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Chronic Inflammatory Disease, Lifestyle and Treatment Response (BELIEVE)

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ClinicalTrials.gov Identifier: NCT03173144
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : September 10, 2018
Sponsor:
Collaborators:
Hospital of Southern Jutland
University Hospital Bispebjerg and Frederiksberg
University of Copenhagen
Odense University Hospital
University of Aarhus
Aalborg University Hospital
Herning Hospital
Hospital of South West Jutland
Sygehus Lillebaelt
Aalborg University
University of Kiel
Colitis-Crohn Foreningen
Herlev Hospital
Regionshospitalet Silkeborg
Aarhus University Hospital
The Danish Psoriasis Association
Information provided by (Responsible Party):
Vibeke Andersen, University of Southern Denmark

Brief 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 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.

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.


Condition or disease Intervention/treatment
Autoimmune Diseases Inflammatory Bowel Diseases Crohn Disease (CD) Colitis, Ulcerative (UC) Arthritis, Rheumatoid (RA) Spondylarthropathies Arthritis, Psoriatic (PsA) Psoriasis Hidradenitis Suppurativa (HS) Uveitis Other: Primary exposure variable Other: Other (exploratory) exposure variables

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 16 Weeks
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
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber


Intervention Details:
  • Other: Primary exposure variable
    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 Name: intake of red and processed meat and fibres
  • Other: Other (exploratory) exposure variables
    • 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


Primary Outcome Measures :
  1. Clinical response to therapy depending on condition [ Time Frame: week 14-16 ]

    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


Secondary Outcome Measures :
  1. Crohns disease: Disease-specific core outcome sets-1 [ Time Frame: week 14-16 ]
    • STRIDE (y/n)

  2. Crohns disease: Disease-specific core outcome sets-2 [ Time Frame: week 14-16 ]
    • HBI (score)

  3. Crohns disease: Disease-specific core outcome sets-3 [ Time Frame: week 14-16 ]
    • Physician global assessment (score)

  4. Crohns disease: Disease-specific core outcome sets-4 [ Time Frame: week 14-16 ]
    • Number of draining fistulas (only fistulising CD) (number)

  5. Crohns disease: Disease-specific core outcome sets-5 [ Time Frame: week 14-16 ]
    • Corticosteroid-Free Remission (y/n)

  6. Crohns disease: Disease-specific core outcome sets-6 [ Time Frame: week 14-16 ]
    • Supplemental medication (y/n)

  7. Ulcerative Colitis: Disease-specific core outcome sets-1 [ Time Frame: week 14-16 ]
    • STRIDE criteria (y/n)

  8. Ulcerative Colitis: Disease-specific core outcome sets-2 [ Time Frame: week 14-16 ]
    • Mayo Clinical Score (score)

  9. Ulcerative Colitis: Disease-specific core outcome sets-3 [ Time Frame: week 14-16 ]
    • Mayo "normal mucosal appearance" (y/n)

  10. Ulcerative Colitis: Disease-specific core outcome sets-4 [ Time Frame: week 14-16 ]
    • Mayo clinical response (y/n)

  11. Ulcerative Colitis: Disease-specific core outcome sets-5 [ Time Frame: week 14-16 ]
    • SCCAI (score)

  12. Ulcerative Colitis: Disease-specific core outcome sets-6 [ Time Frame: week 14-16 ]
    • Corticosteroid-Free Remission (y/n)

  13. Ulcerative Colitis: Disease-specific core outcome sets-7 [ Time Frame: week 14-16 ]
    • Supplemental medication (y/n)

  14. Rheumatoid Arthritis: Disease-specific core outcome sets-1 [ Time Frame: week 14-16 ]
    • Tender joints (number)

  15. Rheumatoid Arthritis: Disease-specific core outcome sets-2 [ Time Frame: week 14-16 ]
    • Swollen joints (number)

  16. Rheumatoid Arthritis: Disease-specific core outcome sets-3 [ Time Frame: week 14-16 ]
    • Pain (0-100 mm VAS)

  17. Rheumatoid Arthritis: Disease-specific core outcome sets-4 [ Time Frame: week 14-16 ]
    • Physician global assessment (0-100 mm VAS)

  18. Rheumatoid Arthritis: Disease-specific core outcome sets-5 [ Time Frame: week 14-16 ]
    • Patient global assessment (0-100 mm VAS)

