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Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)

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ClinicalTrials.gov Identifier: NCT00805766
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : December 5, 2012
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn's Disease
Intervention Drug: TA-650
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TA-650
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Screening period: From the beginning of TA-650 5 mg/kg administration to the beginning of TA-650 10 mg/kg administration in the increased dose period in order to confirm that the effects of treatment with TA-650 5 mg/kg at 8-week intervals were insufficient. The screening period was to be up to 16 weeks. Patients who did not satisfy the dose-increasing criteria discontinued study treatment.Patients who discontinued study treatment during the screening period were to be evaluated until withdrawal.

Increased dose period: From the beginning of administration of TA-650 10 mg/kg to evaluation at week 40. Patients who discontinued study treatment during the increased dose period were to be evaluated until withdrawal.

Period Title: Screening Period
Started 45
Completed 39
Not Completed 6
Reason Not Completed
Adverse Event             1
Lack of Efficacy             2
Pregnancy             1
Responder             2
Period Title: Increased Dose Period
Started 39
Completed 26
Not Completed 13
Reason Not Completed
Adverse Event             4
Lack of Efficacy             7
Pregnancy             1
Withdrawal by Subject             1
Arm/Group Title TA-650
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
29.5  (7.3)
[1]
Measure Description: Screening period:
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
14
  31.1%
Male
31
  68.9%
[1]
Measure Description: Screening period:
1.Primary Outcome
Title Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period
Hide Description To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
Time Frame Increased Dose Period (Week 0 to Week 8)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title TA-650
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[Not Specified]
Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: units on a scale
95.0
(70.0 to 134.0)
2.Secondary Outcome
Title CDAI at Each Evaluation Time Point in the Increased Dose Period
Hide Description CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
Time Frame Increased Dose Period (every 4 weeks for up to 40 weeks)
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Hide Analysis Population Description
One patient whose data after week 4 in the increased dose period was missing was excluded from the analysis. Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.
Arm/Group Title TA-650
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[Not Specified]
Overall Number of Participants Analyzed 38
Median (Full Range)
Unit of Measure: units on a scale
Week 0 Number Analyzed 38 participants
296.5
(185 to 523)
Week 4 Number Analyzed 37 participants
119.0
(17 to 318)
Week 8 Number Analyzed 33 participants
194.0
(51 to 456)
Week 12 Number Analyzed 30 participants
126.0
(14 to 419)
Week 16 Number Analyzed 29 participants
182.0
(70 to 398)
Week 20 Number Analyzed 29 participants
121.0
(13 to 304)
Week 24 Number Analyzed 28 participants
197.5
(81 to 379)
Week 28 Number Analyzed 28 participants
105.0
(4 to 289)
Week 32 Number Analyzed 27 participants
163.0
(72 to 410)
Week 36 Number Analyzed 27 participants
141.0
(-3 to 315)
Week 40 Number Analyzed 26 participants
148.5
(41 to 407)
Week 40 (the last time point) Number Analyzed 38 participants
210.5
(34 to 479)
3.Secondary Outcome
Title CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Hide Description CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
Time Frame Increased Dose Period (every 4 weeks for up to 40 weeks)
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Hide Analysis Population Description
Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.
Arm/Group Title TA-650
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[Not Specified]
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4 Number Analyzed 37 participants
59.5
(42.1 to 75.2)
Week 8 Number Analyzed 33 participants
39.4
(22.9 to 57.9)
Week 12 Number Analyzed 30 participants
70.0
(50.6 to 85.3)
Week 16 Number Analyzed 29 participants
31.0
(15.3 to 50.8)
Week 20 Number Analyzed 29 participants
58.6
(38.9 to 76.5)
Week 24 Number Analyzed 28 participants
28.6
(13.2 to 48.7)
Week 28 Number Analyzed 28 participants
60.7
(40.6 to 78.5)
Week 32 Number Analyzed 27 participants
37.0
(19.4 to 57.6)
Week 36 Number Analyzed 27 participants
59.3
(38.8 to 77.6)
Week 40 Number Analyzed 26 participants
50.0
(29.9 to 70.1)
Week 40 (the last time point) Number Analyzed 39 participants
41.0
(25.6 to 57.9)
4.Secondary Outcome
Title CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Hide Description To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.
