Inflammatory Bowel DiseasesNCT05291039
Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.
A study testing Infliximab and Adalimumab in people with Inflammatory Bowel Diseases, run by Rehab Werida at 1 site in Egypt.
Trial summary
This study aims to assess trough, TREM-1 levels and efficacy of IFX and ADA in IBD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Infliximab and Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Apr 2023
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients between 18 years and 80 years.
- Patients having moderate to severe IBD according to European Crohn's and colitis organization (ECCO) guidelines.
- IBD patients receiving either IFX or ADA.
Who cannot join
- Patients missed one-year follow-up or with missed data.
- Patients having mild IBD according to ECCO guidelines.
- Patients having any of the Contraindications to the biological Therapy e.g.: latent TB, viral or fungal or bacterial infection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tropical Medicine department, Ain Shams University Hospitals.
Cairo, 31527
About this study
Official title: Assessment of Trough Levels and Efficacy of Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.
This study aims to assess trough, TREM-1 levels and efficacy of IFX and ADA in IBD patients.
Read the detailed description
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University 2. All participants agree to take part in this clinical study, will agree to provide an informed written consent 3. Patients will be divided into 2 treatment groups [group 1 (n=20): patients will receive IFX], [group 2 (n=20): patients will receive ADA]. 4. Statistical tests appropriate to the study will be conducted to evaluate significance of results 5. Results, conclusion, discussion and recommendations will be given
- Type of Study: prospective study for IBD patients receiving either adalimumab or infliximab.
- Study Setting: The Inflammatory Bowel disease outpatient clinic, Tropical Medicine department, Ain Shams University Hospitals.
- Sample Size: Study will be conducted on 40 patients with Inflammatory Bowel Disease (IBD).
- Study procedure
- Laboratory investigations
- At baseline, all patients will be subjected to i. full history taking regarding: Loss of appetite, abdominal pain, number of motions, bleeding per rectum, number of attacks per year, need for hospitalization per year, Loss of weight, extra intestinal manifestations, anemic manifestations, drug history, ii. Testing the viral markers (HCV Ab, HBs Ag, HB core IgG, HIV) and Tuberculine test or Quantifferon test. (To Exclude latent TB) b) At Baseline and in follow ups, patient will be assessed for the following laboratory investigations: i. Complete blood count (CBC). ii. Liver profile (albumin, INR, total \& direct bilirubin, AST, ALT) iii. Kidney function tests e.g BUN and creatinine. iv. Inflammatory Markers (C-reactive protein (CRP), estimated sedimentation Ratio (ESR)).
- Stool analysis (WBC's, RBC's, Parasite) vi. Stool culture and sensitivity. vii. Urine analysis. c) Trough concentration of ADA and IFX will be assessed after reaching steady state levels.
- TREM-1 levels will be measured for all patients.
- Endoscopic intervention
- Colonoscopy with terminal ileoscopy with assessment according to Mayo score (loss of vascular pattern, presence of polyps, opacity of mucosa, bleeding on touch, excess exudates, diffuse ulceration, masses, pseudo polyps, site of involvement, linear ulcers, cobblestone appearance, conclusion)
- Histopathological examination: (aggregates of PMN's, cryptitis, infiltration of lamina propria, granuloma, depletion of goblet cells, thickened muscularis mucosa, dysplasia \& it's degree, malignancy)
Efficacy and safety Assessments
- Target response will be measured according to mucosal healing, ESR and CRP then patients will be reassessed by ECCO guidelines.
- Safety of drugs will be assessed by the monthly follow up of CBC, Liver functions and kidney functions.
- Patients will be asked for the occurrence of any sides in the monthly follow up visits.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Infliximab, Adalimumab
- Keywords
- Infliximab, Adalimumab
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called IFX
group 1 (n=20): patients will receive IFX
AdalimumabDrug
Also called ADA
group 2 (n=20): patients will receive ADA
| Study group | Role | What they receive |
|---|---|---|
| Infliximab. | Active comparator | group 1 (n=20): patients will receive IFX, Receives: Drug: Infliximab |
| Adalimumab. | Active comparator | group 2 (n=20): patients will receive ADA Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough concentration of ADA and IFX will be assessed after reaching steady state levels.
Blood Level
Measured: 1 month
myeloid cells 1 (TREM1) levels
predictive biomarker
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Jan 2022
- Primary completion30 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective study for IBD patients receiving either adalimumab (group 1) or infliximab (group 2).
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehab Werida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass Prof., Principal investigator, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291039
- Sponsor's protocol ID
- Infliximab & Adalimumab in IBD
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seyedian SS, Nokhostin F, Malamir MD. A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease. J Med Life. 2019 Apr-Jun;12(2):113-122. doi: 10.25122/jml-2018-0075.
PubMed 31406511Fluxa, D. and M.T. Abreu, Therapeutic targets in inflammatory bowel disease. Revista Médica Clínica Las Condes, 2019. 30(4): p. 315-322.
Shivaji UN, Sharratt CL, Thomas T, Smith SCL, Iacucci M, Moran GW, Ghosh S, Bhala N. Review article: managing the adverse events caused by anti-TNF therapy in inflammatory bowel disease. Aliment Pharmacol Ther. 2019 Mar;49(6):664-680. doi: 10.1111/apt.15097. Epub 2019 Feb 8.
PubMed 30735257Kamal ME, Werida RH, Radwan MA, Askar SR, Omran GA, El-Mohamdy MA, Hagag RS. Efficacy and safety of infliximab and adalimumab in inflammatory bowel disease patients. Inflammopharmacology. 2024 Oct;32(5):3259-3269. doi: 10.1007/s10787-024-01508-w. Epub 2024 Jul 10.
PubMed 38985232
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Trough Levels and Efficacy of Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.
