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A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate (TRANSIT)

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ClinicalTrials.gov Identifier: NCT01059773
Recruitment Status : Completed
First Posted : February 1, 2010
Results First Posted : January 30, 2012
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Ustekinumab
Drug: Methotrexate
Enrollment 490
Recruitment Details  
Pre-assignment Details One patient received on-study methotrexate only but no ustekinumab and was therefore excluded from the analysis.
Arm/Group Title UST / MTX Stopped UST / MTX Gradually Withdrawn
Hide Arm/Group Description Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy. Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
Period Title: Overall Study
Started 244 245
Completed 224 [1] 221 [1]
Not Completed 20 24
Reason Not Completed
Adverse Event             2             2
Withdrawal by Subject             1             5
Lost to Follow-up             1             1
Pregnancy             1             1
Protocol Violation             6             2
Physician Decision             5             4
Lack of Efficacy             3             3
Death             0             1
Malignancy including squamous cell skin             0             1
Ineligible follow TB screening criteria             0             1
Other             1             3
[1]
Completed is refering to no Discontinuation of Study Agent Through Week 52
Arm/Group Title UST / MTX Stopped UST / MTX Gradually Withdrawn Total
Hide Arm/Group Description Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy. Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy. Total of all reporting groups
Overall Number of Baseline Participants 244 245 489
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants 245 participants 489 participants
45.1  (12.1) 47.3  (12.6) 46.2  (12.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 244 participants 245 participants 489 participants
18-29 years 29 20 49
30-39 years 57 48 105
40-49 years 69 75 144
50-59 years 56 60 116
>=60 years 33 42 75
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 245 participants 489 participants
Female
74
  30.3%
83
  33.9%
157
  32.1%
Male
170
  69.7%
162
  66.1%
332
  67.9%
Weight, Categorized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 244 participants 245 participants 489 participants
<= 100 kg 195 196 391
> 100 kg 49 49 98
1.Primary Outcome
Title Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12
Hide Description [Not Specified]
Time Frame from week 0 to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.
Arm/Group Title UST / MTX Stopped UST / MTX Gradually Withdrawn
Hide Arm/Group Description:
Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
Overall Number of Participants Analyzed 244 245
Measure Type: Number
Unit of Measure: participants
149 158
2.Secondary Outcome
Title Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Hide Description The number of patients with any of the following Treatment Emergent AEs (TEAEs) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE; SAE and Death.
Time Frame at week 12, 16, 28 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.
Arm/Group Title UST / MTX Stopped: Patients <=100 kg UST / MTX Stopped: Patients >100kg UST / MTX Gradually Withdrawn: Patients <=100 kg UST / MTX Gradually Withdrawn: Patients >100kg
Hide Arm/Group Description:
Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
Overall Number of Participants Analyzed 195 49 196 49
Measure Type: Number
Unit of Measure: Number of patients
Any TEAE: through week 12 116 33 124 34
Any TEAE: through week 16 127 35 135 40
Any TEAE: through week 28 141 39 147 42
Any TEAE: through week 40 149 40 160 44
Any TEAE: through week 52 155 40 162 46
Any serious TEAE: through week 12 5 2 3 3
Any serious TEAE: through week 16 6 4 6 3
Any serious TEAE: through week 28 7 4 10 3
Any serious TEAE: through week 40 10 4 14 3
Any serious TEAE: through week 52 15 5 15 5
Any Death: through week 12 0 0 0 1
Any Death: through week 16 0 0 0 1
Any Death: through week 28 0 0 0 1
Any Death: through week 40 0 0 0 1
Any Death: through week 52 0 0 0 1
3.Secondary Outcome
Title Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Hide Description The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE with severe intensity; AE or SAE reasonably related to ustekinumab (i.e., AEs classified by the investigator as ‘possibly’, ‘probably’, or ‘very likely’ related to study agent); AE or SAE leading to permanent discontinuation of ustekinumab.
Time Frame at week 12, 16, 28 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information
Arm/Group Title UST / MTX Stopped: Patients <=100 kg UST / MTX Stopped: Patients >100kg UST / MTX Gradually Withdrawn: Patients <=100 kg UST / MTX Gradually Withdrawn: Patients >100kg
Hide Arm/Group Description:
Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
Overall Number of Participants Analyzed 195 49 196 49
Measure Type: Number
Unit of Measure: Number of patients
Any severe TEAE: through week 12 11 2 5 0
Any severe TEAE: through week 16 11 3 5 0
Any severe TEAE: through week 28 11 3 7 0
Any TEAE: through week 40 14 4 12 1
Any severe TEAE: through week 52 18 5 13 3
Any TEAE related to UST: through week 12 41 10 43 13
Any TEAE related to UST: through week 16 46 11 46 14
Any TEAE related to UST: through week 28 47 15 49 15
Any TEAE related to UST: through week 40 54 17 60 17
Any TEAE related to UST: through week 52 56 17 60 18
Any Serious TEAE related to UST through week 12 0 1 0 0
Any Serious TEAE related to UST through week 16 0 1 0 0
Any Serious TEAE related to UST through week 28 0 1 1 0
Any Serious TEAE related to UST through week 40 0 1 4 0
Any Serious TEAE related to UST through week 52 1 1 4 1
Permanently discontinued UST due to AE: week 12 2 1 1 0
Permanently discontinued UST due to AE: week 16 2 2 1 0
Permanently discontinued UST due to AE: week 28 2 2 1 0
Permanently discontinued UST due to AE: week 40 2 2 2 0
Permanently discontinued UST due to AE: week 52 2 2 1 0
4.Secondary Outcome
Title Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Hide Description The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): infections, serious infections, and infections requiring oral or parenteral antimicrobial treatment (infections being considered any event that by the investigator was indicated as infection on the CRF).
Time Frame at week 12, 16, 28 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information
Arm/Group Title UST / MTX Stopped: Patients <=100 kg UST / MTX Stopped: Patients >100kg UST / MTX Gradually Withdrawn: Patients <=100 kg UST / MTX Gradually Withdrawn: Patients >100kg
Hide Arm/Group Description:
Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
Overall Number of Participants Analyzed 195 49 196 49
Measure Type: Number
Unit of Measure: Number of patients
Any treatment-emergent (TE) infection: week 12 36 13 42 11
Any TE infection: week 16 43 14 50 13
Any TE infection: week 28 55 18 68 19
Any TE infection: week 40 61 21 76 23
Any TE infection: week 52 64 22 81 23
Any serious TE infection: through week 12 0 1 0 0
Any serious TE infection: through week 16 0 1 0 0
Any serious TE infection: through week 28 0 1 1 0
Any serious TE infection: through week 40 0 1 3 0
Any serious TE infection: through week 52 0 1 3 0
Infection requiring antibiotic treatment: week 12 13 5 12 2
Infection requiring antibiotic treatment: week 16 19 6 15 2
Infection requiring antibiotic treatment: week 28 23 10 22 6
Infection requiring antibiotic treatment: week 40 25 12 31 7
Infection requiring antibiotic treatment: week 52 27 13 32 8
5.Secondary Outcome
Title Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Hide Description The number of patients with a malignancy and other event of clinical interest (tuberculosis, serious cardiovascular events, anaphylactic/serum sickness reaction) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg)
Time Frame at week 12, 16, 28 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information
Arm/Group Title UST / MTX Stopped: Patients <=100 kg UST / MTX Stopped: Patients >100kg UST / MTX Gradually Withdrawn: Patients <=100 kg UST / MTX Gradually Withdrawn: Patients >100kg
Hide Arm/Group Description:
Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
Overall Number of Participants Analyzed 195 49 196 49
Measure Type: Number
Unit of Measure: Number of patients
Any treatment-emergent (TE) malignancy: week 12 0 0 0 0
Any TE malignancy: week 16 0 0 0 0
Any TE malignancy: week 28 0 0 2 0
Any TE malignancy: week 40 0 0 2 0
Any TE malignancy: week 52 2 0 2 0
Any TE tuberculosis: through week 12 0 0 0 0
Any TE tuberculosis: through week 16 0 0 0 0
Any TE tuberculosis: through week 28 0 0 0 0
Any TE tuberculosis: through week 40 0 0 0 0
Any TE tuberculosis: through week 52 0 0 0 0
Any TE serious cardiovascular event: week 12 0 0 0 0
Any TE serious cardiovascular event: week 16 0 0 0 0
Any TE serious cardiovascular event: week 28 0 0 0 0
Any TE serious cardiovascular event: week 40 0 0 1 0
Any TE serious cardiovascular event: week 52 0 0 1 1
TE anaphylactic/serum sickness reaction: week 12 0 0 0 0
TE anaphylactic/serum sickness reaction: week 16 0 0 0 0
TE anaphylactic/serum sickness reaction: week 28 0 0 0 0
TE anaphylactic/serum sickness reaction: week 40 0 0 0 0
TE anaphylactic/serum sickness reaction: week 52 0 0 0 0
6.Secondary Outcome
Title Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline
Hide Description Change from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Time Frame at Weeks 0, 2, 4, 12, 16, 28, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) analysis includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis
Arm/Group Title UST / MTX Stopped UST / MTX Gradually Withdrawn: Patients <=100 kg
Hide Arm/Group Description:
Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
Overall Number of Participants Analyzed 244 243
Mean (Standard Deviation)
Unit of Measure: Units on a scale
week 2 -3.73  (4.69) -4.28  (4.37)
week 4 -7.65  (5.93) -7.82  (5.42)
week 12 -12.93  (7.35) -12.7  (6.6)
week 16 -12.84  (7.44) -12.97  (7.11)
week 28 -13.38  (7.8) -13.43  (7.47)
week 40 -13.78  (7.65) -13.47  (6.61)
week 52 -13.84  (7.24) -13.98  (6.62)
7.Secondary Outcome
Title Proportion of Patients Achieving PASI 50 Response
Hide Description This is based on the number of participants achieving at least 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Time Frame at Weeks 2, 4, 12, 16, 28, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.
Arm/Group Title UST / MTX Stopped UST / MTX Gradually Withdrawn
Hide Arm/Group Description:
Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
Overall Number of Participants Analyzed 244 243
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
week 2
10.3
(6.5 to 14.1)
15.6
(11.1 to 20.2)
week 4
39.3
(33.1 to 45.4)
49.2
(42.9 to 55.5)
week 12
83.8
(79.2 to 88.5)
86.1
(81.7 to 90.5)
week 16
83.5
(78.7 to 88.2)
84.2
(79.5 to 88.8)
week 28
84.9
(80.3 to 89.5)
87.7
(83.5 to 91.9)
week 40
90.7
(86.9 to 94.5)
88.5
(84.3 to 92.7)
week 52
90.6
(86.8 to 94.4)
91.0
(87.2 to 94.7)
8.Secondary Outcome
Title Proportion of Patients Achieving PASI 75 Response
Hide Description This is based on the number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Time Frame at Weeks 2, 4, 12, 16, 28, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.
Arm/Group Title UST / MTX Stopped UST / MTX Gradually Withdrawn
Hide Arm/Group Description:
Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
Overall Number of Participants Analyzed 244 243
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
week 2
2.9
(0.8 to 5.0)
2.5
(0.5 to 4.4)
week 4
12.0
(7.9 to 16.1)
15.3
(10.8 to 19.8)
week 12
58.1
(51.9 to 64.3)
62.2
(56.0 to 68.3)
week 16
63.6
(57.4 to 69.7)
64.6
(58.5 to 70.6)
week 28
71.1
(65.3 to 77.0)
71.1
(65.3 to 76.9)
week 40
76.9
(71.4 to 82.4)
72.1
(66.3 to 78.0)
week 52
76.3
(70.8 to 81.9)
76.9
(71.4 to 82.5)
9.Secondary Outcome
Title Proportion of Patients Achieving PASI 90 Response
Hide Description This is based on the number of participants achieving at least 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Time Frame at Weeks 2, 4, 12, 16, 28, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.
Arm/Group Title UST / MTX Stopped UST / MTX Gradually Withdrawn
Hide Arm/Group Description:
Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
Overall Number of Participants Analyzed 244 243
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
week 2
0.4
(0.0 to 1.2)
0.8
(0.0 to 2.0)
week 4
3.3
(1.1 to 5.6)
3.3
(1.1 to 5.6)
week 12
33.2
(27.2 to 39.1)
31.9
(26.0 to 37.9)
week 16
39.0
(32.8 to 45.2)
42.1
(35.8 to 48.3)
week 28
46.6
(40.1 to 53.0)
47.7
(41.3 to 54.0)
week 40
46.7
(40.1 to 53.2)
49.1
(42.6 to 55.6)
week 52
47.8
(41.2 to 54.3)
49.3
(42.7 to 55.9)
Time Frame From week 0 to week 52
Adverse Event Reporting Description Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
 
Arm/Group Title UST / MTX Stopped UST / MTX Gradually Withdrawn
Hide Arm/Group Description Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy. Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
All-Cause Mortality
UST / MTX Stopped UST / MTX Gradually Withdrawn
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
UST / MTX Stopped UST / MTX Gradually Withdrawn
Affected / at Risk (%) Affected / at Risk (%)
Total   20/244 (8.20%)   20/245 (8.16%) 
Cardiac disorders     
Cardio-respiratory arrest * 1  0/244 (0.00%)  1/245 (0.41%) 
Myocardial infarction * 1  0/244 (0.00%)  1/245 (0.41%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/244 (0.00%)  2/245 (0.82%) 
Immune system disorders     
Drug hypersensitivity * 1  0/244 (0.00%)  1/245 (0.41%) 
Infections and infestations     
Erysipelas * 1  0/244 (0.00%)  1/245 (0.41%) 
Hepatitis B * 1  1/244 (0.41%)  0/245 (0.00%) 
Laryngitis * 1  0/244 (0.00%)  1/245 (0.41%) 
Pilonidal cyst * 1  0/244 (0.00%)  1/245 (0.41%) 
Pneumonia * 1  0/244 (0.00%)  1/245 (0.41%) 
Injury, poisoning and procedural complications     
Ankle fracture * 1  2/244 (0.82%)  0/245 (0.00%) 
Foot fracture * 1  1/244 (0.41%)  0/245 (0.00%) 
Joint dislocation * 1  1/244 (0.41%)  0/245 (0.00%) 
Ligament rupture * 1  1/244 (0.41%)  0/245 (0.00%) 
Meniscus lesion * 1  2/244 (0.82%)  0/245 (0.00%) 
Vascular graft thrombosis * 1  1/244 (0.41%)  0/245 (0.00%) 
Musculoskeletal and connective tissue disorders     
Foot deformity * 1  1/244 (0.41%)  0/245 (0.00%) 
Intervertebral disc protrusion * 1  1/244 (0.41%)  1/245 (0.41%) 
Synovial cyst * 1  1/244 (0.41%)  0/245 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer in situ * 1  1/244 (0.41%)  0/245 (0.00%) 
Cervix carcinoma stage 0 * 1  0/244 (0.00%)  1/245 (0.41%) 
Keratoacanthoma * 1  0/244 (0.00%)  1/245 (0.41%) 
Prostate cancer metastatic * 1  1/244 (0.41%)  0/245 (0.00%) 
Nervous system disorders     
Cerebrovascular accident * 1  0/244 (0.00%)  1/245 (0.41%) 
Headache * 1  1/244 (0.41%)  0/245 (0.00%) 
Loss of consciousness * 1  0/244 (0.00%)  1/245 (0.41%) 
Transient ischaemic attack * 1  0/244 (0.00%)  1/245 (0.41%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy * 1  0/244 (0.00%)  1/245 (0.41%) 
Psychiatric disorders     
Alcoholism * 1  1/244 (0.41%)  0/245 (0.00%) 
Renal and urinary disorders     
Renal cyst * 1  0/244 (0.00%)  1/245 (0.41%) 
Reproductive system and breast disorders     
Uterine polyp * 1  0/244 (0.00%)  1/245 (0.41%) 
Skin and subcutaneous tissue disorders     
Psoriasis * 1  3/244 (1.23%)  0/245 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  0/244 (0.00%)  1/245 (0.41%) 
Femoral artery occlusion * 1  0/244 (0.00%)  1/245 (0.41%) 
Haemorrhage * 1  1/244 (0.41%)  0/245 (0.00%) 
Hypertension * 1  0/244 (0.00%)  1/245 (0.41%) 
Varicose vein * 1  1/244 (0.41%)  0/245 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
UST / MTX Stopped UST / MTX Gradually Withdrawn
Affected / at Risk (%) Affected / at Risk (%)
Total   113/244 (46.31%)   132/245 (53.88%) 
Infections and infestations     
Nasopharyngitis * 1  49/244 (20.08%)  57/245 (23.27%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  25/244 (10.25%)  27/245 (11.02%) 
Back pain * 1  14/244 (5.74%)  14/245 (5.71%) 
Nervous system disorders     
Headache * 1  33/244 (13.52%)  33/245 (13.47%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  8/244 (3.28%)  17/245 (6.94%) 
Psoriasis * 1  9/244 (3.69%)  20/245 (8.16%) 
Vascular disorders     
Hypertension * 1  16/244 (6.56%)  19/245 (7.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
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 prior to submission for publication or presentation. No paper that incorporates Confidential Information will be submitted for publication without Sponsor’s prior written consent. If requested in writing, such publication will be withheld for up to an additional 60 calendar days. A publication from the individual Study site data will not be published until the combined results have been published.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: EMEA THERAPEUTIC AREA LEADER
Organization: Janssen-Cilag France
Phone: +33 6 15167408
Layout table for additonal information
Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01059773     History of Changes
Other Study ID Numbers: CR016639
CR016639 ( Registry Identifier: ClinicalTrials.gov )
CNTO1275PSO4004 ( Other Identifier: Janssen CTMS ID )
First Submitted: January 28, 2010
First Posted: February 1, 2010
Results First Submitted: December 22, 2011
Results First Posted: January 30, 2012
Last Update Posted: November 24, 2014