A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00299546
First received: March 3, 2006
Last updated: January 27, 2014
Last verified: January 2014
Results First Received: May 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: Placebo
Biological: Golimumab 50 mg
Biological: Golimumab 100 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 461 participants were enrolled at 86 sites in North America, Europe, Australia and New Zealand.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1: Placebo Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
Group 2: Golimumab 50 mg Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
Group 3: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.

Participant Flow:   Overall Study
    Group 1: Placebo     Group 2: Golimumab 50 mg     Group 3: Golimumab 100 mg  
STARTED     155     153     153  
COMPLETED     55     61     67  
NOT COMPLETED     100     92     86  
Death                 3                 2                 0  
Lost to Follow-up                 2                 2                 5  
Adverse Event                 37                 22                 27  
Unsatisfactory therapeutic effect                 34                 39                 34  
Not specified                 24                 26                 19  
Not treated                 0                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1: Placebo Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
Group 2: Golimumab 50 mg Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
Group 3: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
Total Total of all reporting groups

Baseline Measures
    Group 1: Placebo     Group 2: Golimumab 50 mg     Group 3: Golimumab 100 mg     Total  
Number of Participants  
[units: participants]
  155     153     153     461  
Age  
[units: years]
Mean ± Standard Deviation
  54.8  ± 13.07     53.9  ± 11.47     53.7  ± 12.26     54.1  ± 12.27  
Gender  
[units: participants]
       
Female     132     113     122     367  
Male     23     40     31     94  



  Outcome Measures
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1.  Primary:   American College of Rheumatology (ACR) 20 Response at Week 14.   [ Time Frame: Week 14 ]

2.  Secondary:   American College of Rheumatology (ACR) 50 Response at Week 14   [ Time Frame: Week 14 ]

3.  Secondary:   Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14   [ Time Frame: Week 14 ]

4.  Secondary:   American College of Rheumatology (ACR) 20 at Week 24   [ Time Frame: From Baseline to Week 24 ]

5.  Secondary:   Health Assessment Questionnaire (HAQ) Score at Week 24   [ Time Frame: From Baseline to Week 24 ]


  Serious Adverse Events
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Time Frame Adverse event data were collected for 5 years
Additional Description Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.

Reporting Groups
  Description
Group 1: Golimumab 50 mg SC Injections Only Participants who were treated with golimumab and received golimumab 50 mg injections only during the study.
Group 2: Golimumab 100 mg SC Injections Only Participants who were treated with golimumab and received golimumab 100 mg injections only during the study.
Group 3: Golimumab 50 and 100 mg SC Injections Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study.

