Trial Outcomes & Findings for Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD) (NCT NCT00805766)
NCT ID: NCT00805766
Last Updated: 2026-01-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
Increased Dose Period (Week 0 to Week 8)
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
TA-650
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.
|
|---|---|
|
Screening Period
STARTED
|
45
|
|
Screening Period
COMPLETED
|
39
|
|
Screening Period
NOT COMPLETED
|
6
|
|
Increased Dose Period
STARTED
|
39
|
|
Increased Dose Period
COMPLETED
|
26
|
|
Increased Dose Period
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
TA-650
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.
|
|---|---|
|
Screening Period
Adverse Event
|
1
|
|
Screening Period
Lack of Efficacy
|
2
|
|
Screening Period
Pregnancy
|
1
|
|
Screening Period
Responder
|
2
|
|
Increased Dose Period
Adverse Event
|
4
|
|
Increased Dose Period
Lack of Efficacy
|
7
|
|
Increased Dose Period
Pregnancy
|
1
|
|
Increased Dose Period
Withdrawal by Subject
|
1
|
Baseline Characteristics
Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)
Baseline characteristics by cohort
| Measure |
TA-650
n=45 Participants
|
|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 7.3 • n=37 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: Increased Dose Period (Week 0 to Week 8)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.
Outcome measures
| Measure |
TA-650
n=33 Participants
|
Increased Dose Period
|
|---|---|---|
|
Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period
|
95.0 units on a scale
Interval 70.0 to 134.0
|
—
|
SECONDARY outcome
Timeframe: Increased Dose Period (every 4 weeks for up to 40 weeks)Population: 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.
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.
Outcome measures
| Measure |
TA-650
n=38 Participants
|
Increased Dose Period
|
|---|---|---|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 0
|
296.5 units on a scale
Interval 185.0 to 523.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 4
|
119.0 units on a scale
Interval 17.0 to 318.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 8
|
194.0 units on a scale
Interval 51.0 to 456.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 12
|
126.0 units on a scale
Interval 14.0 to 419.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 16
|
182.0 units on a scale
Interval 70.0 to 398.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 20
|
121.0 units on a scale
Interval 13.0 to 304.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 24
|
197.5 units on a scale
Interval 81.0 to 379.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 28
|
105.0 units on a scale
Interval 4.0 to 289.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 32
|
163.0 units on a scale
Interval 72.0 to 410.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 36
|
141.0 units on a scale
Interval -3.0 to 315.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 40
|
148.5 units on a scale
Interval 41.0 to 407.0
|
—
|
|
CDAI at Each Evaluation Time Point in the Increased Dose Period
Week 40 (the last time point)
|
210.5 units on a scale
Interval 34.0 to 479.0
|
—
|
SECONDARY outcome
Timeframe: Increased Dose Period (every 4 weeks for up to 40 weeks)Population: Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.
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.
Outcome measures
| Measure |
TA-650
n=39 Participants
|
Increased Dose Period
|
|---|---|---|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 40 (the last time point)
|
41.0 percentage of participants
Interval 25.6 to 57.9
|
—
|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 4
|
59.5 percentage of participants
Interval 42.1 to 75.2
|
—
|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 8
|
39.4 percentage of participants
Interval 22.9 to 57.9
|
—
|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 12
|
70.0 percentage of participants
Interval 50.6 to 85.3
|
—
|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 16
|
31.0 percentage of participants
Interval 15.3 to 50.8
|
—
|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 20
|
58.6 percentage of participants
Interval 38.9 to 76.5
|
—
|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 24
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
—
|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 28
|
60.7 percentage of participants
Interval 40.6 to 78.5
|
—
|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 32
|
37.0 percentage of participants
Interval 19.4 to 57.6
|
—
|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 36
|
59.3 percentage of participants
Interval 38.8 to 77.6
|
—
|
|
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
Week 40
|
50.0 percentage of participants
Interval 29.9 to 70.1
|
—
|
SECONDARY outcome
Timeframe: Increased Dose Period (every 4 weeks for up to 40 weeks)Population: 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.
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.
Outcome measures
| Measure |
TA-650
n=38 Participants
|
Increased Dose Period
|
|---|---|---|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to 40(last measurable time point)
|
87.0 units on a scale
Interval -63.0 to 390.0
|
—
|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to Week 20
|
164.0 units on a scale
Interval -63.0 to 343.0
|
—
|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to Week 4
|
163.0 units on a scale
Interval 24.0 to 356.0
|
—
|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to Week 8
|
95.0 units on a scale
Interval -26.0 to 301.0
|
—
|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to Week 12
|
161.0 units on a scale
Interval -17.0 to 342.0
|
—
|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to Week 16
|
95.0 units on a scale
Interval -36.0 to 240.0
|
—
|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to Week 24
|
100.0 units on a scale
Interval -21.0 to 252.0
|
—
|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to Week 28
|
156.5 units on a scale
Interval 0.0 to 352.0
|
—
|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to Week 32
|
110.0 units on a scale
Interval -28.0 to 279.0
|
—
|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to Week 36
|
139.0 units on a scale
Interval 20.0 to 359.0
|
—
|
|
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
Week 0 to Week 40
|
95.0 units on a scale
Interval -54.0 to 390.0
|
—
|
SECONDARY outcome
Timeframe: 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 weeksPopulation: Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.
