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Rheumatoid ArthritisNOR-DRUMNCT03074656

The Norwegian Drug Monitoring Study

A study testing Therapeutic drug monitoring in people with Rheumatoid Arthritis and Spondyloarthritis, run by Diakonhjemmet Hospital at 21 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Infliximab and other TNF-inhibitors have revolutionised the treatment of several immunological inflammatory diseases. Still, more than half of the patients either do not respond sufficiently to infliximab therapy or loose efficacy over time. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Therapeutic drug monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
611 participants
Where
21 sitesNorway
Study dates
1 Mar 2017to 14 Dec 2020
Phase
Interventional
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • NOR-DRUM A
  • A clinical diagnosis of one of the following; rheumatoid arthritis, spondyloarthritis (including ankylosing spondylitis), psoriatic arthritis*, ulcerative colitis, Crohn's disease or chronic plaque psoriasis
  • Male or non-pregnant female
  • ≥18 and < 75 years of age at screening
  • A clinical indication to start INX
  • Subject not in remission according to diagnosis-specific disease activity scores
Show all 16Show fewer
  • Subject capable of understanding and signing an informed consent form
  • Patients with psoriatic arthritis with predominantly axial manifestations should be included and assessed as spondyloarthritis
  • NOR-DRUM B
  • A clinical diagnosis of one of the following; rheumatoid arthritis, spondyloarthritis (including ankylosing spondylitis), psoriatic arthritis*, ulcerative colitis, Crohn's disease or chronic plaque psoriasis
  • Male or non-pregnant female
  • ≥18 and < 75 years of age at screening
  • On maintenance therapy with infliximab for a minimum of 30 weeks and a maximum of 3 years
  • A clinical indication for further infliximab treatment
  • Subject capable of understanding and signing an informed consent form
  • Patients with psoriatic arthritis and predominantly axial manifestations should be included and assessed as spondyloarthritis

Who cannot join

  • NOR-DRUM A
  • Major co-morbidities, such as previous malignancies within the last 5 years, severe 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, laboratory abnormalities or significant renal or hepatic disease and/or other diseases or conditions where treatment with infliximab is either found contra-indicated by the clinician or which make adherence to the protocol difficult
  • A positive screening for TB and hepatitis
  • Inadequate birth control, 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 which makes adherence to the study protocol difficult
  • Prior use of infliximab within the last 6 months
Show all 10Show fewer
  • NOR-DRUM B
  • Major co-morbidities, such as previous malignancies within the last 5 years, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, laboratory abnormalities or significant renal or hepatic disease and/or other diseases or conditions where treatment with infliximab is either found contra-indicated by the clinician or which make adherence to the protocol difficult
  • Inadequate birth control, 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 which makes adherence to the study protocol difficult

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Norway21 sites

  • Ålesund, HELSE MØRE OG ROMSDAL HF

    Ålesund

  • Sørlandet Sykehus, Arendal

    Arendal

  • Haukeland, HELSE BERGEN HF,

    Bergen

  • Bodø, NORDLANDSSYKEHUSET

    Bodø

  • Drammen, VESTRE VIKEN HF

    Drammen

  • Elverum, SYKEHUSET INNLANDET HF

    Elverum

  • Helse Førde Hf

    Førde

  • Hamar, SYKEHUSET INNLANDET HF

    Hamar

  • HAUGESUND SANITETSFORENING revmatismesykehus

    Haugesund

  • Haugesund Sjukehus

    Haugesund

  • SØRLANDET SYKEHUS HF Kristiansand

    Kristiansand

  • REVMATISMESYKEHUSET AS, Lillehammer

    Lillehammer

  • Sykehuset Østfold Moss

    Moss, 1535

  • Akershus University Hospital

    Oslo, Lørenskog, 1478

  • Rikshospitalet

    Oslo, 0372

  • Diakonhjemmet Sykehus

    Oslo, 0687

  • Betanien Hospital

    Skien

  • Stavanger Universitetssjukehus

    Stavanger

  • Sykehuset Vestfold, Tønsberg

    Tønsberg

  • Tromsø, UNIVERSITETSSYKEHUSET NORD-NORGE HF

    Tromsø

  • St Olavs Hospital

    Trondheim

Other trials in Norway

About this study

Official title: A NORwegian Multicentre Randomised Controlled Trial Assessing the Effectiveness of Tailoring Infliximab Treatment by Therapeutic DRUg Monitoring - The NOR-DRUM Study

