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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up through week 288
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up through week 288
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 moreSecondary 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 • NCT016443968%
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
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
~6480
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,010 Previous Clinical Trials
518,645 Total Patients Enrolled
32 Trials studying Ulcerative Colitis
22,265 Patients Enrolled for Ulcerative Colitis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,520 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
13,496 Patients Enrolled for Ulcerative Colitis
ABBVIE INC.Study DirectorAbbVie
435 Previous Clinical Trials
159,925 Total Patients Enrolled
18 Trials studying Ulcerative Colitis
17,151 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Subjects receiving Adalimumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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