Trial · NCT01536535

Predicting Response to Standardized Pediatric Colitis Therapy

NCT01536535, Phase 4, Completed, Connecticut Children's Medical Center; results first posted 2019-08-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Predicting Response to Standardized Pediatric Colitis Therapy. Trials, record NCT01536535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01536535

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Predicting Response to Standardized Pediatric Colitis Therapy
NCT number: NCT01536535
Status: Completed
Phases: Phase 4
Enrollment: 431 participants, actual
Lead sponsor: Connecticut Children's Medical Center
Conditions: Ulcerative Colitis
Interventions: Mesalazine, IV Corticosteroid, Oral Corticosteroids, Additional Therapies, Colectomy
First posted: 2012-02-22
Last updated: 2019-09-20
Results first posted: 2019-08-28

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Corticosteroid Free Remission (SFR)	52 weeks	Week 52 CS-free remission: Number of participants with a PUCAI \< 10 and no corticosteroids (CS) for 28 days without additional therapy or colectomy. Participants in both groups received corticosteroids, biologics, or colectomies, if symptomatic. The Pediatric Ulcerative Colitis Activity Index (PUCAI) is a non-invasive disease activity index. The index measures include abdominal pain, rectal bleeding, stool consistency, number of stools per 24 hours, nocturnal stools, and activity level. A total score less than 10 indicates remission, Mild disease activity is 10-30, Moderate 35-60, Severe disease activity 65-85.
Primary	Number of Participants Who Needed Additional Therapy or Colectomy	Within 52 weeks	Number of participants who needed additional therapy or colectomy. Additional therapy included Anti-Tumour Necrosis Factor alpha (TNFα), Calcineurin inhibitor, Immunomodulator
Secondary	Number of Participants Receiving a Colectomy	Within 52 weeks	Number of participants who received a colectomy within 52 weeks

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With Corticosteroid Free Remission (SFR)	52 weeks	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Who Needed Additional Therapy or Colectomy	Within 52 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Receiving a Colectomy	Within 52 weeks	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Corticosteroid Free Remission (SFR)	Mild UC	80	Participants
Number of Participants With Corticosteroid Free Remission (SFR)	Moderate to Severe UC	70	Participants
Number of Participants Who Needed Additional Therapy or Colectomy	Mild UC Disease	46	Participants
Number of Participants Who Needed Additional Therapy or Colectomy	Moderate to Severe UC	151	Participants
Number of Participants Receiving a Colectomy	Mild UC Disease	2	Participants
Number of Participants Receiving a Colectomy	Moderate to Severe UC	23	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mild UC Disease	178
Overall Study	STARTED	Moderate to Severe UC	250
Overall Study	COMPLETED	Mild UC Disease	163
Overall Study	COMPLETED	Moderate to Severe UC	237
Overall Study	NOT COMPLETED	Mild UC Disease	15
Overall Study	NOT COMPLETED	Moderate to Severe UC	13

Source ClinicalTrials.gov

Adverse events46

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal Pain	Gastrointestinal disorders	Mild UC	56	178
other	Abdominal Pain	Gastrointestinal disorders	Moderate to Severe UC	71	250
other	Diarrhea	Gastrointestinal disorders	Mild UC	52	178
other	Diarrhea	Gastrointestinal disorders	Moderate to Severe UC	71	250
other	Headache	General disorders	Mild UC	21	178
other	Headache	General disorders	Moderate to Severe UC	23	250
other	Nausea	Gastrointestinal disorders	Mild UC	10	178
other	Nausea	Gastrointestinal disorders	Moderate to Severe UC	17	250
other	Vomiting	Gastrointestinal disorders	Mild UC	7	178
other	Vomiting	Gastrointestinal disorders	Moderate to Severe UC	11	250

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mild UC	0	178
Total, all-cause mortality	Moderate to Severe UC	0	250
Total, other adverse events	Mild UC	157	178
Total, other adverse events	Moderate to Severe UC	224	250
Total, serious adverse events	Mild UC	21	178
Total, serious adverse events	Moderate to Severe UC	79	250

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28939374	RESULT	PubMed
30935734	DERIVED	PubMed
31373712	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U01DK095745	Predicting Response to Standardized Pediatric Colitis Therapy: PROTECT Study	HYAMS, JEFFREY SAMUEL; DENSON, LEE ARMISTEAD	CONNECTICUT CHILDREN'S MEDICAL CENTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2012 to 2016	NIH RePORTER
U34DK090804	Predicting Response to Standardized Pediatric Colitis Therapy: The PROTECT Study	HYAMS, JEFFREY SAMUEL; DENSON, LEE ARMISTEAD; KIM, MI-OK	CONNECTICUT CHILDREN'S MEDICAL CENTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2010 to 2011	NIH RePORTER

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Mild UC vs Moderate to Severe UC: Number of Participants With Corticosteroid Free Remission (SFR)	Trial comparisons
Mild UC Disease vs Moderate to Severe UC: Number of Participants Who Needed Additional Therapy or Colectomy	Trial comparisons
Mild UC Disease vs Moderate to Severe UC: Number of Participants Receiving a Colectomy	Trial comparisons
Mild UC vs Moderate to Severe UC: deaths from any cause	Trial comparisons
Mild UC vs Moderate to Severe UC: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01536535

GET https://conductscience.org/api/trials/v1/NCT01536535/events?page=2

API reference For AI assistants