Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01369342
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Crohn's Disease
Inflammatory Bowel Disease
IBD
Colitis
Interventions Drug: Group 1: Placebo
Drug: Group 2 ustekinumab 130 mg
Drug: Group 3: ustekinumab approximately 6 mg/kg
Enrollment 640
Recruitment Details A total of 640 participants were randomly assigned to receive study agent. The analyses (efficacy) were based on the 628 participants who were randomized after the study was restarted. However, one additional participant was excluded from efficacy analyses due to misconduct by the investigative site.
Pre-assignment Details In November 2011, due to stability issue with the batch of the IV drug (130 mg Ustekinumab) sponsor temporarily suspended dosing of participants with ustekinumab. Study was restarted with 90 mg/ml on 17 February 2012.
Arm/Group Title Placebo IV Ustekinumab 130 Milligram (mg) Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Hide Arm/Group Description Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0. Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0. Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
Period Title: Overall Study
Started 214 213 213
Completed 201 204 210
Not Completed 13 9 3
Reason Not Completed
Withdrawal by Subject             7             7             2
Lost to Follow-up             5             2             1
Not Treated             1             0             0
Arm/Group Title Placebo IV Ustekinumab 130 Milligram (mg) Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg) Total
Hide Arm/Group Description Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0. Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0. Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg. Total of all reporting groups
Overall Number of Baseline Participants 214 213 213 640
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 214 participants 213 participants 213 participants 640 participants
40.1  (13.09) 39.2  (13.74) 38.8  (13.65) 39.4  (13.48)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 213 participants 213 participants 640 participants
Female
113
  52.8%
107
  50.2%
122
  57.3%
342
  53.4%
Male
101
  47.2%
106
  49.8%
91
  42.7%
298
  46.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 213 participants 213 participants 640 participants
Australia 8 7 5 20
Belgium 1 1 2 4
Bulgaria 8 5 11 24
Brazil 2 5 2 9
Canada 14 18 10 42
Germany 19 15 13 47
Spain 0 1 0 1
France 3 2 5 10
United Kingdom 8 8 5 21
Croatia 1 2 1 4
Hungary 23 20 18 61
Iceland 0 1 1 2
Israel 2 3 6 11
Italy 2 2 5 9
Japan 9 8 9 26
Korea 7 7 6 20
Netherland 1 1 2 4
New Zealand 2 8 4 14
Poland 8 8 10 26
Russia 6 6 5 17
Serbia 4 8 3 15
United States 72 72 76 220
South Africa 14 5 14 33
1.Primary Outcome
Title Number of Participants With Clinical Response at Week 6
Hide Description Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses set included all the participants who were randomized after the study was restarted.
Arm/Group Title Placebo Ustekinumab 130 mg Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Hide Arm/Group Description:
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
Overall Number of Participants Analyzed 209 209 209
Measure Type: Number
Unit of Measure: participants
60 108 116
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 130 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).
2.Secondary Outcome
Title Number of Participants in Clinical Remission at Week 8
Hide Description Clinical remission at Week 8 was defined as a Crohn’s Disease Activity Index (CDAI) score of <150 points.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses set included all the participants who were randomized after the study was restarted.
Arm/Group Title Placebo Ustekinumab 130 mg Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Hide Arm/Group Description:
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
Overall Number of Participants Analyzed 209 209 209
Measure Type: Number
Unit of Measure: participants
41 64 84
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 130 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).
3.Secondary Outcome
Title Number of Participants in Clinical Response at Week 8
Hide Description Clinical response at Week 8 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses set included all the participants who were randomized after the study was restarted.
Arm/Group Title Placebo Ustekinumab 130 mg Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Hide Arm/Group Description:
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
Overall Number of Participants Analyzed 209 209 209
Measure Type: Number
Unit of Measure: participants
67 99 121
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 130 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).
4.Secondary Outcome
Title Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6
Hide Description 70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses set included all the participants who were randomized after the study was restarted.
Arm/Group Title Placebo Ustekinumab 130 mg Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Hide Arm/Group Description:
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
Overall Number of Participants Analyzed 209 209 209
Measure Type: Number
Unit of Measure: participants
81 123 135
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 130 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).
5.Secondary Outcome
Title Number of Participants With CDAI 70 Point Response at Week 3
Hide Description 70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses set included all the participants who were randomized after the study was restarted.
Arm/Group Title Placebo Ustekinumab 130 mg Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Hide Arm/Group Description:
Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
Overall Number of Participants Analyzed 209 209 209
Measure Type: Number
Unit of Measure: participants
66 103 106
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 130 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
Method Cochran-Mantel-Haenszel chi-square test
Comments 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).