Infliximab and other TNF-inhibitors have revolutionised the treatment of several immunological inflammatory diseases. Still, more than half of the patients either do not respond sufficiently to infliximab therapy or loose efficacy over time. The large individual variation in the serum drug concentrations on standard doses and the development of anti-drug antibodies are thought to be main reasons for these treatment failures. An individualised treatment strategy based on systematic assessments of serum drug concentrations, therapeutic drug monitoring, has been proposed as a clinical tool to optimise efficacy of infliximab treatment. Therapeutic drug monitoring seems reasonable both from a clinical and an economical point of view, but the effectiveness of this treatment strategy still remain to be shown. The NOR-DRUM study is planned as a national, randomised controlled multicentre trial in two parts aiming to assess the effectiveness of therapeutic drug monitoring in order to achieve remission in patients with immunological inflammatory diseases starting infliximab treatment (part A) and in order to maintain disease control in patients on maintenance infliximab treatment (part B). The results of the NOR-DRUM study will hopefully contribute to an implementation of a personalised medicine approach to treatment with infliximab and other biological drugs.

Being tested
Therapeutic drug monitoring, Standard care
Keywords
infliximab, therapeutic drug monitoring, anti drug antibodies, TDM
Medical subject headings
Arthritis, Rheumatoid, Spondylarthritis, Spondylitis, Ankylosing, Crohn Disease, Colitis, Ulcerative, Psoriasis, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic drug monitoringOther

    Treatment algorithm based on assessments of serum drug levels and anti-drug antibodies

  • Standard careOther

    Treatment algorithm based on standard clinical assessments, without knowledge of serum drug levels and anti-drug antibodies

Study groups in NCT03074656
Study groupRoleWhat they receive
Therapeutic drug monitoringExperimentalAdministration of infliximab according to a treatment strategy based on therapeutic drug monitoring and assessments of anti-drug antibodies
Receives: Other: Therapeutic drug monitoring
Standard careActive comparatorAdministration of infliximab according to standard clinical care, without knowledge of drug levels or status of anti-drug antibodies
Receives: Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients in remission defined by disease specific composite scores Study part A

    Definition of remission: DAS 28 score <2.6 in patients with RA and PsA, ASDAS score <1.3 in patients with SpA, Mayo score of ≤2 with no sub scores >1 in patients with UC, HBI score of ≤4 in CD and PASI score of ≤4 in patients with Ps.

    Measured: 30 weeks

  2. Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B

    Definition of disease worsening: RA/PsA: Change DAS28 of ≥ 1.2 and min DAS 3.2 SpA: Increase in ASDAS of ≥1.1 and min ASDAS of 2.1 UC: Increase in Partial Mayo score of ≥ 3 and min score of ≥ 5 CD: Increase in HBI of ≥ 4 points and min score of 7 Ps: Increase in PASI of ≥ 3 points and min PASI score of 5 Or: Patient and investigator consensus on disease worsening

    Measured: 52 weeks

Secondary outcomes (35)

  1. Time to sustained remission (Part A)

    Remission at all following visit

    Measured: Assessed at all time points up to 30 weeks

  2. Patient's and physician's global assessment of disease activity (Part A and B)

    Visual analogue scale (VAS) 0 mm-100 mm (100 mm worst outcome)

    Measured: 30 weeks (A) and 52 weeks (B)

  3. ESR (Part A and B)

    0-100 mmHg

    Measured: 30 weeks (A) and 52 weeks (B)

  4. CRP (Part A and B)

    mg/L

    Measured: 30 weeks (A) and 52 weeks (B)

  5. Occurrence of anti-drug antibodies (Part A and B)

    Defined as ADAb ≥15 µg/L

    Measured: 30 weeks (A) and 52 weeks (B)

  6. Occurrence of drug discontinuation (Part A and B)

    Infliximab discontinuation

    Measured: 30 weeks (A) and 52 weeks (B)

  7. Cost effectiveness, QALY

    Part A and B (Incremental Quality adjusted life years (QALYs) of the intervention arm and active comparator)

    Measured: 30 weeks (A) and 52 weeks (B)

  8. Cost effectiveness, ICERs

    Part A and B (Cost-effectiveness ratios (ICERs) of the intervention arm and active comparator)

    Measured: 30 weeks (A) and 52 weeks (B)

  9. Health utility (EQ-5D)

    EuroQol 5 (EQ-5D) dimensions The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state

    Measured: 30 weeks (A) and 52 weeks (B)

  10. Quality of life (SF-36)

    The SF-36 is a multi-purpose, short-form health survey with 36 questions. The SF-36 will be scored according to RAND 36-Item Health Survey 1.0 to form eight measures scores 0-100 (100 worst outcome): physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.

    Measured: 30 weeks (A) and 52 weeks (B)

  11. Safety (adverse events frequency)

    A and B

    Measured: 30 weeks (A) and 52 weeks (B)

  12. Time to disease worsening

    Part B

    Measured: 52 weeks

  13. Proportion of patients in remission, diagnostic subgroups (overall in B)

    RA/PsA: DAS28 remission, SDAI remission, ACR/EULAR remission, SpA: ASDAS inactive disease, UC: PMS, CD: HBI, Ps PASI

    Measured: 30 weeks (A) and 52 weeks (B)

  14. Serum drug level

    Trough level

    Measured: Assessed at all time points up to 30 weeks

  15. Proportion of patients with improvement defined by disease specific composite scores (Part A)

    • Improvement in RA and PsA Improvement is defined as a decrease in DAS28 of ≥1.2 from baseline
    • Improvement in SpA Improvement is defined as a decrease in ASDAS of ≥1.1 from baseline
    • Improvement in UC Improvement in UC is defined as a decrease in the partial Mayo score of ≥ 3 points from baseline or a partial Mayo score of 0
    • Improvement in CD Improvement in CD is defined as a decrease in HBI of ≥ 4 points from baseline
    • Improvement in Ps Improvement in Ps is defined as PASI 50 (A 50% decrease in the PASI obtained at baseline)
    • Patient and investigators consensus on improvement

    Measured: 14 weeks

  16. Time to remission (Part A)

    Definition of remission: DAS 28 score <2.6 in patients with RA and PsA, ASDAS score <1.3 in patients with SpA, Mayo score of ≤2 with no sub scores >1 in patients with UC, HBI score of ≤4 in CD and PASI score of ≤4 in patients with Ps.

    Measured: Assessed at all time points up to week 30

  17. DAS28 (RA and PsA only)

    The 28-joint Disease Activity Score (DAS28) includes the 28- tender joint counts (TJC28), 28-swollen joint counts (SJC28), Erythrocyte Sedimentation Rate (ESR) and Patient Global Assessment (PGA) on a VAS

    According to DAS28, the following cut-points are used:

    High disease activity: DAS28 > 5.1 Moderate disease activity: 5.1 ≥ DAS28>3.2 Low disease activity: 3.2 ≥ DAS28 ≥ 2.6 In remission: DAS28 < 2.6

    Measured: 30 weeks (A) and 52 weeks (B)

  18. Partial Mayo score

    The Mayo score consists of four components (rectal bleeding, stool frequency, physician rating of disease activity, and mucosal appearance at endoscopy) rated from 0-3 that are summed to give a total score that ranges from 0-12. The non-invasive partial Mayo score (PMS) does not require an endoscopy, and thereby ranging from 0-9.

    Remission is defined as a partial Mayo score of ≤ 2 with no individual subscore >1

    Measured: 30 weeks (A) and 52 weeks (B)

  19. SDAI (RA and PsA only)

    The Simplified Disease Activity Index (SDAI) includes TCJ28, SJC28, PGA, PhGA and CRP. In remission: SDAI ≤ 3.3. High values denotes worse outcomes. High values denotes worse outcomes.

    Measured: 30 weeks (A) and 52 weeks (B)

  20. EULAR response (RA and PsA only)

    Defined according to EULAR definition

    Measured: 30 weeks (A)

  21. ACR/EULAR remission

    • TJC28 ≤ 1
    • SJC28 ≤ 1
    • CRP ≤ 10 (mg/l)
    • PGA ≤ 14

    Measured: 30 weeks (A)

  22. ACR response

    If a patient experiences a flare and treatment is escalated, the ACR response rates ACR20, ACR50, ACR70 and ACR90 as well as ACR remission rates will be calculated.

    An ACR20 response is defined if the following criteria are fulfilled:

    • 20% improvement in RAI AND
    • 20% improvement in swollen joint count 44 AND
    • 20% improvement in at least 3 of 5 other core set items

    The other core set items consist of:

    • Investigator global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient pain
    • Disability
    • ESR/CRP

    Measured: 30 weeks (A)

  23. DAPSA (PsA only)

    Disease Activity index for PSoriatic Arthritis (DAPSA) is calculated as follows: TJC68 + SJC66 + CRP(mg/L)/10 + PGA(0-100)/10+VAS Pain(0-100)/10. High values denotes worse outcomes.

    Measured: 30 weeks (A) and 52 weeks (B)

  24. BASDAI (SpA only)

    The Bath Ankylosing Spondylitits Disease Activity Index (BASDAI) includes six questions pertaining to the five major symptoms of ankylosing spondylitis: fatigue (Q1), spinal pain (Q2), joint pain/swelling (Q3), areas of localized tenderness (Q4), morning stiffness duration (Q5) and morning stiffness severity (Q6). Each question is scored on an NRS (0-10).

    Measured: 30 weeks (A) and 52 weeks (B)

  25. ASDAS

    The Ankylosing Spondylitis Disease Activity Score (ASDAS) is computed based on patient reported outcomes (components of BASDAI) and the CRP. The ASDAS-CRP is calculated as follows:

    ASDAS-CRP=0.121*total back pain + 0.0110*patient global + 0.073*peripheral pain/swelling + 0.058*duration of morning stiffness + 0.579*ln(CRP+1 High values denotes worse outcomes

    Measured: 30 weeks (A) and 52 weeks (B)

  26. Partial Mayo Score (UC only)

    The Mayo score consists of four components (rectal bleeding, stool frequency, physician rating of disease activity, and mucosal appearance at endoscopy) rated from 0-3 that are summed to give a total score that ranges from 0-12. The non-invasive partial Mayo score (PMS) does not require an endoscopy, and thereby ranging from 0-9.

    Remission is defined as a partial Mayo score of ≤ 2 with no individual subscore >1

    Measured: 30 weeks (A) and 52 weeks (B)

  27. Harvey-Bradshaw Index (CD only)

    The Harvey-Bradshaw index (HBI) consists of five domains, general well-being (0-4), abdominal pain (0-3), number of liquid soft stools per day, abdominal mass (0-3) and number of predefined complications. The scores of each sub-domain is summed up to compute the HBI.

    Remission is defined as a HBI score ≤ 4 points.

    Measured: 30 weeks (A) and 52 weeks (B)

  28. Psoriasis Area and Severity Index (PASI) (Ps only)

    A PASI 50/75 means a 50% /75% reduction in the PASI score. Complete clearance is defined as PASI=0, mild to moderate psoriasis is defined as PASI < 10, moderate to severe psoriasis between 10 and 20 and severe psoriasis above 20.

    Remission is defined as PASI <4

    Measured: 30 weeks (A) and 52 weeks (B)

  29. Modified Health Assessment Questionnaire

    Each item of the Modified Health Assessment Questionnaire (MHAQ) is scored on a categorical 0-3 scale and the sum score is divided by 8 to form the MHAQ score 0.0 to 3.0 (3.0 worst outcome possible)

    Measured: 30 weeks (A) and 52 weeks (B)

  30. Rheumatoid Arthritis Impact of Disease (RA only)

    The Rheumatoid Arthritis Impact of Disease (RAID) score is calculated based on seven numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10. The seven NRS correspond to pain, function, fatigue, sleep, emotional wellbeing, physical wellbeing and coping/self-efficacy.

    Measured: 30 weeks (A) and 52 weeks (B)

  31. Psoriatic Arthritis Impact of Disease (PsAID) score

    Psoriatic Arthritis Impact of Disease (PsAID) score is a questionnaire with 9 domains of health. The nine domains with relative weights are: pain (0.174), fatigue (0.131), skin (0.121), work and/or leisure activities (0.110), function (0.107), discomfort (0.098), sleep (0.089), coping (0.087) and anxiety (0.085), each rated on an NRS (0-10). The rates of each domain are weighted and summed to form a score in the range of 0-10 (10 worst outcome possible). The final RAID score is computed. The scale 0-10 where higher figures indicate worse status.

    Measured: 30 weeks (A) and 52 weeks (B)

  32. Inflammatory Bowel Disease Questionnaire (IBDQ)

    The Inflammatory Bowel Disease Questionnaire (IBDQ) is widely used tool to measure health-related quality of life in patients with inflammatory bowel diseases. The questionnaire consists of 32 questions scored in four domains: bowel symptoms, emotional health, systemic systems and social function. The total IBDQ score is the sum of all the question scores, ranging 32 to 224 (224 worst possible)

    Measured: 30 weeks (A) and 52 weeks (B)

  33. Total drug consumption

    mg/kg/ week

    Measured: 30 weeks (A) and 52 weeks (B)

  34. Dermatology Life Quality Index (DLQI)

    The Dermatology Life Quality Index (DLQI) consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. It has been validated for adult dermatology patients aged 16 years and older. The items of the DLQI encompass aspects of symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. Each question is scored on a 4-point Likert scale: Not at all/Not relevant=0, A little=1, A lot=2 and Very much=3. Scores of individual items (0-3) are added to yield a total score (0-30); higher scores mean greater impairment of patient's QoL. The DLQI will only be presented to patients with chronic plaque psoriasis.

    Measured: 30 weeks (A) and 52 weeks (B)

  35. Calprotectin

    Faecal calprotectin is an inflammatory marker for IBD. It is measured in mg/kg

    Measured: 30 weeks (A) and 52 weeks (B)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2017
  2. Study start1 Mar 2017
  3. Primary completion14 Dec 2020
  4. Study completion14 Dec 2020

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
611 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03074656
Sponsor's protocol ID
DIA2016-1
Acronym
NOR-DRUM
Status last verified
Mar 2021
First submitted
10 Feb 2017
Last updated
8 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Holly T, Kirkesaether Brun M, Jorgensen KK, Goll GL, Sexton J, Gehin JE, Kvien TK, Jahnsen J, Provan SA, Bolstad N, Aas E, Haavardsholm EA, Kristiansen IS, Syversen SW, Hagen G. Cost-effectiveness of proactive therapeutic drug monitoring of maintenance infliximab treatment in patients with immune-mediated inflammatory diseases: results from a randomised controlled trial. RMD Open. 2026 Mar 19;12(1):e006329. doi: 10.1136/rmdopen-2025-006329.

    PubMed 41856561

  • Syversen SW, Jorgensen KK, Goll GL, Brun MK, Sandanger O, Bjorlykke KH, Sexton J, Olsen IC, Gehin JE, Warren DJ, Klaasen RA, Noraberg G, Bruun TJ, Dotterud CK, Ljosa MKA, Haugen AJ, Njalla RJ, Zettel C, Ystrom CM, Bragnes YH, Skorpe S, Thune T, Seeberg KA, Michelsen B, Blomgren IM, Strand EK, Mielnik P, Torp R, Mork C, Kvien TK, Jahnsen J, Bolstad N, Haavardsholm EA. Effect of Therapeutic Drug Monitoring vs Standard Therapy During Maintenance Infliximab Therapy on Disease Control in Patients With Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial. JAMA. 2021 Dec 21;326(23):2375-2384. doi: 10.1001/jama.2021.21316.

    PubMed 34932077

  • Syversen SW, Goll GL, Jorgensen KK, Sandanger O, Sexton J, Olsen IC, Gehin JE, Warren DJ, Brun MK, Klaasen RA, Karlsen LN, Noraberg G, Zettel C, Ljosa MKA, Haugen AJ, Njalla RJ, Bruun TJ, Seeberg KA, Michelsen B, Strand EK, Skorpe S, Blomgren IM, Bragnes YH, Dotterud CK, Thune T, Ystrom CM, Torp R, Mielnik P, Mork C, Kvien TK, Jahnsen J, Bolstad N, Haavardsholm EA. Effect of Therapeutic Drug Monitoring vs Standard Therapy During Infliximab Induction on Disease Remission in Patients With Chronic Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial. JAMA. 2021 May 4;325(17):1744-1754. doi: 10.1001/jama.2021.4172.

    PubMed 33944876

  • Syversen SW, Goll GL, Jorgensen KK, Olsen IC, Sandanger O, Gehin JE, Warren DJ, Sexton J, Mork C, Jahnsen J, Kvien TK, Bolstad N, Haavardsholm EA. Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (the NOR-DRUM study). Trials. 2020 Jan 6;21(1):13. doi: 10.1186/s13063-019-3734-4.

    PubMed 31907007

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic drug monitoring in people with Rheumatoid Arthritis and Spondyloarthritis, run by Diakonhjemmet Hospital at 21 sites in Norway.

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 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients in remission defined by disease specific composite scores Study part A (time frame: 30 weeks). The study lists 2 primary outcomes in all. 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 NCT03074656, which also lists 4 linked publications.

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 8 Mar 2021.

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