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CompletedNCT00805766Updated Jan 7, 2026Results posted

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

A Phase 3 interventional study of TA-650 in Crohn's Disease, sponsored by Tanabe Pharma Corporation. Completed at 4 sites in Japan. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
16 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to assess the efficacy, safety and pharmacokinetics after administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.

02

Conditions studied

  • Crohn's Disease

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Keywords

  • Infliximab
  • REMICADE
  • Crohn's disease
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 39 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with Crohn's disease
  • Patients who have relapsed with symptoms associated with Crohn's disease within 8 weeks in spite of maintenance treatment with 5mg/kg REMICADE every 8 weeks, and who are judged to be showing an insufficient response to the previous treatment by their physician

Exclusion criteria

Exclusion Criteria:

  • Severe intestinal strictures (which may have an effect on the number of loose stools or diarrhea or dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy), a diagnosis of short bowel syndrome, or previous stoma surgery
  • The presence of significant internal fistula (possibility that surgery might be needed, etc.) is confirmed
  • A history of a serious infusion reaction to REMICADE
  • Pregnant, lactating, and probably pregnant women
  • Patients who have participated in other trials and have been administered other investigational products within 12 weeks before consent
  • Patients judged to be inadequate to participate in this study by their physician
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    TA-650

    Drug: TA-650

Interventions

  • DrugTA-650

    (1) Screening Period: 5 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at week 0. If patients do not meet the Eligibility Criteria at week 8, they will be administered 5 mg/kg of TA-650 at week 8. (2) Increased Dose Period: 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours every 8 weeks for 32 weeks.

    Also known as: Infliximab

06

What researchers measure

Primary outcomes

  1. Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period

    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)

Secondary outcomes

  1. CDAI at Each Evaluation Time Point in the Increased Dose Period

    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)

  2. CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period

    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)

  3. CDAI Change at Each Evaluation Time Point in the Increased Dose Period

    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)

  4. Serum Concentration of TA-650 at Each Time Point

    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

  5. Antibody to TA-650 Determination

    Time frame: Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)

07

Results

Posted Dec 5, 2012

Participant flow

Screening Period
Participant flow — Screening Period
MilestoneTA-650
Started45
Completed39
Not completed6
Withdrew: Adverse event1
Withdrew: Lack of efficacy2
Withdrew: Pregnancy1
Withdrew: Responder2
Increased Dose Period
Participant flow — Increased Dose Period
MilestoneTA-650
Started39
Completed26
Not completed13
Withdrew: Adverse event4
Withdrew: Lack of efficacy7
Withdrew: Pregnancy1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryMedian Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period

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)
Reported as:
Median · units on a scale
Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period
units on a scaleTA-650
Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period95.0 (70.0 to 134.0)
SecondaryCDAI at Each Evaluation Time Point in the Increased Dose Period

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)
Reported as:
Median · units on a scale
CDAI at Each Evaluation Time Point in the Increased Dose Period
units on a scaleTA-650
Week 0296.5 (185 to 523)
Week 4119.0 (17 to 318)
Week 8194.0 (51 to 456)
Week 12126.0 (14 to 419)
Week 16182.0 (70 to 398)
Week 20121.0 (13 to 304)
Week 24197.5 (81 to 379)
Week 28105.0 (4 to 289)
Week 32163.0 (72 to 410)
Week 36141.0 (-3 to 315)
Week 40148.5 (41 to 407)
Week 40 (the last time point)210.5 (34 to 479)
SecondaryCDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period

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)
Reported as:
Number · percentage of participants
CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
percentage of participantsTA-650
Week 459.5 (42.1 to 75.2)
Week 839.4 (22.9 to 57.9)
Week 1270.0 (50.6 to 85.3)
Week 1631.0 (15.3 to 50.8)
Week 2058.6 (38.9 to 76.5)
Week 2428.6 (13.2 to 48.7)
Week 2860.7 (40.6 to 78.5)
Week 3237.0 (19.4 to 57.6)
Week 3659.3 (38.8 to 77.6)
Week 4050.0 (29.9 to 70.1)
Week 40 (the last time point)41.0 (25.6 to 57.9)
SecondaryCDAI Change at Each Evaluation Time Point in the Increased Dose Period