  19. Rheumatoid Arthritis: Disease-specific core outcome sets-6 [ Time Frame: week 14-16 ]
    • HAQ-DI (score)

  20. Rheumatoid Arthritis: Disease-specific core outcome sets-7 [ Time Frame: week 14-16 ]
    • C-Reactive protein (mg/l)

  21. Rheumatoid Arthritis: Disease-specific core outcome sets-8 [ Time Frame: week 14-16 ]
    • DAS28-CRP (score)

  22. Rheumatoid Arthritis: Disease-specific core outcome sets-9 [ Time Frame: week 14-16 ]
    • Simplified Disease Activity Index (SDAI) (index)

  23. Axial Spondyloarthropathy: Disease-specific core outcome sets-1 [ Time Frame: week 14-16 ]
    • BASFI (score)

  24. Axial Spondyloarthropathy: Disease-specific core outcome sets-2 [ Time Frame: week 14-16 ]
    • BASDAI (score)

  25. Axial Spondyloarthropathy: Disease-specific core outcome sets-3 [ Time Frame: week 14-16 ]
    • BASMI (score)

  26. Axial Spondyloarthropathy: Disease-specific core outcome sets-4 [ Time Frame: week 14-16 ]
    • Total score for back pain (0-100 mm VAS)

  27. Axial Spondyloarthropathy: Disease-specific core outcome sets-5 [ Time Frame: week 14-16 ]
    • Physician global assessment (0-100 mm VAS)

  28. Axial Spondyloarthropathy: Disease-specific core outcome sets-6 [ Time Frame: week 14-16 ]
    • Patient global assessment (0-100 mm VAS)

  29. Axial Spondyloarthropathy: Disease-specific core outcome sets-7 [ Time Frame: week 14-16 ]
    • C-Reactive protein (mg/l)

  30. Psoriatic Arthritis: Disease-specific core outcome sets-1 [ Time Frame: week 14-16 ]
    • Tender joints (number)

  31. Psoriatic Arthritis: Disease-specific core outcome sets-2 [ Time Frame: week 14-16 ]
    • Swollen joints (number)

  32. Psoriatic Arthritis: Disease-specific core outcome sets-3 [ Time Frame: week 14-16 ]
    • Psoriatic Arthritis Pain VAS (0-100 mm VAS)

  33. Psoriatic Arthritis: Disease-specific core outcome sets-4 [ Time Frame: week 14-16 ]
    • Physician global assessment (0-100 mm VAS)

  34. Psoriatic Arthritis: Disease-specific core outcome sets-5 [ Time Frame: week 14-16 ]
    • Patient global assessment (0-100 mm VAS)

  35. Psoriatic Arthritis: Disease-specific core outcome sets-6 [ Time Frame: week 14-16 ]
    • HAQ-DI (score)

  36. Psoriatic Arthritis: Disease-specific core outcome sets-7 [ Time Frame: week 14-16 ]
    • C-Reactive protein (mg/l)

  37. Psoriatic Arthritis: Disease-specific core outcome sets-8 [ Time Frame: week 14-16 ]
    • DAS28-CRP (score)

  38. Psoriatic Arthritis: Disease-specific core outcome sets-9 [ Time Frame: week 14-16 ]
    • Simplified Disease Activity Index (SDAI)(score)

  39. Psoriatic Arthritis: Disease-specific core outcome sets-10 [ Time Frame: week 14-16 ]
    • PASI (score)

  40. Psoriasis: Disease-specific core outcome sets-1 [ Time Frame: week 14-16 ]
    • PASI (score)

  41. Psoriasis: Disease-specific core outcome sets-2 [ Time Frame: week 14-16 ]
    • Physician global assessment (0-100 mm VAS)

  42. Psoriasis: Disease-specific core outcome sets-3 [ Time Frame: week 14-16 ]
    • Patient global assessment (0-100 mm VAS)

  43. Psoriasis: Disease-specific core outcome sets-4 [ Time Frame: week 14-16 ]
    • Dermatology Life Quality Index (DLQI) Total Score (score)

  44. Hidradenitis Suppurativa: Disease-specific core outcome sets-1 [ Time Frame: week 14-16 ]
    • Participants who achieve Abscess and Inflammatory Nodule (AN) Count of 0, 1, and 2, respectively (score)

