Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01009086
First received: November 5, 2009
Last updated: February 11, 2015
Last verified: February 2015
Results First Received: October 11, 2013  
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, Psoriatic
Interventions: Drug: Placebo
Drug: Ustekinumab 45 mg
Drug: Ustekinumab 90 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group 1: PLACEBO Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
Group 2: USTEKINUMAB 45 MG Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
Group 3: USTEKINUMAB 90 MG Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.

Participant Flow:   Overall Study
    Group 1: PLACEBO     Group 2: USTEKINUMAB 45 MG     Group 3: USTEKINUMAB 90 MG  
STARTED     206     205     204  
COMPLETED     162     158     170  
NOT COMPLETED     44     47     34  
Lack of Efficacy                 16                 15                 9  
Lost to Follow-up                 4                 5                 3  
Adverse Event                 12                 11                 8  
Withdrawal by Subject                 9                 11                 13  
Unspecified                 3                 5                 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.
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Reporting Groups
  Description
Group 1: PLACEBO Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
Group 2: USTEKINUMAB 45 MG Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
Group 3: USTEKINUMAB 90 MG Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
Total Total of all reporting groups

Baseline Measures
    Group 1: PLACEBO     Group 2: USTEKINUMAB 45 MG     Group 3: USTEKINUMAB 90 MG     Total  
Number of Participants  
[units: participants]
  206     205     204     615  
Age  
[units: years]
Mean ± Standard Deviation
  47.4  ± 12.29     47.1  ± 12.64     46.8  ± 11.75     47.1  ± 12.21  
Gender  
[units: participants]
       
Female     98     99     88     285  
Male     108     106     116     330  



  Outcome Measures
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1.  Primary:   Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.   [ Time Frame: Week 24 ]

2.  Secondary:   Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)   [ Time Frame: Day 1 (Baseline) and Week 24 ]

3.  Secondary:   Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24   [ Time Frame: Week 24 ]

5.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24   [ Time Frame: Week 24 ]

6.  Secondary:   Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002   [ Time Frame: Day 1 (Baseline) and Week 24 ]


  Serious Adverse Events
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Time Frame Baseline up to Week 108
Additional Description Safety population included all participants who received the investigational drug and had safety data.

Reporting Groups
  Description
Placebo (CP) Controlled period (Week 0-16) - Placebo group. Placebo Subcutaneous (SC) injections will be received at Weeks 0, 4 and 16.
Ustekinumab 45 mg (CP) Controlled period (Week 0-16) - Ustekinumab 45 mg group. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and 16.
Ustekinumab 90 mg (CP) Controlled period (Week 0-16) - Ustekinumab 90 mg group. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and 16.
Placebo (After CP) After Controlled period (Week 16-24) – participants receiving placebo at Weeks 0, 4, 16, and 20, then crossed over to ustekinumab 45 mg at Week 24.
Placebo -> Ustekinumab 45 mg (After CP) After Controlled period (Week 16-108) – participants randomized to placebo who early escaped to ustekinumab 45 mg at Week 16 or who crossed over to ustekinumab 45 mg at Week 24.
Ustekinumab 45 mg (After CP) After Controlled period (Week 16-108) – participants randomized to ustekinumab 45 mg at Week 0, irrespective of their early escape status.
Ustekinumab 90 mg (After CP) After Controlled period (Week 16-108) – participants randomized to ustekinumab 90 mg at Week 0, irrespective of their early escape status.

Serious Adverse Events
    Placebo (CP)     Ustekinumab 45 mg (CP)     Ustekinumab 90 mg (CP)     Placebo (After CP)     Placebo -> Ustekinumab 45 mg (After CP)     Ustekinumab 45 mg (After CP)     Ustekinumab 90 mg (After CP)  
Total, serious adverse events                
# participants affected / at risk     4/205 (1.95%)     5/205 (2.44%)     3/204 (1.47%)     2/140 (1.43%)     14/189 (7.41%)     20/203 (9.85%)     13/199 (6.53%)  
Blood and lymphatic system disorders                
Idiopathic Thrombocytopenic Purpura † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Cardiac disorders                
Acute Coronary Syndrome † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Acute Myocardial Infarction † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     1/199 (0.50%)  
Angina Pectoris † 1              
# participants affected / at risk     1/205 (0.49%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Atrial Fibrillation † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Atrioventricular Block † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Cardiac Failure Congestive † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Ischaemic Cardiomyopathy † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Myocardial Infarction † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     2/203 (0.99%)     0/199 (0.00%)  
Eye disorders                
Retinal Detachment † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Gastrointestinal disorders                
Colitis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Duodenitis † 1              
# participants affected / at risk     0/205 (0.00%)     1/205 (0.49%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Gastritis Haemorrhagic † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Gastroduodenitis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     1/204 (0.49%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Gastrointestinal Haemorrhage † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Inguinal Hernia † 1              
# participants affected / at risk     0/205 (0.00%)     1/205 (0.49%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Pancreatitis Chronic † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     1/204 (0.49%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Rectal Haemorrhage † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
General disorders                
Chest Pain † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Hepatobiliary disorders                
Cholecystitis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     1/204 (0.49%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Cholecystitis Acute † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Chronic Hepatitis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Infections and infestations                
Device Related Infection † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Erysipelas † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Escherichia Sepsis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Lobar Pneumonia † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Parotitis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Pharyngolaryngeal Abscess † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Pneumonia † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Pneumonia Mycoplasmal † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Postoperative Wound Infection † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Proteus Infection † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Salpingitis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Injury, poisoning and procedural complications                
Joint Dislocation † 1              
# participants affected / at risk     1/205 (0.49%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Radius Fracture † 1              
# participants affected / at risk     1/205 (0.49%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Spinal Compression Fracture † 1              
# participants affected / at risk     0/205 (0.00%)     1/205 (0.49%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Metabolism and nutrition disorders                
Dehydration † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     1/199 (0.50%)  
Musculoskeletal and connective tissue disorders                
Arthritis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Finger Deformity † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Foot Deformity † 1              
# participants affected / at risk     1/205 (0.49%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Lumbar Spinal Stenosis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Osteoarthritis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     1/199 (0.50%)  
Osteoporotic Fracture † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Psoriatic Arthropathy † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Spinal Column Stenosis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Synovial Cyst † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                
B-Cell Lymphoma † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Renal Cell Carcinoma † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Squamous Cell Carcinoma † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Uterine Leiomyoma † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Nervous system disorders                
Intracranial Aneurysm † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Ischaemic Stroke † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Presyncope † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Psychiatric disorders                
Anxiety † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     1/204 (0.49%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Depression † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     1/204 (0.49%)     1/140 (0.71%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Suicidal Ideation † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     1/140 (0.71%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Renal and urinary disorders                
Renal Failure Acute † 1              
# participants affected / at risk     0/205 (0.00%)     1/205 (0.49%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Tubulointerstitial Nephritis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Reproductive system and breast disorders                
Cervical Polyp † 1              
# participants affected / at risk     0/205 (0.00%)     1/205 (0.49%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Respiratory, thoracic and mediastinal disorders                
Asthma † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     1/203 (0.49%)     0/199 (0.00%)  
Skin and subcutaneous tissue disorders                
Erythrodermic Psoriasis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     1/204 (0.49%)     1/140 (0.71%)     0/189 (0.00%)     0/203 (0.00%)     0/199 (0.00%)  
Urticaria † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     0/203 (0.00%)     0/199 (0.00%)  
Vascular disorders                
Aortic Aneurysm † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Deep Vein Thrombosis † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     0/189 (0.00%)     0/203 (0.00%)     1/199 (0.50%)  
Hypertension † 1              
# participants affected / at risk     0/205 (0.00%)     0/205 (0.00%)     0/204 (0.00%)     0/140 (0.00%)     1/189 (0.53%)     1/203 (0.49%)     0/199 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA Version 16.0




  Other Adverse Events


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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
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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.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Janssen Research & Development, LLC
phone: 1-800-526-7736


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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01009086     History of Changes
Obsolete Identifiers: NCT01902706
Other Study ID Numbers: CR016315, CNTO1275PSA3001, 2009-012264-14
Study First Received: November 5, 2009
Results First Received: October 11, 2013
Last Updated: February 11, 2015
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Great Britain: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines