Pancreatitis, ChronicPhase 2TOPACNCT06426160
Tocilizumab for Painful Chronic Pancreatitis
A Phase 2 study testing Tocilizumab 20 MG/ML [Actemra] and Sodium Chloride 0.9% Inj in people with Pancreatitis, Chronic, run by Soren Schou Olesen at 1 site in Denmark.
Trial summary
This placebo-controlled study will investigate the effect of tocilizumab (an anti-interleukin-6 receptor antibody) on symptom burden, physical functioning, and quality of life in patients with chronic pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Chronic
- What is being tested?
- Tocilizumab 20 MG/ML [Actemra] and Sodium Chloride 0.9% Inj
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 21 May 2024to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Signed informed consent.
- Probable or definitive diagnosis of CP according to the M-ANNHEIM criteria. This entails a typical clinical history of CP, including recurrent pancreatitis or abdominal pain in combination with the following additional criteria:
- A definitive diagnosis of CP is established by one or more of the following additional criteria:
- i) Pancreatic calcification
- ii) Moderate or marked ductal lesions (according to the Cambridge classification)
- iii) Exocrine pancreatic insufficiency, defined as pancreatic steatorrhea markedly reduced by enzyme supplementation
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- iv) Histological verification of CP
- A probable diagnosis of CP is established by one or more of the following additional criteria:
- i) Mild ductal alterations (according to the Cambridge classification)
- ii) Recurrent or persistent pseudocysts
- iii) Pathological test of pancreatic exocrine function (such as faecal elastase-1 test, secretin test, secretin-pancreozymin test)
- iv) Diabetes mellitus
- Abdominal pain of presumed pancreatic origin (i.e., upper abdominal pain radiating to the back).
- Evidence of ongoing pancreatic inflammatory activity, with an inflammatory pancreatic flare occurring one or more times within the past six months. An inflammatory pancreatic flare is defined as an exacerbation of pancreatic pain in combination with one or more of the following criteria:
- i) Plasma amylase levels elevated 2-fold or more than the participant's usual amylase level.
- ii) Elevated plasma levels of CRP 2-fold the upper normal level without suspicion of other sources such as infection.
- iii) Signs of pancreatic inflammation on cross-sectional imaging.
- ≥ 18 years of age
- The participant must be able to read and understand the informed consent forms.
- The participant is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures.
Who cannot join
- End-stage CP indicated by severe pancreatic atrophy defined as segmented pancreas volume <20 ml on the latest available cross-sectional imaging examination (Computed Tomography (CT) or MRI).
- Pancreatic duct obstruction by a stricture and/or stone amendable to endoscopic or surgical treatment. Patients with previous pancreatic duct decompression procedures are allowed to participate.
- Ongoing alcohol or substance abuse. The patient must document abstinence from alcohol and substance abuse for the preceding six months prior to study enrolment. Recreational alcohol consumption within the safety limits recommended by the National Danish Health Authorities (i.e., max. ten units of alcohol per week) is allowed.
- Active or recurrent infections.
- Untreated ulcers in the gastrointestinal tract (however, those who have undergone proper treatment and one month has elapsed with no recurrence of symptoms will not be excluded).
- Known hypersensitivity to Tocilizumab.
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- Positive test for Tuberculosis during screening
- Positive test for Hepatitis during screening
- Severe liver disease, indicated by ALT with >5 upper normal limits.
- Thrombocytopenia (platelet count < 50 x 109/L).
- Neutropenia (neutrophil count <2 x 109/L).
- Pregnancy and no contraception use, fertile women (<55 years) must provide a urine sample for pregnancy test upon inclusion.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre for Pancreatic Diseases and Mech-Sense research laboratory, Aalborg University Hospital
Aalborg, North Denmark, 9000
About this study
Official title: Tocilizumab for Painful Chronic Pancreatitis: A Randomised, Placebo-Controlled, Double-blinded, Investigator Initiated Trial (TOPAC Trial)
This placebo-controlled study will investigate the effect of tocilizumab (an anti-interleukin-6 receptor antibody) on symptom burden, physical functioning, and quality of life in patients with chronic pancreatitis.
