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Thiamine Against Chronic Rheumatoid Arthritis Fatigue
EU CTIS ID: 2022-500922-13-00
What this study is testing
The main objective of this study is to investigate the efficacy of 4 weeks of high dose oral thiamine as treatment for chronic fatigue in patients with rheumatoid arthritis. The primary outcome is a change in fatigue level immediately after 4 weeks of treatment, measured using the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ).
- Phase II and Phase III (Integrated)
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
- Rheumatoid arthritis diagnosed > 3 months ago.
- In remission/mild disease activity (CRP < 10 mg/l, MD-HAQ < 1,3, DAS28 < 3,2)
- Chronic fatigue (duration of fatigue ≥ 6 months, BRAF total fatigue score ≥ 16)
- Age ≥18 years
- Signed informed consent
- Anticontraceptive (People who can get pregnant will need to use a safe anticontraceptive during the trial (12 weeks). Safe anticontraceptive is defined as: combination pills, intrauterine device, depot injection, subdermal implant, hormonal vaginal ring, or transdermal depot patch)
You likely can't join if
- Patients with co-morbidity which can explain the participants fatigue, including: Anaemia (haemoglobin < 7,1 mmol/l [female]; < 8,1 mmol/l [male], Iron deficiency (Ferritin < 30 μg/l), Vitamin B12 deficiency (Vitamin B12 <125 pmol/l), Folate deficiency (Folate < 9 nmol/l), Vitamin D deficiency (25-Hydroxy-Vitamin D[D3+D2] < 50 nmol/l), Diabetes (HbA1c ≥ 48 mmol/mol or medication), Hypo/hyperthyroidism (TSH <0,300 or > 4,5 IU/l or medication)
- Participants who are unable to cooperate and follow the protocol
- Pregnant patients
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.