Diabetes Mellitus, Type 2Phase 4TRACKNCT02236481
Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes
A Phase 4 study testing Anakinra and TNF alpha inhibitors in people with Diabetes Mellitus, Type 2 and Arthritis, Rheumatoid, run by Prof. Roberto Giacomelli at 1 site in Italy.
Trial summary
The TRACK [Treatment of Rheumatoid Arthritis and Comorbidities with Kineret (anakinra)]-study: a randomized, open-label multicenter study assessing the efficacy of anakinra in lowering HbA1c (glycated hemoglobin) as well as changes in DAS28 in Rheumatoid Arthritis (R.A.) patients with type 2 diabetes (T2D) Authors: R. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Arthritis, Rheumatoid
- What is being tested?
- Anakinra and TNF alpha inhibitors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2013to Dec 2017
- Phase
- Phase 4
- 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
Who may be able to join
- male and female patients aged ≥ 18 years;
- previous diagnosis of RA with criteria of the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR);
- Diagnosis of Diabetes Mellitus type II according to the American Diabetes Association (ADA) criteria since at least 6 months;
- Patients with an inadequate response to previous treatment with methotrexate (determined on the basis of the evaluation of the physician);
- BMI <35
- Glycated hemoglobin > 7% <10%
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- Minimum score Disease Activity Score-28 (DAS 28) > 3.2
- For patients previously treated with a biologic drug, wash out of the treatment for at least 1 month prior to enrollment;
- For patients in treatment with hypoglycemic drugs at enrollment, no change of the hypoglycemic treatment in terms of type of drug and dosage, for a period of at least 3 months before enrolment
- For patients in therapy with other drugs at baseline, no change in terms of drug administered and the dosage regimen for a period of at least 1 month prior to enrollment;
- Absence of signs and symptoms related to ischemic heart disease
- Signature of written Informed Consent Form.
Who cannot join
- DM2 diagnosed since more than 10 years;
- Ongoing Acute infection or chronic infection, which has one or more of following:
- Increased levels of C-reactive protein > 30 mg / L
- fever
- Ongoing treatment with antibiotics ;
- Chronic granulomatous infections (ie. tuberculosis diagnosed by radiography or by laboratory tests)
Show all 23Show fewer
- History of recurrent infections or presence of diseases that induce to infections;
- C-peptide values <0.5 ng / mL ( 0.1665 nmol / L)
- presence of neutropenia ( WBC < 2000/mm3 ) or anemia (hemoglobin < 11g/dL for man and 10g/dl for the woman) ;
- presence of one or more contraindication indicate in SmPC of study drug (anakinra);
- presence of one or more contraindication indicate in SmPC of control drug (inhibitors of TNF -alpha ; ATC L04AB);
- presence of one or more contraindications to treatment with methotrexate ;
- previous ischemic attack or myocardial infarction;
- heart failure NYHA class III or IV;
- hepatic or progressive liver disease ( values of ALAT / ASAT increased by at least two -fold compared to normal limits );
- pregnant, or women not using contraceptive measures;
- breast-feeding;
- participation in another clinical study up to 6 months before randomization;
- depressive syndrome or other serious psychiatric illness that, in the opinion of the physician, may preclude participation in the study;
- presence of known malignancy ;
- Clinically significant history of alcohol abuse or drug addiction , that, in the opinion of the physician, may preclude participation in the study;
- any condition that, in the opinion of the physician, precludes the possibility of using the study drug (anakinra , Kineret ) or the control drug (inhibitors of TNF alpha; L04AB ATC ) in compliance with SmPC indications ;
- any other condition or laboratory parameter that , in the opinion of the physician, precludes the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: No-profit" Study to Ensure Normal Clinical Practice, to Evaluate the Efficacy of Anakinra in Reducing the Glycated Haemoglobin in Patients Affected by Rheumatoid Arthritis and Diabetes; Randomized, Open Label, Parallel Group,Controlled Clinical Study
The TRACK [Treatment of Rheumatoid Arthritis and Comorbidities with Kineret (anakinra)]-study: a randomized, open-label multicenter study assessing the efficacy of anakinra in lowering HbA1c (glycated hemoglobin) as well as changes in DAS28 in Rheumatoid Arthritis (R.A.) patients with type 2 diabetes (T2D) Authors: R. Giacomelli,(A,B) P. Cipriani (A) and P. Ruscitti (A) on behalf of the TRACK study-group; (A) University of L'Aquila, L'Aquila, Italy; Background: Interleukin-1 (IL-1) plays a pivotal role in R.A., joint erosion and cartilage destruction.(1) Anakinra (a recombinant form of the naturally occurring IL-1 receptor antagonist (IL-1Ra), which blocks the activity of both IL-1α and IL-1β) has shown in a number of RCTs (2-6) to be effective in the treatment of R.A., in monotherapy,(2,4) as well as associated to methotrexate (MTX).(3,5,6) IL-1β plays also an important role in the pathogenesis of T2D: Glucose has been shown to induce IL-1β hypersecretion through inflammasome activation, while IL-1β induces impairment of β-cell secretory function and β-cell apoptosis.(7) In prediabetic subjects, the expression of IL-1Ra is induced by IL-1β and reflects the body's response to counterbalance increased IL-1β activity.(7) Levels of IL-1Ra tend to rise up to 6 years before the diagnosis of T2D.(8,9) IL-1Ra has been successfully used as a marker for the risk of developing T2D in subjects with metabolic syndrome.(10) As a clinical proof of concept, IL-1 inhibition with anakinra in patients with T2D has shown to improve the secretorial function of beta-cells as well as to lower the ratio of proinsulin/insulin and glycated hemoglobin/hemoglobin significantly, favoring glycemic control and possibly reducing the severity and prevalence of the associated complications of this disease.(11) Summarizing, IL-1 inhibition with anakinra has a clinical impact on R.A. as well as T2D. As from 6-10% of Italian R.A. patients have also T2D, this trial aims at investigating the impact of IL-1 inhibition on both diseases. Very recent data also show that T2D is a predictor of response to anakinra-treatment in R.A. patients,(12) which furthermore justifies the use of anakinra in this subset of R.A. patients. Objectives: [Primary] To evaluate the change in HbA1c between baseline, 3 months, 6 months, 1 year and at last follow up of 2 years from the beginning; [Secondary] To evaluate the efficacy on controlling signs \& symptoms of R.A., assessing the remission rate at 3 months, 6 months, 1 year and at follow up (2 years), using the evaluation scale of disease activity on 28 joints, DAS28 and SDAI improvements from baseline conditions over time points, according to EULAR response criteria. Methods: 200 patients in 28 Italian centers with active R.A. refractory to treatment with methotrexate and T2D will be enrolled and randomized to receive either 100mg of anakinra once daily by subcutaneous injection or any anti-TNF-alfa drug treatment. [84 subjects will be required in each treatment arm to reach 90% power with an alpha error of 0.05 to detect a mean difference between the study arms of 0.25 percentage points of HbA1c . The assumed difference of HbA1c is rather conservative when compared to previously published changes in T2D patients (11).] Anti-diabetic treatment is required to be unchanged for at least one month prior to enrolment. Patients will be invited to maintain dietary habits and lifestyle during the study period. Further details can be viewed on the trials website after subscription.(13) References: (1) Arend \& Dayer, Adv. Imm. 1993; 54: 167-227. (2) Bresnihan, Arthritis Rheum. 1998; 41: 2196-2204. (3) Cohen, Arthritis Rheum. 2002; 46: 614-624. (4) Nuki, Arthritis. Rheum. 2002; 46: 2838-2846. (5) Cohen, ARD 2004; 63: 1062-1068. (6) Cohen, Rheumatology 2004; 43: 704-711. (7) Donath, Nat. Rev. Immunol. 2011; 11: 98-107. (8) Herder, Diabetes Care 2009; 32: 421-423. (9) Carstensen, Diabetes 2010; 59: 1222-1227. (10) Luotola, J. Intern. Med. 2011; 269: 322-332. (11) Larsen, NEJM 2007; 356: 1517-1526. (12) Missler-Karger, EULAR 2013, Abs. FRI0219. (13) http://www.anakinra-ra-diabetes.org/ Disclosure: This trial is receiving support from Swedish Orphan Biovitrum AB according to the Italian law decree 17 December 2004. (B) speaker fees
- Conditions
- Diabetes Mellitus, Type 2, Arthritis, Rheumatoid
- Being tested
- Anakinra, TNF alpha inhibitors
- Medical subject headings
- Diabetes Mellitus, Type 2, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret
TNF alpha inhibitorsDrug
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Experimental | 100 mg of anakinra once daily by subcutaneous injection for 24 months Receives: Drug: Anakinra |
| TNF alpha inhibitors | Active comparator | treatment with TNF-alpha inhibitors according to the relative summary of product charateristics Receives: Drug: TNF alpha inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin
Measured: up to 24th months of treatment
Secondary outcomes (7)
Percentage of patients in remission ( EULAR Criteria )
Measured: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
Percentage of patients improved ( EULAR criteria)
Measured: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
Count of tender joints (66 joints)
Measured: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
Count of swollen joints (68 joints)
Measured: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
Administration at Health Assessment Questionnaire ( HAQ)
Measured: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR )
Measured: baseline , after 3 months, 6 months , 12 months and 24 months of treatment:
Plasma levels of glucose
Measured: baseline , after 3 months, 6 months , 12 months and 24 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 posted10 Sep 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Decision of the Sponsor for Early Benefits
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Roberto Giacomelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Roberto Giacomelli, University of L'Aquila
- Investigators
- Roberto Giacomelli, Professor, Principal investigator, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236481
- Sponsor's protocol ID
- TRACK
- Acronym
- TRACK
- Status last verified
- Dec 2018
- First submitted
- 8 Sep 2014
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruscitti P, Masedu F, Alvaro S, Airo P, Battafarano N, Cantarini L, Cantatore FP, Carlino G, D'Abrosca V, Frassi M, Frediani B, Iacono D, Liakouli V, Maggio R, Mule R, Pantano I, Prevete I, Sinigaglia L, Valenti M, Viapiana O, Cipriani P, Giacomelli R. Anti-interleukin-1 treatment in patients with rheumatoid arthritis and type 2 diabetes (TRACK): A multicentre, open-label, randomised controlled trial. PLoS Med. 2019 Sep 12;16(9):e1002901. doi: 10.1371/journal.pmed.1002901. eCollection 2019 Sep.