Read the detailed description
Recent independent research has emphasized the crucial role of immune cell infiltration and its interaction with pancreatic stellate cells in driving the inflammatory process and fibrogenesis in chronic pancreatitis (CP). The cytokine Interleukin 6 (IL-6) has been identified as a key mediator in this process, and preclinical studies have indicated that inhibiting IL-6 signaling can lead to favorable therapeutic outcomes. Consequently, targeting IL-6 signaling therapeutically holds great promise as a disease-modifying treatment for CP.
Until now, there have been no placebo-controlled trials in humans to test immune-modulating treatments for CP. However, there have been some promising results in preclinical studies. For example, administering an anti-IL-6 receptor antibody to an animal model of CP reduced pancreatitis-related pain, indicating a potential therapeutic effect. Blocking IL-6 signaling in an in-silico model of CP was also shown to have disease-modifying effects. Recent anecdotal evidence indicates that using tocilizumab to treat patients with COVID-19 and concomitant pancreatitis can decrease inflammation and pain in the pancreas. Additionally, blocking IL-6 signaling has been demonstrated to have anti-fibrotic effects in patients with systemic sclerosis. Taken together, these findings suggest that targeting IL-6 signaling could be a promising approach for reducing inflammation and fibrogenesis in CP. Tocilizumab (RoActemra) is an anti-IL-6 receptor antibody currently used to treat several inflammatory diseases.
Objectives:
The investigators hypothesize that treatment with tocilizumab, compared with a placebo, will reduce symptom burden (CP-related pain) and improve physical functioning and quality of life in patients with CP. In addition, the investigators hypothesize that the clinical effects will be linked to a decrease in pancreatic inflammation and fibrosis as well as systemic inflammation. The investigators also hypothesize that the pain-relieving effect of tocilizumab will lead to the normalization of pain processing in CP patients. To test these hypotheses, the project is organized into four sub-studies.
Sub-study 1 (main study - randomized placebo-controlled trial): The objective of sub-study 1 is to conduct an investigator-initiated phase 2b double-blinded, placebo-controlled, randomized clinical trial to investigate the clinical effect of tocilizumab on patient-reported outcomes.
Sub-study 2 (inflammatory biomarkers): The objective of sub-study 2 is to investigate the effects of tocilizumab on systemic inflammation using blood-based immune and fibrosis markers.
Sub-study 3 (quantitative imaging biomarkers): The objective of sub-study 3 is to investigate the effect of tocilizumab on pancreatic inflammation and fibrosis using Magnetic Resonance Imaging (MRI) of the pancreas.
Sub-study 4 (pain processing): The objective of sub-study 4 is to investigate the effect of tocilizumab on pain processing using Pancreatic Quantitative Sensory Testing (P-QST) and electrophysiological methods (EEG and ECG).
- Conditions
- Pancreatitis, Chronic
- Being tested
- Tocilizumab 20 MG/ML [Actemra], Sodium Chloride 0.9% Inj
- Keywords
- Inflammation, Pancreatic diseases, Digestive System Diseases
- Medical subject headings
- Pancreatitis, Chronic, Inflammation, Pancreatic Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab 20 MG/ML [Actemra]Drug
Also called RoActemra, Actemra
Tocilizumab 8 mg/kg every four weeks for 24 weeks.
Sodium Chloride 0.9% InjDrug
Also called Natriumchloride 0.9 % Inj
Placebo (Sodium chloride) every four weeks for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Active comparator | 8 mg / kg Tocilizumab will be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %) Receives: Drug: Tocilizumab 20 MG/ML [Actemra] |
| Placebo | Placebo comparator | 100 ml sodium chloride 9 mg/mL (0.9 %). Receives: Drug: Sodium Chloride 0.9% Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) Questionnaire
The between-group difference (tocilizumab vs. placebo) of the change from baseline in the COMPAT-SF score at 24 weeks. The COMPAT-SF score is noramlized on a 0-100 score. Higher scores indicate a higher degree of pain.
Measured: The intervention period is 24 weeks (assessed every 4 weeks from baseline to finalization)
Secondary outcomes (17)
Global Quality of Life Score (EORTC-QLQ-C30)
The between-group difference in the Global Quality of Life Score from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ-C30) questionnaire at 24 weeks. The global quality of life score range from 0 to 100. A high score on the Global Quality of Life score represents a high level of life quality.
Measured: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Physical Functional Score (EORTC-QLQ-C30)
The between-group difference in Physical Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The physical functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning.
Measured: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Role Functional Score (EORTC-QLQ-C30)
The between-group difference in Role Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The role functional score ranges from 0 to 100 A high score on the functional scales represents a high level of daily functioning.
Measured: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Cognitive Functional Score (EORTC-QLQ-C30)
The between-group difference in Cognitive Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The cognitive functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning.
Measured: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Emotional Functional Score (EORTC-QLQ-C30)
The between-group difference in Emotional Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The emotional functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning.
Measured: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Social Functional Score (EORTC-QLQ-C30)
The between-group difference in Social Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The social functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning.
Measured: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Symptom Burden Score (EORTC-QLQ-C30)
The between-group difference in Symptom Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The symptom burden score ranges from 0 to 100. A high score for the symptom items represents a high level of symptomatology.
Measured: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Pain severity Score (modified BPI)
The between-group difference in Pain severity score from baseline in the modified Brief Pain Inventory at 24 weeks. The pain severity score is rated on a visual analogue scale (VAS), 0 = no pain, 10 = worst pain imaginable), based on four pain severity items. Higher scores reflect more severe pain.
Measured: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Pain Interference Score (modified BPI)
The between-group difference in Pain Interference score from baseline in the modified Brief Pain Inventory at 24 weeks. The pain interference score is rated on a VAS, 0 = no pain, 10 = worst pain imaginable, based on seven pain interference items. Higher scores reflect more pain interference with daily life.
Measured: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Average Daily Pain Score (modified BPI)
The between-group difference in Average Daily Pain score from baseline in the modified Brief Pain Inventory at 24 weeks. The average daily pain score ranges is rated on a VAS-scale, 0-10, 0 = no pain, and 10 = worst pain imaginable.
Measured: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Patient's Global Impression of Change (PGIC) Questionnaire
The between-group difference in the PGIC questionnaire, a self-reporting seven-point rating scale (points from 1-7) on how the participant experiences treatment change from baseline at 24 weeks. Higher score corresponds to improvement.
Measured: The intervention period is 24 weeks (assessed at week 24)
CP Prognosis Score
The between-group difference in the CP prognosis score from baseline at 24 weeks. The CP prognosis score ranges from 5-15 points. Higher scores indicates higher risk of readmission to hospital.
Measured: The intervention period is 24 weeks (assessed at weeks 0 and 24)
Number of patient using prescription opioids for pain control
Opioid use (yes, no, binary answer) continuously through the entire study
Measured: The intervention period is 24 weeks (continuously throughout the entire study)
Daily opioid dose for patients using prescription opiods
The between and within-group difference of opioid dose (continuous variable in mg of moprhine equivalent) in patients, from baseline at 24 weeks.
Measured: The intervention period is 24 weeks (continuously throughout the entire study)
Number of patient using weak analgesics for pain control
Weak analgesic use (yes, no, binary answer) continuously through the entire study
Measured: The intervention period is 24 weeks (continuously throughout the entire study)
Daily weak analgesics dose for patients
The between and within-group difference of weak analgesic dose (continuous variable in mg) in patients, from baseline at 24 weeks.
Measured: The intervention period is 24 weeks (continuously throughout the entire study)
Frequency of adverse events (Patient Diary)
The frequency of adverse events from baseline at 24 weeks.
Measured: The intervention period is 24 weeks (continuously throughout the entire study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start21 May 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, ChronicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, placebo-controlled, double-blinded investigator-initiated trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soren Schou Olesen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus, Viborg Regional Hospital, Stanford University, Haukeland University Hospital
- Responsible party
- Sponsor-investigator, Soren Schou Olesen, Aalborg University Hospital
- Investigators
- Søren S Olesen, MD, Ph.D., Principal investigator, Mech-Sense, Department of Gastroenterology, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426160
- Sponsor's protocol ID
- F2024-054
- Other IDs
- 2023-510084-35-00, 2023
- Acronym
- TOPAC
- Status last verified
- Sep 2025
- First submitted
- 14 May 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to the data is available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocilizumab for Painful Chronic Pancreatitis: A Randomised, Placebo-Controlled, Double-blinded, Investigator Initiated Trial (TOPAC Trial)
- ClinicalTrials.gov ID
- NCT06426160
- Acronym / sponsor ID
- TOPAC / F2024-054
- Conditions
- Pancreatitis, Chronic
- Keywords
- Inflammation, Pancreatic diseases, Digestive System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Soren Schou OlesenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus, Viborg Regional Hospital, Stanford University, Haukeland University Hospital
- Study start
- 21 May 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 May 2024 (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 placebo-controlled study will investigate the effect of tocilizumab (an anti-interleukin-6 receptor antibody) on symptom burden, physical functioning, and quality of life in patients with chronic pancreatitis.
Detailed description
Recent independent research has emphasized the crucial role of immune cell infiltration and its interaction with pancreatic stellate cells in driving the inflammatory process and fibrogenesis in chronic pancreatitis (CP). The cytokine Interleukin 6 (IL-6) has been identified as a key mediator in this process, and preclinical studies have indicated that inhibiting IL-6 signaling can lead to favorable therapeutic outcomes. Consequently, targeting IL-6 signaling therapeutically holds great promise as a disease-modifying treatment for CP.
Until now, there have been no placebo-controlled trials in humans to test immune-modulating treatments for CP. However, there have been some promising results in preclinical studies. For example, administering an anti-IL-6 receptor antibody to an animal model of CP reduced pancreatitis-related pain, indicating a potential therapeutic effect. Blocking IL-6 signaling in an in-silico model of CP was also shown to have disease-modifying effects. Recent anecdotal evidence indicates that using tocilizumab to treat patients with COVID-19 and concomitant pancreatitis can decrease inflammation and pain in the pancreas. Additionally, blocking IL-6 signaling has been demonstrated to have anti-fibrotic effects in patients with systemic sclerosis. Taken together, these findings suggest that targeting IL-6 signaling could be a promising approach for reducing inflammation and fibrogenesis in CP. Tocilizumab (RoActemra) is an anti-IL-6 receptor antibody currently used to treat several inflammatory diseases.
Objectives:
The investigators hypothesize that treatment with tocilizumab, compared with a placebo, will reduce symptom burden (CP-related pain) and improve physical functioning and quality of life in patients with CP. In addition, the investigators hypothesize that the clinical effects will be linked to a decrease in pancreatic inflammation and fibrosis as well as systemic inflammation. The investigators also hypothesize that the pain-relieving effect of tocilizumab will lead to the normalization of pain processing in CP patients. To test these hypotheses, the project is organized into four sub-studies.
Sub-study 1 (main study - randomized placebo-controlled trial): The objective of sub-study 1 is to conduct an investigator-initiated phase 2b double-blinded, placebo-controlled, randomized clinical trial to investigate the clinical effect of tocilizumab on patient-reported outcomes.
Sub-study 2 (inflammatory biomarkers): The objective of sub-study 2 is to investigate the effects of tocilizumab on systemic inflammation using blood-based immune and fibrosis markers.
Sub-study 3 (quantitative imaging biomarkers): The objective of sub-study 3 is to investigate the effect of tocilizumab on pancreatic inflammation and fibrosis using Magnetic Resonance Imaging (MRI) of the pancreas.
Sub-study 4 (pain processing): The objective of sub-study 4 is to investigate the effect of tocilizumab on pain processing using Pancreatic Quantitative Sensory Testing (P-QST) and electrophysiological methods (EEG and ECG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised, placebo-controlled, double-blinded investigator-initiated trial
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Active comparator | Drug: Tocilizumab 20 MG/ML [Actemra]8 mg / kg Tocilizumab will be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %) |
| Placebo | Placebo comparator | Drug: Sodium Chloride 0.9% Inj100 ml sodium chloride 9 mg/mL (0.9 %). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed informed consent.