  45. Hidradenitis Suppurativa: Disease-specific core outcome sets-2 [ Time Frame: week 14-16 ]
    • Patient's Global Assessment of Skin Pain (0-100 mm VAS)

  46. Hidradenitis Suppurativa: Disease-specific core outcome sets-3 [ Time Frame: week 14-16 ]
    • Modified Sartorius Score (score)

  47. Non-Infectious Uveitis: Disease-specific core outcome sets-1 [ Time Frame: week 14-16 ]
    • New active, inflammatory chorioretinal or retinal vascular lesions relative to Baseline (y/n)

  48. Non-Infectious Uveitis: Disease-specific core outcome sets-2 [ Time Frame: week 14-16 ]
    • 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)

  49. Non-Infectious Uveitis: Disease-specific core outcome sets-3 [ Time Frame: week 14-16 ]
    • Worsening of best corrected visual acuity by ≥ 15 letters relative to best state achieved (y/n)

  50. Health-related quality of life-1 [ Time Frame: week 14-16 ]
    • SF12 (Short Form Health Survey) (score)

  51. Health-related quality of life and disability-2 [ Time Frame: week 14-16 ]
    • SHS (Short Health Scale) (score)

  52. Health-related quality of life-2 [ Time Frame: week 14-16 ]
    • SHS (Short Health Scale) (score)

  53. Global assessment-1 [ Time Frame: week 14-16 ]
    • Physician global assessment (0-100 mm VAS)

  54. Global assessment-2 [ Time Frame: week 14-16 ]
    • Patient global assessment (0-100 mm VAS)


Other Outcome Measures:
  1. Exploratory outcome measure - Serious adverse events [ Time Frame: week 14-16 ]
    • Serious adverse events (y/n)

  2. Biological response [ Time Frame: week 14-16 ]
    • CRP (mg/l)


Biospecimen Retention:   Samples With DNA
blood, urine, feces, intestinal biopsies


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
targeted therapy and able to read and understand Danish.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• not mentally able to reply the questionnaire


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173144


Contacts
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Contact: Vibeke Andersen, Prof 004521157790 vandersen@health.sdu.dk
Contact: Robin Christensen, Prof 004538164165 robin.christensen@regionh.dk

Locations
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Denmark
Hospital of Southern Jutland Recruiting
Aabenraa, Denmark, 6200
Contact: Andersen       vibeke.andersen1@rsyd.dk   
Principal Investigator: Vibeke Andersen         
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Nielsen         
Contact       ole.haagen.nielsen@regionh.dk   
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Kjeldsen       Jens.Kjeldsen@rsyd.dk   
Principal Investigator: Kjeldsen         
Principal Investigator: Bugym         
Principal Investigator: Ellingsen         
Sponsors and Collaborators
University of Southern Denmark
Hospital of Southern Jutland
University Hospital Bispebjerg and Frederiksberg
University of Copenhagen
Odense University Hospital
University of Aarhus
Aalborg University Hospital
Herning Hospital
Hospital of South West Jutland
Sygehus Lillebaelt
Aalborg University
University of Kiel
Colitis-Crohn Foreningen
Herlev Hospital
Regionshospitalet Silkeborg
Aarhus University Hospital
The Danish Psoriasis Association
Investigators
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Principal Investigator: Vibeke Andersen, Prof University of Southern Denmark

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vibeke Andersen, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03173144     History of Changes
Other Study ID Numbers: MOK1
733100 ( Other Grant/Funding Number: European Union's Horizon 2020 R.I.P. )
KBF nr. 2016-056 ( Other Grant/Funding Number: Odense Patient data Explorative Network )
2016-11-29 ( Other Grant/Funding Number: Knud og Edith Eriksens Mindefond )
J.nr 16/36626 ( Other Grant/Funding Number: Region of Southern Denmark, University of Southern Denmark )
OCAY-13-309 ( Other Grant/Funding Number: Oak Foundation )
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vibeke Andersen, University of Southern Denmark:
Life Style
Diet
Food
Exercise
Treatment Outcome
Biomarkers
Smoking
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylarthropathies
Crohn Disease
Inflammatory Bowel Diseases
Colitis, Ulcerative
Uveitis
Hidradenitis
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Uveal Diseases
Eye Diseases
Immune System Diseases
Rheumatic Diseases
Connective Tissue Diseases
Sweat Gland Diseases
Skin Diseases, Bacterial
Bacterial Infections