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TNF-alpha inhibitor

Adalimumab for Pediatric Ulcerative Colitis

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up through week 288
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial looked at the effects of a medication called adalimumab on children with ulcerative colitis. The study found that the drug was safe and effective in treating the condition.

Who is the study for?
This trial is for children with ulcerative colitis who have finished the M11-290 study. It's not open to those whom the investigator thinks shouldn't participate for any reason.
What is being tested?
The trial is looking at how safe and effective Adalimumab, a medication used to treat inflammatory conditions, is over a long period in kids with ulcerative colitis.
What are the potential side effects?
Adalimumab may cause injection site reactions, infections, headaches, rash, nausea. In rare cases, it can lead to more serious issues like immune system problems or heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up through week 288
This trial's timeline: 3 weeks for screening, Varies for treatment, and up through week 288 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of subjects who achieve PUCAI response
Proportion of subjects who achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) remission
Proportion of subjects who achieve clinical remission as measured by PMS
+1 more
Secondary study objectives
Assessing activity impairment using the Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI: UC)
Assessing impact on children who have inflammatory bowel disease (ulcerative colitis) using IMPACT III questionnaire
Proportion of subjects who achieve remission/response based on Full Mayo score
Other study objectives
Mucosal Healing

Side effects data

From 2013 Phase 4 trial • 50 Patients • NCT01644396
8%
LATENT TUBERCULOSIS
6%
RHINITIS
2%
ORAL HERPES
2%
RESPIRATORY TRACT INFECTION
2%
CONTUSION
2%
EXCORIATION
2%
ASPARTATE AMINOTRANSFERASE INCREASED
2%
BLOOD GLUCAGON INCREASED
2%
BLOOD TRIGLYCERIDES INCREASED
2%
RENAL COLIC
2%
EPISTAXIS
2%
URTICARIA
2%
ANAEMIA
2%
FURUNCLE
2%
HERPES SIMPLEX
2%
ALANINE AMINOTRANSFERASE INCREASED
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects receiving AdalimumabExperimental Treatment1 Intervention
Subjects receiving Adalimumab up to 288 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adalimumab
2013
Completed Phase 4
~7950

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,020 Previous Clinical Trials
519,990 Total Patients Enrolled
31 Trials studying Colitis
21,109 Patients Enrolled for Colitis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,520 Total Patients Enrolled
13 Trials studying Colitis
13,496 Patients Enrolled for Colitis
ABBVIE INC.Study DirectorAbbVie
442 Previous Clinical Trials
160,439 Total Patients Enrolled
18 Trials studying Colitis
17,151 Patients Enrolled for Colitis

Media Library

Adalimumab (TNF-alpha inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02632175 — Phase 3
Colitis Research Study Groups: Subjects receiving Adalimumab
Colitis Clinical Trial 2023: Adalimumab Highlights & Side Effects. Trial Name: NCT02632175 — Phase 3
Adalimumab (TNF-alpha inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02632175 — Phase 3
~2 spots leftby Jan 2025
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