BEAT Fatigue

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05], Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]

Decision date (initial)

2026-06-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective is to compare the effect of High Dose Tiamine (HDT,) relative to placebo, on the change from baseline to 4 weeks in the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional-Questionnaire global (BRAF-MDQ-global) (16), among patients diagnosed with RA suffering from fatigue.

Secondary objectives 5

1. To examine potential differences in the response to HDT treatment across various sections of the BRAF-MDQ (16), which address the impact of fatigue on physical functioning, daily activities, cognitive abilities, and emotional well-being.
2. To explore whether HDT treatment influences the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF-NRS) (17), specifically focusing on the severity (BRAF-NRS Severity), impact (BRAF-NRS Effect), and coping (BRAF-NRS Coping) scales.
3. To evaluate the effect of HDT of Thiamine on core outcome set measures defined by OMERACT (10).
4. To evaluate the proportion of patients achieving a 20%, 50%, and 70% reduction in BRAF-MDQ after 4 weeks of treatment in each group (HDT vs. placebo).
5. To evaluate changes from baseline to week 4 according to the EQ-5D-5L

Conditions and MedDRA coding

Fatigue in rheumatoid arthritis patients

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients with an established diagnose of rheumatoid arthritis
2. > 18 years of age
3. Able to read and understand Danish and give informed consent
4. Score of > 50 mm on a 100 mm visual analogue fatigue scale
5. Willingness to ensure effective contraception during the study period.

Exclusion criteria 11

1. Patients who by virtue of illiteracy or cognitive impairment are unable to complete the questionnaires.
2. Known allergic reaction to Thiaminhydrochlorid
3. Iron deficiency (Ferritin < 15 µg/L)
4. Folate acid deficiency (< 9 nmol/L)
5. Vitamin B12 deficiency (cobalamin < 200 ρmol/L)
6. Vitamin D deficiency (< 50 nmol/L)
7. Pregnant women
8. Co-morbidity that can explain high levels of fatigue including cancer, chronic kidney disease, chronic heart failure, diabetes.
9. Modification of treatment of the inflammatory rheumatic disease within 3 months.
10. Patients treated with doses of prednisone exceeding 10 mg/day.
11. TSH abnormalities

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The difference in least squares mean changes in the BRAF-MDQ global score from baseline to 4 weeks.

Secondary endpoints 5

1. Changes from baseline to week 4 in the specific domains assessed by the BRAF-MDQ including Physical Fatigue, Living Fatigue, Cognitive Fatigue, and Emotional Fatigue
2. Changes in BRAF-NRS Severity scale, BRAF-NRS Effect scale, BRAF-NRS Coping scale from baseline to week 4.
3. Number of (1) swollen out of 28 and (2) tender joints out of 28, (3) pain (assessed through a visual analogue scale [VAS] ranging from 0-100 where higher numbers indicates worse pain), (4) physical disability (assessed by the Health Assessment Questionnaire [HAQ]), (5) patient- and (6) doctors global assessment (assessed through a VAS ranging from 0-100 where higher numbers indicates worse assessment), and finally (7) acute phase reactants will be evaluated based on the C-reactive protein.
4. Proportion of patients achieving a 20%, 50%, and 70% reduction in BRAF-MDQ after 4 weeks of treatment
5. Changes from baseline to week 4 according to the EQ-5D-5L questionnaire

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J B Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

Torkell Ellingsen

Public contact point

Organisation

Odense University Hospital

Contact name

Torkell Ellingsen

Third parties 1

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications