Trial Title:
Effect of Proactive Therapeutic Drug Monitoring on Maintenance of Sustained Disease Control in Adults With Rheumatoid Arthritis on a Subcutaneous TNF Inhibitor: The Rheumatoid Arthritis Therapeutic DRUg Monitoring Trial (RA-DRUM)
NCT ID:
NCT06440629
Condition:
Rheumatoid Arthritis
Conditions: Official terms:
Arthritis
Arthritis, Rheumatoid
Adalimumab
Conditions: Keywords:
Rheumatoid arthritis
Therapeutic drug monitoring
Tumor necrosis factor inhibitor
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
The joint assessor will be blinded.
Intervention:
Intervention type:
Drug
Intervention name:
Therapeutic drug monitoring (TDM) of adalimumab
Description:
In the TDM-group, the adalimumab dose will be adjusted according to the following
algorithms in order to keep the drug level within the therapeutic range:
- Serum drug level within therapeutic range : keep dose
- Low drug levels, ADAb undetectable or low levels : Decrease dosing interval by one
week to a maximum of 40 mg/week
- Low drug levels, ADAb high levels : Switch to another therapy
- High drug levels : Increase dosing interval by one week up to a maximum of 6 weeks
Arm group label:
TDM-group
Summary:
The goal of this clinical trial is to compare therapeutic drug monitoring (TDM) versus
Standard of care in patients with rheumatoid arthritis treated with a subcutaneous tumor
necrosis factor inhibitor (adalimumab).
The main question it aims to answer is:
Is TDM superior to standard of care in order to maintain sustained disease control
without flares?
Participants will be followed with blood sampling every second month, measuring serum
drug levels and anti-drug antibodies of the TNFi. In the TDM-group, the researchers will
adjust the dosage of the TNFi based on knowledge on optimal therapeutic ranges. In the
Standard of care group, the TNFi will be administered according to standard of care
without knowledge of serum drug levels or anti-drug antibodies.
Detailed description:
There is a considerable variation in serum drug levels among rheumatoid arthritis (RA)
patients on tumor necrosis factor inhibitors (TNFi), and a high number develop
neutralizing anti-drug antibodies (ADAb). Sub-therapeutic drug levels and ADAb formation
are major contributors to TNFi treatment failure and disease flare. Proactive therapeutic
drug monitoring (TDM), i.e., individualized drug dosing based on regular assessments of
serum drug levels and ADAb, has the potential to optimize the efficacy and safety of TNFi
treatment.
The aim of the RA-DRUM trial is to assess whether TDM is superior to standard of care in
order to maintain sustained disease control without flares in patients with RA treated
with the SC TNFi adalimumab.
Participants will be randomized to:
- Administration of TNFi based on proactive TDM (TDM group)
- Administration of TNFi based on standard of care without knowledge of serum drug
levels or ADAb status (Standard of care group)
Participants will be followed for 18 months with on-site visits at baseline, 4, 8, 12 and
18 months and digital visits at 2, 6, 10, 14, and 16 months. Blood sampling for serum
drug levels and anti-drug antibodies will be done at all visits.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. A clinical diagnosis of RA
2. ≥ 18 and under 75 years of age at screening
3. On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3
months and a maximum of 24 months
4. In low disease activity or remission (DAS28-CRP under 3.2) and indication for
continuation of treatment according to the treating physician
5. Subject capable of understanding and signing an informed consent form
Exclusion Criteria:
1. Major comorbidities, such as previous malignancies within the last 5 years,
uncontrolled diabetes mellitus, severe infections (including HIV), uncontrollable
hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory
diseases, demyelinating disease, significant chronic widespread pain syndrome,
significant renal or hepatic disease, and/or other diseases or conditions which
either contraindicate treatment with SC TNFi or make adherence to the protocol
difficult
2. Hypersensitivity to sc TNFi (adalimumab).
3. Pregnancy, or subject considering becoming pregnant during the study period
4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language
barriers, or other factors that makes adherence to the study protocol difficult
5. Changes in csDMARD co-medication, including dose changes of csDMARD or changes in
the dose of corticosteroids within the last 2 months
6. Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding
csDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily).