- Probable or definitive diagnosis of CP according to the M-ANNHEIM criteria. This entails a typical clinical history of CP, including recurrent pancreatitis or abdominal pain in combination with the following additional criteria:
- A definitive diagnosis of CP is established by one or more of the following additional criteria:
- i) Pancreatic calcification
- ii) Moderate or marked ductal lesions (according to the Cambridge classification)
Key exclusion criteria (12 listed)
- End-stage CP indicated by severe pancreatic atrophy defined as segmented pancreas volume <20 ml on the latest available cross-sectional imaging examination (Computed Tomography (CT) or MRI).
- Pancreatic duct obstruction by a stricture and/or stone amendable to endoscopic or surgical treatment. Patients with previous pancreatic duct decompression procedures are allowed to participate.
- Ongoing alcohol or substance abuse. The patient must document abstinence from alcohol and substance abuse for the preceding six months prior to study enrolment. Recreational alcohol consumption within the safety limits recommended by the National Danish Health Authorities (i.e., max. ten units of alcohol per week) is allowed.
- Active or recurrent infections.
- Untreated ulcers in the gastrointestinal tract (however, those who have undergone proper treatment and one month has elapsed with no recurrence of symptoms will not be excluded).
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 |
|---|---|---|
| Tocilizumab 20 MG/ML [Actemra]Also: RoActemra, ActemraTocilizumab 8 mg/kg every four weeks for 24 weeks. | Drug | Tocilizumab |
| Sodium Chloride 0.9% InjAlso: Natriumchloride 0.9 % InjPlacebo (Sodium chloride) every four weeks for 24 weeks. | Drug | Placebo |
Primary outcome
The Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) Questionnaire
Time frame: The intervention period is 24 weeks (assessed every 4 weeks from baseline to finalization)
The between-group difference (tocilizumab vs. placebo) of the change from baseline in the COMPAT-SF score at 24 weeks. The COMPAT-SF score is noramlized on a 0-100 score. Higher scores indicate a higher degree of pain.
17 secondary outcomes
Global Quality of Life Score (EORTC-QLQ-C30)
Time frame: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Physical Functional Score (EORTC-QLQ-C30)
Time frame: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Role Functional Score (EORTC-QLQ-C30)
Time frame: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Cognitive Functional Score (EORTC-QLQ-C30)
Time frame: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Emotional Functional Score (EORTC-QLQ-C30)
Time frame: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Social Functional Score (EORTC-QLQ-C30)
Time frame: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Symptom Burden Score (EORTC-QLQ-C30)
Time frame: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Pain severity Score (modified BPI)
Time frame: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Pain Interference Score (modified BPI)
Time frame: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Average Daily Pain Score (modified BPI)
Time frame: The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)
Patient's Global Impression of Change (PGIC) Questionnaire
Time frame: The intervention period is 24 weeks (assessed at week 24)
CP Prognosis Score
Time frame: The intervention period is 24 weeks (assessed at weeks 0 and 24)
Number of patient using prescription opioids for pain control
Time frame: The intervention period is 24 weeks (continuously throughout the entire study)
Daily opioid dose for patients using prescription opiods
Time frame: The intervention period is 24 weeks (continuously throughout the entire study)
Number of patient using weak analgesics for pain control
Time frame: The intervention period is 24 weeks (continuously throughout the entire study)
Daily weak analgesics dose for patients
Time frame: The intervention period is 24 weeks (continuously throughout the entire study)
Frequency of adverse events (Patient Diary)
Time frame: The intervention period is 24 weeks (continuously throughout the entire study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No. Access to the data is available upon reasonable request.
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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.
Søren S Olesen, MD, Ph.D. principal investigator
Mech-Sense, Department of Gastroenterology, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab 20 MG/ML [Actemra] and Sodium Chloride 0.9% Inj in people with Pancreatitis, Chronic, run by Soren Schou Olesen at 1 site in Denmark.
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 20 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) Questionnaire (time frame: The intervention period is 24 weeks (assessed every 4 weeks from baseline to finalization)). 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 14 Aug 2026.