%) 
Hypoglycaemia * 1  3/60 (5.00%) 
Hypokalaemia * 1  10/60 (16.67%) 
Hypomagnesaemia * 1  5/60 (8.33%) 
Hyponatraemia * 1  2/60 (3.33%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  20/60 (33.33%) 
Back Pain * 1  19/60 (31.67%) 
Bone Pain * 1  2/60 (3.33%) 
Flank Pain * 1  3/60 (5.00%) 
Joint Stiffness * 1  2/60 (3.33%) 
Joint Swelling * 1  2/60 (3.33%) 
Muscle Spasms * 1  7/60 (11.67%) 
Muscular Weakness * 1  6/60 (10.00%) 
Musculoskeletal Chest Pain * 1  2/60 (3.33%) 
Musculoskeletal Pain * 1  11/60 (18.33%) 
Myalgia * 1  4/60 (6.67%) 
Neck Pain * 1  7/60 (11.67%) 
Pain in Extremity * 1  14/60 (23.33%) 
Plantar Fasciitis * 1  2/60 (3.33%) 
Rotator Cuff Syndrome * 1  2/60 (3.33%) 
Spinal Column Stenosis * 1  2/60 (3.33%) 
Synovial Cyst * 1  2/60 (3.33%) 
Tendonitis * 1  2/60 (3.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour Pain * 1  4/60 (6.67%) 
Nervous system disorders   
Amnesia * 1  2/60 (3.33%) 
Dizziness * 1  14/60 (23.33%) 
Headache * 1  14/60 (23.33%) 
Hypoaesthesia * 1  5/60 (8.33%) 
Memory Impairment * 1  2/60 (3.33%) 
Neuropathy Peripheral * 1  4/60 (6.67%) 
Paraesthesia * 1  6/60 (10.00%) 
Peripheral Motor Neuropathy * 1  5/60 (8.33%) 
Peripheral Sensory Neuropathy * 1  15/60 (25.00%) 
Polyneuropathy * 1  2/60 (3.33%) 
Somnolence * 1  3/60 (5.00%) 
Tremor * 1  2/60 (3.33%) 
Psychiatric disorders   
Anxiety * 1  5/60 (8.33%) 
Depression * 1  8/60 (13.33%) 
Insomnia * 1  11/60 (18.33%) 
Nightmare * 1  2/60 (3.33%) 
Renal and urinary disorders   
Azotaemia * 1  4/60 (6.67%) 
Dysuria * 1  3/60 (5.00%) 
Haematuria * 1  3/60 (5.00%) 
Nephrolithiasis * 1  2/60 (3.33%) 
Pollakiuria * 1  3/60 (5.00%) 
Renal Impairment * 1  6/60 (10.00%) 
Urinary Retention * 1  2/60 (3.33%) 
Reproductive system and breast disorders   
Erectile Dysfunction * 1  3/60 (5.00%) 
Menorrhagia * 1  2/60 (3.33%) 
Pelvic Pain * 1  3/60 (5.00%) 
Prostatitis * 1  2/60 (3.33%) 
Prostatomegaly * 1  2/60 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  19/60 (31.67%) 
Dyspnoea * 1  13/60 (21.67%) 
Dyspnoea Exertional * 1  3/60 (5.00%) 
Epistaxis * 1  4/60 (6.67%) 
Nasal Congestion * 1  3/60 (5.00%) 
Oropharyngeal Pain * 1  15/60 (25.00%) 
Pneumonitis * 1  3/60 (5.00%) 
Productive Cough * 1  5/60 (8.33%) 
Rhinitis Allergic * 1  2/60 (3.33%) 
Sinus Congestion * 1  3/60 (5.00%) 
Upper-Airway Cough Syndrome * 1  4/60 (6.67%) 
Wheezing * 1  3/60 (5.00%) 
Skin and subcutaneous tissue disorders   
Acne * 1  2/60 (3.33%) 
Blister * 1  2/60 (3.33%) 
Dermatitis * 1  2/60 (3.33%) 
Dermatitis Acneiform * 1  3/60 (5.00%) 
Dermatitis Allergic * 1  3/60 (5.00%) 
Dry Skin * 1  8/60 (13.33%) 
Eczema * 1  7/60 (11.67%) 
Hyperhidrosis * 1  9/60 (15.00%) 
Night Sweats * 1  9/60 (15.00%) 
Pruritus * 1  19/60 (31.67%) 
Pruritus Generalised * 1  3/60 (5.00%) 
Psoriasis * 1  2/60 (3.33%) 
Rash * 1  21/60 (35.00%) 
Rash Maculo-Papular * 1  16/60 (26.67%) 
Rash Pruritic * 1  3/60 (5.00%) 
Scar Pain * 1  2/60 (3.33%) 
Seborrhoeic Dermatitis * 1  2/60 (3.33%) 
Skin Hyperpigmentation * 1  3/60 (5.00%) 
Skin Induration * 1  2/60 (3.33%) 
Skin Lesion * 1  2/60 (3.33%) 
Urticaria * 1  4/60 (6.67%) 
Vitiligo * 1  2/60 (3.33%) 
Vascular disorders   
Flushing * 1  7/60 (11.67%) 
Hot Flush * 1  4/60 (6.67%) 
Hypertension * 1  15/60 (25.00%) 
Hypotension * 1  6/60 (10.00%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
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.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Leader
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01400503     History of Changes
Other Study ID Numbers: CR018469
CNTO328MCD2002 ( Other Identifier: Janssen Research & Development, LLC )
2010-022837-27 ( EudraCT Number )
First Submitted: April 21, 2011
First Posted: July 22, 2011
Results First Submitted: March 1, 2018
Results First Posted: March 29, 2018
Last Update Posted: May 22, 2018