BridgeMD
BEAT Fatigue
EU CTIS ID: 2024-519268-41-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with an established diagnose of rheumatoid arthritis
- > 18 years of age
- Able to read and understand Danish and give informed consent
- Score of > 50 mm on a 100 mm visual analogue fatigue scale
- Willingness to ensure effective contraception during the study period.
You likely can't join if
- Patients who by virtue of illiteracy or cognitive impairment are unable to complete the questionnaires.
- Patients treated with doses of prednisone exceeding 10 mg/day.
- TSH abnormalities
- Known allergic reaction to Thiaminhydrochlorid
- Iron deficiency (Ferritin < 15 µg/L)
- Folate acid deficiency (< 9 nmol/L)
See the full eligibility criteria
- Patients with an established diagnose of rheumatoid arthritis
- > 18 years of age
- Able to read and understand Danish and give informed consent
- Score of > 50 mm on a 100 mm visual analogue fatigue scale
- Willingness to ensure effective contraception during the study period.
- Patients who by virtue of illiteracy or cognitive impairment are unable to complete the questionnaires.
- Patients treated with doses of prednisone exceeding 10 mg/day.
- TSH abnormalities
- Known allergic reaction to Thiaminhydrochlorid
- Iron deficiency (Ferritin < 15 µg/L)
- Folate acid deficiency (< 9 nmol/L)
- Vitamin B12 deficiency (cobalamin < 200 ρmol/L)
- Vitamin D deficiency (< 50 nmol/L)
- Pregnant women
- Co-morbidity that can explain high levels of fatigue including cancer, chronic kidney disease, chronic heart failure, diabetes.
- Modification of treatment of the inflammatory rheumatic disease within 3 months.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.