Serious Adverse Events
    Group 1: Golimumab 50 mg SC Injections Only     Group 2: Golimumab 100 mg SC Injections Only     Group 3: Golimumab 50 and 100 mg SC Injections  
Total, serious adverse events        
# participants affected / at risk     34/98 (34.69%)     46/138 (33.33%)     71/195 (36.41%)  
Blood and lymphatic system disorders        
Pancytopenia † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Thrombocytopenia † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Cardiac disorders        
Acute Coronary Syndrome † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     2/195 (1.03%)  
Acute Myocardial Infarction † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Angina Pectoris † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Aortic Valve Incompetence † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Atrial Fibrillation † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     2/195 (1.03%)  
Atrial Flutter † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Cardiac Failure Congestive † 1      
# participants affected / at risk     0/98 (0.00%)     2/138 (1.45%)     0/195 (0.00%)  
Cardiomyopathy † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Cardiovascular Disorder † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Coronary Artery Disease † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     1/195 (0.51%)  
Myocardial Infarction † 1      
# participants affected / at risk     0/98 (0.00%)     2/138 (1.45%)     0/195 (0.00%)  
Sick Sinus Syndrome † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Supraventricular Tachycardia † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Tachycardia † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Torsade De Pointes † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Congenital, familial and genetic disorders        
Branchial Cleft Cyst † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Endocrine disorders        
Adrenal Insufficiency † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Gastrointestinal disorders        
Abdominal Pain † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     1/195 (0.51%)  
Colitis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     2/195 (1.03%)  
Colitis Ulcerative † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Colonic Polyp † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Diarrhoea † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     1/195 (0.51%)  
Diverticulum Intestinal † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Gastric Polyps † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Gastritis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     2/195 (1.03%)  
Gastritis Erosive † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Gastrointestinal Disorder † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Inguinal Hernia † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Large Intestine Perforation † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Nausea † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Oesophagitis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Pancreatitis † 1      
# participants affected / at risk     0/98 (0.00%)     2/138 (1.45%)     0/195 (0.00%)  
Rectal Haemorrhage † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Small Intestinal Obstruction † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Splenic Artery Aneurysm † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Varices Oesophageal † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Vomiting † 1      
# participants affected / at risk     2/98 (2.04%)     0/138 (0.00%)     0/195 (0.00%)  
General disorders        
Chest Pain † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Device Breakage † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Device Dislocation † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Device Failure † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Generalised Oedema † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Hernia † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Multi-Organ Failure † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Non-Cardiac Chest Pain † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Pain † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Pyrexia † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Hepatobiliary disorders        
Bile Duct Stone † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Biliary Cirrhosis Primary † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Cholecystitis † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     1/195 (0.51%)  
Cholecystitis Acute † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Cholecystitis Chronic † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Cholelithiasis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Drug-Induced Liver Injury † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Infections and infestations        
Abdominal Abscess † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Appendicitis † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Bacteraemia † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Bronchitis † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Cellulitis † 1      
# participants affected / at risk     1/98 (1.02%)     1/138 (0.72%)     2/195 (1.03%)  
Cellulitis Streptococcal † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Diverticulitis † 1      
# participants affected / at risk     0/98 (0.00%)     2/138 (1.45%)     2/195 (1.03%)  
Erysipelas † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Extradural Abscess † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Gastroenteritis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     2/195 (1.03%)  
Gastroenteritis Salmonella † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Herpes Zoster † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Histoplasmosis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Histoplasmosis Disseminated † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Infected Skin Ulcer † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Infection † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     2/195 (1.03%)  
Intervertebral Discitis † 1      
# participants affected / at risk     1/98 (1.02%)     1/138 (0.72%)     0/195 (0.00%)  
Lung Infection Pseudomonal † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Osteomyelitis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Pelvic Abscess † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Periorbital Cellulitis † 1      
# participants affected / at risk     1/98 (1.02%)     1/138 (0.72%)     0/195 (0.00%)  
Pneumonia † 1      
# participants affected / at risk     3/98 (3.06%)     5/138 (3.62%)     10/195 (5.13%)  
Post Procedural Infection † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Pulmonary Tuberculosis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Pyelonephritis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Salpingitis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Sepsis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     5/195 (2.56%)  
Staphylococcal Abscess † 1      
# participants affected / at risk     1/98 (1.02%)     1/138 (0.72%)     0/195 (0.00%)  
Staphylococcal Infection † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Subcutaneous Abscess † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Tracheobronchitis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Upper Respiratory Tract Infection † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Urinary Tract Infection † 1      
# participants affected / at risk     0/98 (0.00%)     2/138 (1.45%)     5/195 (2.56%)  
Urosepsis † 1      
# participants affected / at risk     2/98 (2.04%)     0/138 (0.00%)     0/195 (0.00%)  
Injury, poisoning and procedural complications        
Ankle Fracture † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Concussion † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Contusion † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Femoral Neck Fracture † 1      
# participants affected / at risk     1/98 (1.02%)     1/138 (0.72%)     1/195 (0.51%)  
Femur Fracture † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Fractured Sacrum † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Hip Fracture † 1      
