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Trial record 31 of 38 for:    "Spinal Disease" | "Benzocaine"

An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis

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: NCT00267956
Recruitment Status : Completed
First Posted : December 22, 2005
Results First Posted : September 5, 2012
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: CNTO 1275 63 mg
Drug: Placebo
Enrollment 146
Recruitment Details 146 participants were randomly assigned to receive either placebo or ustekinumab (CNTO 1275) at 24 sites in North America and Europe.
Pre-assignment Details  
Arm/Group Title Placebo (CP) Ustekinumab x 4 (CP) Placebo -> Ustekinumab (After CP) Ustekinumab x 4 (After CP)
Hide Arm/Group Description Controlled period (Week 0-12) - Placebo Group Controlled period (Week 0-12) - Ustekinumab x 4 Group After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16 After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
Period Title: Controlled Period
Started 70 76 0 [1] 0 [1]
Completed 57 72 0 0
Not Completed 13 4 0 0
Reason Not Completed
Adverse Event             4             1             0             0
Lack of Efficacy             4             2             0             0
Lost to Follow-up             2             0             0             0
Withdrew consent             3             1             0             0
[1]
"0" in column indicates this reporting group is not relevant to Controlled Period.
Period Title: After Controlled Period
Started 0 [1] 0 [1] 57 72
Completed 0 0 52 70
Not Completed 0 0 5 2
Reason Not Completed
Adverse Event             0             0             2             1
Lack of Efficacy             0             0             1             1
Lost to Follow-up             0             0             1             0
Withdrew consent             0             0             1             0
[1]
"0" in column indicates this reporting group is not relevant to after Controlled Period.
Arm/Group Title Group I: Placebo Group II: Ustekinumab x 4 Total
Hide Arm/Group Description Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC. Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg. Total of all reporting groups
Overall Number of Baseline Participants 70 76 146
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 76 participants 146 participants
47.1  (10.52) 50.2  (11.23) 48.7  (10.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 76 participants 146 participants
Female
33
  47.1%
31
  40.8%
64
  43.8%
Male
37
  52.9%
45
  59.2%
82
  56.2%
1.Primary Outcome
Title Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12
Hide Description ACR 20 response is an improvement of greater than or equal to 20 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
Time Frame Week 0 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.
Arm/Group Title Group I: Placebo Group II: Ustekinumab x 4
Hide Arm/Group Description:
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
Overall Number of Participants Analyzed 70 76
Measure Type: Number
Unit of Measure: Participants
10 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Ustekinumab x 4
Comments Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05. Sample Size and power: With 70 partcipants in each treatment group, 5000 repetitions. Assuming a 20% ACR20 response in placebo participants regardless of prior anti-TNF exposure and a 35% ACR 20 and 45% ACR20 response in ustekinumab group for participants who had prior anti-TNF exposure, and who had no prior anti-TNF exposures, the power to detect the treatment difference is 0.85.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The study is designed to maintain a Type I error of 0.05 or less for the primary analysis
Method Cochran-Mantel-Haenszel (CMH) chi-square
Comments Stratified by subject’s prior anti-Tumor Necrosis Factor (TNF) exposure status (Yes/No).
2.Secondary Outcome
Title Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12
Hide Description ACR 50 response is an improvement of greater than or equal to 50 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.
Arm/Group Title Group I: Placebo Group II: Ustekinumab x 4
Hide Arm/Group Description:
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
Overall Number of Participants Analyzed 70 76
Measure Type: Number
Unit of Measure: Participants
5 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Ustekinumab x 4
Comments Hypothesis: No difference between Group II and Group I at a significant level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments No multiplicity adjustment was made and nominal p-value was reported.
Method Cochran-Mantel-Haenszel (CMH) chi-square
Comments Stratified by participant's prior anti-TNF exposure status (Yes/No).
3.Secondary Outcome
Title Number of Participants With an American College of Rheumatology (ACR) 70 Response at Week 12
Hide Description ACR 70 response is an improvement of greater than or equal to 70 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat. All participant randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.
Arm/Group Title Group I: Placebo Group II: Ustekinumab x 4
Hide Arm/Group Description:
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
Overall Number of Participants Analyzed 70 76
Measure Type: Number
Unit of Measure: Participants
0 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Ustekinumab x 4
Comments Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments No multiplicity adjustment was made and nominal p-value was reported.
Method Cochran-Mantel-Haenszel (CMH) chi-square
Comments Stratified by participant's prior anti-TNF exposure status (Yes/No).
4.Secondary Outcome
Title Change in Health Assessment Questionnaire (HAQ) at Week 12
Hide Description The HAQ is a 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.
Time Frame Week 0 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.
Arm/Group Title Group I: Placebo Group II: Ustekinumab x 4
Hide Arm/Group Description:
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
Overall Number of Participants Analyzed 64 75
Median (Inter-Quartile Range)
Unit of Measure: Scores on scale
0.00
(-0.25 to 0.13)
-0.25
(-0.50 to 0.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Ustekinumab x 4
Comments Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No multiplicity adjustment was made and nominal p-value was reported.
Method ANOVA on van der Waerden normal scores
Comments Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.
5.Secondary Outcome
Title Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent at Week 12
Hide Description Number of participants achieving greater than or equal to 75 perccentage mprovement PASI at Week 12. PASI is widely used tool for the measurement of severity of psoriasis. This is a test of how bad person's psoriasis is. The combine redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized with baseline ≥ 3% body surface area (BSA) psoriatic involvement and with evaluable measurement are included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.
Arm/Group Title Group I: Placebo Group II: Ustekinumab x 4
Hide Arm/Group Description:
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
Overall Number of Participants Analyzed 55 63
Measure Type: Number
Unit of Measure: Participants
3 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Ustekinumab x 4
Comments Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No multiplicity adjustment was made and nominal p-value was reported.
Method Cochran-Mantel-Haenszel (CMH) chi-square
Comments Stratified by participant's prior anti-TNF exposure status (Yes/No).
6.Secondary Outcome
Title Change in Dermatology Life Quality Index (DLQI) at Week 12
Hide Description Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10 item questionnaire, is designed to assess the impact of the disease on a participant’s quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The score ranges from 0 (better quality of life) to 30 (worse quality of life).
Time Frame Week 0 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized with baseline ≥ 3% body surface area psoriatic involvement were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.
Arm/Group Title Group I: Placebo Group II: Ustekinumab x 4
Hide Arm/Group Description:
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
Overall Number of Participants Analyzed 55 63
Median (Inter-Quartile Range)
Unit of Measure: Scores on scale
0.00
(-4.0 to 2.0)
-6.0
(-14.0 to -3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Ustekinumab x 4
Comments Hypothesis: No difference between ustekinumab x 4 and placebo at asignificant level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments No multiplicity adjustment was made and nominal p-value was reported.
Method ANOVA on van der Waerden normal scores
Comments Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.
Time Frame 36 weeks
Adverse Event Reporting Description 2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
 
Arm/Group Title Placebo (CP) Ustekinumab x 4 (CP) Placebo -> Ustekinumab (After CP) Ustekinumab x 4 (After CP)
Hide Arm/Group Description Controlled period (Week 0-12) - Placebo Group Controlled period (Week 0-12) - Ustekinumab (CNTO 1275) x 4 Group After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16 After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
All-Cause Mortality
Placebo (CP) Ustekinumab x 4 (CP) Placebo -> Ustekinumab (After CP) Ustekinumab x 4 (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (CP) Ustekinumab x 4 (CP) Placebo -> Ustekinumab (After CP) Ustekinumab x 4 (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/70 (4.29%)   0/76 (0.00%)   4/57 (7.02%)   2/74 (2.70%) 
Cardiac disorders         
Cardiac failure congestive  1  0/70 (0.00%)  0/76 (0.00%)  1/57 (1.75%)  0/74 (0.00%) 
Myocardial infarction  1  1/70 (1.43%)  0/76 (0.00%)  1/57 (1.75%)  0/74 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  0/70 (0.00%)  0/76 (0.00%)  1/57 (1.75%)  0/74 (0.00%) 
Gastric ulcer haemorrhage  1  1/70 (1.43%)  0/76 (0.00%)  1/57 (1.75%)  0/74 (0.00%) 
General disorders         
Chest pain  1  1/70 (1.43%)  0/76 (0.00%)  1/57 (1.75%)  0/74 (0.00%) 
Infections and infestations         
Respiratory tract infection  1  0/70 (0.00%)  0/76 (0.00%)  0/57 (0.00%)  1/74 (1.35%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/70 (0.00%)  0/76 (0.00%)  1/57 (1.75%)  0/74 (0.00%) 
Nervous system disorders         
Haemorrhagic stroke  1  0/70 (0.00%)  0/76 (0.00%)  1/57 (1.75%)  0/74 (0.00%) 
Syncope  1  0/70 (0.00%)  0/76 (0.00%)  0/57 (0.00%)  1/74 (1.35%) 
Vascular disorders         
Hypertension  1  0/70 (0.00%)  0/76 (0.00%)  1/57 (1.75%)  0/74 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (CP) Ustekinumab x 4 (CP) Placebo -> Ustekinumab (After CP) Ustekinumab x 4 (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/70 (27.14%)   29/76 (38.16%)   19/57 (33.33%)   24/74 (32.43%) 
Gastrointestinal disorders         
Diarrhoea  1  2/70 (2.86%)  5/76 (6.58%)  2/57 (3.51%)  2/74 (2.70%) 
Nausea  1  0/70 (0.00%)  2/76 (2.63%)  3/57 (5.26%)  1/74 (1.35%) 
Infections and infestations         
Bronchitis  1  0/70 (0.00%)  0/76 (0.00%)  3/57 (5.26%)  2/74 (2.70%) 
Influenza  1  4/70 (5.71%)  1/76 (1.32%)  2/57 (3.51%)  3/74 (4.05%) 
Nasopharyngitis  1  2/70 (2.86%)  8/76 (10.53%)  4/57 (7.02%)  2/74 (2.70%) 
Sinusitis  1  0/70 (0.00%)  1/76 (1.32%)  3/57 (5.26%)  3/74 (4.05%) 
Upper respiratory tract infection  1  6/70 (8.57%)  10/76 (13.16%)  6/57 (10.53%)  7/74 (9.46%) 
Investigations         
C-reactive protein increased  1  1/70 (1.43%)  1/76 (1.32%)  2/57 (3.51%)  5/74 (6.76%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/70 (0.00%)  1/76 (1.32%)  1/57 (1.75%)  4/74 (5.41%) 
Nervous system disorders         
Headache  1  4/70 (5.71%)  5/76 (6.58%)  2/57 (3.51%)  1/74 (1.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
The count of patients with any nonserious adverse event (NAE) excludes patients who only had NAE that occured in <= 5% of patients. This information may vary from existing approved labeling and publications due to the requirements of this website.
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.
Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Clinical Research
Organization: Centocor Research & Development, Inc
Phone: 1-800-457-6399
Layout table for additonal information
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00267956     History of Changes
Other Study ID Numbers: CR006322
C0743T10 ( Other Identifier: Centocor )
2005-003525-92 ( EudraCT Number )
First Submitted: December 20, 2005
First Posted: December 22, 2005
Results First Submitted: October 23, 2009
Results First Posted: September 5, 2012
Last Update Posted: June 5, 2013