Rheumatoid ArthritisPhase 4RA-DRUMNCT06440629
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)
A Phase 4 study testing Therapeutic drug monitoring (TDM) of adalimumab in people with Rheumatoid Arthritis, run by Diakonhjemmet Hospital at 22 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Therapeutic drug monitoring (TDM) of adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 20 Aug 2024to 31 Dec 2027
- Phase
- Phase 4
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of RA
- ≥ 18 and under 75 years of age at screening
- On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3 months and a maximum of 24 months
- In low disease activity or remission (DAS28-CRP under 3.2) and indication for continuation of treatment according to the treating physician
- Subject capable of understanding and signing an informed consent form
Who cannot join
- 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
- Hypersensitivity to sc TNFi (adalimumab).
- Pregnancy, or subject considering becoming pregnant during the study period
- Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that makes adherence to the study protocol difficult
- Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within the last 2 months
- Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily).
- Active participation in any other interventional study.
- In need of live vaccines during the study period.
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
Norway16 sites
Ålesund Hospital
Ålesund, 6017
Haukeland University Hospital
Bergen, 5009
Nordland Hospital Trust
Bodø, 8005
Drammen Hospital
Drammen, 3004
Førde Hospital Trust
Førde, 6812
Haugesund Rheumatism Hospital
Haugesund, 5528
Hospital of Southern Norway Trust
Kristiansand, 4615
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, 2609
Helgeland Hospital Trust
Mo i Rana, 8613
Østfold Hospital Trust
Moss, 1535
Diakonhjemmet sykehus
Oslo, N-0319, 0319
Martina Hansen's Hospital
Sandvika
Betanien Hospital
Skien, 3722
Stavanger University Hospital
Stavanger, 4019
University Hospital of North Norway
Tromsø, 9019
St.Olavs Hospital
Trondheim, 7030
Sweden2 sites
Sahlgrenska Universitetssjukehuset
Gothenburg, 41345
Karolinska University Hospital
Stockholm, 141 86
Romania1 site
Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest
About this study
Official title: A Multi-center, Open, Randomized, 18-month, Parallel-group, Superiority Study to Compare the Effect of Proactive Therapeutic Drug Monitoring Versus Standard of Care With Regards to Maintenance of Sustained Disease Control Without Flare in Adults With Rheumatoid Arthritis Treated With a Subcutaneous Tumor Necrosis Factor Inhibitor
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:
Read more
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Therapeutic drug monitoring (TDM) of adalimumab
- Keywords
- Rheumatoid arthritis, Therapeutic drug monitoring, Tumor necrosis factor inhibitor
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic drug monitoring (TDM) of adalimumabDrug
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
| Study group | Role | What they receive |
|---|---|---|
| TDM-group | Experimental | In the TDM-group, the TNFi dose will be adjusted in order to keep the drug level within the therapeutic range Receives: Drug: Therapeutic drug monitoring (TDM) of adalimumab |
| Standard of Care group | No intervention | In the Standard of Care group, TNFi will be administered according to standard of care without knowledge of serum drug levels or ADAb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained disease control over the follow-up period of 18 months without flare
A flare defined as either of the following:
A combination of an increase in Disease Activity Score using 28 joints C-reactive protein (DAS28-CRP) ≥ 1.2, or ≥ 0.6 if DAS28-CRP ≥ 3.2, AND ≥ 2 swollen joints on examination of 44 joints
OR
Consensus between patient and physician that a disease flare has occurred, leading to a major change* in treatment
*Please see protocol for the definition of a major change in treatment (due to word restrictions)
Measured: 4, 8, 12, 18 months
Secondary outcomes (14)
Disease activity assessed by Disease Activity Score using 28 joints C-reactive protein (DAS28-CRP)
The DAS28-CRP composite score includes the 28 tender and swollen joint counts, CRP and a Patient Global Assessment of Disease activity (PGA).
The DAS28-CRP is calculated as follows:
DAS28-CRP = 0.56*√ (tender joints 28) + 0.28*√ (swollen joints 28) + 0.36*ln(CRP (mg/L)+1) + 0.014*PGA + 0.96 High disease activity is defined as a DAS28-CRP value > 5.1, moderate disease activity as DAS28-CRP > 3.2 - 5.1, low disease activity as a DAS28-CRP-value of 2.6 - 3.2, and remission as DAS28-CRP < 2.6
PGA is measured on a 100 mm VAS according to the question: "Considering all the ways your arthritis has affected you, how did you feel your arthritis was over the last week?" (on a 0-100mm Visual Analogue Scale (VAS) with with 0 = excellent and 100 = very poor).
Measured: 4, 8, 12, and 18 months
Disease activity measured by 44 joint count
44 joint count are included in the original Disease Activity Score (DAS) and in addition to the joints included in DAS28 it includes the MTP joints and the sternoclavicular joints for a more comprehensive valuation of the participants' joints.