7. Active participation in any other interventional study.
8. In need of live vaccines during the study period.
Gender:
All
Minimum age:
18 Years
Maximum age:
74 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical University Vienna
Address:
City:
Vienna
Zip:
A-1090
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Helga Lechner-Radner, PhD, MD
Phone:
+43 1 40400-43010
Email:
helga.lechner-radner@meduniwien.ac.at
Investigator:
Last name:
Helga Lechner-Radner, PhD, MD
Email:
Principal Investigator
Facility:
Name:
Diakonhjemmet sykehus
Address:
City:
Oslo
Zip:
0319
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Ingrid Jyssum, PhD, MD
Phone:
+4722451500
Email:
ingrid.jyssum@gmail.com
Contact backup:
Last name:
Silje W Syversen, PhD, MD
Phone:
+4722451500
Email:
s.w.syversen@gmail.com
Investigator:
Last name:
Ingrid Jyssum, MD
Email:
Principal Investigator
Facility:
Name:
Haukeland University Hospital
Address:
City:
Bergen
Zip:
5009
Country:
Norway
Status:
Not yet recruiting
Contact:
Last name:
Anne- Kristine Halse, MD, PhD
Phone:
+4755975000
Email:
anne.kristine.hjorteseth.halse@helse-bergen.no
Investigator:
Last name:
Anne- Kristine Halse, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Nordland Hospital Trust
Address:
City:
Bodø
Zip:
8005
Country:
Norway
Status:
Not yet recruiting
Contact:
Last name:
Sonja Pedersen, MD
Phone:
+4775534000
Email:
Sonja.Pedersen@nordlandssykehuset.no
Investigator:
Last name:
Sonja Pedersen, MD
Email:
Principal Investigator
Facility:
Name:
Drammen Hospital
Address:
City:
Drammen
Zip:
3004
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Fillip Skovlund, MD
Phone:
+4703525
Email:
filsko@vestreviken.no
Investigator:
Last name:
Fillip Skovlund, MD
Email:
Principal Investigator
Facility:
Name:
Førde Hospital Trust
Address:
City:
Førde
Zip:
6812
Country:
Norway
Status:
Not yet recruiting
Contact:
Last name:
Pawel F Mienik, MD, PhD
Phone:
+4757839000
Email:
pawel.franciszek.mielnik@helse-forde.no
Investigator:
Last name:
Pawel F Mienik, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Haugesund Rheumatism Hospital
Address:
City:
Haugesund
Zip:
5528
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Svanaug Skorpe, MD
Phone:
+4752805000
Email:
svanaug.skorpe@hsr.as
Investigator:
Last name:
Svanaug Skorpe, MD
Email:
Principal Investigator
Facility:
Name:
Hospital of Southern Norway Trust
Address:
City:
Kristiansand
Zip:
4615
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Jintana B Andersen, MD, PhD
Phone:
+4738073000
Email:
Jintana.Bunpan.Andersen@sshf.no
Investigator:
Last name:
Jintana B Andersen, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Lillehammer Hospital for Rheumatic Diseases
Address:
City:
Lillehammer
Zip:
2609
Country:
Norway
Status:
Not yet recruiting
Contact:
Last name:
Eldri K Strand, MD
Phone:
+4761279500
Email:
Eldri.Kveine.Strand@revmatismesykehuset.no
Investigator:
Last name:
Eldri K Strand, MD
Email:
Principal Investigator
Facility:
Name:
Helgeland Hospital Trust
Address:
City:
Mo I Rana
Zip:
8613
Country:
Norway
Status:
Not yet recruiting
Contact:
Last name:
Petya S Galabova, MD
Phone:
+4775660000
Email:
Petya.Stefanova.Galabova@helgelandssykehuset.no
Investigator:
Last name:
Petya S Galabova, MD
Email:
Principal Investigator
Facility:
Name:
Østfold Hospital Trust
Address:
City:
Moss
Zip:
1535
Country:
Norway
Status:
Not yet recruiting
Contact:
Last name:
Anne J Haugen, MD, PhD
Phone:
+4769860000
Email:
annhau@so-hf.no
Investigator:
Last name:
Anne J Haugen, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Martina Hansen's Hospital
Address:
City:
Sandvika
Country:
Norway
Status:
Not yet recruiting
Contact:
Last name:
Anne B Haaversen, MD
Phone:
+4767500800
Email:
Anne.Bull.Haaversen@mhh.no
Investigator:
Last name:
