Study on Long-Term Safety of Adalimumab for Children with Ulcerative Colitis Who Completed Previous Study

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What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a medication called adalimumab in children with Ulcerative Colitis. Ulcerative Colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine. The medication being tested, adalimumab, is a type of drug known as a monoclonal antibody, which is designed to target and block a specific protein in the body that causes inflammation.

The purpose of this study is to evaluate how safe and well-tolerated adalimumab is when given repeatedly over a long period. Participants in this study are children who have previously completed a related study, known as Protocol M11-290. During the study, participants will receive adalimumab as a solution for injection, which means the medication is administered through a needle under the skin. The study will monitor the participants’ health and any side effects they may experience while taking the medication.

This study is open-label, meaning both the researchers and participants know which treatment is being administered. The study will continue to observe the participants to ensure the medication is safe and effective in maintaining a clinical response, which refers to the improvement of symptoms associated with Ulcerative Colitis. The study aims to provide valuable information about the long-term use of adalimumab in managing this condition in children.

1 joining the study

Participation begins after successful completion of a previous study, Protocol M11-290, through Week 52.

Eligibility is confirmed based on prior study completion.

2 medication administration

The medication used in this study is adalimumab, administered as a solution for injection.

The injections are given subcutaneously (under the skin).

Available dosages include 40 mg, 80 mg, and 20 mg, provided in pre-filled syringes.

3 treatment schedule

The study involves repeated administration of adalimumab to evaluate long-term safety and tolerability.

The frequency and duration of administration are determined by the study protocol and medical team.

4 monitoring and evaluation

The study aims to assess the long-term safety and maintenance of clinical response to adalimumab.

Efficacy is measured using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and other scoring systems if available.

5 safety analysis

Safety analyses are conducted for all participants who receive at least one dose of the study drug.

The study is designed to ensure the well-being of participants throughout the trial.

6 study duration

The estimated end date for the study is May 14, 2025.

The study is conducted over several years to gather comprehensive data on long-term effects.

Who Can Join the Study?

The patient must have a condition called Ulcerative Colitis, which is a disease that causes inflammation and sores in the colon and rectum.
The patient must have successfully enrolled in and completed a previous study called Protocol M11-290 through Week 52.
The patient must be a child or teenager, as the study is for pediatric subjects.
Both boys and girls can participate in the study.
The study includes individuals who may be considered part of a vulnerable population, meaning they might need extra care or protection.

Who Cannot Join the Study?

Patients who have not successfully completed the previous study, Protocol M11-290, through Week 52 cannot participate.
Patients with medical conditions other than Ulcerative Colitis that might interfere with the study cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who have any other health issues that the study doctors think might make it unsafe for them to participate cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Univerzitna Nemocnica Martin	Martin	Slovakia
Eb Group Sp. z o.o.	Warsaw	Poland
Uniwersytecki Szpital Dzieciecy W Krakowie	Cracow	Poland
MD Korczowski Bartosz Gabinet Lekarski	Rzeszow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	26.11.2015
Slovakia	Not recruiting	26.11.2015

Trial locations

Investigated drugs:

Adalimumab

Adalimumab is a medication used in this clinical trial. It is a human anti-TNF monoclonal antibody. The trial aims to evaluate the long-term safety and tolerability of repeated administration of this medication in children with ulcerative colitis. Adalimumab works by reducing inflammation in the body, which can help manage symptoms of ulcerative colitis. The study focuses on ensuring that the medication is safe and effective for long-term use in pediatric patients who have already completed a previous study with this treatment.

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in the gut.

Trial ID:

2023-504711-32-00

Protocol code:

M10-870

NCT ID:

NCT02632175

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-Term Safety of Adalimumab for Children with Ulcerative Colitis Who Completed Previous Study

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?