Chronic Inflammatory Disease, Lifestyle and Treatment Response

NCT03173144 | Completed

• 6 other identifiers: MOK1733100KBF nr. 2016-0562016-11-29J.nr 16/36626OCAY-13-309
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 3

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.

Conditions

Autoimmune Diseases; Inflammatory Bowel Diseases; Crohn Disease (CD); Colitis, Ulcerative (UC); Arthritis, Rheumatoid (RA); Spondylarthropathies; Arthritis, Psoriatic (PsA); Psoriasis; Hidradenitis Suppurativa (HS); Uveitis

Keywords

Life Style; Diet; Food; Exercise; Treatment Outcome; Biomarkers; Smoking

Outcome Measures

Primary Outcomes (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

  week 14-16

Secondary Outcomes (54)

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

  week 14-16

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

  week 14-16

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

  week 14-16

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

  week 14-16

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

  week 14-16

Other Outcomes (2)

• Exploratory outcome measure - Serious adverse events

  week 14-16

• Biological response

  week 14-16

Interventions

Primary exposure variable OTHER

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

Also known as: intake of red and processed meat and fibres

Other (exploratory) exposure variables OTHER

* 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

targeted therapy and able to read and understand Danish.

You may qualify if:

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

You may not qualify if:

• not mentally able to reply the questionnaire

Sponsors & Collaborators

• Aalborg University: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• Sygehus Lillebaelt: collaborator
• University of Southern Denmark: lead
• Hospital of Southern Jutland: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator
• University of Copenhagen: collaborator
• Odense University Hospital: collaborator
• University of Aarhus: collaborator
• Aalborg University Hospital: collaborator
• Herning Hospital: collaborator
• University of Kiel: collaborator
• Colitis-Crohn Foreningen: collaborator
• Herlev Hospital: collaborator
• Regionshospitalet Silkeborg: collaborator
• Aarhus University Hospital: collaborator
• The Danish Psoriasis Association: collaborator

Study Sites (3)

Hospital of Southern Jutland

Aabenraa, 6200, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (4)

• 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.

  PMID: 40545788 DERIVED

• 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.

  PMID: 38973149 DERIVED

• 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.

  PMID: 36313095 DERIVED

• 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.

  PMID: 29439003 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, feces, intestinal biopsies

MeSH Terms

Conditions

Autoimmune Diseases; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Arthritis, Rheumatoid; Spondylarthropathies; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Uveitis; Motor Activity; Smoking

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases; Uveal Diseases; Eye Diseases; Behavior

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vibeke Andersen, Prof

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: June 1, 2017
• Study Start: September 21, 2017
• Primary Completion: July 22, 2020
• Study Completion: April 30, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (3)