Pediatric Ulcerative ColitisPhase 3NCT01585155

Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis

A Phase 3 study testing TA-650 in people with Pediatric Ulcerative Colitis, run by Tanabe Pharma Corporation at 7 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks at weeks 14 and… Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Pediatric Ulcerative Colitis
What is being tested?: TA-650
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 7 sitesJapan
Study dates: Feb 2012to Sep 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients who have been diagnosed as ulcerative colitis at least 3 months prior to screening.
Have active ulcerative colitis despite adequate conventional therapy.

Who cannot join

Patients who have severe pancolitis.
Patients who have undergone surgery for ulcerative colitis within 8 weeks before enrollment or who were judged to require surgery for ulcerative colitis at enrollment.
Patients who have a history of treatment with infliximab or other biologic products (anti-TNFα agents, anti-IL-6 agents, etc.).

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Japan7 sites

Investigational site
Chūbu
Investigational site
Hokkaido
Investigational site
Hokuriku
Investigational site
Kanto
Investigational site
Kinki
Investigational site
Kyusyu
Investigational site
Tōhoku

Other trials in Japan

About this study

Official title: Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.

Conditions: Pediatric Ulcerative Colitis
Being tested: TA-650
Keywords: Infliximab, REMICADE, TA-650
Medical subject headings: Pediatric ulcerative colitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TA-650Drug
TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Weeks 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 22.

Study groups in NCT01585155
Study group	Role	What they receive
TA-650	Experimental	Not described Receives: Drug: TA-650

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Patients Who Achieved CAI Remission
Clinical activity index (CAI) remission was defined as a case where a CAI score was not more than 4 on the evaluation day.
CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity.
Measured: Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30

Secondary outcomes (3)

CAI Score
CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity.
Measured: Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
Partial Mayo Score
Mayo score consists of four subscores (stool frequency, rectal bleeding, physician's global assessment and findings of endoscopy), each of which was assessed according to a four-level rating scale (0 to 3 points), and was determined from a total of the four subscores (0 to 12 points). In addition, the sum of the subscores (0 to 9 points) for stool frequency, rectal bleeding and physician's global assessment was used as a partial Mayo score. A higher score indicates greater disease activity.
Measured: Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
PUCAI score was determined as a total of the subscores for each of the six evaluation items (0 to 85), including abdominal pain, rectal bleeding, stool consistency of most stools, number of stools per 24 hours, nocturnal stools and activity level. A higher score indicates greater disease activity.
Measured: Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Sep 2014

First posted25 Apr 2012 (estimated)
Study startFeb 2012
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pediatric Ulcerative ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01585155
Sponsor's protocol ID: TA-650-21
Status last verified: Dec 2025
First submitted: 24 Apr 2012
Last updated: 7 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tajiri H, Arai K, Kagimoto S, Kunisaki R, Hida N, Sato N, Yamada H, Nagano M, Susuta Y, Ozaki K, Kondo K, Hibi T. Infliximab for pediatric patients with ulcerative colitis: a phase 3, open-label, uncontrolled, multicenter trial in Japan. BMC Pediatr. 2019 Oct 13;19(1):351. doi: 10.1186/s12887-019-1739-5.
PubMed 31607268

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis.
ClinicalTrials.gov ID: NCT01585155
Acronym / sponsor ID: TA-650-21
Conditions: Pediatric Ulcerative Colitis
Keywords: Infliximab, REMICADE, TA-650
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 25 Apr 2012 (estimated)
Results: Posted 21 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TA-650	Experimental	Drug: TA-650

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Patients who have been diagnosed as ulcerative colitis at least 3 months prior to screening.
Have active ulcerative colitis despite adequate conventional therapy.

Key exclusion criteria (3 listed)

Patients who have severe pancolitis.
Patients who have undergone surgery for ulcerative colitis within 8 weeks before enrollment or who were judged to require surgery for ulcerative colitis at enrollment.
Patients who have a history of treatment with infliximab or other biologic products (anti-TNFα agents, anti-IL-6 agents, etc.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TA-650TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Weeks 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 22.	Drug	TA-650

Primary outcome

Percent of Patients Who Achieved CAI Remission
Time frame: Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
Clinical activity index (CAI) remission was defined as a case where a CAI score was not more than 4 on the evaluation day. CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity.

3 secondary outcomes

CAI Score
Time frame: Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
Partial Mayo Score
Time frame: Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30
Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
Time frame: Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30

Results and safety

Results posted to the registry on 21 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TA-650	21	16

Primary outcome: Percent of Patients Who Achieved CAI Remission

Time frame: Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30. Number. Unit: percentage of participants

Measure	TA-650 n = 21
Weeks 2	60.0
Weeks 6	80.0
Weeks 8	80.0
Weeks 10	77.8
Weeks 14	87.5
Weeks 18	87.5
Weeks 22	64.3
Weeks 26	85.7

Population analysed: Five patients were discontinued. The reasons for discontinuation were adverse event in 1 patient, lack of efficacy in 2 patients, and worsening ulcerative colitis in 2 patients. Two non-responders were observed, and both of them completed the efficacy evaluation at Week 8.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TA-650	3 of 21 (14.3%)	19 of 21 (90.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31607268Tajiri H, Arai K, Kagimoto S, Kunisaki R, Hida N, Sato N, Yamada H, Nagano M, Susuta Y, Ozaki K, Kondo K, Hibi T. Infliximab for pediatric patients with ulcerative colitis: a phase 3, open-label, uncontrolled, multicenter trial in Japan. BMC Pediatr. 2019 Oct 13;19(1):351. doi: 10.1186/s12887-019-1739-5.

Related trials for Pediatric Ulcerative Colitis

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Active, not recruitingObservational study
A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Toshifumi Hibi, MD study director

Kitasato University Kitasato Institute Hospital

Kazuoki Kondo, MD study director

Mitsubihsi Tanabe Pharma Corporation

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TA-650 in people with Pediatric Ulcerative Colitis, run by Tanabe Pharma Corporation at 7 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Patients Who Achieved CAI Remission (time frame: Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01585155, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.