Time Frame Increased Dose Period (every 4 weeks for up to 40 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
One patient whose data after week 4 in the increased dose period was missing was excluded from the analysis. Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.
Arm/Group Title TA-650
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 38
Median (Full Range)
Unit of Measure: units on a scale
Week 0 to Week 4 Number Analyzed 37 participants
163.0
(24 to 356)
Week 0 to Week 8 Number Analyzed 33 participants
95.0
(-26 to 301)
Week 0 to Week 12 Number Analyzed 30 participants
161.0
(-17 to 342)
Week 0 to Week 16 Number Analyzed 29 participants
95.0
(-36 to 240)
Week 0 to Week 20 Number Analyzed 29 participants
164.0
(-63 to 343)
Week 0 to Week 24 Number Analyzed 28 participants
100.0
(-21 to 252)
Week 0 to Week 28 Number Analyzed 28 participants
156.5
(0 to 352)
Week 0 to Week 32 Number Analyzed 27 participants
110.0
(-28 to 279)
Week 0 to Week 36 Number Analyzed 27 participants
139.0
(20 to 359)
Week 0 to Week 40 Number Analyzed 26 participants
95.0
(-54 to 390)
Week 0 to 40(last measurable time point) Number Analyzed 38 participants
87.0
(-63 to 390)
5.Secondary Outcome
Title Serum Concentration of TA-650 at Each Time Point
Hide Description [Not Specified]
Time Frame Screening Period (every 4 weeks for up to 16 weeks), Increased Dose Period (every 4 weeks for up to 40 weeks), a total of 56 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.
Arm/Group Title TA-650
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: μg/mL
Screening Period (SP), Week 0 (pre-dose) Number Analyzed 39 participants
1.12
(0.00 to 13.29)
SP, 1 hr after treatment end for week 0 Number Analyzed 39 participants
97.74
(42.98 to 132.99)
SP, Week 4 Number Analyzed 39 participants
4.93
(0.00 to 27.70)
SP, Week 8 Number Analyzed 39 participants
0.30
(0.00 to 10.69)
SP, Week 12 Number Analyzed 2 participants
5.25
(0.00 to 10.49)
SP, Week 16 Number Analyzed 2 participants
0.79
(0.00 to 1.57)
Increased dose Period(IP), Week0 (pre-dose) Number Analyzed 39 participants
0.30
(0.00 to 10.69)
IP, 1 hr after treatment end for week 0 Number Analyzed 39 participants
191.24
(144.56 to 293.32)
IP, Week 4 Number Analyzed 37 participants
9.93
(0.00 to 43.55)
IP, Week 8 Number Analyzed 33 participants
1.29
(0.00 to 21.82)
IP, Week 12 Number Analyzed 31 participants
11.20
(0.00 to 48.30)
IP, Week 16 (pre-dose) Number Analyzed 29 participants
1.31
(0.00 to 23.67)
IP, 1hr after administration at week 16 Number Analyzed 29 participants
203.16
(140.33 to 306.48)
IP, Week 20 Number Analyzed 29 participants
8.71
(0.00 to 44.62)
IP, Week 24 Number Analyzed 28 participants
1.83
(0.00 to 25.84)
IP, Week 28 Number Analyzed 28 participants
9.97
(0.00 to 43.55)
IP, Week 32 Number Analyzed 27 participants
1.60
(0.00 to 23.11)
IP, Week 36 Number Analyzed 27 participants
12.72
(0.00 to 54.37)
IP, Week 40 Number Analyzed 26 participants
2.18
(0.00 to 22.60)
6.Secondary Outcome
Title Antibody to TA-650 Determination
Hide Description [Not Specified]
Time Frame Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Screening Period Increased Dose Period
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 39 39
Measure Type: Number
Unit of Measure: percentage of participants
Negative 23.1 17.9
Positive 5.1 5.1
Inconclusive 71.8 76.9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Entire Evaluation Period Screening Period Increased Dose Period
Hide Arm/Group Description Screening Period + Increased Dose Period [Not Specified] [Not Specified]
All-Cause Mortality
Entire Evaluation Period Screening Period Increased Dose Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Entire Evaluation Period Screening Period Increased Dose Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/45 (20.00%)   2/45 (4.44%)   8/39 (20.51%) 
Gastrointestinal disorders       
Crohn's disease  6/45 (13.33%)  1/45 (2.22%)  5/39 (12.82%) 
Melaena  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Peritonitis  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Infections and infestations       
