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Autoimmune DiseasesBELIEVENCT03173144

Chronic Inflammatory Disease, Lifestyle and Treatment Response

An observational study of Autoimmune Diseases and Inflammatory Bowel Diseases, run by University of Southern Denmark at 3 sites in Denmark.

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

Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis are treated with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Primary exposure variable and Other (exploratory) exposure variables
How many people
233 participants
Where
3 sitesDenmark
Study dates
21 Sep 2017to 30 Apr 2021
How long will I take part?
16 Weeks
Phase
Observational
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

Study population: targeted therapy and able to read and understand Danish.

Who may be able to join

  • diagnosed with chronic inflammatory disease
  • initiation of targeted therapy
  • able to read and understand Danish

Who cannot join

  • not mentally able to reply the questionnaire

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Hospital of Southern Jutland

    Aabenraa, 6200

  • Herlev Hospital

    Herlev, 2730

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: Impact of Red and Processed Meat and Fibre Intake on Treatment Outcome Among Patients With Chronic Inflammatory Diseases: Protocol for a Prospective Cohort Study on Prognostic Factors and Personalised Medicine

Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis are treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do, however, not respond to biologics and lifestyle is assumed to affect the treatment outcome. However, little is known on the effects of lifestyle as a prognostic factor (possibly enabling personalised medicine). The aims of this multidisciplinary collaboration are to identify lifestyle factors that support individualised forecasting of optimised treatment outcome on these costly drugs.

This prospective cohort study will enrol CID patients assigned for biologic treatment. At baseline (Pre-treatment), patient characteristics are assessed using patient-reported outcome measures and clinical assessments on disease activity, quality of life, and lifestyle together with registry data on comorbidity and medication. Follow-up will be conducted at week 14-16 after treatment initiation (according to the current Danish standards). Evaluation of a successful treatment outcome response will - for each disease - be based on most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients with specific lifestyle characteristics.

Read more

The overarching goal of this project is to improve the lives of patients suffering from CID, by providing evidence to support dietary recommendations likely to improve the clinical outcome.

The study is approved by the local Ethics Committee (S-20160124) and the local Data Agency (2008-58-035). The study findings will be disseminated in peer-reviewed journals, via patient associations, and presented at national and international conferences.

Read the detailed description

Chronic inflammatory diseases (CID), including inflammatory bowel diseases (IBD) (of which Crohn's disease [CD] and ulcerative colitis [UC] are the two most prevailed entities), rheumatic conditions (rheumatoid arthritis [RA], axial spondyloarthropathy [axSpA], psoriatic arthritis [PsA]), skin diseases (psoriasis [PsO], hidradenitis suppurativa [HS]), and eye disease (non-infectious uveitis [NiU]), are diseases of the immune system that are managed with biological agents targeting the pro-inflammatory cytokine tumour necrosis factor-α (TNF), i.e. TNF inhibitors.

Design In this prospective cohort study disease activity prior to and after (14-16 weeks) initiation of biologic treatment will be assessed. The endpoint is the treatment outcome defined as A: Responder according to the specific criteria described below (incl. drug-continuation) or B: Non-responder (incl. drug-discontinuation due to unacceptable side effects). Whether a patient will discontinue therapy is assumed to be based on a certain degree of shared decision making between the patient and physician supported by principles from national guidelines for each CID as recommended in the respective national guidelines and laboratory data.

Setting All patients assigned for initiation of biologic treatment at 1) Department of Gastroenterology and Hepatology, Aalborg University Hospital; 2) Department of Hepatology and Gastroenterology, Aarhus University Hospital; 3) Diagnostic Centre, Silkeborg Regional Hospital; 4) Department of Internal Medicine, Herning Regional Hospital; 5) Department of Gastroenterology, Herlev Hospital; 6) Organ Centre, Hospital of Southern Jutland; 7) Department of Gastroenterology Hospital of South West Jutland; 8) Department of Medical Gastroenterology, Department of Rheumatology, Department of Dermatology and Allergy Centre, and Department of Ophthalmology, Odense University Hospital from 1st of April 2017 and until 31th of Marts 2019 or until a minimum of 100 patients with IBD, 100 patients with RA, and 120 patients with axSpA, PsA, PsO, HS and NiU are achieved.