Anne B Haaversen, MD
Email:
Principal Investigator
Facility:
Name:
Betanien Hospital
Address:
City:
Skien
Zip:
3722
Country:
Norway
Status:
Not yet recruiting
Contact:
Last name:
Christine Stillum, MD
Phone:
+4735900700
Email:
stillum@hotmail.com
Investigator:
Last name:
Christine Stillum, MD
Email:
Principal Investigator
Facility:
Name:
Stavanger University Hospital
Address:
City:
Stavanger
Zip:
4019
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Kjartan Bryne, MD
Phone:
+4751518000
Email:
kjartan.bryne@sus.no
Investigator:
Last name:
Kjartan Bryne, MD
Email:
Principal Investigator
Facility:
Name:
University Hospital of North Norway
Address:
City:
Tromsø
Zip:
9019
Country:
Norway
Status:
Not yet recruiting
Contact:
Last name:
Trude J Bruun, MD
Phone:
+4777626000
Email:
trude.jannecke.bruun@unn.no
Investigator:
Last name:
Trude J Bruun, MD
Email:
Principal Investigator
Facility:
Name:
St.Olavs Hospital
Address:
City:
Trondheim
Zip:
7030
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Mari Hoff, MD, PhD
Phone:
+4772573000
Email:
mari.hoff@stolav.no
Investigator:
Last name:
Mari Hoff, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Ålesund Hospital
Address:
City:
Ålesund
Zip:
6017
Country:
Norway
Status:
Not yet recruiting
Contact:
Last name:
Astrid B Langhammer, MD
Phone:
+4770105000
Email:
Astrid.Jordet.Langhammer@helse-mr.no
Investigator:
Last name:
Astrid B Langhammer, MD
Email:
Principal Investigator
Facility:
Name:
Carol Davila University of Medicine and Pharmacy Bucharest
Address:
City:
Bucharest
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Catalin Codreanu, MD PHD
Phone:
+40722204389
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Zip:
141 86
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Aikaterini Chatzidionysiou, MD, PhD
Email:
aikaterini.chatzidionysiou@ki.se
Investigator:
Last name:
Aikaterini Chatzidionysiou, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Queen Mary
Address:
City:
London
Zip:
SW15 5PN
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Michele Bombardieri, MD, PhD
Email:
m.bombardieri@qmul.ac.uk
Investigator:
Last name:
Michele Bombardieri, MD, PhD
Email:
Principal Investigator
Start date:
August 20, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Diakonhjemmet Hospital
Agency class:
Other
Collaborator:
Agency:
Oslo University Hospital
Agency class:
Other
Collaborator:
Agency:
Karolinska University Hospital
Agency class:
Other
Collaborator:
Agency:
Queen Mary University of London
Agency class:
Other
Collaborator:
Agency:
Medical University of Vienna
Agency class:
Other
Collaborator:
Agency:
Alesund Hospital
Agency class:
Other
Collaborator:
Agency:
St. Olavs Hospital
Agency class:
Other
Collaborator:
Agency:
Helse Stavanger HF
Agency class:
Other
Collaborator:
Agency:
Drammen sykehus
Agency class:
Other
Collaborator:
Agency:
University Hospital of North Norway
Agency class:
Other
Collaborator:
Agency:
Førde Hospital Trust
Agency class:
Other
Collaborator:
Agency:
Hospital of Southern Norway Trust
Agency class:
Other
Collaborator:
Agency:
Haukeland University Hospital
Agency class:
Other
Collaborator:
Agency:
Ostfold Hospital Trust
Agency class:
Other
Collaborator:
Agency:
Lillehammer Hospital for Rheumatic Diseases
Agency class:
Other
Collaborator:
Agency:
Martina Hansen's Hospital
Agency class:
Other
Collaborator:
Agency:
Haugesund Rheumatism Hospital
Agency class:
Other
Collaborator:
Agency:
Betanien Hospital
Agency class:
Other
Collaborator:
Agency:
Helgeland Hospital Trust
Agency class:
Other
Collaborator:
Agency:
Nordlandssykehuset HF
Agency class:
Other
Collaborator:
Agency:
Carol Davila University of Medicine and Pharmacy Bucharest
Agency class:
Other
Source:
Diakonhjemmet Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06440629
