IBDNCT05720221
Biologics in Management of Inflammatory Bowel Disease in Egyptian Patients
An observational study of IBD, run by Helwan University at 1 site in Egypt.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBD
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2021to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Age less than 18 years.
- Malignancy.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adalimumab Versus Ustekinumab in Management of Inflammatory Bowel Disease in Egyptian Patients
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.
Read the detailed description
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. There has been a global rise in the incidence of IBD over the last few decades, in 2017; there were 6.8 million cases of IBD globally. The age-standardized prevalence rate increased from 79.5 per 100, 000 population in 1990 to 84.3 per 100, 000 population in 2017. The annual incidence of Crohn's disease is 5.0 per 100,000 person-years in Asia and the Middle East, whereas incidence rates of ulcerative colitis are 6.3 per 100,000 person-years in Asia and the Middle East. The male-to-female ratio is approximately 1:1 for ulcerative colitis and Crohn's disease, with females having a slightly greater incidence. Both diseases are most commonly diagnosed in young adults (i.e., late adolescence to the third decade of life). Although the etiology of IBD remains largely unknown, it involves a complex interaction between the genetic, environmental or microbial factors and the immune responses. The symptoms of IBD include: diarrhea (often loose and watery with Crohn's disease or bloody with ulcerative colitis), severe or chronic cramping pain in the abdomen, loss of appetite leading to weight loss, fatigue, fever, rectal bleeding, joint pain and skin problems, such as rashes. 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, the optimization of older therapies, including rugs such as immunomodulators and 5-aminosalicylic acid (5-ASA), and a better understanding of the mucosal immune system and the genetics involved in the pathogenesis of IBD.
Adalimumab (ADA) is a monoclonal immunoglobulin G1 antibody that binds with high affinity and specificity to human TNF. ADA is an anti-TNF agent that has been shown to be effective in inducing and maintaining remission in patients with IBD 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 adalimumab as a second-line therapy has also been documented for patients with loss of response or intolerance to infliximab. Ustekinumab, the monoclonal antibody to the p40 subunit of interleukin IL-12 and IL-23, has been approved in 2016 for the use in patients with moderate to severe active Crohn's disease (CD) and it was approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe ulcerative colitis in October 2019. The administration of ustekinumab for induction is intravenous and weight-based followed by a subcutaneous dose injection with a fixed dose (90 mg) for maintenance.
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: Baseline to four months.
Secondary outcomes (1)
Percentage of patients achieving the clinical remission after 4 months from baseline
Percentage of patients achieving the clinical remission that defined as Harvey Bradshaw Index (HBI) < 5 points (in chrons disease patients) and Partial mayo score (PMS) < 2 points (in ulcerative colitis patients).
Measured: Baseline to six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start15 Jul 2021
- Primary completion11 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Magdy El-sayed El-yamany, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720221
- Sponsor's protocol ID
- Biologics in IBD
- Status last verified
- Feb 2023
- First submitted
- 2 Dec 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.
PubMed 17499605GBD 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.
PubMed 31648971Molodecky 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.
PubMed 22001864Langholz E. Current trends in inflammatory bowel disease: the natural history. Ther Adv Gastroenterol. 2010 Mar;3(2):77-86. doi: 10.1177/1756283X10361304.
PubMed 21180592Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.
PubMed 24415861Amezaga 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.
PubMed 27184044Pithadia AB, Jain S. Treatment of inflammatory bowel disease (IBD). Pharmacol Rep. 2011;63(3):629-42. doi: 10.1016/s1734-1140(11)70575-8.
PubMed 21857074Hinojosa 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.
PubMed 31039560Guidi 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.
PubMed 21904462Restellini 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.
PubMed 33802816Ahmed 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.
PubMed 31636774Ochsenkuhn 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.
PubMed 32213052
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adalimumab Versus Ustekinumab in Management of Inflammatory Bowel Disease in Egyptian Patients
- ClinicalTrials.gov ID
- NCT05720221
- Acronym / sponsor ID
- Biologics in IBD
- Conditions
- IBD
- Keywords
- Ustekinumab, Adalimumab, IBD, Stelara, Humira
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. There has been a global rise in the incidence of IBD over the last few decades, in 2017; there were 6.8 million cases of IBD globally. The age-standardized prevalence rate increased from 79.5 per 100, 000 population in 1990 to 84.3 per 100, 000 population in 2017. The annual incidence of Crohn's disease is 5.0 per 100,000 person-years in Asia and the Middle East, whereas incidence rates of ulcerative colitis are 6.3 per 100,000 person-years in Asia and the Middle East. The male-to-female ratio is approximately 1:1 for ulcerative colitis and Crohn's disease, with females having a slightly greater incidence. Both diseases are most commonly diagnosed in young adults (i.e., late adolescence to the third decade of life). Although the etiology of IBD remains largely unknown, it involves a complex interaction between the genetic, environmental or microbial factors and the immune responses. The symptoms of IBD include: diarrhea (often loose and watery with Crohn's disease or bloody with ulcerative colitis), severe or chronic cramping pain in the abdomen, loss of appetite leading to weight loss, fatigue, fever, rectal bleeding, joint pain and skin problems, such as rashes. 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, the optimization of older therapies, including rugs such as immunomodulators and 5-aminosalicylic acid (5-ASA), and a better understanding of the mucosal immune system and the genetics involved in the pathogenesis of IBD.
Adalimumab (ADA) is a monoclonal immunoglobulin G1 antibody that binds with high affinity and specificity to human TNF. ADA is an anti-TNF agent that has been shown to be effective in inducing and maintaining remission in patients with IBD 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 adalimumab as a second-line therapy has also been documented for patients with loss of response or intolerance to infliximab. Ustekinumab, the monoclonal antibody to the p40 subunit of interleukin IL-12 and IL-23, has been approved in 2016 for the use in patients with moderate to severe active Crohn's disease (CD) and it was approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe ulcerative colitis in October 2019. The administration of ustekinumab for induction is intravenous and weight-based followed by a subcutaneous dose injection with a fixed dose (90 mg) for maintenance.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Age less than 18 years.
- Malignancy.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients achieving the clinical response after 4 months from baseline
Time frame: Baseline to four months.
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]
1 secondary outcome
Percentage of patients achieving the clinical remission after 4 months from baseline
Time frame: Baseline to six months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Background: PubMed 17499605Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.
- Background: PubMed 31648971GBD 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.
- Background: PubMed 22001864Molodecky 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.
- Background: PubMed 21180592Langholz E. Current trends in inflammatory bowel disease: the natural history. Ther Adv Gastroenterol. 2010 Mar;3(2):77-86. doi: 10.1177/1756283X10361304.
- Background: PubMed 24415861Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.
- Background: PubMed 27184044Amezaga 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.
- Background: PubMed 21857074Pithadia AB, Jain S. Treatment of inflammatory bowel disease (IBD). Pharmacol Rep. 2011;63(3):629-42. doi: 10.1016/s1734-1140(11)70575-8.
- Background: PubMed 31039560Hinojosa 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.
- Background: PubMed 21904462Guidi 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.
- Background: PubMed 33802816Restellini 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.
- Background: PubMed 31636774Ahmed 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.
- Background: PubMed 32213052Ochsenkuhn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, run by Helwan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving the clinical response after 4 months from baseline (time frame: Baseline to four months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05720221, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.