Clinical data consist of personal data, data on health and disease, lifestyle, laboratory measure, and disease activity scores including using patient-reported outcome measures (PROMs), clinical assessments, and laboratory data. Each participant will fill out validated questionnaires on disease activity, quality of life, and lifestyle using an electronic link. Studies have found electronic questionnaires to be equivalent to paper-based in relation to PROMs.

Data management The electronic questionnaire is in Danish language and the participants will have access to the questionnaire by an electronic link sent to their personal, electronic mailbox. All data will be stored in a secure research storage facility. Information registered by clinicians and technicians will be transferred from paper format to electronic format using either double entry of data or automated forms processing.

Statistical methods The investigators will use this rigorously designed, prospective cohort study to explore the ability to predict clinical response across the conditions included (Y=primary endpoint), and explore whether patients who are on a diet high in fibre AND low in red and processed meat (X=assessed at baseline) is an informative prognostic factor. Per default, the statistical model will include condition (any of the CID conditions included), and clinical centre (site #1 to #8) as fixed effects.

Sample size considerations: It is a well-known difficulty for exploratory prognostic factor research studies like this, to formalize how many participants (i.e. with events) to include. In order to consider an adequate number of outcome events, the investigators apply "the rule of thumb" that dictates that 10 outcome events are needed for each independent variable (possible predictors); the investigators plan to enrol 320 patients in total, and anticipate that 50% of these will experience a clinical response during the 14-16 week period after therapy is initiated. With this in mind: Anticipating that at least 160 will achieve clinical responses (among the 320 patients), this study will have a reasonable power to explore the impact of as many as 16 independent (predictor) variables (including condition and clinical centre).

Focusing on the contrast between groups, for a comparison of two independent binomial proportions (those with high fibre AND low meat intake vs other) using Pearson's Chi-square statistic with a Chi-square approximation with a two-sided significance level of 0.05 (P<0.05), a total sample size of 318 assuming an allocation ratio of 1 to 2 has an approximate power of 0.924 (i.e. >90% statistical power) when the proportions responding are 60% and 40%, respectively.

All the statistical programming will be done in SAS (Statistical Analysis Software), STATA or R, transparently reporting the source code used to analyse the data. All computational details will be available in the pre-specified Statistical Analysis Plan (will be finalised before data collection is complete).

Project organisation The project is organised with a Clinical Research Group and an Analytical Research Group. The clinical group includes specialists from the medical, gastroenterological, rheumatological, dermatological and ophthalmological departments that are sampling the cohort. The analytical group will perform the analyses on the biological material.

Being tested
Primary exposure variable, Other (exploratory) exposure variables
Keywords
Life Style, Diet, Food, Exercise, Treatment Outcome, Biomarkers, Smoking
Medical subject headings
Autoimmune Diseases, Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Arthritis, Rheumatoid, Spondylarthropathies, Arthritis, Psoriatic, Psoriasis

What participants receive

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

  • Primary exposure variableOther

    Also called intake of red and processed meat and fibres

    1. Upper tertile (33.3% of the total sample) based on the ratio: fibre/meat intake is associated with better treatment outcome
    2. Low intake of red and processed meat (defined as below the lower tertile [33.3% of the total sample]) and high intake of dietary fibres (defined as those above the upper tertile [33.3% of the total sample]) are independently associated with better treatment outcome, and their synergy (interaction between the factors meat and fibres) gives the best treatment outcome

  • Other (exploratory) exposure variablesOther

    • Lifestyle factors independently or combined (red and processed meat, vegetable, dietary fibre, cereals, gluten, legumes, red wine, dairy products, physical activity, smoking, total protein/ fat, protein/ fat from red and processed meat, glucemic index)
    • Pretreatment lifestyle-associated biomarkers
    • Combinations of lifestyle factors and lifestyle-associated biomarkers
    • Gene-environment interaction analyses
    • Pretreatment levels of inflammatory molecules

What is being measured

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

  1. Clinical response to therapy depending on condition

    The predefined primary endpoint will be the proportion of patients with clinical response to therapy at first clinical follow-up.

    • Crohn's disease: HBI of 4 or less
    • Ulcerative colitis: Mayo Clinic Score of 2 or less (with no individual subscore of >1)
    • Rheumatoid arthritis: ACR20
    • Axial spondyloarthritis: ASAS20
    • Psoriatic arthritis: ACR20
    • Psoriasis: PASI75
    • Hidradenitis suppurativa: HiSCR
    • Uveitis: those who did not have a treatment failure

    Measured: week 14-16

Secondary outcomes (54)

  1. Crohns disease: Disease-specific core outcome sets-1

    • STRIDE (y/n)

    Measured: week 14-16

  2. Crohns disease: Disease-specific core outcome sets-2

    • HBI (score)

    Measured: week 14-16

  3. Crohns disease: Disease-specific core outcome sets-3

    • Physician global assessment (score)

    Measured: week 14-16

  4. Crohns disease: Disease-specific core outcome sets-4

    • Number of draining fistulas (only fistulising CD) (number)

    Measured: week 14-16

  5. Crohns disease: Disease-specific core outcome sets-5

    • Corticosteroid-Free Remission (y/n)

    Measured: week 14-16

  6. Crohns disease: Disease-specific core outcome sets-6

    • Supplemental medication (y/n)

    Measured: week 14-16

  7. Ulcerative Colitis: Disease-specific core outcome sets-1

    • STRIDE criteria (y/n)

    Measured: week 14-16

  8. Ulcerative Colitis: Disease-specific core outcome sets-2

    • Mayo Clinical Score (score)

    Measured: week 14-16

  9. Ulcerative Colitis: Disease-specific core outcome sets-3

    • Mayo "normal mucosal appearance" (y/n)

    Measured: week 14-16

  10. Ulcerative Colitis: Disease-specific core outcome sets-4

    • Mayo clinical response (y/n)

    Measured: week 14-16

  11. Ulcerative Colitis: Disease-specific core outcome sets-5

    • SCCAI (score)

    Measured: week 14-16

  12. Ulcerative Colitis: Disease-specific core outcome sets-6

    • Corticosteroid-Free Remission (y/n)

    Measured: week 14-16

  13. Ulcerative Colitis: Disease-specific core outcome sets-7

    • Supplemental medication (y/n)

    Measured: week 14-16

  14. Rheumatoid Arthritis: Disease-specific core outcome sets-1

    • Tender joints (number)

    Measured: week 14-16

  15. Rheumatoid Arthritis: Disease-specific core outcome sets-2

    • Swollen joints (number)

    Measured: week 14-16

  16. Rheumatoid Arthritis: Disease-specific core outcome sets-3

    • Pain (0-100 mm VAS)

    Measured: week 14-16

  17. Rheumatoid Arthritis: Disease-specific core outcome sets-4

    • Physician global assessment (0-100 mm VAS)

    Measured: week 14-16

  18. Rheumatoid Arthritis: Disease-specific core outcome sets-5

    • Patient global assessment (0-100 mm VAS)

    Measured: week 14-16

  19. Rheumatoid Arthritis: Disease-specific core outcome sets-6

    • HAQ-DI (score)

    Measured: week 14-16

  20. Rheumatoid Arthritis: Disease-specific core outcome sets-7

    • C-Reactive protein (mg/l)

    Measured: week 14-16

  21. Rheumatoid Arthritis: Disease-specific core outcome sets-8

    • DAS28-CRP (score)

    Measured: week 14-16

  22. Rheumatoid Arthritis: Disease-specific core outcome sets-9

    • Simplified Disease Activity Index (SDAI) (index)

    Measured: week 14-16

  23. Axial Spondyloarthropathy: Disease-specific core outcome sets-1

    • BASFI (score)

    Measured: week 14-16

  24. Axial Spondyloarthropathy: Disease-specific core outcome sets-2

    • BASDAI (score)

    Measured: week 14-16

  25. Axial Spondyloarthropathy: Disease-specific core outcome sets-3

    • BASMI (score)

    Measured: week 14-16

  26. Axial Spondyloarthropathy: Disease-specific core outcome sets-4

    • Total score for back pain (0-100 mm VAS)

    Measured: week 14-16

  27. Axial Spondyloarthropathy: Disease-specific core outcome sets-5

    • Physician global assessment (0-100 mm VAS)

    Measured: week 14-16

  28. Axial Spondyloarthropathy: Disease-specific core outcome sets-6

    • Patient global assessment (0-100 mm VAS)

    Measured: week 14-16

  29. Axial Spondyloarthropathy: Disease-specific core outcome sets-7

    • C-Reactive protein (mg/l)

    Measured: week 14-16

  30. Psoriatic Arthritis: Disease-specific core outcome sets-1

    • Tender joints (number)

    Measured: week 14-16

  31. Psoriatic Arthritis: Disease-specific core outcome sets-2

    • Swollen joints (number)

    Measured: week 14-16

  32. Psoriatic Arthritis: Disease-specific core outcome sets-3

    • Psoriatic Arthritis Pain VAS (0-100 mm VAS)

    Measured: week 14-16

  33. Psoriatic Arthritis: Disease-specific core outcome sets-4

    • Physician global assessment (0-100 mm VAS)

    Measured: week 14-16

  34. Psoriatic Arthritis: Disease-specific core outcome sets-5

    • Patient global assessment (0-100 mm VAS)

    Measured: week 14-16

  35. Psoriatic Arthritis: Disease-specific core outcome sets-6

    • HAQ-DI (score)

    Measured: week 14-16

  36. Psoriatic Arthritis: Disease-specific core outcome sets-7

    • C-Reactive protein (mg/l)

    Measured: week 14-16

  37. Psoriatic Arthritis: Disease-specific core outcome sets-8

    • DAS28-CRP (score)

    Measured: week 14-16

  38. Psoriatic Arthritis: Disease-specific core outcome sets-9

    • Simplified Disease Activity Index (SDAI)(score)

    Measured: week 14-16

  39. Psoriatic Arthritis: Disease-specific core outcome sets-10

    • PASI (score)

    Measured: week 14-16

  40. Psoriasis: Disease-specific core outcome sets-1

    • PASI (score)

    Measured: week 14-16

  41. Psoriasis: Disease-specific core outcome sets-2

    • Physician global assessment (0-100 mm VAS)

    Measured: week 14-16

  42. Psoriasis: Disease-specific core outcome sets-3

    • Patient global assessment (0-100 mm VAS)

    Measured: week 14-16

  43. Psoriasis: Disease-specific core outcome sets-4

    • Dermatology Life Quality Index (DLQI) Total Score (score)

    Measured: week 14-16

  44. Hidradenitis Suppurativa: Disease-specific core outcome sets-1

    • Participants who achieve Abscess and Inflammatory Nodule (AN) Count of 0, 1, and 2, respectively (score)

    Measured: week 14-16

  45. Hidradenitis Suppurativa: Disease-specific core outcome sets-2

    • Patient's Global Assessment of Skin Pain (0-100 mm VAS)

    Measured: week 14-16

  46. Hidradenitis Suppurativa: Disease-specific core outcome sets-3

    • Modified Sartorius Score (score)

    Measured: week 14-16

  47. Non-Infectious Uveitis: Disease-specific core outcome sets-1

    • New active, inflammatory chorioretinal or retinal vascular lesions relative to Baseline (y/n)

    Measured: week 14-16

  48. Non-Infectious Uveitis: Disease-specific core outcome sets-2

    • Inability to achieve ≤ 0.5+ or a 2-step increase relative to best state achieved at all visits in anterior chamber cell grade or vitreous haze grade (y/n)

    Measured: week 14-16

  49. Non-Infectious Uveitis: Disease-specific core outcome sets-3

    • Worsening of best corrected visual acuity by ≥ 15 letters relative to best state achieved (y/n)

    Measured: week 14-16

  50. Health-related quality of life-1

    • SF12 (Short Form Health Survey) (score)

    Measured: week 14-16

  51. Health-related quality of life and disability-2

    • SHS (Short Health Scale) (score)

    Measured: week 14-16

  52. Health-related quality of life-2

    • SHS (Short Health Scale) (score)

    Measured: week 14-16

  53. Global assessment-1

    • Physician global assessment (0-100 mm VAS)

    Measured: week 14-16

  54. Global assessment-2

    • Patient global assessment (0-100 mm VAS)

    Measured: week 14-16

Timeline

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

  1. First posted1 Jun 2017
  2. Study start21 Sep 2017
  3. Primary completion22 Jul 2020
  4. Study completion30 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
233 participants (actual)
Target duration
16 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT03173144
Sponsor's protocol ID
MOK1
Other IDs
733100, KBF nr. 2016-056, 2016-11-29, J.nr 16/36626, OCAY-13-309
Acronym
BELIEVE
Status last verified
Jun 2021
First submitted
17 May 2017
Last updated
2 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Pseudoanonymised data on Health, lifestyle, treatment response and biological analyses will be shared with the Horizon 2020-project "A Systems medicine approach to chronic inflammatory disease" (SYSCID) partners.

Publications

  • Eggers KR, Mollegaard KM, Gregersen L, Overgaard SH, Hikmat Z, Ellingsen T, Kjeldsen J, Pedersen AK, Petersen SR, Jawhara M, Nexoe AB, Bygum A, Hvas CL, Dahlerup JF, Bergenheim FO, Glerup H, Brodersen JB, Munk HL, Pedersen N, Nielsen OH, Andersen KW, Heitmann BL, Christensen R, Andersen V. Impact of Obesity on Treatment Response in Patients With Chronic Inflammatory Disease Receiving Biologic Therapy: Secondary Analysis of the Prospective Multicentre BELIEVE Cohort Study. Scand J Immunol. 2025 Jun;101(6):e70035. doi: 10.1111/sji.70035.

    PubMed 40545788

  • Larsen MGR, Overgaard SH, Petersen SR, Mollegaard KM, Munk HL, Nexoe AB, Glerup H, Guldmann T, Pedersen N, Saboori S, Dahlerup JF, Hvas CL, Andersen KW, Jawhara M, Haagen Nielsen O, Bergenheim FO, Brodersen JB, Bygum A, Ellingsen T, Kjeldsen J, Christensen R, Andersen V. Effects of smoking on clinical treatment outcomes amongst patients with chronic inflammatory diseases initiating biologics: secondary analyses of the prospective BELIEVE cohort study. Scand J Immunol. 2024 Sep;100(3):e13395. doi: 10.1111/sji.13395. Epub 2024 Jul 7.

    PubMed 38973149

  • Overgaard SH, Sorensen SB, Munk HL, Nexoe AB, Glerup H, Henriksen RH, Guldmann T, Pedersen N, Saboori S, Hvid L, Dahlerup JF, Hvas CL, Jawhara M, Andersen KW, Pedersen AK, Nielsen OH, Bergenheim F, Brodersen JB, Heitmann BL, Halldorsson TI, Holmskov U, Bygum A, Christensen R, Kjeldsen J, Ellingsen T, Andersen V. Impact of fibre and red/processed meat intake on treatment outcomes among patients with chronic inflammatory diseases initiating biological therapy: A prospective cohort study. Front Nutr. 2022 Oct 13;9:985732. doi: 10.3389/fnut.2022.985732. eCollection 2022.

    PubMed 36313095

  • Christensen R, Heitmann BL, Andersen KW, Nielsen OH, Sorensen SB, Jawhara M, Bygum A, Hvid L, Grauslund J, Wied J, Glerup H, Fredberg U, Villadsen JA, Kjaer SG, Fallingborg J, Moghadd SAGR, Knudsen T, Brodersen J, Frojk J, Dahlerup JF, Bojesen AB, Sorensen GL, Thiel S, Faergeman NJ, Brandslund I, Bennike TB, Stensballe A, Schmidt EB, Franke A, Ellinghaus D, Rosenstiel P, Raes J, Boye M, Werner L, Nielsen CL, Munk HL, Nexoe AB, Ellingsen T, Holmskov U, Kjeldsen J, Andersen V. Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases: protocol for a prospective cohort study of prognostic factors and personalised medicine. BMJ Open. 2018 Feb 8;8(2):e018166. doi: 10.1136/bmjopen-2017-018166.

    PubMed 29439003

Questions about this trial

What is this clinical trial studying?

An observational study of Autoimmune Diseases and Inflammatory Bowel Diseases, run by University of Southern Denmark at 3 sites 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 3 inclusion and 1 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 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. 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?

Clinical response to therapy depending on condition (time frame: week 14-16). 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 NCT03173144, 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 2 Jul 2021.

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