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)
Reported as:
Median · units on a scale
CDAI Change at Each Evaluation Time Point in the Increased Dose Period
units on a scaleTA-650
Week 0 to Week 4163.0 (24 to 356)
Week 0 to Week 895.0 (-26 to 301)
Week 0 to Week 12161.0 (-17 to 342)
Week 0 to Week 1695.0 (-36 to 240)
Week 0 to Week 20164.0 (-63 to 343)
Week 0 to Week 24100.0 (-21 to 252)
Week 0 to Week 28156.5 (0 to 352)
Week 0 to Week 32110.0 (-28 to 279)
Week 0 to Week 36139.0 (20 to 359)
Week 0 to Week 4095.0 (-54 to 390)
Week 0 to 40(last measurable time point)87.0 (-63 to 390)
SecondarySerum Concentration of TA-650 at Each Time Point
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
Reported as:
Median · μg/mL
Serum Concentration of TA-650 at Each Time Point
μg/mLTA-650
Screening Period (SP), Week 0 (pre-dose)1.12 (0.00 to 13.29)
SP, 1 hr after treatment end for week 097.74 (42.98 to 132.99)
SP, Week 44.93 (0.00 to 27.70)
SP, Week 80.30 (0.00 to 10.69)
SP, Week 125.25 (0.00 to 10.49)
SP, Week 160.79 (0.00 to 1.57)
Increased dose Period(IP), Week0 (pre-dose)0.30 (0.00 to 10.69)
IP, 1 hr after treatment end for week 0191.24 (144.56 to 293.32)
IP, Week 49.93 (0.00 to 43.55)
IP, Week 81.29 (0.00 to 21.82)
IP, Week 1211.20 (0.00 to 48.30)
IP, Week 16 (pre-dose)1.31 (0.00 to 23.67)
IP, 1hr after administration at week 16203.16 (140.33 to 306.48)
IP, Week 208.71 (0.00 to 44.62)
IP, Week 241.83 (0.00 to 25.84)
IP, Week 289.97 (0.00 to 43.55)
IP, Week 321.60 (0.00 to 23.11)
IP, Week 3612.72 (0.00 to 54.37)
IP, Week 402.18 (0.00 to 22.60)
SecondaryAntibody to TA-650 Determination
Time frame:
Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)
Reported as:
Number · percentage of participants
Antibody to TA-650 Determination
percentage of participantsScreening PeriodIncreased Dose Period
Negative23.117.9
Positive5.15.1
Inconclusive71.876.9

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Entire Evaluation Period—9/45 (20%)37/45 (82.2%)
Screening Period—2/45 (4.4%)25/45 (55.6%)
Increased Dose Period—8/39 (20.5%)29/39 (74.4%)
Most frequent serious events
Most frequent serious events
EventEntire Evaluation PeriodScreening PeriodIncreased Dose Period
Crohn's diseaseGastrointestinal disorders6/451/455/39
MelaenaGastrointestinal disorders1/450/451/39
PeritonitisGastrointestinal disorders1/450/451/39
BronchitisInfections and infestations1/450/451/39
Cytomegalovirus infectionInfections and infestations1/450/451/39
Upper limb fractureInjury, poisoning and procedural complications1/450/451/39
Chronic inflammatory demyelinating polyradiculoneuropathyNervous system disorders1/451/450/39
Most frequent other events
Showing 10 of 43
Most frequent other events
EventEntire Evaluation PeriodScreening PeriodIncreased Dose Period
DNA antibody positiveInvestigations18/4515/454/39
NasopharyngitisInfections and infestations12/453/4511/39
Oropharyngeal painRespiratory, thoracic and mediastinal disorders5/452/453/39
InfluenzaInfections and infestations3/451/452/39
HeadacheNervous system disorders3/452/452/39
EczemaSkin and subcutaneous tissue disorders3/452/451/39
GastroenteritisInfections and infestations2/450/452/39
PharyngitisInfections and infestations2/450/452/39
Liver function test abnormalInvestigations2/450/452/39
Blood urine presentInvestigations2/452/451/39

Baseline characteristics

Age, Continuous
Age, Continuous(years)TA-650
Mean29.5 ± 7.3
Sex: Female, Male
Sex: Female, Male(Participants)TA-650
Female14
Male31
08

Study locations

4 sites
  • Investigational site
    Hokkaido, Japan
  • Investigational site
    Kansai, Japan
  • Investigational site
    Kanto, Japan
  • Investigational site
    Kyushu, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00805766
Lead sponsor
Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Dec 10, 2008
Start date
Dec 2008
Primary completion
Nov 2009
Completion
Jul 2010
Results posted
Dec 5, 2012
Last update
Jan 7, 2026

Study contacts

Toshifumi Hibi, Professor
study chair · Department of Internal Medicine, Keio University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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