Time Frame Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
Adverse Event Reporting Description 1 participant randomized to placebo never received study agent (not included in the AE analysis) and 1 participant randomized to placebo received ustekinumab (analyzed for safety in 130 mg group);2 participants randomized to -6 mg/kg received dose closer to 130 mg of ustekinumab (analyzed for safety in 130 mg group).
 
Arm/Group Title Placebo IV Ustekinumab 130 Milligram (mg) Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Hide Arm/Group Description Participants received single dose of Placebo Intravenous (IV) infusion at week 0. Participants received single dose of ustekinumab 130 milligram (mg) IV at week 0. Participants received a single tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
All-Cause Mortality
Placebo IV Ustekinumab 130 Milligram (mg) Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo IV Ustekinumab 130 Milligram (mg) Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/212 (7.08%)   10/216 (4.63%)   9/211 (4.27%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/212 (0.47%)  1/216 (0.46%)  0/211 (0.00%) 
Pancytopenia * 1  1/212 (0.47%)  0/216 (0.00%)  0/211 (0.00%) 
Cardiac disorders       
Atrial Fibrillation * 1  1/212 (0.47%)  0/216 (0.00%)  0/211 (0.00%) 
Gastrointestinal disorders       
Colitis * 1  0/212 (0.00%)  0/216 (0.00%)  1/211 (0.47%) 
Crohn's Disease * 1  5/212 (2.36%)  5/216 (2.31%)  2/211 (0.95%) 
Diarrhoea * 1  0/212 (0.00%)  1/216 (0.46%)  0/211 (0.00%) 
Intestinal Obstruction * 1  1/212 (0.47%)  0/216 (0.00%)  0/211 (0.00%) 
Localised Intraabdominal Fluid Collection * 1  0/212 (0.00%)  1/216 (0.46%)  0/211 (0.00%) 
Small Intestinal Obstruction * 1  1/212 (0.47%)  1/216 (0.46%)  2/211 (0.95%) 
Small Intestinal Perforation * 1  1/212 (0.47%)  0/216 (0.00%)  0/211 (0.00%) 
General disorders       
Chest Pain * 1  0/212 (0.00%)  0/216 (0.00%)  1/211 (0.47%) 
Impaired Healing * 1  0/212 (0.00%)  1/216 (0.46%)  0/211 (0.00%) 
Non-Cardiac Chest Pain * 1  0/212 (0.00%)  1/216 (0.46%)  0/211 (0.00%) 
Hepatobiliary disorders       
Bile Duct Stone * 1  1/212 (0.47%)  0/216 (0.00%)  0/211 (0.00%) 
Infections and infestations       
Anal Abscess * 1  3/212 (1.42%)  2/216 (0.93%)  0/211 (0.00%) 
Gastroenteritis * 1  0/212 (0.00%)  0/216 (0.00%)  1/211 (0.47%) 
Genital Herpes * 1  1/212 (0.47%)  0/216 (0.00%)  0/211 (0.00%) 
Pneumonia * 1  1/212 (0.47%)  0/216 (0.00%)  0/211 (0.00%) 
Injury, poisoning and procedural complications       
Incisional Hernia * 1  0/212 (0.00%)  1/216 (0.46%)  0/211 (0.00%) 
Nervous system disorders       
Headache * 1  1/212 (0.47%)  0/216 (0.00%)  0/211 (0.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea * 1  1/212 (0.47%)  0/216 (0.00%)  0/211 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pneumothorax Spontaneous * 1  0/212 (0.00%)  1/216 (0.46%)  1/211 (0.47%) 
Pulmonary Granuloma * 1  0/212 (0.00%)  0/216 (0.00%)  1/211 (0.47%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 17
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo IV Ustekinumab 130 Milligram (mg) Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/212 (20.75%)   40/216 (18.52%)   44/211 (20.85%) 
Gastrointestinal disorders       
Nausea * 1  5/212 (2.36%)  7/216 (3.24%)  11/211 (5.21%) 
General disorders       
Pyrexia * 1  10/212 (4.72%)  6/216 (2.78%)  11/211 (5.21%) 
Infections and infestations       
Nasopharyngitis * 1  10/212 (4.72%)  10/216 (4.63%)  14/211 (6.64%) 
Upper Respiratory Tract Infection * 1  11/212 (5.19%)  4/216 (1.85%)  7/211 (3.32%) 
Nervous system disorders       
Headache * 1  14/212 (6.60%)  20/216 (9.26%)  10/211 (4.74%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 17
The global study was interrupted due to issues with the clinical supply.
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: Vice President
Organization: Janssen Research & Development, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01369342     History of Changes
Other Study ID Numbers: CR018418
CNTO1275CRD3002 ( Other Identifier: Janssen Research & Development, LLC )
2010-022759-42 ( EudraCT Number )
First Submitted: June 7, 2011
First Posted: June 8, 2011
Results First Submitted: September 1, 2016
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017