Bronchitis  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Cytomegalovirus infection  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Injury, poisoning and procedural complications       
Upper limb fracture  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Nervous system disorders       
Chronic inflammatory demyelinating polyradiculoneuropathy  1/45 (2.22%)  1/45 (2.22%)  0/39 (0.00%) 
1
Term from vocabulary, MedDRA/J ver. 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Entire Evaluation Period Screening Period Increased Dose Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/45 (82.22%)   25/45 (55.56%)   29/39 (74.36%) 
Blood and lymphatic system disorders       
Anaemia  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Iron deficiency anaemia  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Gastrointestinal disorders       
Periodontitis  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
General disorders       
Pyrexia  2/45 (4.44%)  1/45 (2.22%)  1/39 (2.56%) 
Oedema peripheral  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Infections and infestations       
Nasopharyngitis  12/45 (26.67%)  3/45 (6.67%)  11/39 (28.21%) 
Influenza  3/45 (6.67%)  1/45 (2.22%)  2/39 (5.13%) 
Gastroenteritis  2/45 (4.44%)  0/45 (0.00%)  2/39 (5.13%) 
Pharyngitis  2/45 (4.44%)  0/45 (0.00%)  2/39 (5.13%) 
Bronchitis  1/45 (2.22%)  1/45 (2.22%)  0/39 (0.00%) 
Folliculitis  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Otitis externa  1/45 (2.22%)  1/45 (2.22%)  0/39 (0.00%) 
Otitis media  1/45 (2.22%)  1/45 (2.22%)  0/39 (0.00%) 
Vulvovaginal candidiasis  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Anal fistula infection  1/45 (2.22%)  1/45 (2.22%)  0/39 (0.00%) 
Injury, poisoning and procedural complications       
Injury  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Contusion  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Investigations       
DNA antibody positive  18/45 (40.00%)  15/45 (33.33%)  4/39 (10.26%) 
Blood urine present  2/45 (4.44%)  2/45 (4.44%)  1/39 (2.56%) 
Liver function test abnormal  2/45 (4.44%)  0/45 (0.00%)  2/39 (5.13%) 
Protein urine present  2/45 (4.44%)  2/45 (4.44%)  0/39 (0.00%) 
Blood alkaline phosphatase increased  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Chest X-ray abnormal  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1/45 (2.22%)  1/45 (2.22%)  1/39 (2.56%) 
Musculoskeletal stiffness  1/45 (2.22%)  1/45 (2.22%)  1/39 (2.56%) 
Musculoskeletal pain  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Nervous system disorders       
Headache  3/45 (6.67%)  2/45 (4.44%)  2/39 (5.13%) 
Dizziness  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Somnolence  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Renal and urinary disorders       
Renal mass  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Reproductive system and breast disorders       
Haematospermia  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  5/45 (11.11%)  2/45 (4.44%)  3/39 (7.69%) 
Dyspnoea  2/45 (4.44%)  1/45 (2.22%)  1/39 (2.56%) 
Upper respiratory tract inflammation  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Cough  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Epistaxis  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Rhinitis allergic  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Skin and subcutaneous tissue disorders       
Eczema  3/45 (6.67%)  2/45 (4.44%)  1/39 (2.56%) 
Acne  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Alopecia  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Polymorphic light eruption  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Pruritus  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
Vascular disorders       
Hot flush  1/45 (2.22%)  0/45 (0.00%)  1/39 (2.56%) 
1
Term from vocabulary, MedDRA/J ver. 13.0
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
EMail: cti-inq-ml@ml.mt-pharma.co.jp
Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00805766    
Other Study ID Numbers: TA-650-19
First Submitted: December 9, 2008
First Posted: December 10, 2008
Results First Submitted: September 2, 2012
Results First Posted: December 5, 2012
Last Update Posted: February 9, 2018