Measured: 4, 8, 12, and 18 months
Patient Global assessment of disease activity (PGA)
PGA is measured on a 100 mm VAS according to the question: "Considering all the ways your arthritis has affected you, how did you feel your arthritis was over the last week?" (on a 0-100mm Visual Analogue Scale (VAS) with with 0 = excellent and 100 = very poor).
Measured: 4, 8, 12, and 18 months
Evaluators Global Assessment of Disease Activity (EGA)
EGA is measured on a NRS according to the question "Please rate the patient's overall (global) disease activity", with 0 = best and 10 = worst.
Measured: 4, 8, 12, and 18 months
Disease activity assessed by Clinical Disease Activity Index (CDAI)
CDAI includes the 28 tender and swollen joint counts, Patient Global Assessment of Disease activity (PGA) and Evaluators Global Assessment of Disease Activity (EGA)
The formula for CDAI is: swollen joints 28 + tender joints 28 + (PGA (VAS 0-100)/10) + EGA (NRS 0-10).
PGA is measured on a 100 mm VAS according to the question: "Considering all the ways your arthritis has affected you, how did you feel your arthritis was over the last week?" (on a 0-100mm Visual Analogue Scale (VAS) with with 0 = excellent and 100 = very poor).
EGA is measured on a NRS according to the question "Please rate the patient's overall (global) disease activity", with 0 = best and 10 = worst.
Measured: 4, 8, 12, and 18 months
Disease activity assessed by Simple Disease Activity Index (SDAI)
SDAI includes the 28 tender and swollen joint counts, Patient Global Assessment of Disease activity (PGA) and Evaluators Global Assessment of Disease Activity (EGA) and C-reactive protein (CRP).
The formula for SDAI is: swollen joints 28 + tender joints 28 + (PGA(VAS 0-100)/10) + EGA(NRS 0-10) + (CRP (mg/dL)/10).
PGA is measured on a 100 mm VAS according to the question: "Considering all the ways your arthritis has affected you, how did you feel your arthritis was over the last week?" (on a 0-100mm Visual Analogue Scale (VAS) with with 0 = excellent and 100 = very poor).
EGA is measured on a NRS according to the question "Please rate the patient's overall (global) disease activity", with 0 = best and 10 = worst.
Measured: 4, 8, 12, and 18 months
Remission assessed by American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) remission criteria
The ACR/EULAR remission criteria defines a patient in remission when either
- the patient is in Boolean 2.0 remission with each of the variables tender joint count, swollen joint count and CRP having a value of ≤1 and Patient Global Assessment of Disease activity (PGA) having a value ≤ 2 (PGA on a Visual Analogue Scale (VAS)100mm/10 with 0=best and 100= worst, CRP in mg/dl) OR
- the SDAI score is ≤ 3.3
Measured: 4, 8, 12, and 18 months
Rheumatoid Arthritis Impact of Disease (RAID)
The RAID questionnaire includes seven domains with the following relative weights: pain (0.21), functional disability (0.16), fatigue (0.15), emotional well-being (0.12), sleep (0.12), coping (0.12) and physical well-being (0.12) each rated on an Numeric Rating Scale (NRS) (0-10 with 0=best and 10=worst). The rates of each domain are weighted and summed to form a score in the range of 0-10
Measured: 4, 8, 12, and 18 months
Evaluation of physical function measured by Modified Health Assessment Questionnaire (MHAQ)
The MHAQ includes eight items covering the physical function of patients with inflammatory joint diseases.
Each item is scored on a categorical 0-3 scale (0=best and 3= worst) and the sum score is divided by 8 to form the MHAQ score 0.0 to 3.0
Measured: 4, 8, 12, and 18 months
Number and type of adverse events (AE)
Assessments of AE
Measured: 4, 8, 12, and 18 months
Drug survival
Drug survival assessed by survival analyses
Measured: 4, 8, 12, and 18 months
Drug consumption
Assessments of drug consumption
Measured: 18 months
Occurrence of anti-drug antibodies (ADAb)
ADAb will be assessed in all serum samples with adalimumab levels <3mg/L.
Measured: 2, 4, 6, 8, 10, 12, 14, 16, 18 months
Serum drug levels
Serum drug levels will be assessed at all visits, both clinical and digital.
Measured: 2, 4, 6, 8, 10, 12, 14, 16, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start20 Aug 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Karolinska University Hospital, Queen Mary University of London, Medical University of Vienna, Alesund Hospital, St. Olavs Hospital, Helse Stavanger HF, Drammen sykehus, University Hospital of North Norway, Førde Hospital Trust, Hospital of Southern Norway Trust, Haukeland University Hospital, Ostfold Hospital Trust, Lillehammer Hospital for Rheumatic Diseases, Vestre Viken Hospital Trust, Haugesund Rheumatism Hospital, Betanien Hospital, Helgeland Hospital Trust, Nordlandssykehuset HF, Carol Davila University of Medicine and Pharmacy, Humanitas Research Hospital IRCCS, Rozzano-Milan, Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Espen A Haavardsholm, Phd, MD, Study director, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440629
- Sponsor's protocol ID
- EU CT No 2023-510184-35-00
- Acronym
- RA-DRUM
- Status last verified
- Jun 2026
- First submitted
- 23 May 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified patient data set can be made available to researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open, Randomized, 18-month, Parallel-group, Superiority Study to Compare the Effect of Proactive Therapeutic Drug Monitoring Versus Standard of Care With Regards to Maintenance of Sustained Disease Control Without Flare in Adults With Rheumatoid Arthritis Treated With a Subcutaneous Tumor Necrosis Factor Inhibitor
- ClinicalTrials.gov ID
- NCT06440629
- Acronym / sponsor ID
- RA-DRUM / EU CT No 2023-510184-35-00
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Therapeutic drug monitoring, Tumor necrosis factor inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Karolinska University Hospital, Queen Mary University of London, Medical University of Vienna, Alesund Hospital, St. Olavs Hospital, Helse Stavanger HF, Drammen sykehus, University Hospital of North Norway, Førde Hospital Trust, Hospital of Southern Norway Trust, Haukeland University Hospital, Ostfold Hospital Trust, Lillehammer Hospital for Rheumatic Diseases, Vestre Viken Hospital Trust, Haugesund Rheumatism Hospital, Betanien Hospital, Helgeland Hospital Trust, Nordlandssykehuset HF, Carol Davila University of Medicine and Pharmacy, Humanitas Research Hospital IRCCS, Rozzano-Milan, Sahlgrenska University Hospital
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDM-group | Experimental | Drug: Therapeutic drug monitoring (TDM) of adalimumabIn the TDM-group, the TNFi dose will be adjusted in order to keep the drug level within the therapeutic range |
| Standard of Care group | No intervention | –In the Standard of Care group, TNFi will be administered according to standard of care without knowledge of serum drug levels or ADAb |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A clinical diagnosis of RA
- ≥ 18 and under 75 years of age at screening
- On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3 months and a maximum of 24 months
- In low disease activity or remission (DAS28-CRP under 3.2) and indication for continuation of treatment according to the treating physician
- Subject capable of understanding and signing an informed consent form
Key exclusion criteria (8 listed)
- 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
- Hypersensitivity to sc TNFi (adalimumab).
- Pregnancy, or subject considering becoming pregnant during the study period
- Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that makes adherence to the study protocol difficult
- Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within the last 2 months
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 |
|---|---|---|
| Therapeutic drug monitoring (TDM) of adalimumabIn 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 | Drug | TDM-group |
Primary outcome
Sustained disease control over the follow-up period of 18 months without flare
Time frame: 4, 8, 12, 18 months
A flare defined as either of the following: A combination of an increase in Disease Activity Score using 28 joints C-reactive protein (DAS28-CRP) ≥ 1.2, or ≥ 0.6 if DAS28-CRP ≥ 3.2, AND ≥ 2 swollen joints on examination of 44 joints OR Consensus between patient and physician that a disease flare has occurred, leading to a major change* in treatment *Please see protocol for the definition of a major change in treatment (due to word restrictions)
14 secondary outcomes
Disease activity assessed by Disease Activity Score using 28 joints C-reactive protein (DAS28-CRP)
Time frame: 4, 8, 12, and 18 months
Disease activity measured by 44 joint count
Time frame: 4, 8, 12, and 18 months
Patient Global assessment of disease activity (PGA)
Time frame: 4, 8, 12, and 18 months
Evaluators Global Assessment of Disease Activity (EGA)
Time frame: 4, 8, 12, and 18 months
Disease activity assessed by Clinical Disease Activity Index (CDAI)
Time frame: 4, 8, 12, and 18 months
Disease activity assessed by Simple Disease Activity Index (SDAI)
Time frame: 4, 8, 12, and 18 months
Remission assessed by American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) remission criteria
Time frame: 4, 8, 12, and 18 months
Rheumatoid Arthritis Impact of Disease (RAID)
Time frame: 4, 8, 12, and 18 months
Evaluation of physical function measured by Modified Health Assessment Questionnaire (MHAQ)
Time frame: 4, 8, 12, and 18 months
Number and type of adverse events (AE)
Time frame: 4, 8, 12, and 18 months
Drug survival
Time frame: 4, 8, 12, and 18 months
Drug consumption
Time frame: 18 months
Occurrence of anti-drug antibodies (ADAb)
Time frame: 2, 4, 6, 8, 10, 12, 14, 16, 18 months
Serum drug levels
Time frame: 2, 4, 6, 8, 10, 12, 14, 16, 18 months
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 1 Jul 2026.
- Individual participant dataSharing planned: Yes. A de-identified patient data set can be made available to researchers 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.
Espen A Haavardsholm, Phd, MD study director
Diakonhjemmet Hospital
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Therapeutic drug monitoring (TDM) of adalimumab in people with Rheumatoid Arthritis, run by Diakonhjemmet Hospital at 22 sites in 6 countries.
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 5 inclusion and 8 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Norway, Sweden, Austria, Italy, Romania and 1 more country. 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?
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?
Sustained disease control over the follow-up period of 18 months without flare (time frame: 4, 8, 12, 18 months). 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 1 Jul 2026.