# participants affected / at risk     1/98 (1.02%)     1/138 (0.72%)     1/195 (0.51%)  
Humerus Fracture † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Lower Limb Fracture † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Meniscus Lesion † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Muscle Rupture † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Open Fracture † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Pelvic Fracture † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Pubis Fracture † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Stress Fracture † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Wound Dehiscence † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Metabolism and nutrition disorders        
Dehydration † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Diabetic Ketoacidosis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Hyponatraemia † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Musculoskeletal and connective tissue disorders        
Arthralgia † 1      
# participants affected / at risk     1/98 (1.02%)     2/138 (1.45%)     1/195 (0.51%)  
Arthritis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Back Pain † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Bone Disorder † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Bursitis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Compartment Syndrome † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Intervertebral Disc Protrusion † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Joint Effusion † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Joint Swelling † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Lumbar Spinal Stenosis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Mobility Decreased † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Neck Pain † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Osteoarthritis † 1      
# participants affected / at risk     2/98 (2.04%)     1/138 (0.72%)     8/195 (4.10%)  
Osteonecrosis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     2/195 (1.03%)  
Osteoporosis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Pain in Extremity † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Rheumatoid Arthritis † 1      
# participants affected / at risk     4/98 (4.08%)     2/138 (1.45%)     8/195 (4.10%)  
Rheumatoid Nodule † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Rotator Cuff Syndrome † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Scleroderma † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Spinal Column Stenosis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Spondylolisthesis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Synovitis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Tenosynovitis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
B-Cell Lymphoma † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Basal Cell Carcinoma † 1      
# participants affected / at risk     0/98 (0.00%)     3/138 (2.17%)     1/195 (0.51%)  
Breast Cancer † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Cervix Carcinoma † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Diffuse Large B-Cell Lymphoma † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Leukaemia † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Lung Carcinoma Cell Type Unspecified Stage Iv † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Lymphoma † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Pancreatic Carcinoma † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Rectal Cancer † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Squamous Cell Carcinoma † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     2/195 (1.03%)  
Squamous Cell Carcinoma of Skin † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Thyroid Adenoma † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Urinary Tract Neoplasm † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Nervous system disorders        
Carpal Tunnel Syndrome † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     2/195 (1.03%)  
Cerebrovascular Accident † 1      
# participants affected / at risk     1/98 (1.02%)     3/138 (2.17%)     1/195 (0.51%)  
Cervicobrachial Syndrome † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Convulsion † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Demyelination † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Hypoaesthesia † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Migraine † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Neuralgia † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Paraesthesia † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Presyncope † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Sciatica † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Syncope † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Transient Ischaemic Attack † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Viith Nerve Paralysis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Psychiatric disorders        
Depression † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Mental Status Changes † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Renal and urinary disorders        
Calculus Urinary † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Renal Disorder † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Renal Failure † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Renal Failure Acute † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Renal Tubular Necrosis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Vesical Fistula † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Reproductive system and breast disorders        
Endometriosis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Female Genital Tract Fistula † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Uterine Haemorrhage † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Alveolitis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Asthma † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Dyspnoea † 1      
# participants affected / at risk     0/98 (0.00%)     2/138 (1.45%)     1/195 (0.51%)  
Mediastinal Mass † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Pleural Fibrosis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Pleurisy † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     1/195 (0.51%)  
Pneumonitis † 1      
# participants affected / at risk     1/98 (1.02%)     1/138 (0.72%)     0/195 (0.00%)  
Pulmonary Embolism † 1      
# participants affected / at risk     1/98 (1.02%)     2/138 (1.45%)     1/195 (0.51%)  
Pulmonary Hypertension † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Skin and subcutaneous tissue disorders        
Psoriasis † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Surgical and medical procedures        
Drug Detoxification † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Vascular disorders        
Aortic Thrombosis † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Deep Vein Thrombosis † 1      
# participants affected / at risk     0/98 (0.00%)     3/138 (2.17%)     0/195 (0.00%)  
Haematoma † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     2/195 (1.03%)  
Haemorrhage † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Hypertension † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     2/195 (1.03%)  
Hypotension † 1      
# participants affected / at risk     0/98 (0.00%)     1/138 (0.72%)     0/195 (0.00%)  
Labile Blood Pressure † 1      
# participants affected / at risk     1/98 (1.02%)     0/138 (0.00%)     0/195 (0.00%)  
Orthostatic Hypotension † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Subclavian Artery Stenosis † 1      
# participants affected / at risk     0/98 (0.00%)     0/138 (0.00%)     1/195 (0.51%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA Version 15.0




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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.  


Results Point of Contact:  
Name/Title: Associate Director Clinical Research
Organization: Centocor Research & Development, Inc.
phone: 1-800-457-6399


No publications provided by Centocor, Inc.

Publications automatically indexed to this study:

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00299546     History of Changes
Other Study ID Numbers: CR006334, C0524T11
Study First Received: March 3, 2006
Results First Received: May 21, 2009
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration