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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

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
958 Previous Clinical Trials
502,325 Total Patients Enrolled
30 Trials studying Ulcerative Colitis
21,395 Patients Enrolled for Ulcerative Colitis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,498 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
13,496 Patients Enrolled for Ulcerative Colitis
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,039 Total Patients Enrolled
16 Trials studying Ulcerative Colitis
16,281 Patients Enrolled for Ulcerative Colitis

Media Library

Adalimumab (TNF-alpha inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02632175 — Phase 3
Ulcerative Colitis Research Study Groups: Subjects receiving Adalimumab
Ulcerative 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what diseases or conditions is Adalimumab most frequently prescribed?

"Adalimumab is frequently used to ameliorate the symptoms of ankylosing spondylitis. However, it has also been shown to reduce the pain and swelling caused by rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis."

Answered by AI

Are octogenarians still qualified to participate in this research?

"This particular clinical trial is open to those who are under 17 years old and have already celebrated their 4th birthday."

Answered by AI

Are eligible individuals being sought for this clinical trial at present?

"As of right now, this study has completed recruitment for participants. This trial was first posted on November 26th, 2015 and the most recent update was on January 20th, 2022. If you are still interested in participating in clinical trials related to ulcerative colitis, 423 studies are currently enrolling patients while 52 trials are seeking Adalimumab volunteers."

Answered by AI

How many people fit the qualifications to enroll in this research project?

"This study is not admitting patients at the moment. The clinical trial was initially posted on 11/26/2015 and was last updated on 1/20/2022. If you are looking for other studies, there 423 trials actively recruiting ulcerative colitis patients and 52 trials for Adalimumab that are still searching for participants."

Answered by AI

Where does this research stand in relation to other Adalimumab trials?

"The University of Nebraska Medical Center first studied adalimumab in 2007 and there are now 283 completed trials. Out of the 52 active studies, many are based in Tacoma, Washington."

Answered by AI

Do numerous hospitals in Canada administer this clinical trial?

"Currently, this trial is enrolling patients from 7 locations. These sites are based in Tacoma, Orlando and Rochester among others. To minimize travel requirements, please select the location nearest you when enrolling for the trial."

Answered by AI

When was Adalimumab cleared by the FDA?

"Adalimumab's safety is well-documented, as this drug has been studied in multiple Phase 3 clinical trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
2015. "Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02632175.
All > Inflammatory Bowel Disease > Colitis
~4 spots leftby Jan 2025
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