-
Study aim
-
Determining the efficacy and side effects of adalimumab in children aged 2-18 years with inflammatory bowel disease
-
Design
-
This study is conducted as a single-group clinical trial in phase 3 on 25 patients.
-
Settings and conduct
-
This study will be conducted on 25 children and adolescents aged 2-18 years. The study will be conducted as a single-group clinical trial with the administration of adalimumab as the intervention group. At the beginning and after 4 and 26 weeks, the different effects of the intervention are examined and compared.
-
Participants/Inclusion and exclusion criteria
-
Girls and boys aged 2 to 18 years . Diagnosis of IBD based on endoscopic, laboratory studies, and clinical examinations . Absences other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, other gastrointestinal diseases, chronic diseases (including type one or two diabetes, cardiovascular, pulmonary and celiac disease), autoimmune diseases Known and inherited and metabolic disorders. No pregnancy or breastfeeding in women . No substance abuse, no chronic inflammatory disease, no history of cancer, no hormone therapy. presence of perianal fistula. active disease despite administration of corticosteroids.
-
Intervention groups
-
Administration of adalimumab (40 mg/0.8 ml) which is injected in patients weighing less than 40 kg based on the following dose: 80 mg first, 40 mg two weeks later, 20 mg two weeks after the second dose and then depending on the response, 20 mg should be taken subcutaneously once every one or two weeks. Also, subcutaneous injection was performed for people weighing more than 40 kg based on the following dose: first 160 mg, two weeks later 80 mg, two weeks after the second dose 40 mg, then according to the response, 40 mg is injected every one or two weeks.
-
Main outcome variables
-
Clinical activity score, weight, fecal calprotectin.