PubMed 31513665
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No-profit" Study to Ensure Normal Clinical Practice, to Evaluate the Efficacy of Anakinra in Reducing the Glycated Haemoglobin in Patients Affected by Rheumatoid Arthritis and Diabetes; Randomized, Open Label, Parallel Group,Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02236481
- Acronym / sponsor ID
- TRACK / TRACK
- Conditions
- Diabetes Mellitus, Type 2, Arthritis, Rheumatoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision of the Sponsor for Early Benefits
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Prof. Roberto GiacomelliUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Sep 2014 (estimated)
- 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.
The TRACK [Treatment of Rheumatoid Arthritis and Comorbidities with Kineret (anakinra)]-study: a randomized, open-label multicenter study assessing the efficacy of anakinra in lowering HbA1c (glycated hemoglobin) as well as changes in DAS28 in Rheumatoid Arthritis (R.A.) patients with type 2 diabetes (T2D) Authors: R. Giacomelli,(A,B) P. Cipriani (A) and P. Ruscitti (A) on behalf of the TRACK study-group; (A) University of L'Aquila, L'Aquila, Italy; Background: Interleukin-1 (IL-1) plays a pivotal role in R.A., joint erosion and cartilage destruction.(1) Anakinra (a recombinant form of the naturally occurring IL-1 receptor antagonist (IL-1Ra), which blocks the activity of both IL-1α and IL-1β) has shown in a number of RCTs (2-6) to be effective in the treatment of R.A., in monotherapy,(2,4) as well as associated to methotrexate (MTX).(3,5,6) IL-1β plays also an important role in the pathogenesis of T2D: Glucose has been shown to induce IL-1β hypersecretion through inflammasome activation, while IL-1β induces impairment of β-cell secretory function and β-cell apoptosis.(7) In prediabetic subjects, the expression of IL-1Ra is induced by IL-1β and reflects the body's response to counterbalance increased IL-1β activity.(7) Levels of IL-1Ra tend to rise up to 6 years before the diagnosis of T2D.(8,9) IL-1Ra has been successfully used as a marker for the risk of developing T2D in subjects with metabolic syndrome.(10) As a clinical proof of concept, IL-1 inhibition with anakinra in patients with T2D has shown to improve the secretorial function of beta-cells as well as to lower the ratio of proinsulin/insulin and glycated hemoglobin/hemoglobin significantly, favoring glycemic control and possibly reducing the severity and prevalence of the associated complications of this disease.(11) Summarizing, IL-1 inhibition with anakinra has a clinical impact on R.A. as well as T2D. As from 6-10% of Italian R.A. patients have also T2D, this trial aims at investigating the impact of IL-1 inhibition on both diseases. Very recent data also show that T2D is a predictor of response to anakinra-treatment in R.A. patients,(12) which furthermore justifies the use of anakinra in this subset of R.A. patients. Objectives: [Primary] To evaluate the change in HbA1c between baseline, 3 months, 6 months, 1 year and at last follow up of 2 years from the beginning; [Secondary] To evaluate the efficacy on controlling signs \& symptoms of R.A., assessing the remission rate at 3 months, 6 months, 1 year and at follow up (2 years), using the evaluation scale of disease activity on 28 joints, DAS28 and SDAI improvements from baseline conditions over time points, according to EULAR response criteria. Methods: 200 patients in 28 Italian centers with active R.A. refractory to treatment with methotrexate and T2D will be enrolled and randomized to receive either 100mg of anakinra once daily by subcutaneous injection or any anti-TNF-alfa drug treatment. [84 subjects will be required in each treatment arm to reach 90% power with an alpha error of 0.05 to detect a mean difference between the study arms of 0.25 percentage points of HbA1c . The assumed difference of HbA1c is rather conservative when compared to previously published changes in T2D patients (11).] Anti-diabetic treatment is required to be unchanged for at least one month prior to enrolment. Patients will be invited to maintain dietary habits and lifestyle during the study period. Further details can be viewed on the trials website after subscription.(13) References: (1) Arend \& Dayer, Adv. Imm. 1993; 54: 167-227. (2) Bresnihan, Arthritis Rheum. 1998; 41: 2196-2204. (3) Cohen, Arthritis Rheum. 2002; 46: 614-624. (4) Nuki, Arthritis. Rheum. 2002; 46: 2838-2846. (5) Cohen, ARD 2004; 63: 1062-1068. (6) Cohen, Rheumatology 2004; 43: 704-711. (7) Donath, Nat. Rev. Immunol. 2011; 11: 98-107. (8) Herder, Diabetes Care 2009; 32: 421-423. (9) Carstensen, Diabetes 2010; 59: 1222-1227. (10) Luotola, J. Intern. Med. 2011; 269: 322-332. (11) Larsen, NEJM 2007; 356: 1517-1526. (12) Missler-Karger, EULAR 2013, Abs. FRI0219. (13) http://www.anakinra-ra-diabetes.org/ Disclosure: This trial is receiving support from Swedish Orphan Biovitrum AB according to the Italian law decree 17 December 2004. (B) speaker fees