Outcome measures
| Measure |
TA-650
n=39 Participants
|
Increased Dose Period
|
|---|---|---|
|
Serum Concentration of TA-650 at Each Time Point
Screening Period (SP), Week 0 (pre-dose)
|
1.12 μg/mL
Interval 0.0 to 13.29
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
SP, 1 hr after treatment end for week 0
|
97.74 μg/mL
Interval 42.98 to 132.99
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
SP, Week 4
|
4.93 μg/mL
Interval 0.0 to 27.7
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
SP, Week 8
|
0.30 μg/mL
Interval 0.0 to 10.69
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
SP, Week 12
|
5.25 μg/mL
Interval 0.0 to 10.49
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
SP, Week 16
|
0.79 μg/mL
Interval 0.0 to 1.57
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
Increased dose Period(IP), Week0 (pre-dose)
|
0.30 μg/mL
Interval 0.0 to 10.69
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, 1 hr after treatment end for week 0
|
191.24 μg/mL
Interval 144.56 to 293.32
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, Week 4
|
9.93 μg/mL
Interval 0.0 to 43.55
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, Week 8
|
1.29 μg/mL
Interval 0.0 to 21.82
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, Week 12
|
11.20 μg/mL
Interval 0.0 to 48.3
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, Week 16 (pre-dose)
|
1.31 μg/mL
Interval 0.0 to 23.67
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, 1hr after administration at week 16
|
203.16 μg/mL
Interval 140.33 to 306.48
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, Week 20
|
8.71 μg/mL
Interval 0.0 to 44.62
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, Week 24
|
1.83 μg/mL
Interval 0.0 to 25.84
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, Week 28
|
9.97 μg/mL
Interval 0.0 to 43.55
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, Week 32
|
1.60 μg/mL
Interval 0.0 to 23.11
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, Week 36
|
12.72 μg/mL
Interval 0.0 to 54.37
|
—
|
|
Serum Concentration of TA-650 at Each Time Point
IP, Week 40
|
2.18 μg/mL
Interval 0.0 to 22.6
|
—
|
SECONDARY outcome
Timeframe: Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)Outcome measures
| Measure |
TA-650
n=39 Participants
|
Increased Dose Period
n=39 Participants
|
|---|---|---|
|
Antibody to TA-650 Determination
Positive
|
5.1 percentage of participants
|
5.1 percentage of participants
|
|
Antibody to TA-650 Determination
Inconclusive
|
71.8 percentage of participants
|
76.9 percentage of participants
|
|
Antibody to TA-650 Determination
Negative
|
23.1 percentage of participants
|
17.9 percentage of participants
|
Adverse Events
Entire Evaluation Period
Serious events: 9 serious events
Other events: 37 other events
Deaths: 0 deaths
Screening Period
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Increased Dose Period
Serious events: 8 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entire Evaluation Period
n=45 participants at risk
Screening Period + Increased Dose Period
|
Screening Period
n=45 participants at risk
|
Increased Dose Period
n=39 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
13.3%
6/45
|
2.2%
1/45
|
12.8%
5/39
|
|
Gastrointestinal disorders
Melaena
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Gastrointestinal disorders
Peritonitis
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Infections and infestations
Bronchitis
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Infections and infestations
Cytomegalovirus infection
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
2.2%
1/45
|
2.2%
1/45
|
0.00%
0/39
|
Other adverse events
| Measure |
Entire Evaluation Period
n=45 participants at risk
Screening Period + Increased Dose Period
|
Screening Period
n=45 participants at risk
|
Increased Dose Period
n=39 participants at risk
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Nervous system disorders
Headache
|
6.7%
3/45
|
4.4%
2/45
|
5.1%
2/39
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Nervous system disorders
Somnolence
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.7%
3/45
|
4.4%
2/45
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Polymorphic light eruption
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
General disorders
Pyrexia
|
4.4%
2/45
|
2.2%
1/45
|
2.6%
1/39
|
|
General disorders
Oedema peripheral
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Vascular disorders
Hot flush
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Injury, poisoning and procedural complications
Injury
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Gastrointestinal disorders
Periodontitis
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Renal and urinary disorders
Renal mass
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Reproductive system and breast disorders
Haematospermia
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Infections and infestations
Nasopharyngitis
|
26.7%
12/45
|
6.7%
3/45
|
28.2%
11/39
|
|
Infections and infestations
Influenza
|
6.7%
3/45
|
2.2%
1/45
|
5.1%
2/39
|
|
Infections and infestations
Gastroenteritis
|
4.4%
2/45
|
0.00%
0/45
|
5.1%
2/39
|
|
Infections and infestations
Pharyngitis
|
4.4%
2/45
|
0.00%
0/45
|
5.1%
2/39
|
|
Infections and infestations
Bronchitis
|
2.2%
1/45
|
2.2%
1/45
|
0.00%
0/39
|
|
Infections and infestations
Folliculitis
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Infections and infestations
Otitis externa
|
2.2%
1/45
|
2.2%
1/45
|
0.00%
0/39
|
|
Infections and infestations
Otitis media
|
2.2%
1/45
|
2.2%
1/45
|
0.00%
0/39
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Infections and infestations
Anal fistula infection
|
2.2%
1/45
|
2.2%
1/45
|
0.00%
0/39
|
|
Investigations
DNA antibody positive
|
40.0%
18/45
|
33.3%
15/45
|
10.3%
4/39
|
|
Investigations
Blood urine present
|
4.4%
2/45
|
4.4%
2/45
|
2.6%
1/39
|
|
Investigations
Liver function test abnormal
|
4.4%
2/45
|
0.00%
0/45
|
5.1%
2/39
|
|
Investigations
Protein urine present
|
4.4%
2/45
|
4.4%
2/45
|
0.00%
0/39
|
|
Investigations
Blood alkaline phosphatase increased
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Investigations
Chest X-ray abnormal
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
5/45
|
4.4%
2/45
|
7.7%
3/39
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.4%
2/45
|
2.2%
1/45
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.2%
1/45
|
0.00%
0/45
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/45
|
2.2%
1/45
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.2%
1/45
|
2.2%
1/45
|
2.6%
1/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER