NeutropeniaNCT07237906
Neutropenia With TNF-α Inhibitors
An observational study of Neutropenia and TNF-alpha Inhibitors, run by Burak Ugur Cetin at 1 site in Turkey (Türkiye).
Trial summary
Tumor necrosis factor-alpha (TNF-α) inhibitors, including infliximab, etanercept, adalimumab, certolizumab, and golimumab, have become cornerstone therapies in the management of rheumatologic disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenia, TNF-alpha Inhibitors
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inflammatory arthritis who were treated with TNF-α inhibitor therapy at the Physical Medicine and Rehabilitation Department of Istanbul University-Cerrahpasa, a tertiary care center in Istanbul, Turkey, between September 2023 and January 2025.
Who may be able to join
- Initiation of TNF-alpha inhibitor therapy at least once in our clinic between September 2023 and January 2025
- Age 18 years or older
- At least one complete blood count performed during the follow-up period
- Availability of complete clinical and laboratory data in the hospital's electronic medical records or patient files
Who cannot join
- History of other hematologic disorders that may contribute to the development of neutropenia (e.g., aplastic anemia, leukemia, myelodysplastic syndrome)
- Concurrent treatment with cytotoxic chemotherapy or immunosuppressive agents (e.g., azathioprine, cyclophosphamide)
- Insufficient follow-up duration or incomplete laboratory data that precluded adequate evaluation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa (IUC)
Istanbul, 34098
About this study
Official title: Neutropenia in Patients Treated With TNF-α Inhibitors: Frequency and Clinical Implications From a Retrospective Cohort
Tumor necrosis factor-alpha (TNF-α) inhibitors, including infliximab, etanercept, adalimumab, certolizumab, and golimumab, have become cornerstone therapies in the management of rheumatologic disorders. Although their efficacy and tolerability are well established, accumulating evidence indicates that these agents may also induce hematologic adverse events. The most frequently documented hematologic complication of TNF-α inhibitor therapy is neutropenia. Previous studies have reported neutropenia in approximately 10-19% of patients receiving TNF-α inhibitors.
Neutropenia is defined as a decrease in circulating neutrophils to an absolute neutrophil count (ANC) below 1500 cells/μL. Clinically, neutropenia is stratified according to the ANC as mild (1000-1500/μL), moderate (500-1000/μL), or severe (<500/μL). While mild neutropenia is frequently asymptomatic, severe neutropenia is associated with a substantially elevated risk of serious and potentially life-threatening infections .
Read more
The pathophysiological mechanisms underlying drug-induced neutropenia remain incompletely understood; however, proposed explanations include immune-mediated peripheral destruction of granulocytes, bone marrow suppression or impaired maturation of granulocyte precursors. Autoimmune pathways may also contribute, as evidenced by recurrence of neutropenia following drug rechallenge.
Neutropenia associated with TNF-α inhibitor therapy is typically mild; however, its development warrants careful clinical attention. Certain clinical risk factors have been identified. Identified risk factors include a previous history of neutropenia, prior neutropenia under disease-modifying antirheumatic drugs (DMARDs) therapy, and lower baseline neutrophil counts, each of which may predispose patients to subsequent neutropenia. Notably, most cases emerge within the first three months after treatment initiation. Although discontinuation is rarely required and serious infections are uncommon, the possibility of hematologic complications underscores the importance of close monitoring and routine hematologic assessments throughout therapy. Despite the growing recognition of TNF-α inhibitor-induced neutropenia, current data regarding its rate, clinical course, and impact on treatment outcomes remain limited, particularly in real-world patient populations. The present study aimed to determine the frequency of neutropenia in this population and to evaluate its clinical characteristics and impact on treatment outcomes.
- Conditions
- Neutropenia, TNF-alpha Inhibitors
- Keywords
- Adverse drug event, Arthritis, Neutropenia, Tumor necrosis factor-alpha inhibitors
- Medical subject headings
- Neutropenia, Drug-Related Side Effects and Adverse Reactions, Arthritis
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 |
|---|---|---|
| Patient Group | Patients receiving TNF-α inhibitor therapy for inflammatory arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neutropenia
Incidence of neutropenia in patients receiving TNF-α inhibitors
Measured: From initiation of TNF-α inhibitor therapy to 12 months of treatment
Secondary outcomes (1)
Severity of neutropenia
Clinically, neutropenia is stratified according to the ANC as mild (1000-1500/μL), moderate (500-1000/μL), or severe (<500/μL).
Measured: From initiation of TNF-α inhibitor therapy to 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Sep 2023
- Primary completion1 Jan 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burak Ugur Cetin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burak Ugur Cetin, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237906
- Sponsor's protocol ID
- IstanbulUC-BCetin-02
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a retrospective, single-center study based on patient records. Due to privacy concerns and institutional regulations, individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutropenia in Patients Treated With TNF-α Inhibitors: Frequency and Clinical Implications From a Retrospective Cohort
- ClinicalTrials.gov ID
- NCT07237906
- Acronym / sponsor ID
- IstanbulUC-BCetin-02
- Conditions
- Neutropenia, TNF-alpha Inhibitors
- Keywords
- Adverse drug event, Arthritis, Neutropenia, Tumor necrosis factor-alpha inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Burak Ugur CetinUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 20 Nov 2025 (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.
Tumor necrosis factor-alpha (TNF-α) inhibitors, including infliximab, etanercept, adalimumab, certolizumab, and golimumab, have become cornerstone therapies in the management of rheumatologic disorders. Although their efficacy and tolerability are well established, accumulating evidence indicates that these agents may also induce hematologic adverse events. The most frequently documented hematologic complication of TNF-α inhibitor therapy is neutropenia. Previous studies have reported neutropenia in approximately 10-19% of patients receiving TNF-α inhibitors.
Neutropenia is defined as a decrease in circulating neutrophils to an absolute neutrophil count (ANC) below 1500 cells/μL. Clinically, neutropenia is stratified according to the ANC as mild (1000-1500/μL), moderate (500-1000/μL), or severe (<500/μL). While mild neutropenia is frequently asymptomatic, severe neutropenia is associated with a substantially elevated risk of serious and potentially life-threatening infections .
The pathophysiological mechanisms underlying drug-induced neutropenia remain incompletely understood; however, proposed explanations include immune-mediated peripheral destruction of granulocytes, bone marrow suppression or impaired maturation of granulocyte precursors. Autoimmune pathways may also contribute, as evidenced by recurrence of neutropenia following drug rechallenge.
Neutropenia associated with TNF-α inhibitor therapy is typically mild; however, its development warrants careful clinical attention. Certain clinical risk factors have been identified. Identified risk factors include a previous history of neutropenia, prior neutropenia under disease-modifying antirheumatic drugs (DMARDs) therapy, and lower baseline neutrophil counts, each of which may predispose patients to subsequent neutropenia. Notably, most cases emerge within the first three months after treatment initiation. Although discontinuation is rarely required and serious infections are uncommon, the possibility of hematologic complications underscores the importance of close monitoring and routine hematologic assessments throughout therapy. Despite the growing recognition of TNF-α inhibitor-induced neutropenia, current data regarding its rate, clinical course, and impact on treatment outcomes remain limited, particularly in real-world patient populations. The present study aimed to determine the frequency of neutropenia in this population and to evaluate its clinical characteristics and impact on treatment outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | –Patients receiving TNF-α inhibitor therapy for inflammatory arthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory arthritis who were treated with TNF-α inhibitor therapy at the Physical Medicine and Rehabilitation Department of Istanbul University-Cerrahpasa, a tertiary care center in Istanbul, Turkey, between September 2023 and January 2025.
Key inclusion criteria (4 listed)
- Initiation of TNF-alpha inhibitor therapy at least once in our clinic between September 2023 and January 2025
- Age 18 years or older
- At least one complete blood count performed during the follow-up period
- Availability of complete clinical and laboratory data in the hospital's electronic medical records or patient files
Key exclusion criteria (3 listed)
- History of other hematologic disorders that may contribute to the development of neutropenia (e.g., aplastic anemia, leukemia, myelodysplastic syndrome)
- Concurrent treatment with cytotoxic chemotherapy or immunosuppressive agents (e.g., azathioprine, cyclophosphamide)
- Insufficient follow-up duration or incomplete laboratory data that precluded adequate evaluation
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
Incidence of neutropenia
Time frame: From initiation of TNF-α inhibitor therapy to 12 months of treatment
Incidence of neutropenia in patients receiving TNF-α inhibitors
1 secondary outcome
Severity of neutropenia
Time frame: From initiation of TNF-α inhibitor therapy to 12 months of treatment
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 20 Nov 2025.
- Individual participant dataSharing planned: No. This is a retrospective, single-center study based on patient records. Due to privacy concerns and institutional regulations, individual participant data will not be shared.
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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 Neutropenia and TNF-alpha Inhibitors, run by Burak Ugur Cetin at 1 site in Turkey (Türkiye).
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 20 Nov 2025. 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 Turkey (Türkiye). 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?
Incidence of neutropenia (time frame: From initiation of TNF-α inhibitor therapy to 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.