Biologics in Management of Inflammatory Bowel Disease in Egyptian Patients

NCT05720221 | Completed

• 1 other identifier: Biologics in IBD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic inflammatory relapsing disorder affecting the gastrointestinal tract and is characterized by a progressive and unpredictable disease course.The two goals of therapy are the achievement of remission (induction) and the prevention of disease flares (maintenance). Medical therapy for IBD has advanced dramatically in the last decade with the introduction of targeted biologic therapies including infliximab,adalimumab and ustekinumab.There is paucity of head-to-head studies comparing the effectiveness of ustekinumab and adalimumab in inflammatory bowel disease patients especially in Egyptian population which prompted this study to be conducted.

Conditions

IBD

Keywords

Ustekinumab; Adalimumab; IBD; Stelara; Humira

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving the clinical response after 4 months from baseline

  Percentage of patients achieving the clinical response will be assessed, the clinical response defined as reduction of at least 3 points of Harvey Bradshaw Index (HBI) from baseline (in chrons disease) and reduction of at least 2 points of Partial Mayo Score (PMS) from baseline (in ulcerative colitis). \[time frame baseline to 4 months\]

  Baseline to four months.

Secondary Outcomes (1)

• Percentage of patients achieving the clinical remission after 4 months from baseline

  Baseline to six months.

Study Arms (2)

Adalimumab group

Patients receive adalimumab (Humira) at an induction dose of 160/80 mg (week 0 and 2) and at a maintenance dose of 40 mg every other week. The efficacy of the drug will be assessed.

Ustekinumab group

Patients receive ustekinumab (Stelara) through intravenous infusion with a weight based dose for treatment induction, followed by a subcutaneous dose injection with a fixed dose (90 mg) for maintenance every 8 weeks. The efficacy of the drug will be assessed.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A comparative, prospective, observational cohort study will be conducted. Patients will be selected according to the inclusion and the exclusion criteria. Patient's clinical data will include: age, sex, surgical history and associated comorbidities. The patients will be divided into two groups: Group 1 is adalimumab group Group 2 is ustekinumab group The follow up duration will be six months for each patient. Follow up duration: six months. Parameters will be monitored in both groups during the study period as: C-reactive protein (CRP) , complete blood count (CBC) and clinical scores.

You may qualify if:

• Age:18 year old or more.
• Gender: both male and female patients.
• Patients with IBD diagnosis established by clinical, laboratory and endoscopic findings.
• Moderate to severe inflammatory bowel disease patients.

You may not qualify if:

• Age less than 18 years.
• Malignancy.
• Pregnant women.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Faculty of pharmacy-Helwan University

Cairo, 11795, Egypt

Location

Related Publications (12)

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  PMID: 17499605 BACKGROUND

• GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30. doi: 10.1016/S2468-1253(19)30333-4. Epub 2019 Oct 21.

  PMID: 31648971 BACKGROUND

• Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.

  PMID: 22001864 BACKGROUND

• Langholz E. Current trends in inflammatory bowel disease: the natural history. Therap Adv Gastroenterol. 2010 Mar;3(2):77-86. doi: 10.1177/1756283X10361304.

  PMID: 21180592 BACKGROUND

• Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.

  PMID: 24415861 BACKGROUND

• Amezaga AJ, Van Assche G. Practical Approaches to "Top-Down" Therapies for Crohn's Disease. Curr Gastroenterol Rep. 2016 Jul;18(7):35. doi: 10.1007/s11894-016-0507-z.

  PMID: 27184044 BACKGROUND

• Pithadia AB, Jain S. Treatment of inflammatory bowel disease (IBD). Pharmacol Rep. 2011;63(3):629-42. doi: 10.1016/s1734-1140(11)70575-8.

  PMID: 21857074 BACKGROUND

• Hinojosa J, Munoz F, Martinez-Romero GJ. Relationship between Serum Adalimumab Levels and Clinical Outcome in the Treatment of Inflammatory Bowel Disease. Dig Dis. 2019;37(6):444-450. doi: 10.1159/000499870. Epub 2019 Apr 30.

  PMID: 31039560 BACKGROUND

• Guidi L, Pugliese D, Armuzzi A. Update on the management of inflammatory bowel disease: specific role of adalimumab. Clin Exp Gastroenterol. 2011;4:163-72. doi: 10.2147/CEG.S14558. Epub 2011 Jul 15.

  PMID: 21904462 BACKGROUND

• Restellini S, Afif W. Update on TDM (Therapeutic Drug Monitoring) with Ustekinumab, Vedolizumab and Tofacitinib in Inflammatory Bowel Disease. J Clin Med. 2021 Mar 17;10(6):1242. doi: 10.3390/jcm10061242.

  PMID: 33802816 BACKGROUND

• Ahmed Z, Venkata K, Zhang N, Malik TA. Comparative Effectiveness of Ustekinumab Versus Adalimumab in Induction of Clinical Response and Remission in Crohn's Disease: Experience of a Real-World Cohort at a Tertiary Care Inflammatory Bowel Disease Referral Center. Gastroenterology Res. 2019 Oct;12(5):245-251. doi: 10.14740/gr1194. Epub 2019 Oct 4.

  PMID: 31636774 BACKGROUND

• Ochsenkuhn T, Tillack C, Szokodi D, Janelidze S, Schnitzler F. Clinical outcomes with ustekinumab as rescue treatment in therapy-refractory or therapy-intolerant ulcerative colitis. United European Gastroenterol J. 2020 Feb;8(1):91-98. doi: 10.1177/2050640619895361. Epub 2019 Dec 12.

  PMID: 32213052 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at pharmacy practice department, Faculty of Pharmacy

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: February 9, 2023
• Study Start: July 15, 2021
• Primary Completion: January 11, 2023
• Study Completion: January 20, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

EG (1)