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Experimental | Drug: Anakinra100 mg of anakinra once daily by subcutaneous injection for 24 months |
| TNF alpha inhibitors | Active comparator | Drug: TNF alpha inhibitorstreatment with TNF-alpha inhibitors according to the relative summary of product charateristics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- male and female patients aged ≥ 18 years;
- previous diagnosis of RA with criteria of the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR);
- Diagnosis of Diabetes Mellitus type II according to the American Diabetes Association (ADA) criteria since at least 6 months;
- Patients with an inadequate response to previous treatment with methotrexate (determined on the basis of the evaluation of the physician);
- BMI <35
Key exclusion criteria (23 listed)
- DM2 diagnosed since more than 10 years;
- Ongoing Acute infection or chronic infection, which has one or more of following:
- Chronic granulomatous infections (ie. tuberculosis diagnosed by radiography or by laboratory tests)
- History of recurrent infections or presence of diseases that induce to infections;
- C-peptide values <0.5 ng / mL ( 0.1665 nmol / L)
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 |
|---|---|---|
| AnakinraAlso: Kineret | Drug | Anakinra |
| TNF alpha inhibitors | Drug | TNF alpha inhibitors |
Primary outcome
Glycated Hemoglobin
Time frame: up to 24th months of treatment
7 secondary outcomes
Percentage of patients in remission ( EULAR Criteria )
Time frame: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
Percentage of patients improved ( EULAR criteria)
Time frame: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
Count of tender joints (66 joints)
Time frame: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
Count of swollen joints (68 joints)
Time frame: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
Administration at Health Assessment Questionnaire ( HAQ)
Time frame: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR )
Time frame: baseline , after 3 months, 6 months , 12 months and 24 months of treatment:
Plasma levels of glucose
Time frame: baseline , after 3 months, 6 months , 12 months and 24 months of treatment
Results and safety
The study was stopped early (reason given: Decision of the Sponsor for Early Benefits). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Derived from this study: PubMed 31513665Ruscitti P, Masedu F, Alvaro S, Airo P, Battafarano N, Cantarini L, Cantatore FP, Carlino G, D'Abrosca V, Frassi M, Frediani B, Iacono D, Liakouli V, Maggio R, Mule R, Pantano I, Prevete I, Sinigaglia L, Valenti M, Viapiana O, Cipriani P, Giacomelli R. Anti-interleukin-1 treatment in patients with rheumatoid arthritis and type 2 diabetes (TRACK): A multicentre, open-label, randomised controlled trial. PLoS Med. 2019 Sep 12;16(9):e1002901. doi: 10.1371/journal.pmed.1002901. eCollection 2019 Sep.
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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.
Roberto Giacomelli, Professor principal investigator
University of L'Aquila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anakinra and TNF alpha inhibitors in people with Diabetes Mellitus, Type 2 and Arthritis, Rheumatoid, run by Prof. Roberto Giacomelli at 1 site in Italy.
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 12 inclusion and 23 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: stopped early, as of the sponsor's last update on 14 Dec 2018. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Decision of the Sponsor for Early Benefits). Results are not available in the source record.
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?
Glycated Hemoglobin (time frame: up to 24th months of treatment). 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 NCT02236481, which also lists 1 linked publication.
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 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.