- ClinicalTrials.gov ID
- NCT05291039
- Acronym / sponsor ID
- Infliximab & Adalimumab in IBD
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Infliximab, Adalimumab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Rehab WeridaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 22 Mar 2022 (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.
This study aims to assess trough, TREM-1 levels and efficacy of IFX and ADA in IBD patients.
Detailed description
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University 2. All participants agree to take part in this clinical study, will agree to provide an informed written consent 3. Patients will be divided into 2 treatment groups [group 1 (n=20): patients will receive IFX], [group 2 (n=20): patients will receive ADA]. 4. Statistical tests appropriate to the study will be conducted to evaluate significance of results 5. Results, conclusion, discussion and recommendations will be given
- Type of Study: prospective study for IBD patients receiving either adalimumab or infliximab.
- Study Setting: The Inflammatory Bowel disease outpatient clinic, Tropical Medicine department, Ain Shams University Hospitals.
- Sample Size: Study will be conducted on 40 patients with Inflammatory Bowel Disease (IBD).
- Study procedure
- Laboratory investigations
- At baseline, all patients will be subjected to i. full history taking regarding: Loss of appetite, abdominal pain, number of motions, bleeding per rectum, number of attacks per year, need for hospitalization per year, Loss of weight, extra intestinal manifestations, anemic manifestations, drug history, ii. Testing the viral markers (HCV Ab, HBs Ag, HB core IgG, HIV) and Tuberculine test or Quantifferon test. (To Exclude latent TB) b) At Baseline and in follow ups, patient will be assessed for the following laboratory investigations: i. Complete blood count (CBC). ii. Liver profile (albumin, INR, total \& direct bilirubin, AST, ALT) iii. Kidney function tests e.g BUN and creatinine. iv. Inflammatory Markers (C-reactive protein (CRP), estimated sedimentation Ratio (ESR)).
- Stool analysis (WBC's, RBC's, Parasite) vi. Stool culture and sensitivity. vii. Urine analysis. c) Trough concentration of ADA and IFX will be assessed after reaching steady state levels.
- TREM-1 levels will be measured for all patients.
- Endoscopic intervention
- Colonoscopy with terminal ileoscopy with assessment according to Mayo score (loss of vascular pattern, presence of polyps, opacity of mucosa, bleeding on touch, excess exudates, diffuse ulceration, masses, pseudo polyps, site of involvement, linear ulcers, cobblestone appearance, conclusion)
- Histopathological examination: (aggregates of PMN's, cryptitis, infiltration of lamina propria, granuloma, depletion of goblet cells, thickened muscularis mucosa, dysplasia \& it's degree, malignancy)
Efficacy and safety Assessments
- Target response will be measured according to mucosal healing, ESR and CRP then patients will be reassessed by ECCO guidelines.
- Safety of drugs will be assessed by the monthly follow up of CBC, Liver functions and kidney functions.
- Patients will be asked for the occurrence of any sides in the monthly follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective study for IBD patients receiving either adalimumab (group 1) or infliximab (group 2).
| Arm | Type | Receives |
|---|---|---|
| Infliximab. | Active comparator | Drug: Infliximabgroup 1 (n=20): patients will receive IFX, |
| Adalimumab. | Active comparator | Drug: Adalimumabgroup 2 (n=20): patients will receive ADA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients between 18 years and 80 years.
- Patients having moderate to severe IBD according to European Crohn's and colitis organization (ECCO) guidelines.
- IBD patients receiving either IFX or ADA.
Key exclusion criteria (3 listed)
- Patients missed one-year follow-up or with missed data.
- Patients having mild IBD according to ECCO guidelines.
- Patients having any of the Contraindications to the biological Therapy e.g.: latent TB, viral or fungal or bacterial infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabAlso: IFXgroup 1 (n=20): patients will receive IFX | Drug | Infliximab. |
| AdalimumabAlso: ADAgroup 2 (n=20): patients will receive ADA | Drug | Adalimumab. |
Primary outcome
Trough concentration of ADA and IFX will be assessed after reaching steady state levels.
Time frame: 1 month
Blood Level
myeloid cells 1 (TREM1) levels
Time frame: 1 month
predictive biomarker
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 28 Mar 2024.
- Background: PubMed 31406511Seyedian SS, Nokhostin F, Malamir MD. A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease. J Med Life. 2019 Apr-Jun;12(2):113-122. doi: 10.25122/jml-2018-0075.
- BackgroundFluxa, D. and M.T. Abreu, Therapeutic targets in inflammatory bowel disease. Revista Médica Clínica Las Condes, 2019. 30(4): p. 315-322.
- Background: PubMed 30735257Shivaji UN, Sharratt CL, Thomas T, Smith SCL, Iacucci M, Moran GW, Ghosh S, Bhala N. Review article: managing the adverse events caused by anti-TNF therapy in inflammatory bowel disease. Aliment Pharmacol Ther. 2019 Mar;49(6):664-680. doi: 10.1111/apt.15097. Epub 2019 Feb 8.
- Derived from this study: PubMed 38985232Kamal ME, Werida RH, Radwan MA, Askar SR, Omran GA, El-Mohamdy MA, Hagag RS. Efficacy and safety of infliximab and adalimumab in inflammatory bowel disease patients. Inflammopharmacology. 2024 Oct;32(5):3259-3269. doi: 10.1007/s10787-024-01508-w. Epub 2024 Jul 10.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
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.
Rehab H Werida, Ass Prof. principal investigator
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infliximab and Adalimumab in people with Inflammatory Bowel Diseases, run by Rehab Werida 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 3 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 28 Mar 2024. 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?
Trough concentration of ADA and IFX will be assessed after reaching steady state levels. (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT05291039, which also lists 4 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 28 Mar 2024.